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    Clinical Trial Results:
    A Phase 1/2a Study of BMS-986178 Administered Alone or in Combination with Nivolumab and/or Ipilimumab in Subjects with Advanced Solid Tumors

    Summary
    EudraCT number
    2015-004816-39
    Trial protocol
    ES   NL   IT  
    Global end of trial date
    02 Nov 2020

    Results information
    Results version number
    v1(current)
    This version publication date
    18 Nov 2021
    First version publication date
    18 Nov 2021
    Other versions

    Trial information

    Close Top of page
    Trial identification
    Sponsor protocol code
    CA012-004
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Bristol-Myers Squibb
    Sponsor organisation address
    Chaussée de la Hulpe 185, Brussels, Belgium, 1170
    Public contact
    EU Study Start-Up Unit, Bristol-Myers Squibb International Corporation, Clinical.Trials@bms.com
    Scientific contact
    Bristol-Myers Squibb Study Director, Bristol-Myers Squibb, Clinical.Trials@bms.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    01 Sep 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Nov 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective is to determine the safety, tolerability, dose-limiting toxicities (DLTs), and maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of BMS-986178 administered alone or in combination with nivolumab and/or ipilimumab in subjects with advanced solid tumors.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization Good Clinical Practice Guidelines. All the local regulatory requirements pertinent to safety of trial participants were followed.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    17 Jun 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Canada: 27
    Country: Number of subjects enrolled
    Israel: 2
    Country: Number of subjects enrolled
    United States: 68
    Country: Number of subjects enrolled
    Italy: 2
    Country: Number of subjects enrolled
    Netherlands: 17
    Country: Number of subjects enrolled
    Spain: 50
    Worldwide total number of subjects
    166
    EEA total number of subjects
    69
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    100
    From 65 to 84 years
    66
    85 years and over
    0

    Subject disposition

    Close Top of page
    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    165 participants were randomized and treated in Parts 1-8. 1 Participant was randomized and treated in Part 9 Cohort 1. Parts 2B, 2D, 2E, 3B, 3C, and Part 9 Cohort 2 did not enroll any participants.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Part 1: BMS 20 mg Q2W
    Arm description
    Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 20mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
    Arm type
    Experimental

    Investigational medicinal product name
    BMS-986178
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    20 mg - The administration of the entire bag or syringe (if syringe pump is used) contents should be infused over approximately 30 minutes (including a flush up to 20 mL to completely flush the infusion line), through an IV infusion set

    Arm title
    Part 1: BMS 40 mg Q2W
    Arm description
    Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 40mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
    Arm type
    Experimental

    Investigational medicinal product name
    BMS-986178
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    40 mg - The administration of the entire bag or syringe (if syringe pump is used) contents should be infused over approximately 30 minutes (including a flush up to 20 mL to completely flush the infusion line), through an IV infusion set

    Arm title
    Part 1: BMS 80 mg Q2W
    Arm description
    Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 80mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
    Arm type
    Experimental

    Investigational medicinal product name
    BMS-986178
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    80 mg - The administration of the entire bag or syringe (if syringe pump is used) contents should be infused over approximately 30 minutes (including a flush up to 20 mL to completely flush the infusion line), through an IV infusion set

    Arm title
    Part 1: BMS 160 mg Q2W
    Arm description
    Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 160mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
    Arm type
    Experimental

    Investigational medicinal product name
    BMS-986178
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    160 mg - The administration of the entire bag or syringe (if syringe pump is used) contents should be infused over approximately 30 minutes (including a flush up to 20 mL to completely flush the infusion line), through an IV infusion set

    Arm title
    Part 1: BMS 320 mg Q2W
    Arm description
    Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 320mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
    Arm type
    Experimental

    Investigational medicinal product name
    BMS-986178
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    320 mg - The administration of the entire bag or syringe (if syringe pump is used) contents should be infused over approximately 30 minutes (including a flush up to 20 mL to completely flush the infusion line), through an IV infusion set

    Arm title
    Part 2 BMS 20 mg + Nivo 240 mg Q2W
    Arm description
    Dosing of BMS-986178 20mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
    Arm type
    Experimental

    Investigational medicinal product name
    BMS-986178
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    20 mg - The administration of the entire bag or syringe (if syringe pump is used) contents should be infused over approximately 30 minutes (including a flush up to 20 mL to completely flush the infusion line), through an IV infusion set

    Investigational medicinal product name
    Nivolumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    240 mg - Administered as a flat dose

    Arm title
    Part 2: BMS 40 mg + Nivo 240 mg Q2W
    Arm description
    Dosing of BMS-986178 40mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
    Arm type
    Experimental

    Investigational medicinal product name
    Nivolumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    240 mg - Administered as a flat dose

    Investigational medicinal product name
    BMS-986178
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    40 mg - The administration of the entire bag or syringe (if syringe pump is used) contents should be infused over approximately 30 minutes (including a flush up to 20 mL to completely flush the infusion line), through an IV infusion set

    Arm title
    Part 2: BMS 80 mg + Nivo 240 mg Q2W
    Arm description
    Dosing of BMS-986178 80mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
    Arm type
    Experimental

    Investigational medicinal product name
    Nivolumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    240 mg - Administered as a flat dose

    Investigational medicinal product name
    BMS-986178
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    80 mg - The administration of the entire bag or syringe (if syringe pump is used) contents should be infused over approximately 30 minutes (including a flush up to 20 mL to completely flush the infusion line), through an IV infusion set

    Arm title
    Part 2: BMS 160 mg + Nivo 240 mg Q2W
    Arm description
    Dosing of BMS-986178 160mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
    Arm type
    Experimental

    Investigational medicinal product name
    BMS-986178
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    160 mg - The administration of the entire bag or syringe (if syringe pump is used) contents should be infused over approximately 30 minutes (including a flush up to 20 mL to completely flush the infusion line), through an IV infusion set

    Investigational medicinal product name
    Nivolumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    240 mg - Administered as a flat dose

    Arm title
    Part 2: BMS 320 mg + Nivo 240 mg Q2W
    Arm description
    Dosing of BMS-986178 320mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
    Arm type
    Experimental

    Investigational medicinal product name
    Nivolumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    240 mg - Administered as a flat dose

    Investigational medicinal product name
    BMS-986178
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    320 mg - The administration of the entire bag or syringe (if syringe pump is used) contents should be infused over approximately 30 minutes (including a flush up to 20 mL to completely flush the infusion line), through an IV infusion set

    Arm title
    Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W
    Arm description
    Each treatment cycle will be 3 weeks in length. BMS-986178 20mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
    Arm type
    Experimental

    Investigational medicinal product name
    BMS-986178
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    20 mg - The administration of the entire bag or syringe (if syringe pump is used) contents should be infused over approximately 30 minutes (including a flush up to 20 mL to completely flush the infusion line), through an IV infusion set

    Investigational medicinal product name
    Ipilimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    1 mg/kg

    Arm title
    Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W
    Arm description
    Each treatment cycle will be 3 weeks in length. BMS-986178 40mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
    Arm type
    Experimental

    Investigational medicinal product name
    BMS-986178
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    40 mg - The administration of the entire bag or syringe (if syringe pump is used) contents should be infused over approximately 30 minutes (including a flush up to 20 mL to completely flush the infusion line), through an IV infusion set

    Investigational medicinal product name
    Ipilimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    1 mg/kg

    Arm title
    Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W
    Arm description
    Each treatment cycle will be 3 weeks in length. BMS-986178 80mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
    Arm type
    Experimental

    Investigational medicinal product name
    BMS-986178
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    80 mg - The administration of the entire bag or syringe (if syringe pump is used) contents should be infused over approximately 30 minutes (including a flush up to 20 mL to completely flush the infusion line), through an IV infusion set

    Investigational medicinal product name
    Ipilimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    1 mg/kg

    Arm title
    Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W
    Arm description
    Each treatment cycle will be 3 weeks in length. BMS-986178 160mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
    Arm type
    Experimental

    Investigational medicinal product name
    Ipilimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    1 mg/kg

    Investigational medicinal product name
    BMS-986178
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    160 mg - The administration of the entire bag or syringe (if syringe pump is used) contents should be infused over approximately 30 minutes (including a flush up to 20 mL to completely flush the infusion line), through an IV infusion set

    Arm title
    Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W
    Arm description
    Each treatment cycle will be 3 weeks in length. BMS-986178 320mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
    Arm type
    Experimental

    Investigational medicinal product name
    Ipilimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    1 mg/kg

    Investigational medicinal product name
    BMS-986178
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    320 mg - The administration of the entire bag or syringe (if syringe pump is used) contents should be infused over approximately 30 minutes (including a flush up to 20 mL to completely flush the infusion line), through an IV infusion set

    Arm title
    Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC)
    Arm description
    Participants with bladder cancer receive BMS-986178 (80 mg) and Nivolumab administered at a flat dose of 240 mg. Each treatment cycle will be 2 weeks in length and study drugs will be administered every 2 weeks starting on Day 1 of each cycle for up to 12 cycles.
    Arm type
    Experimental

    Investigational medicinal product name
    Nivolumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    240 mg - Administered as a flat dose

    Investigational medicinal product name
    BMS-986178
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    80 mg - The administration of the entire bag or syringe (if syringe pump is used) contents should be infused over approximately 30 minutes (including a flush up to 20 mL to completely flush the infusion line), through an IV infusion set

    Arm title
    Part 4: BMS 80 mg + Nivo 480mg Q4W
    Arm description
    Combination arm of BMS-986178 (80 mg) with nivolumab (480 mg) to be administered every 4 weeks (q4w).
    Arm type
    Experimental

    Investigational medicinal product name
    BMS-986178
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    80 mg - The administration of the entire bag or syringe (if syringe pump is used) contents should be infused over approximately 30 minutes (including a flush up to 20 mL to completely flush the infusion line), through an IV infusion set

    Investigational medicinal product name
    Nivolumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    480 mg - Administered as a flat dose

    Arm title
    Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W
    Arm description
    Combination arm of BMS-986178 (80 mg) with Ipilimumab 3 mg/kg administered every 3 weeks (q3w) for 4 doses, followed by monotherapy with BMS-986178 (maintenance therapy).
    Arm type
    Experimental

    Investigational medicinal product name
    Ipilimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    3 mg/kg

    Investigational medicinal product name
    BMS-986178
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    80 mg - The administration of the entire bag or syringe (if syringe pump is used) contents should be infused over approximately 30 minutes (including a flush up to 20 mL to completely flush the infusion line), through an IV infusion set

    Arm title
    Part 6A:BMS40mg+Nivo 240mg+Ipi 1mg/kgQ3W/BMS 40mg+Nivo480mgQ4W
    Arm description
    Participants with renal cell carcinoma (RCC) recieve BMS-986178 (40mg) administered at a flat dose in combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4, followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 (40 mg) and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
    Arm type
    Experimental

    Investigational medicinal product name
    BMS-986178
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    40 mg - The administration of the entire bag or syringe (if syringe pump is used) contents should be infused over approximately 30 minutes (including a flush up to 20 mL to completely flush the infusion line), through an IV infusion set

    Investigational medicinal product name
    Ipilimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    1 mg/kg

    Investigational medicinal product name
    Nivolumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    240 mg - Administered as a flat dose

    Arm title
    Part6B:BMS40mg+Nivo240 mg+Ipi1mg/kgQ3W/BMS 40 mg+Nivo480 mgQ4W
    Arm description
    Participants with renal cell carcinoma (RCC) receive BMS-986178 (40mg) administered combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4 followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
    Arm type
    Experimental

    Investigational medicinal product name
    Ipilimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    1 mg/kg

    Investigational medicinal product name
    BMS-986178
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    40 mg - The administration of the entire bag or syringe (if syringe pump is used) contents should be infused over approximately 30 minutes (including a flush up to 20 mL to completely flush the infusion line), through an IV infusion set

    Arm title
    Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W
    Arm description
    BMS-986178 will be administered at a flat dose of 40 mg (q2w) in combination with nivolumab (240 mg; q2w) and ipilimumab (1 mg/kg; q6w) for four 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle. If participants continue for additional cycles, past cycle 4, all study drugs (BMS-986178/nivolumab/ipilimumab) will continue for all cycles.
    Arm type
    Experimental

    Investigational medicinal product name
    BMS-986178
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    40 mg - The administration of the entire bag or syringe (if syringe pump is used) contents should be infused over approximately 30 minutes (including a flush up to 20 mL to completely flush the infusion line), through an IV infusion set

    Investigational medicinal product name
    Ipilimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    1 mg/kg

    Investigational medicinal product name
    Nivolumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    240 mg - Administered as a flat dose

    Arm title
    Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W
    Arm description
    Participants with non-small cell lung cancer (NSCLC) receive BMS-986178 (40 mg) in combination with nivolumab 240 mg every 2 weeks (q2w) and ipilimumab 1 mg/kg every 6 weeks (q6w) for four, 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle.
    Arm type
    Experimental

    Investigational medicinal product name
    BMS-986178
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    40 mg - The administration of the entire bag or syringe (if syringe pump is used) contents should be infused over approximately 30 minutes (including a flush up to 20 mL to completely flush the infusion line), through an IV infusion set

    Investigational medicinal product name
    Nivolumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    240 mg - Administered as a flat dose

    Investigational medicinal product name
    Nivolumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    240 mg - Administered as a flat dose

    Investigational medicinal product name
    Ipilimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    1 mg/kg

    Arm title
    Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W
    Arm description
    BMS-986178 (20 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
    Arm type
    Experimental

    Investigational medicinal product name
    BMS-986178
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    20 mg - The administration of the entire bag or syringe (if syringe pump is used) contents should be infused over approximately 30 minutes (including a flush up to 20 mL to completely flush the infusion line), through an IV infusion set

    Investigational medicinal product name
    Nivolumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    480 mg - Administered as a flat dose

    Investigational medicinal product name
    Tetanus vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    Tdap preferred, Td or equivalent administered first on Cycle 1 Day 1 prior to administration of other study treatments

    Arm title
    Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W
    Arm description
    BMS-986178 (40 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
    Arm type
    Experimental

    Investigational medicinal product name
    BMS-986178
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    40 mg - The administration of the entire bag or syringe (if syringe pump is used) contents should be infused over approximately 30 minutes (including a flush up to 20 mL to completely flush the infusion line), through an IV infusion set

    Investigational medicinal product name
    Nivolumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    480 mg - Administered as a flat dose

    Investigational medicinal product name
    Tetanus vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    Tdap preferred, Td or equivalent administered first on Cycle 1 Day 1 prior to administration of other study treatments

    Arm title
    Part 8: Cohort 3- BMS 80 mg Q12W + Nivo 480 mg Q4W
    Arm description
    BMS-986178 (80 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
    Arm type
    Experimental

    Investigational medicinal product name
    BMS-986178
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    80 mg - The administration of the entire bag or syringe (if syringe pump is used) contents should be infused over approximately 30 minutes (including a flush up to 20 mL to completely flush the infusion line), through an IV infusion set

    Investigational medicinal product name
    Tetanus vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    Tdap preferred, Td or equivalent administered first on Cycle 1 Day 1 prior to administration of other study treatments

    Investigational medicinal product name
    Nivolumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    480 mg - Administered as a flat dose

    Arm title
    Part 8: Cohort 4- Nivo 480 mg Q4W
    Arm description
    Nivolumab monotherapy will be administered as a flat dose of 480 mg every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length and will be dosed for up to 9 cycles, 24 months of dosing. Treatment will be given on Day 1, Day 29 and 57 of each cycle. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab monotherapy.
    Arm type
    Experimental

    Investigational medicinal product name
    Tetanus vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    Tdap preferred, Td or equivalent administered first on Cycle 1 Day 1 prior to administration of other study treatments

    Investigational medicinal product name
    Nivolumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    480 mg - Administered as a flat dose

    Arm title
    Part 9: BMS 40 mg Q4W + Nivo 480 mg Q4W + DRibble Vaccine
    Arm description
    Cohort 1: Cyclophosphamide 300 mg/m2 was administered 3 days prior to C1D1. DPV-001 1 mg was given on C1D1 intranodal then intradermal on C1D8, C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C9D1 and C12D1. Nivolumab 240 mg was administered on C1D15 followed by nivolumab 480 mg was Q4W on day 1 of cycles 2-26. BMS-986178 40 mg infusion was administered on day 1 of cycles 1-6, 9, and 12. Each treatment cycle is 4 weeks and there are up to 26 cycles.
    Arm type
    Experimental

    Investigational medicinal product name
    BMS-986178
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    40 mg - The administration of the entire bag or syringe (if syringe pump is used) contents should be infused over approximately 30 minutes (including a flush up to 20 mL to completely flush the infusion line), through an IV infusion set

    Investigational medicinal product name
    Nivolumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    480 mg - Administered as a flat dose

    Investigational medicinal product name
    DPV-001 (UbiLT3 and UbiLT6)
    Investigational medicinal product code
    Other name
    DRibbles Vaccine
    Pharmaceutical forms
    Injection
    Routes of administration
    Other use
    Dosage and administration details
    0.5 mL UbiLT3 into 1 lymph node and 0.5 mL of UbiLT6 into another lymph node - administered intranodal under ultrasound guidance.

    Investigational medicinal product name
    DPV-001 (UbiLT3 and UbiLT6)
    Investigational medicinal product code
    Other name
    DRibbles Vaccine
    Pharmaceutical forms
    Injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    1 mg - can alternate between either UbiLT3 or UbiLT6

    Number of subjects in period 1
    Part 1: BMS 20 mg Q2W Part 1: BMS 40 mg Q2W Part 1: BMS 80 mg Q2W Part 1: BMS 160 mg Q2W Part 1: BMS 320 mg Q2W Part 2 BMS 20 mg + Nivo 240 mg Q2W Part 2: BMS 40 mg + Nivo 240 mg Q2W Part 2: BMS 80 mg + Nivo 240 mg Q2W Part 2: BMS 160 mg + Nivo 240 mg Q2W Part 2: BMS 320 mg + Nivo 240 mg Q2W Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC) Part 4: BMS 80 mg + Nivo 480mg Q4W Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W Part 6A:BMS40mg+Nivo 240mg+Ipi 1mg/kgQ3W/BMS 40mg+Nivo480mgQ4W Part6B:BMS40mg+Nivo240 mg+Ipi1mg/kgQ3W/BMS 40 mg+Nivo480 mgQ4W Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W Part 8: Cohort 3- BMS 80 mg Q12W + Nivo 480 mg Q4W Part 8: Cohort 4- Nivo 480 mg Q4W Part 9: BMS 40 mg Q4W + Nivo 480 mg Q4W + DRibble Vaccine
    Started
    4
    4
    4
    4
    4
    7
    8
    12
    8
    8
    4
    10
    7
    8
    6
    18
    12
    6
    7
    1
    6
    9
    2
    2
    2
    2
    1
    Completed
    3
    4
    4
    3
    3
    4
    8
    10
    7
    8
    3
    6
    5
    6
    5
    15
    10
    2
    5
    1
    4
    8
    2
    1
    1
    1
    0
    Not completed
    1
    0
    0
    1
    1
    3
    0
    2
    1
    0
    1
    4
    2
    2
    1
    3
    2
    4
    2
    0
    2
    1
    0
    1
    1
    1
    1
         Adverse event, serious fatal
    1
    -
    -
    1
    -
    -
    -
    2
    -
    -
    -
    4
    2
    2
    -
    2
    2
    2
    1
    -
    -
    -
    -
    -
    -
    -
    -
         Participant withdrew consent
    -
    -
    -
    -
    -
    2
    -
    -
    -
    -
    -
    -
    -
    -
    1
    -
    -
    2
    1
    -
    2
    -
    -
    -
    -
    -
    -
         Other reasons
    -
    -
    -
    -
    1
    1
    -
    -
    1
    -
    1
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    1
    -
    1
    1
    1
    -
         Lost to follow-up
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    1
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
         Disease Progression
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    1

    Baseline characteristics

    Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Part 1: BMS 20 mg Q2W
    Reporting group description
    Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 20mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.

    Reporting group title
    Part 1: BMS 40 mg Q2W
    Reporting group description
    Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 40mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.

    Reporting group title
    Part 1: BMS 80 mg Q2W
    Reporting group description
    Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 80mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.

    Reporting group title
    Part 1: BMS 160 mg Q2W
    Reporting group description
    Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 160mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.

    Reporting group title
    Part 1: BMS 320 mg Q2W
    Reporting group description
    Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 320mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.

    Reporting group title
    Part 2 BMS 20 mg + Nivo 240 mg Q2W
    Reporting group description
    Dosing of BMS-986178 20mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.

    Reporting group title
    Part 2: BMS 40 mg + Nivo 240 mg Q2W
    Reporting group description
    Dosing of BMS-986178 40mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.

    Reporting group title
    Part 2: BMS 80 mg + Nivo 240 mg Q2W
    Reporting group description
    Dosing of BMS-986178 80mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.

    Reporting group title
    Part 2: BMS 160 mg + Nivo 240 mg Q2W
    Reporting group description
    Dosing of BMS-986178 160mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.

    Reporting group title
    Part 2: BMS 320 mg + Nivo 240 mg Q2W
    Reporting group description
    Dosing of BMS-986178 320mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.

    Reporting group title
    Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W
    Reporting group description
    Each treatment cycle will be 3 weeks in length. BMS-986178 20mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.

    Reporting group title
    Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W
    Reporting group description
    Each treatment cycle will be 3 weeks in length. BMS-986178 40mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.

    Reporting group title
    Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W
    Reporting group description
    Each treatment cycle will be 3 weeks in length. BMS-986178 80mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.

    Reporting group title
    Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W
    Reporting group description
    Each treatment cycle will be 3 weeks in length. BMS-986178 160mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.

    Reporting group title
    Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W
    Reporting group description
    Each treatment cycle will be 3 weeks in length. BMS-986178 320mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.

    Reporting group title
    Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC)
    Reporting group description
    Participants with bladder cancer receive BMS-986178 (80 mg) and Nivolumab administered at a flat dose of 240 mg. Each treatment cycle will be 2 weeks in length and study drugs will be administered every 2 weeks starting on Day 1 of each cycle for up to 12 cycles.

    Reporting group title
    Part 4: BMS 80 mg + Nivo 480mg Q4W
    Reporting group description
    Combination arm of BMS-986178 (80 mg) with nivolumab (480 mg) to be administered every 4 weeks (q4w).

    Reporting group title
    Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W
    Reporting group description
    Combination arm of BMS-986178 (80 mg) with Ipilimumab 3 mg/kg administered every 3 weeks (q3w) for 4 doses, followed by monotherapy with BMS-986178 (maintenance therapy).

    Reporting group title
    Part 6A:BMS40mg+Nivo 240mg+Ipi 1mg/kgQ3W/BMS 40mg+Nivo480mgQ4W
    Reporting group description
    Participants with renal cell carcinoma (RCC) recieve BMS-986178 (40mg) administered at a flat dose in combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4, followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 (40 mg) and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.

    Reporting group title
    Part6B:BMS40mg+Nivo240 mg+Ipi1mg/kgQ3W/BMS 40 mg+Nivo480 mgQ4W
    Reporting group description
    Participants with renal cell carcinoma (RCC) receive BMS-986178 (40mg) administered combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4 followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.

    Reporting group title
    Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W
    Reporting group description
    BMS-986178 will be administered at a flat dose of 40 mg (q2w) in combination with nivolumab (240 mg; q2w) and ipilimumab (1 mg/kg; q6w) for four 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle. If participants continue for additional cycles, past cycle 4, all study drugs (BMS-986178/nivolumab/ipilimumab) will continue for all cycles.

    Reporting group title
    Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W
    Reporting group description
    Participants with non-small cell lung cancer (NSCLC) receive BMS-986178 (40 mg) in combination with nivolumab 240 mg every 2 weeks (q2w) and ipilimumab 1 mg/kg every 6 weeks (q6w) for four, 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle.

    Reporting group title
    Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W
    Reporting group description
    BMS-986178 (20 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.

    Reporting group title
    Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W
    Reporting group description
    BMS-986178 (40 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.

    Reporting group title
    Part 8: Cohort 3- BMS 80 mg Q12W + Nivo 480 mg Q4W
    Reporting group description
    BMS-986178 (80 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.

    Reporting group title
    Part 8: Cohort 4- Nivo 480 mg Q4W
    Reporting group description
    Nivolumab monotherapy will be administered as a flat dose of 480 mg every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length and will be dosed for up to 9 cycles, 24 months of dosing. Treatment will be given on Day 1, Day 29 and 57 of each cycle. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab monotherapy.

    Reporting group title
    Part 9: BMS 40 mg Q4W + Nivo 480 mg Q4W + DRibble Vaccine
    Reporting group description
    Cohort 1: Cyclophosphamide 300 mg/m2 was administered 3 days prior to C1D1. DPV-001 1 mg was given on C1D1 intranodal then intradermal on C1D8, C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C9D1 and C12D1. Nivolumab 240 mg was administered on C1D15 followed by nivolumab 480 mg was Q4W on day 1 of cycles 2-26. BMS-986178 40 mg infusion was administered on day 1 of cycles 1-6, 9, and 12. Each treatment cycle is 4 weeks and there are up to 26 cycles.

    Reporting group values
    Part 1: BMS 20 mg Q2W Part 1: BMS 40 mg Q2W Part 1: BMS 80 mg Q2W Part 1: BMS 160 mg Q2W Part 1: BMS 320 mg Q2W Part 2 BMS 20 mg + Nivo 240 mg Q2W Part 2: BMS 40 mg + Nivo 240 mg Q2W Part 2: BMS 80 mg + Nivo 240 mg Q2W Part 2: BMS 160 mg + Nivo 240 mg Q2W Part 2: BMS 320 mg + Nivo 240 mg Q2W Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC) Part 4: BMS 80 mg + Nivo 480mg Q4W Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W Part 6A:BMS40mg+Nivo 240mg+Ipi 1mg/kgQ3W/BMS 40mg+Nivo480mgQ4W Part6B:BMS40mg+Nivo240 mg+Ipi1mg/kgQ3W/BMS 40 mg+Nivo480 mgQ4W Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W Part 8: Cohort 3- BMS 80 mg Q12W + Nivo 480 mg Q4W Part 8: Cohort 4- Nivo 480 mg Q4W Part 9: BMS 40 mg Q4W + Nivo 480 mg Q4W + DRibble Vaccine Total
    Number of subjects
    4 4 4 4 4 7 8 12 8 8 4 10 7 8 6 18 12 6 7 1 6 9 2 2 2 2 1 166
    Age Categorical
    Units: Participants
        <=18 years
    0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
        Between 18 and 65 years
    4 1 2 1 3 5 3 10 5 5 3 7 4 7 4 8 8 5 7 0 2 2 2 1 0 0 1 100
        >=65 years
    0 3 2 3 1 2 5 2 3 3 1 3 3 1 2 10 4 1 0 1 4 7 0 1 2 2 0 66
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    43.5 ( 16.8 ) 68.5 ( 10.8 ) 53.5 ( 18.9 ) 60.0 ( 16.2 ) 55.0 ( 14.0 ) 58.4 ( 6.8 ) 66.8 ( 10.2 ) 55.0 ( 10.3 ) 59.1 ( 12.3 ) 61.1 ( 7.3 ) 56.5 ( 13.2 ) 59.5 ( 8.7 ) 60.3 ( 12.7 ) 47.4 ( 13.7 ) 56.7 ( 10.8 ) 65.8 ( 7.7 ) 56.8 ( 11.1 ) 54.3 ( 15.6 ) 52.0 ( 12.2 ) 71.0 ( 99999 ) 65.3 ( 7.9 ) 69.7 ( 8.3 ) 62.0 ( 2.8 ) 66.5 ( 7.8 ) 71.0 ( 5.7 ) 75.0 ( 5.7 ) 51.0 ( 99999 ) -
    Sex: Female, Male
    Units: Participants
        Female
    1 1 3 1 1 3 6 3 6 2 3 5 4 7 2 1 8 3 2 0 2 0 0 1 1 0 1 67
        Male
    3 3 1 3 3 4 2 9 2 6 1 5 3 1 4 17 4 3 5 1 4 9 2 1 1 2 0 99
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 1
        Asian
    0 1 0 0 0 1 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 4
        Native Hawaiian or Other Pacific Islander
    0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
        Black or African American
    1 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 1 0 0 0 0 0 0 4
        White
    2 3 4 4 3 6 8 12 8 8 4 8 7 7 6 18 11 6 7 1 5 8 2 2 2 2 1 155
        More than one race
    0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
        Unknown or Not Reported
    1 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 2
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    1 0 0 0 0 1 0 1 0 0 0 0 2 0 0 0 0 0 1 0 0 0 0 0 0 0 0 6
        Not Hispanic or Latino
    3 4 4 3 2 6 6 5 3 3 2 7 4 4 5 6 5 3 0 1 4 3 1 2 1 1 1 89
        Unknown or Not Reported
    0 0 0 1 2 0 2 6 5 5 2 3 1 4 1 12 7 3 6 0 2 6 1 0 1 1 0 71

    End points

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    End points reporting groups
    Reporting group title
    Part 1: BMS 20 mg Q2W
    Reporting group description
    Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 20mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.

    Reporting group title
    Part 1: BMS 40 mg Q2W
    Reporting group description
    Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 40mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.

    Reporting group title
    Part 1: BMS 80 mg Q2W
    Reporting group description
    Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 80mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.

    Reporting group title
    Part 1: BMS 160 mg Q2W
    Reporting group description
    Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 160mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.

    Reporting group title
    Part 1: BMS 320 mg Q2W
    Reporting group description
    Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 320mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.

    Reporting group title
    Part 2 BMS 20 mg + Nivo 240 mg Q2W
    Reporting group description
    Dosing of BMS-986178 20mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.

    Reporting group title
    Part 2: BMS 40 mg + Nivo 240 mg Q2W
    Reporting group description
    Dosing of BMS-986178 40mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.

    Reporting group title
    Part 2: BMS 80 mg + Nivo 240 mg Q2W
    Reporting group description
    Dosing of BMS-986178 80mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.

    Reporting group title
    Part 2: BMS 160 mg + Nivo 240 mg Q2W
    Reporting group description
    Dosing of BMS-986178 160mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.

    Reporting group title
    Part 2: BMS 320 mg + Nivo 240 mg Q2W
    Reporting group description
    Dosing of BMS-986178 320mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.

    Reporting group title
    Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W
    Reporting group description
    Each treatment cycle will be 3 weeks in length. BMS-986178 20mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.

    Reporting group title
    Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W
    Reporting group description
    Each treatment cycle will be 3 weeks in length. BMS-986178 40mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.

    Reporting group title
    Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W
    Reporting group description
    Each treatment cycle will be 3 weeks in length. BMS-986178 80mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.

    Reporting group title
    Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W
    Reporting group description
    Each treatment cycle will be 3 weeks in length. BMS-986178 160mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.

    Reporting group title
    Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W
    Reporting group description
    Each treatment cycle will be 3 weeks in length. BMS-986178 320mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.

    Reporting group title
    Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC)
    Reporting group description
    Participants with bladder cancer receive BMS-986178 (80 mg) and Nivolumab administered at a flat dose of 240 mg. Each treatment cycle will be 2 weeks in length and study drugs will be administered every 2 weeks starting on Day 1 of each cycle for up to 12 cycles.

    Reporting group title
    Part 4: BMS 80 mg + Nivo 480mg Q4W
    Reporting group description
    Combination arm of BMS-986178 (80 mg) with nivolumab (480 mg) to be administered every 4 weeks (q4w).

    Reporting group title
    Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W
    Reporting group description
    Combination arm of BMS-986178 (80 mg) with Ipilimumab 3 mg/kg administered every 3 weeks (q3w) for 4 doses, followed by monotherapy with BMS-986178 (maintenance therapy).

    Reporting group title
    Part 6A:BMS40mg+Nivo 240mg+Ipi 1mg/kgQ3W/BMS 40mg+Nivo480mgQ4W
    Reporting group description
    Participants with renal cell carcinoma (RCC) recieve BMS-986178 (40mg) administered at a flat dose in combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4, followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 (40 mg) and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.

    Reporting group title
    Part6B:BMS40mg+Nivo240 mg+Ipi1mg/kgQ3W/BMS 40 mg+Nivo480 mgQ4W
    Reporting group description
    Participants with renal cell carcinoma (RCC) receive BMS-986178 (40mg) administered combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4 followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.

    Reporting group title
    Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W
    Reporting group description
    BMS-986178 will be administered at a flat dose of 40 mg (q2w) in combination with nivolumab (240 mg; q2w) and ipilimumab (1 mg/kg; q6w) for four 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle. If participants continue for additional cycles, past cycle 4, all study drugs (BMS-986178/nivolumab/ipilimumab) will continue for all cycles.

    Reporting group title
    Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W
    Reporting group description
    Participants with non-small cell lung cancer (NSCLC) receive BMS-986178 (40 mg) in combination with nivolumab 240 mg every 2 weeks (q2w) and ipilimumab 1 mg/kg every 6 weeks (q6w) for four, 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle.

    Reporting group title
    Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W
    Reporting group description
    BMS-986178 (20 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.

    Reporting group title
    Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W
    Reporting group description
    BMS-986178 (40 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.

    Reporting group title
    Part 8: Cohort 3- BMS 80 mg Q12W + Nivo 480 mg Q4W
    Reporting group description
    BMS-986178 (80 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.

    Reporting group title
    Part 8: Cohort 4- Nivo 480 mg Q4W
    Reporting group description
    Nivolumab monotherapy will be administered as a flat dose of 480 mg every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length and will be dosed for up to 9 cycles, 24 months of dosing. Treatment will be given on Day 1, Day 29 and 57 of each cycle. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab monotherapy.

    Reporting group title
    Part 9: BMS 40 mg Q4W + Nivo 480 mg Q4W + DRibble Vaccine
    Reporting group description
    Cohort 1: Cyclophosphamide 300 mg/m2 was administered 3 days prior to C1D1. DPV-001 1 mg was given on C1D1 intranodal then intradermal on C1D8, C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C9D1 and C12D1. Nivolumab 240 mg was administered on C1D15 followed by nivolumab 480 mg was Q4W on day 1 of cycles 2-26. BMS-986178 40 mg infusion was administered on day 1 of cycles 1-6, 9, and 12. Each treatment cycle is 4 weeks and there are up to 26 cycles.

    Primary: The number of Participants Experiencing Adverse Events (AEs)

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    End point title
    The number of Participants Experiencing Adverse Events (AEs) [1]
    End point description
    The number of participants experiencing adverse events (AEs) to assess the overall safety and tolerability of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab in participants with advanced solid tumors. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment.
    End point type
    Primary
    End point timeframe
    From first dose to 100 days after last dose (up to approximately 2.5 years)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only summary statistics were planned for these endpoints
    End point values
    Part 1: BMS 20 mg Q2W Part 1: BMS 40 mg Q2W Part 1: BMS 80 mg Q2W Part 1: BMS 160 mg Q2W Part 1: BMS 320 mg Q2W Part 2 BMS 20 mg + Nivo 240 mg Q2W Part 2: BMS 40 mg + Nivo 240 mg Q2W Part 2: BMS 80 mg + Nivo 240 mg Q2W Part 2: BMS 160 mg + Nivo 240 mg Q2W Part 2: BMS 320 mg + Nivo 240 mg Q2W Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC) Part 4: BMS 80 mg + Nivo 480mg Q4W Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W Part 6A:BMS40mg+Nivo 240mg+Ipi 1mg/kgQ3W/BMS 40mg+Nivo480mgQ4W Part6B:BMS40mg+Nivo240 mg+Ipi1mg/kgQ3W/BMS 40 mg+Nivo480 mgQ4W Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W Part 8: Cohort 3- BMS 80 mg Q12W + Nivo 480 mg Q4W Part 8: Cohort 4- Nivo 480 mg Q4W Part 9: BMS 40 mg Q4W + Nivo 480 mg Q4W + DRibble Vaccine
    Number of subjects analysed
    4
    4
    4
    4
    4
    7
    8
    12
    8
    8
    4
    10
    7
    8
    6
    18
    12
    6
    7
    1
    6
    9
    2
    2
    2
    2
    1
    Units: Participants
    4
    4
    4
    3
    4
    7
    8
    12
    7
    8
    4
    10
    7
    8
    6
    18
    12
    6
    6
    1
    6
    9
    2
    2
    2
    2
    1
    No statistical analyses for this end point

    Primary: The Number of Participants Experiencing Serious Adverse Events (SAEs)

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    End point title
    The Number of Participants Experiencing Serious Adverse Events (SAEs) [2]
    End point description
    The number of participants experiencing serious adverse events (SAEs) to assess the overall safety and tolerability of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab in participants with advanced solid tumors. A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, and/or is an important medical event.
    End point type
    Primary
    End point timeframe
    From first dose to 100 days after last dose (up to approximately 2.5 years)
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only summary statistics were planned for these endpoints
    End point values
    Part 1: BMS 20 mg Q2W Part 1: BMS 40 mg Q2W Part 1: BMS 80 mg Q2W Part 1: BMS 160 mg Q2W Part 1: BMS 320 mg Q2W Part 2 BMS 20 mg + Nivo 240 mg Q2W Part 2: BMS 40 mg + Nivo 240 mg Q2W Part 2: BMS 80 mg + Nivo 240 mg Q2W Part 2: BMS 160 mg + Nivo 240 mg Q2W Part 2: BMS 320 mg + Nivo 240 mg Q2W Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC) Part 4: BMS 80 mg + Nivo 480mg Q4W Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W Part 6A:BMS40mg+Nivo 240mg+Ipi 1mg/kgQ3W/BMS 40mg+Nivo480mgQ4W Part6B:BMS40mg+Nivo240 mg+Ipi1mg/kgQ3W/BMS 40 mg+Nivo480 mgQ4W Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W Part 8: Cohort 3- BMS 80 mg Q12W + Nivo 480 mg Q4W Part 8: Cohort 4- Nivo 480 mg Q4W Part 9: BMS 40 mg Q4W + Nivo 480 mg Q4W + DRibble Vaccine
    Number of subjects analysed
    4
    4
    4
    4
    4
    7
    8
    12
    8
    8
    4
    10
    7
    8
    6
    18
    12
    6
    7
    1
    6
    9
    2
    2
    2
    2
    1
    Units: Participants
    3
    4
    2
    3
    3
    3
    6
    7
    4
    5
    2
    6
    6
    5
    2
    11
    7
    4
    4
    1
    6
    5
    0
    1
    1
    1
    1
    No statistical analyses for this end point

    Primary: The Number of Participants with Clinical Laboratory Test Abnormalities (Hematology)

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    End point title
    The Number of Participants with Clinical Laboratory Test Abnormalities (Hematology) [3]
    End point description
    The number of participants with clinical laboratory test abnormalities to assess the overall safety and tolerability of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab in participants with advanced solid tumors. Baseline is defined as the last non-missing measurement prior to the first dosing date and time
    End point type
    Primary
    End point timeframe
    From baseline to 100 days after last dose (up to approximately 2.5 years)
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only summary statistics were planned for these endpoints
    End point values
    Part 1: BMS 20 mg Q2W Part 1: BMS 40 mg Q2W Part 1: BMS 80 mg Q2W Part 1: BMS 160 mg Q2W Part 1: BMS 320 mg Q2W Part 2 BMS 20 mg + Nivo 240 mg Q2W Part 2: BMS 40 mg + Nivo 240 mg Q2W Part 2: BMS 80 mg + Nivo 240 mg Q2W Part 2: BMS 160 mg + Nivo 240 mg Q2W Part 2: BMS 320 mg + Nivo 240 mg Q2W Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC) Part 4: BMS 80 mg + Nivo 480mg Q4W Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W Part 6A:BMS40mg+Nivo 240mg+Ipi 1mg/kgQ3W/BMS 40mg+Nivo480mgQ4W Part6B:BMS40mg+Nivo240 mg+Ipi1mg/kgQ3W/BMS 40 mg+Nivo480 mgQ4W Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W Part 8: Cohort 3- BMS 80 mg Q12W + Nivo 480 mg Q4W Part 8: Cohort 4- Nivo 480 mg Q4W Part 9: BMS 40 mg Q4W + Nivo 480 mg Q4W + DRibble Vaccine
    Number of subjects analysed
    4
    4
    4
    4
    4
    7
    8
    12
    8
    8
    4
    10
    7
    8
    6
    18
    12
    6
    7
    1
    6
    9
    2
    2
    2
    2
    1
    Units: Participants
        HEMOGLOBIN GRADE 1
    2
    0
    4
    1
    2
    1
    4
    3
    3
    6
    3
    4
    2
    5
    1
    9
    4
    1
    3
    1
    2
    7
    1
    1
    1
    1
    1
        HEMOGLOBIN GRADE 2
    1
    2
    0
    2
    1
    4
    2
    5
    2
    0
    1
    6
    3
    1
    4
    6
    5
    2
    2
    0
    2
    2
    1
    0
    1
    0
    0
        HEMOGLOBIN GRADE 3
    1
    1
    0
    1
    0
    1
    1
    1
    2
    1
    0
    0
    1
    2
    1
    3
    1
    2
    0
    0
    1
    0
    0
    1
    0
    1
    0
        PLATELET COUNT GRADE 1
    1
    1
    1
    1
    0
    1
    2
    1
    1
    0
    0
    1
    2
    1
    2
    4
    3
    1
    1
    0
    1
    2
    0
    0
    0
    1
    0
        PLATELET COUNT GRADE 2
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
        PLATELET COUNT GRADE 3
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        LEUKOCYTES GRADE 1
    1
    1
    2
    0
    0
    0
    2
    1
    2
    1
    0
    1
    1
    3
    2
    2
    1
    0
    0
    0
    1
    1
    0
    0
    0
    1
    0
        LEUKOCYTES GRADE 2
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    1
    1
    0
    0
    0
    0
    0
    1
    0
    0
    2
    0
    1
    0
    0
    0
        LEUKOCYTES GRADE 3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        LEUKOCYTES GRADE 4
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        ABSOLUTE NEUTROPHIL COUNT DRV. GRADE 1
    1
    0
    0
    0
    0
    1
    3
    0
    2
    0
    0
    1
    0
    0
    0
    2
    0
    0
    1
    0
    0
    1
    0
    1
    0
    0
    0
        ABSOLUTE NEUTROPHIL COUNT DRV. GRADE 2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        ABSOLUTE NEUTROPHIL COUNT DRV. GRADE 3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
        ABSOLUTE NEUTROPHIL COUNT DRV. GRADE 4
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: The Number of Participants with Clinical Laboratory Test Abnormalities (LIVER AND KIDNEY FUNCTION)

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    End point title
    The Number of Participants with Clinical Laboratory Test Abnormalities (LIVER AND KIDNEY FUNCTION) [4]
    End point description
    The number of participants with clinical laboratory test abnormalities to assess the overall safety and tolerability of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab in participants with advanced solid tumors. Baseline is defined as the last non-missing measurement prior to the first dosing date and time
    End point type
    Primary
    End point timeframe
    From baseline to 100 days after last dose (up to approximately 2.5 years)
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only summary statistics were planned for these endpoints
    End point values
    Part 1: BMS 20 mg Q2W Part 1: BMS 40 mg Q2W Part 1: BMS 80 mg Q2W Part 1: BMS 160 mg Q2W Part 1: BMS 320 mg Q2W Part 2 BMS 20 mg + Nivo 240 mg Q2W Part 2: BMS 40 mg + Nivo 240 mg Q2W Part 2: BMS 80 mg + Nivo 240 mg Q2W Part 2: BMS 160 mg + Nivo 240 mg Q2W Part 2: BMS 320 mg + Nivo 240 mg Q2W Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC) Part 4: BMS 80 mg + Nivo 480mg Q4W Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W Part 6A:BMS40mg+Nivo 240mg+Ipi 1mg/kgQ3W/BMS 40mg+Nivo480mgQ4W Part6B:BMS40mg+Nivo240 mg+Ipi1mg/kgQ3W/BMS 40 mg+Nivo480 mgQ4W Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W Part 8: Cohort 3- BMS 80 mg Q12W + Nivo 480 mg Q4W Part 8: Cohort 4- Nivo 480 mg Q4W Part 9: BMS 40 mg Q4W + Nivo 480 mg Q4W + DRibble Vaccine
    Number of subjects analysed
    4
    4
    4
    4
    4
    7
    8
    12
    8
    8
    4
    10
    7
    8
    6
    18
    12
    6
    7
    1
    6
    9
    2
    2
    2
    2
    1
    Units: Participants
        ALKALINE PHOSPHATASE GRADE 1
    2
    2
    2
    1
    3
    5
    2
    5
    6
    4
    2
    3
    3
    4
    0
    7
    6
    2
    1
    0
    3
    2
    1
    0
    0
    0
    1
        ALKALINE PHOSPHATASE GRADE 2
    1
    1
    1
    2
    0
    1
    1
    0
    0
    0
    1
    2
    0
    1
    1
    3
    1
    0
    1
    1
    1
    2
    0
    1
    0
    0
    1
        ALKALINE PHOSPHATASE GRADE 3
    0
    0
    0
    0
    0
    0
    2
    2
    1
    0
    0
    0
    1
    0
    1
    2
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
        ASPARTATE AMINOTRANSFERASE GRADE 1
    2
    3
    1
    1
    1
    3
    4
    2
    1
    2
    0
    4
    2
    2
    2
    10
    5
    4
    3
    0
    5
    2
    0
    1
    1
    0
    1
        ASPARTATE AMINOTRANSFERASE GRADE 2
    0
    0
    1
    1
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    2
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
        ASPARTATE AMINOTRANSFERASE GRADE 3
    0
    0
    0
    1
    0
    0
    2
    1
    1
    0
    2
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
        ASPARTATE AMINOTRANSFERASE GRADE 4
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
        ALANINE AMINOTRANSFERASE GRADE 1
    1
    3
    2
    2
    0
    2
    4
    1
    2
    0
    1
    4
    1
    1
    2
    7
    4
    3
    1
    0
    3
    3
    0
    1
    0
    0
    1
        ALANINE AMINOTRANSFERASE GRADE 2
    1
    0
    0
    1
    0
    0
    1
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
        ALANINE AMINOTRANSFERASE GRADE 3
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        ALANINE AMINOTRANSFERASE GRADE 4
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
        BILIRUBIN, TOTAL GRADE 1
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    1
    1
    0
    0
    0
    2
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
        BILIRUBIN, TOTAL GRADE 2
    0
    0
    0
    2
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
        BILIRUBIN, TOTAL GRADE 3
    1
    1
    1
    0
    0
    0
    1
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
        BILIRUBIN, TOTAL GRADE 4
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        CREATININE GRADE 1
    2
    1
    2
    1
    0
    0
    3
    6
    1
    1
    0
    1
    1
    3
    2
    7
    0
    1
    2
    1
    2
    3
    1
    1
    1
    1
    0
        CREATININE GRADE 2
    0
    1
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    3
    2
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
        CREATININE GRADE 3
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    2
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: The Number of Participants with Clinical Laboratory Test Abnormalities (OTHER CHEMISTRY TESTING )

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    End point title
    The Number of Participants with Clinical Laboratory Test Abnormalities (OTHER CHEMISTRY TESTING ) [5]
    End point description
    The number of participants with clinical laboratory test abnormalities to assess the overall safety and tolerability of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab in participants with advanced solid tumors. Baseline is defined as the last non-missing measurement prior to the first dosing date and time.
    End point type
    Primary
    End point timeframe
    From baseline to 100 days after last dose (up to approximately 2.5 years)
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only summary statistics were planned for these endpoints
    End point values
    Part 1: BMS 20 mg Q2W Part 1: BMS 40 mg Q2W Part 1: BMS 80 mg Q2W Part 1: BMS 160 mg Q2W Part 1: BMS 320 mg Q2W Part 2 BMS 20 mg + Nivo 240 mg Q2W Part 2: BMS 40 mg + Nivo 240 mg Q2W Part 2: BMS 80 mg + Nivo 240 mg Q2W Part 2: BMS 160 mg + Nivo 240 mg Q2W Part 2: BMS 320 mg + Nivo 240 mg Q2W Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC) Part 4: BMS 80 mg + Nivo 480mg Q4W Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W Part 6A:BMS40mg+Nivo 240mg+Ipi 1mg/kgQ3W/BMS 40mg+Nivo480mgQ4W Part6B:BMS40mg+Nivo240 mg+Ipi1mg/kgQ3W/BMS 40 mg+Nivo480 mgQ4W Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W Part 8: Cohort 3- BMS 80 mg Q12W + Nivo 480 mg Q4W Part 8: Cohort 4- Nivo 480 mg Q4W Part 9: BMS 40 mg Q4W + Nivo 480 mg Q4W + DRibble Vaccine
    Number of subjects analysed
    4
    4
    4
    4
    4
    7
    8
    12
    8
    8
    4
    10
    7
    8
    6
    18
    12
    6
    7
    1
    6
    9
    2
    2
    2
    2
    1
    Units: Participants
        SODIUM, SERUM GRADE 1
    4
    3
    2
    2
    1
    2
    6
    5
    2
    2
    2
    2
    2
    2
    2
    4
    3
    1
    0
    0
    4
    1
    0
    1
    0
    1
    1
        SODIUM, SERUM GRADE 2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        SODIUM, SERUM GRADE 3
    0
    0
    1
    0
    1
    0
    0
    1
    0
    0
    1
    0
    0
    2
    0
    2
    0
    2
    1
    0
    0
    0
    0
    0
    1
    0
    1
        POTASSIUM, SERUM GRADE 1
    0
    3
    0
    2
    0
    1
    4
    3
    2
    2
    0
    2
    3
    2
    2
    8
    3
    0
    1
    0
    2
    2
    1
    1
    0
    0
    0
        POTASSIUM, SERUM GRADE 2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    3
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
        POTASSIUM, SERUM GRADE 3
    0
    0
    0
    1
    1
    0
    1
    0
    1
    1
    0
    0
    0
    1
    0
    1
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
        POTASSIUM, SERUM GRADE 4
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        CALCIUM, TOTAL GRADE 1
    0
    3
    1
    1
    1
    3
    5
    4
    2
    4
    2
    4
    3
    0
    2
    9
    4
    1
    4
    0
    1
    5
    1
    0
    0
    0
    0
        CALCIUM, TOTAL GRADE 2
    1
    0
    2
    0
    0
    0
    1
    3
    0
    0
    0
    0
    0
    1
    0
    1
    2
    1
    0
    0
    1
    0
    1
    1
    0
    0
    0
        CALCIUM, TOTAL GRADE 3
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        MAGNESIUM, SERUM GRADE 1
    1
    1
    0
    2
    2
    0
    1
    3
    4
    1
    2
    4
    0
    0
    2
    6
    2
    2
    0
    0
    3
    1
    0
    0
    0
    2
    0
        MAGNESIUM, SERUM GRADE 2
    0
    0
    0
    0
    0
    1
    2
    0
    0
    2
    0
    0
    1
    0
    0
    1
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        MAGNESIUM, SERUM GRADE 3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        GLUCOSE, FASTING SERUM GRADE 1
    1
    3
    0
    3
    1
    4
    4
    2
    2
    0
    2
    6
    5
    2
    2
    2
    99999
    99999
    0
    99999
    0
    0
    99999
    99999
    99999
    99999
    0
        GLUCOSE, FASTING SERUM GRADE 2
    0
    0
    1
    0
    1
    0
    2
    1
    0
    1
    0
    1
    1
    0
    0
    1
    99999
    99999
    0
    99999
    1
    0
    99999
    99999
    99999
    99999
    0
        GLUCOSE, FASTING SERUM GRADE 3
    1
    0
    1
    0
    1
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    99999
    99999
    0
    99999
    0
    0
    99999
    99999
    99999
    99999
    0
        ALBUMIN GRADE 1
    2
    2
    1
    2
    1
    2
    0
    4
    1
    3
    1
    2
    5
    2
    1
    3
    4
    2
    0
    0
    1
    2
    1
    0
    2
    1
    0
        ALBUMIN GRADE 2
    1
    2
    2
    1
    1
    3
    5
    3
    3
    0
    2
    4
    1
    2
    3
    5
    2
    2
    2
    1
    3
    4
    0
    0
    0
    1
    1
        ALBUMIN GRADE 3
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
        AMYLASE, TOTAL GRADE 1
    1
    0
    0
    0
    1
    1
    0
    3
    1
    0
    0
    1
    0
    0
    0
    2
    2
    1
    1
    0
    0
    1
    0
    0
    0
    0
    0
        AMYLASE, TOTAL GRADE 2
    0
    1
    0
    0
    0
    0
    1
    0
    1
    0
    1
    1
    1
    1
    0
    2
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
        AMYLASE, TOTAL GRADE 3
    0
    0
    2
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        AMYLASE, TOTAL GRADE 4
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
        LIPASE, TOTAL GRADE 1
    0
    0
    0
    0
    0
    0
    1
    1
    1
    0
    0
    1
    0
    0
    1
    2
    1
    1
    1
    1
    1
    2
    0
    0
    1
    0
    0
        LIPASE, TOTAL GRADE 2
    1
    0
    0
    1
    0
    0
    0
    1
    1
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        LIPASE, TOTAL GRADE 3
    1
    1
    0
    1
    0
    0
    0
    2
    0
    1
    0
    1
    0
    0
    0
    2
    1
    2
    2
    0
    1
    2
    0
    0
    0
    0
    0
        LIPASE, TOTAL GRADE 4
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    2
    1
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    No statistical analyses for this end point

    Primary: The number of Participants Experiencing Dose-Limiting Toxicities (DLTs)

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    End point title
    The number of Participants Experiencing Dose-Limiting Toxicities (DLTs) [6]
    End point description
    The number of participants experiencing dose-limiting toxicities (DLTs) to assess the overall safety and tolerability of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab in participants with advanced solid tumors. DLTs are defined based on the incidence, severity, and duration of adverse events (AEs) for which no clear alternative cause is identified. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment.
    End point type
    Primary
    End point timeframe
    From first dose to 28 days after first dose
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only summary statistics were planned for these endpoints
    End point values
    Part 1: BMS 20 mg Q2W Part 1: BMS 40 mg Q2W Part 1: BMS 80 mg Q2W Part 1: BMS 160 mg Q2W Part 1: BMS 320 mg Q2W Part 2 BMS 20 mg + Nivo 240 mg Q2W Part 2: BMS 40 mg + Nivo 240 mg Q2W Part 2: BMS 80 mg + Nivo 240 mg Q2W Part 2: BMS 160 mg + Nivo 240 mg Q2W Part 2: BMS 320 mg + Nivo 240 mg Q2W Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC) Part 4: BMS 80 mg + Nivo 480mg Q4W Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W Part 6A:BMS40mg+Nivo 240mg+Ipi 1mg/kgQ3W/BMS 40mg+Nivo480mgQ4W Part6B:BMS40mg+Nivo240 mg+Ipi1mg/kgQ3W/BMS 40 mg+Nivo480 mgQ4W Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W Part 8: Cohort 3- BMS 80 mg Q12W + Nivo 480 mg Q4W Part 8: Cohort 4- Nivo 480 mg Q4W Part 9: BMS 40 mg Q4W + Nivo 480 mg Q4W + DRibble Vaccine
    Number of subjects analysed
    4
    4
    4
    4
    4
    7
    8
    12
    8
    8
    4
    10
    7
    8
    6
    18
    12
    6
    7
    1
    6
    9
    2
    2
    2
    2
    1
    Units: Participants
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    No statistical analyses for this end point

    Primary: The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation

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    End point title
    The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation [7]
    End point description
    The number of participants experiencing adverse events (AEs) leading to discontinuation of study drug to assess the overall safety and tolerability of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab in participants with advanced solid tumors. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment.
    End point type
    Primary
    End point timeframe
    From first dose to 100 days after last dose (up to approximately 2.5 years)
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only summary statistics were planned for these endpoints
    End point values
    Part 1: BMS 20 mg Q2W Part 1: BMS 40 mg Q2W Part 1: BMS 80 mg Q2W Part 1: BMS 160 mg Q2W Part 1: BMS 320 mg Q2W Part 2 BMS 20 mg + Nivo 240 mg Q2W Part 2: BMS 40 mg + Nivo 240 mg Q2W Part 2: BMS 80 mg + Nivo 240 mg Q2W Part 2: BMS 160 mg + Nivo 240 mg Q2W Part 2: BMS 320 mg + Nivo 240 mg Q2W Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC) Part 4: BMS 80 mg + Nivo 480mg Q4W Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W Part 6A:BMS40mg+Nivo 240mg+Ipi 1mg/kgQ3W/BMS 40mg+Nivo480mgQ4W Part6B:BMS40mg+Nivo240 mg+Ipi1mg/kgQ3W/BMS 40 mg+Nivo480 mgQ4W Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W Part 8: Cohort 3- BMS 80 mg Q12W + Nivo 480 mg Q4W Part 8: Cohort 4- Nivo 480 mg Q4W Part 9: BMS 40 mg Q4W + Nivo 480 mg Q4W + DRibble Vaccine
    Number of subjects analysed
    4
    4
    4
    4
    4
    7
    8
    12
    8
    8
    4
    10
    7
    8
    6
    18
    12
    6
    7
    1
    6
    9
    2
    2
    2
    2
    1
    Units: Participants
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    2
    0
    2
    0
    0
    2
    0
    2
    0
    0
    1
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: The Number of Participant Deaths

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    End point title
    The Number of Participant Deaths [8]
    End point description
    The number of deaths in each arm to assess the overall safety and tolerability of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab in participants with advanced solid tumors.
    End point type
    Primary
    End point timeframe
    From first dose to study completion (up to approximately 5 years)
    Notes
    [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only summary statistics were planned for these endpoints
    End point values
    Part 1: BMS 20 mg Q2W Part 1: BMS 40 mg Q2W Part 1: BMS 80 mg Q2W Part 1: BMS 160 mg Q2W Part 1: BMS 320 mg Q2W Part 2 BMS 20 mg + Nivo 240 mg Q2W Part 2: BMS 40 mg + Nivo 240 mg Q2W Part 2: BMS 80 mg + Nivo 240 mg Q2W Part 2: BMS 160 mg + Nivo 240 mg Q2W Part 2: BMS 320 mg + Nivo 240 mg Q2W Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC) Part 4: BMS 80 mg + Nivo 480mg Q4W Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W Part 6A:BMS40mg+Nivo 240mg+Ipi 1mg/kgQ3W/BMS 40mg+Nivo480mgQ4W Part6B:BMS40mg+Nivo240 mg+Ipi1mg/kgQ3W/BMS 40 mg+Nivo480 mgQ4W Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W Part 8: Cohort 3- BMS 80 mg Q12W + Nivo 480 mg Q4W Part 8: Cohort 4- Nivo 480 mg Q4W Part 9: BMS 40 mg Q4W + Nivo 480 mg Q4W + DRibble Vaccine
    Number of subjects analysed
    4
    4
    4
    4
    4
    7
    8
    12
    8
    8
    4
    10
    7
    8
    6
    18
    12
    6
    7
    1
    6
    9
    2
    2
    2
    2
    1
    Units: Participants
    4
    4
    3
    4
    4
    3
    7
    11
    6
    6
    4
    9
    7
    8
    2
    16
    11
    3
    3
    0
    5
    4
    2
    2
    1
    1
    1
    No statistical analyses for this end point

    Secondary: Objective Response Rate (ORR)

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    End point title
    Objective Response Rate (ORR)
    End point description
    The total number of participants whose best overall response (BOR) is either a complete response (CR) or partial response (PR) Baseline is defined as the last non-missing measurement prior to the first dosing date and time.
    End point type
    Secondary
    End point timeframe
    From baseline up to approximately 2.5 years
    End point values
    Part 1: BMS 20 mg Q2W Part 1: BMS 40 mg Q2W Part 1: BMS 80 mg Q2W Part 1: BMS 160 mg Q2W Part 1: BMS 320 mg Q2W Part 2 BMS 20 mg + Nivo 240 mg Q2W Part 2: BMS 40 mg + Nivo 240 mg Q2W Part 2: BMS 80 mg + Nivo 240 mg Q2W Part 2: BMS 160 mg + Nivo 240 mg Q2W Part 2: BMS 320 mg + Nivo 240 mg Q2W Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC) Part 4: BMS 80 mg + Nivo 480mg Q4W Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W Part 6A:BMS40mg+Nivo 240mg+Ipi 1mg/kgQ3W/BMS 40mg+Nivo480mgQ4W Part6B:BMS40mg+Nivo240 mg+Ipi1mg/kgQ3W/BMS 40 mg+Nivo480 mgQ4W Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W Part 8: Cohort 3- BMS 80 mg Q12W + Nivo 480 mg Q4W Part 8: Cohort 4- Nivo 480 mg Q4W Part 9: BMS 40 mg Q4W + Nivo 480 mg Q4W + DRibble Vaccine
    Number of subjects analysed
    4
    4
    4
    4
    4
    7
    8
    12
    8
    8
    4
    9
    7
    8
    5
    18
    12
    6
    7
    1
    6
    9
    2
    2
    2
    2
    0 [9]
    Units: Participants
    0
    0
    0
    0
    0
    0
    2
    1
    1
    1
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    2
    0
    0
    0
    0
    Notes
    [9] - BOR was not evaluable for the only patient because of death prior to any tumor assessment.
    No statistical analyses for this end point

    Secondary: Duration of Response (DOR)

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    End point title
    Duration of Response (DOR) [10]
    End point description
    The time between the date of first response and the subsequent date of disease progression or death (death after re-treatment will not be considered), whichever occurs first in participants with a best overall response (BOR) of complete response (CR) or partial response (PR). Baseline is defined as the last non-missing measurement prior to the first dosing date and time.
    End point type
    Secondary
    End point timeframe
    From baseline up to approximately 2.5 years
    Notes
    [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Endpoint is specific to Parts 1-8 only
    End point values
    Part 1: BMS 20 mg Q2W Part 1: BMS 40 mg Q2W Part 1: BMS 80 mg Q2W Part 1: BMS 160 mg Q2W Part 1: BMS 320 mg Q2W Part 2 BMS 20 mg + Nivo 240 mg Q2W Part 2: BMS 40 mg + Nivo 240 mg Q2W Part 2: BMS 80 mg + Nivo 240 mg Q2W Part 2: BMS 160 mg + Nivo 240 mg Q2W Part 2: BMS 320 mg + Nivo 240 mg Q2W Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC) Part 4: BMS 80 mg + Nivo 480mg Q4W Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W Part 6A:BMS40mg+Nivo 240mg+Ipi 1mg/kgQ3W/BMS 40mg+Nivo480mgQ4W Part6B:BMS40mg+Nivo240 mg+Ipi1mg/kgQ3W/BMS 40 mg+Nivo480 mgQ4W Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W Part 8: Cohort 3- BMS 80 mg Q12W + Nivo 480 mg Q4W Part 8: Cohort 4- Nivo 480 mg Q4W
    Number of subjects analysed
    0 [11]
    0 [12]
    0 [13]
    0 [14]
    0 [15]
    0 [16]
    0 [17]
    0 [18]
    0 [19]
    0 [20]
    0 [21]
    0 [22]
    0 [23]
    0 [24]
    0 [25]
    0 [26]
    0 [27]
    0 [28]
    0 [29]
    0 [30]
    0 [31]
    0 [32]
    0 [33]
    0 [34]
    0 [35]
    0 [36]
    Units: Weeks
        median (confidence interval 95%)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    Notes
    [11] - The number of responders within each tumor type was not sufficient for analysis.
    [12] - The number of responders within each tumor type was not sufficient for analysis.
    [13] - The number of responders within each tumor type was not sufficient for analysis.
    [14] - The number of responders within each tumor type was not sufficient for analysis.
    [15] - The number of responders within each tumor type was not sufficient for analysis.
    [16] - The number of responders within each tumor type was not sufficient for analysis.
    [17] - The number of responders within each tumor type was not sufficient for analysis.
    [18] - The number of responders within each tumor type was not sufficient for analysis.
    [19] - The number of responders within each tumor type was not sufficient for analysis.
    [20] - The number of responders within each tumor type was not sufficient for analysis.
    [21] - The number of responders within each tumor type was not sufficient for analysis.
    [22] - The number of responders within each tumor type was not sufficient for analysis.
    [23] - The number of responders within each tumor type was not sufficient for analysis.
    [24] - The number of responders within each tumor type was not sufficient for analysis.
    [25] - The number of responders within each tumor type was not sufficient for analysis.
    [26] - The number of responders within each tumor type was not sufficient for analysis.
    [27] - The number of responders within each tumor type was not sufficient for analysis.
    [28] - The number of responders within each tumor type was not sufficient for analysis.
    [29] - The number of responders within each tumor type was not sufficient for analysis.
    [30] - The number of responders within each tumor type was not sufficient for analysis.
    [31] - The number of responders within each tumor type was not sufficient for analysis.
    [32] - The number of responders within each tumor type was not sufficient for analysis.
    [33] - The number of responders within each tumor type was not sufficient for analysis.
    [34] - The number of responders within each tumor type was not sufficient for analysis.
    [35] - The number of responders within each tumor type was not sufficient for analysis.
    [36] - The number of responders within each tumor type was not sufficient for analysis.
    No statistical analyses for this end point

    Secondary: Progression Free Survival (PFS) Rate at 24 Weeks

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    End point title
    Progression Free Survival (PFS) Rate at 24 Weeks [37]
    End point description
    The number of treated participants remaining progression free and surviving at 24 weeks since the first dosing date. 99999- Data could not be calculated due to number at risk being less than 5
    End point type
    Secondary
    End point timeframe
    24 weeks after first dose
    Notes
    [37] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Endpoint is specific to Parts 1-8 only
    End point values
    Part 1: BMS 20 mg Q2W Part 1: BMS 40 mg Q2W Part 1: BMS 80 mg Q2W Part 1: BMS 160 mg Q2W Part 1: BMS 320 mg Q2W Part 2 BMS 20 mg + Nivo 240 mg Q2W Part 2: BMS 40 mg + Nivo 240 mg Q2W Part 2: BMS 80 mg + Nivo 240 mg Q2W Part 2: BMS 160 mg + Nivo 240 mg Q2W Part 2: BMS 320 mg + Nivo 240 mg Q2W Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC) Part 4: BMS 80 mg + Nivo 480mg Q4W Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W Part 6A:BMS40mg+Nivo 240mg+Ipi 1mg/kgQ3W/BMS 40mg+Nivo480mgQ4W Part6B:BMS40mg+Nivo240 mg+Ipi1mg/kgQ3W/BMS 40 mg+Nivo480 mgQ4W Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W Part 8: Cohort 3- BMS 80 mg Q12W + Nivo 480 mg Q4W Part 8: Cohort 4- Nivo 480 mg Q4W
    Number of subjects analysed
    4
    4
    4
    4
    4
    7
    8
    12
    8
    8
    4
    10
    7
    8
    6
    18
    12
    6
    7
    1
    6
    9
    2
    2
    2
    2
    Units: Percent of Participants
        number (confidence interval 95%)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    No statistical analyses for this end point

    Secondary: Cmax: Maximum observed serum concentration

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    End point title
    Cmax: Maximum observed serum concentration
    End point description
    The maximum observed serum concentration was measured after dosing to assess the pharmacokinetics of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab Note: 99999 = N/A
    End point type
    Secondary
    End point timeframe
    Cycle 1-9 timepoints can include (Pre-dose, 0.30, 4, 24, 72, 168, 336, 696 hours post dose)
    End point values
    Part 1: BMS 20 mg Q2W Part 1: BMS 40 mg Q2W Part 1: BMS 80 mg Q2W Part 1: BMS 160 mg Q2W Part 1: BMS 320 mg Q2W Part 2 BMS 20 mg + Nivo 240 mg Q2W Part 2: BMS 40 mg + Nivo 240 mg Q2W Part 2: BMS 80 mg + Nivo 240 mg Q2W Part 2: BMS 160 mg + Nivo 240 mg Q2W Part 2: BMS 320 mg + Nivo 240 mg Q2W Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC) Part 4: BMS 80 mg + Nivo 480mg Q4W Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W Part 6A:BMS40mg+Nivo 240mg+Ipi 1mg/kgQ3W/BMS 40mg+Nivo480mgQ4W Part6B:BMS40mg+Nivo240 mg+Ipi1mg/kgQ3W/BMS 40 mg+Nivo480 mgQ4W Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W Part 8: Cohort 3- BMS 80 mg Q12W + Nivo 480 mg Q4W Part 8: Cohort 4- Nivo 480 mg Q4W Part 9: BMS 40 mg Q4W + Nivo 480 mg Q4W + DRibble Vaccine
    Number of subjects analysed
    4
    4
    4
    4
    4
    7
    8
    12
    8
    8
    4
    10
    7
    8
    6
    18
    12
    6
    7
    1
    6
    9
    2
    2
    2
    2
    0 [38]
    Units: NG/ML
    geometric mean (geometric coefficient of variation)
        CYCLE 1 DAY 1
    4964 ( 99999 )
    11245 ( 99999 )
    19254 ( 99999 )
    36143 ( 99999 )
    68774 ( 99999 )
    9424 ( 99999 )
    11699 ( 99999 )
    19547 ( 99999 )
    39182 ( 99999 )
    76445 ( 99999 )
    7860 ( 99999 )
    9345 ( 99999 )
    17979 ( 99999 )
    55790 ( 99999 )
    65472 ( 99999 )
    17586 ( 99999 )
    19012 ( 99999 )
    21399 ( 99999 )
    11139 ( 99999 )
    99999 ( 99999 )
    14267 ( 99999 )
    15424 ( 99999 )
    3270 ( 99999 )
    11300 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    ( )
        CYCLE 4 DAY 1
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    8960 ( 99999 )
    10273 ( 99999 )
    20900 ( 99999 )
    69922 ( 99999 )
    117839 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    31800 ( 99999 )
    11261 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    14143 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    ( )
        CYCLE 5 DAY 1
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    16912 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    ( )
        CYCLE 9 DAY 1
    99999 ( 99999 )
    99999 ( 99999 )
    23200 ( 99999 )
    61500 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    17392 ( 99999 )
    23097 ( 99999 )
    72991 ( 99999 )
    207853 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    30922 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    ( )
    Notes
    [38] - Only participants with available serum time-concentration data evaluated
    No statistical analyses for this end point

    Secondary:  Tmax: Time of maximum observed serum concentration

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    End point title
     Tmax: Time of maximum observed serum concentration
    End point description
    The time of maximum observed serum concentration was measured after dosing to assess the pharmacokinetics of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab Note: 99999 = N/A
    End point type
    Secondary
    End point timeframe
    Cycle 1-9 timepoints can include (Pre-dose, 0.30, 4, 24, 72, 168, 336, 696 hours post dose)
    End point values
    Part 1: BMS 20 mg Q2W Part 1: BMS 40 mg Q2W Part 1: BMS 80 mg Q2W Part 1: BMS 160 mg Q2W Part 1: BMS 320 mg Q2W Part 2 BMS 20 mg + Nivo 240 mg Q2W Part 2: BMS 40 mg + Nivo 240 mg Q2W Part 2: BMS 80 mg + Nivo 240 mg Q2W Part 2: BMS 160 mg + Nivo 240 mg Q2W Part 2: BMS 320 mg + Nivo 240 mg Q2W Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC) Part 4: BMS 80 mg + Nivo 480mg Q4W Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W Part 6A:BMS40mg+Nivo 240mg+Ipi 1mg/kgQ3W/BMS 40mg+Nivo480mgQ4W Part6B:BMS40mg+Nivo240 mg+Ipi1mg/kgQ3W/BMS 40 mg+Nivo480 mgQ4W Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W Part 8: Cohort 3- BMS 80 mg Q12W + Nivo 480 mg Q4W Part 8: Cohort 4- Nivo 480 mg Q4W Part 9: BMS 40 mg Q4W + Nivo 480 mg Q4W + DRibble Vaccine
    Number of subjects analysed
    4
    4
    4
    4
    4
    7
    8
    12
    8
    8
    4
    10
    7
    8
    6
    18
    12
    6
    7
    1
    6
    9
    2
    2
    2
    2
    0 [39]
    Units: Hours
    median (full range (min-max))
        CYCLE 1 DAY 1
    0.675 (0.467 to 4.52)
    0.575 (0.467 to 0.933)
    4.58 (0.500 to 24.0)
    2.30 (0.567 to 4.02)
    0.558 (0.467 to 4.08)
    0.467 (0.467 to 4.00)
    2.34 (0.467 to 4.08)
    0.517 (0.467 to 4.50)
    0.650 (0.517 to 4.10)
    0.792 (0.450 to 4.50)
    0.667 (0.633 to 4.08)
    4.00 (0.467 to 4.13)
    4.00 (0.467 to 4.43)
    2.55 (0.467 to 24.1)
    4.13 (0.467 to 4.62)
    4.09 (0.467 to 4.82)
    0.550 (0.500 to 24.0)
    2.30 (0.467 to 4.55)
    0.583 (0.467 to 4.08)
    99999 (99999 to 99999)
    4.00 (0.517 to 23.0)
    0.475 (0.467 to 4.75)
    0.533 (0.533 to 0.533)
    4.83 (4.83 to 4.83)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    ( to )
        CYCLE 4 DAY 1
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    0.583 (0.583 to 0.583)
    4.00 (0.617 to 24.0)
    0.583 (0.583 to 0.583)
    4.00 (0.467 to 24.9)
    2.58 (0.467 to 4.68)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    4.03 (4.03 to 4.03)
    0.517 (0.500 to 0.583)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    0.467 (0.000 to 4.00)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    ( to )
        CYCLE 5 DAY 1
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    0.550 (0.517 to 0.583)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    ( to )
        CYCLE 9 DAY 1
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    0.467 (0.467 to 0.467)
    22.7 (22.7 to 22.7)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    0.567 (0.467 to 4.00)
    4.47 (4.02 to 4.50)
    2.38 (0.633 to 4.12)
    4.05 (3.98 to 23.9)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    3.94 (0.500 to 4.03)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    ( to )
    Notes
    [39] - Only participants with available serum time-concentration data evaluated
    No statistical analyses for this end point

    Secondary: AUC(0-t): Area under the serum concentration-time curve from time 0 to time t

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    End point title
    AUC(0-t): Area under the serum concentration-time curve from time 0 to time t
    End point description
    The area under the serum concentration-time curve from time 0 to time t was measured after dosing to assess the pharmacokinetics of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab Note: 99999 = N/A
    End point type
    Secondary
    End point timeframe
    Cycle 1-9 timepoints can include (Pre-dose, 0.30, 4, 24, 72, 168, 336, 696 hours post dose)
    End point values
    Part 1: BMS 20 mg Q2W Part 1: BMS 40 mg Q2W Part 1: BMS 80 mg Q2W Part 1: BMS 160 mg Q2W Part 1: BMS 320 mg Q2W Part 2 BMS 20 mg + Nivo 240 mg Q2W Part 2: BMS 40 mg + Nivo 240 mg Q2W Part 2: BMS 80 mg + Nivo 240 mg Q2W Part 2: BMS 160 mg + Nivo 240 mg Q2W Part 2: BMS 320 mg + Nivo 240 mg Q2W Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC) Part 4: BMS 80 mg + Nivo 480mg Q4W Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W Part 6A:BMS40mg+Nivo 240mg+Ipi 1mg/kgQ3W/BMS 40mg+Nivo480mgQ4W Part6B:BMS40mg+Nivo240 mg+Ipi1mg/kgQ3W/BMS 40 mg+Nivo480 mgQ4W Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W Part 8: Cohort 3- BMS 80 mg Q12W + Nivo 480 mg Q4W Part 8: Cohort 4- Nivo 480 mg Q4W Part 9: BMS 40 mg Q4W + Nivo 480 mg Q4W + DRibble Vaccine
    Number of subjects analysed
    4
    4
    4
    4
    4
    7
    8
    12
    8
    8
    4
    10
    7
    8
    6
    18
    12
    6
    7
    1
    6
    9
    2
    2
    2
    2
    0 [40]
    Units: H*NG/ML
    geometric mean (geometric coefficient of variation)
        CYCLE 1 DAY 1
    577541 ( 99999 )
    1678196 ( 99999 )
    1825502 ( 99999 )
    5024906 ( 99999 )
    9981469 ( 99999 )
    609426 ( 99999 )
    1495494 ( 99999 )
    2324225 ( 99999 )
    5458640 ( 99999 )
    8694104 ( 99999 )
    1047354 ( 99999 )
    1197507 ( 99999 )
    2774058 ( 99999 )
    7257441 ( 99999 )
    10580541 ( 99999 )
    2351794 ( 99999 )
    2000522 ( 99999 )
    3216650 ( 99999 )
    1251698 ( 99999 )
    99999 ( 99999 )
    1653102 ( 99999 )
    864500 ( 99999 )
    390424 ( 99999 )
    2399055 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    ( )
        CYCLE 4 DAY 1
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    773957 ( 99999 )
    2210404 ( 99999 )
    2400433 ( 99999 )
    10729551 ( 99999 )
    23851864 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    2699238 ( 99999 )
    1837861 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    504998 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    ( )
        CYCLE 5 DAY 1
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    2520673 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    ( )
        CYCLE 9 DAY 1
    99999 ( 99999 )
    99999 ( 99999 )
    3952990 ( 99999 )
    13024914 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    2971409 ( 99999 )
    1247687 ( 99999 )
    16483279 ( 99999 )
    28499982 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    4537054 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    ( )
    Notes
    [40] - Only participants with available serum time-concentration data evaluated
    No statistical analyses for this end point

    Secondary: AUC(TAU): Area under the serum concentration-time curve in 1 dosing interval

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    End point title
    AUC(TAU): Area under the serum concentration-time curve in 1 dosing interval
    End point description
    The area under the serum concentration-time curve in 1 dosing interval was measured after dosing to assess the pharmacokinetics of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab Note: 99999 = N/A
    End point type
    Secondary
    End point timeframe
    Cycle 1-9 timepoints can include (Pre-dose, 0.30, 4, 24, 72, 168, 336, 696 hours post dose)
    End point values
    Part 1: BMS 20 mg Q2W Part 1: BMS 40 mg Q2W Part 1: BMS 80 mg Q2W Part 1: BMS 160 mg Q2W Part 1: BMS 320 mg Q2W Part 2 BMS 20 mg + Nivo 240 mg Q2W Part 2: BMS 40 mg + Nivo 240 mg Q2W Part 2: BMS 80 mg + Nivo 240 mg Q2W Part 2: BMS 160 mg + Nivo 240 mg Q2W Part 2: BMS 320 mg + Nivo 240 mg Q2W Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC) Part 4: BMS 80 mg + Nivo 480mg Q4W Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W Part 6A:BMS40mg+Nivo 240mg+Ipi 1mg/kgQ3W/BMS 40mg+Nivo480mgQ4W Part6B:BMS40mg+Nivo240 mg+Ipi1mg/kgQ3W/BMS 40 mg+Nivo480 mgQ4W Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W Part 8: Cohort 3- BMS 80 mg Q12W + Nivo 480 mg Q4W Part 8: Cohort 4- Nivo 480 mg Q4W Part 9: BMS 40 mg Q4W + Nivo 480 mg Q4W + DRibble Vaccine
    Number of subjects analysed
    4
    4
    4
    4
    4
    7
    8
    12
    8
    8
    4
    10
    7
    8
    6
    18
    12
    6
    7
    1
    6
    9
    2
    2
    2
    2
    0 [41]
    Units: H*NG/ML
    geometric mean (geometric coefficient of variation)
        CYCLE 1 DAY 1
    577541 ( 99999 )
    1599886 ( 99999 )
    3142196 ( 99999 )
    5854143 ( 99999 )
    9981469 ( 99999 )
    663257 ( 99999 )
    1515139 ( 99999 )
    2551115 ( 99999 )
    5458640 ( 99999 )
    11483961 ( 99999 )
    1383126 ( 99999 )
    1521223 ( 99999 )
    3133192 ( 99999 )
    7464248 ( 99999 )
    11966698 ( 99999 )
    2602049 ( 99999 )
    2734577 ( 99999 )
    3500606 ( 99999 )
    1568004 ( 99999 )
    99999 ( 99999 )
    1705864 ( 99999 )
    1410042 ( 99999 )
    447709 ( 99999 )
    2812249 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    ( )
        CYCLE 4 DAY 1
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    2210404 ( 99999 )
    99999 ( 99999 )
    12666237 ( 99999 )
    27936423 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    1837861 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    3590883 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    ( )
        CYCLE 5 DAY 1
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    3335668 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    ( )
        CYCLE 9 DAY 1
    99999 ( 99999 )
    99999 ( 99999 )
    3952990 ( 99999 )
    13024914 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    3345948 ( 99999 )
    3307867 ( 99999 )
    16483279 ( 99999 )
    50254284 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    6176469 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    ( )
    Notes
    [41] - Only participants with available serum time-concentration data evaluated
    No statistical analyses for this end point

    Secondary: Ctau: Observed serum concentration at the end of a dosing interval when intensive samples are collected

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    End point title
    Ctau: Observed serum concentration at the end of a dosing interval when intensive samples are collected
    End point description
    The observed serum concentration at the end of a dosing interval when intensive samples are collected was measured after dosing to assess the pharmacokinetics of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab Note: 99999 = N/A
    End point type
    Secondary
    End point timeframe
    Cycle 1-9 timepoints can include (Pre-dose, 0.30, 4, 24, 72, 168, 336, 696 hours post dose)
    End point values
    Part 1: BMS 20 mg Q2W Part 1: BMS 40 mg Q2W Part 1: BMS 80 mg Q2W Part 1: BMS 160 mg Q2W Part 1: BMS 320 mg Q2W Part 2 BMS 20 mg + Nivo 240 mg Q2W Part 2: BMS 40 mg + Nivo 240 mg Q2W Part 2: BMS 80 mg + Nivo 240 mg Q2W Part 2: BMS 160 mg + Nivo 240 mg Q2W Part 2: BMS 320 mg + Nivo 240 mg Q2W Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC) Part 4: BMS 80 mg + Nivo 480mg Q4W Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W Part 6A:BMS40mg+Nivo 240mg+Ipi 1mg/kgQ3W/BMS 40mg+Nivo480mgQ4W Part6B:BMS40mg+Nivo240 mg+Ipi1mg/kgQ3W/BMS 40 mg+Nivo480 mgQ4W Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W Part 8: Cohort 3- BMS 80 mg Q12W + Nivo 480 mg Q4W Part 8: Cohort 4- Nivo 480 mg Q4W Part 9: BMS 40 mg Q4W + Nivo 480 mg Q4W + DRibble Vaccine
    Number of subjects analysed
    4
    4
    4
    4
    4
    7
    8
    12
    8
    8
    4
    10
    7
    8
    6
    18
    12
    6
    7
    1
    6
    9
    2
    2
    2
    2
    0 [42]
    Units: NG/ML
    geometric mean (geometric coefficient of variation)
        CYCLE 1 DAY 1
    657 ( 99999 )
    2577 ( 99999 )
    5354 ( 99999 )
    10852 ( 99999 )
    16514 ( 99999 )
    756 ( 99999 )
    1904 ( 99999 )
    3598 ( 99999 )
    10413 ( 99999 )
    18596 ( 99999 )
    885 ( 99999 )
    604 ( 99999 )
    2335 ( 99999 )
    3059 ( 99999 )
    7739 ( 99999 )
    3928 ( 99999 )
    544 ( 99999 )
    1725 ( 99999 )
    790 ( 99999 )
    99999 ( 99999 )
    1535 ( 99999 )
    1533 ( 99999 )
    0.004 ( 99999 )
    42.9 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    ( )
        CYCLE 4 DAY 1
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    2527 ( 99999 )
    99999 ( 99999 )
    7729 ( 99999 )
    32982 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    1262 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    6906 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    ( )
        CYCLE 5 DAY 1
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    1412 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    ( )
        CYCLE 9 DAY 1
    99999 ( 99999 )
    99999 ( 99999 )
    6470 ( 99999 )
    33600 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    5510 ( 99999 )
    5686 ( 99999 )
    34303 ( 99999 )
    131520 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    13400 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    ( )
    Notes
    [42] - Only participants with available serum time-concentration data evaluated
    No statistical analyses for this end point

    Secondary: CLT: Total body clearance

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    End point title
    CLT: Total body clearance
    End point description
    The total body clearance was measured after dosing to assess the pharmacokinetics of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab Note: 99999 = N/A
    End point type
    Secondary
    End point timeframe
    Cycle 1-9 timepoints can include (Pre-dose, 0.30, 4, 24, 72, 168, 336, 696 hours post dose)
    End point values
    Part 1: BMS 20 mg Q2W Part 1: BMS 40 mg Q2W Part 1: BMS 80 mg Q2W Part 1: BMS 160 mg Q2W Part 1: BMS 320 mg Q2W Part 2 BMS 20 mg + Nivo 240 mg Q2W Part 2: BMS 40 mg + Nivo 240 mg Q2W Part 2: BMS 80 mg + Nivo 240 mg Q2W Part 2: BMS 160 mg + Nivo 240 mg Q2W Part 2: BMS 320 mg + Nivo 240 mg Q2W Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC) Part 4: BMS 80 mg + Nivo 480mg Q4W Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W Part 6A:BMS40mg+Nivo 240mg+Ipi 1mg/kgQ3W/BMS 40mg+Nivo480mgQ4W Part6B:BMS40mg+Nivo240 mg+Ipi1mg/kgQ3W/BMS 40 mg+Nivo480 mgQ4W Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W Part 8: Cohort 3- BMS 80 mg Q12W + Nivo 480 mg Q4W Part 8: Cohort 4- Nivo 480 mg Q4W Part 9: BMS 40 mg Q4W + Nivo 480 mg Q4W + DRibble Vaccine
    Number of subjects analysed
    4
    4
    4
    4
    4
    7
    8
    12
    8
    8
    4
    10
    7
    8
    6
    18
    12
    6
    7
    1
    6
    9
    2
    2
    2
    2
    0 [43]
    Units: L/H
    geometric mean (geometric coefficient of variation)
        CYCLE 4 DAY 1
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    0.018 ( 99999 )
    99999 ( 99999 )
    0.013 ( 99999 )
    0.011 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    0.022 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    0.011 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    ( )
        CYCLE 5 DAY 1
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    0.024 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    ( )
        CYCLE 9 DAY 1
    99999 ( 99999 )
    99999 ( 99999 )
    0.020 ( 99999 )
    0.012 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    0.012 ( 99999 )
    0.024 ( 99999 )
    0.010 ( 99999 )
    0.006 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    0.013 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    ( )
    Notes
    [43] - Only participants with available serum time-concentration data evaluated
    No statistical analyses for this end point

    Secondary: Css-avg: Average concentration over a dosing interval (AUC(TAU)/tau)

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    End point title
    Css-avg: Average concentration over a dosing interval (AUC(TAU)/tau)
    End point description
    The average concentration over a dosing interval (AUC(TAU)/tau) was measured after dosing to assess the pharmacokinetics of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab Note: 99999 = N/A
    End point type
    Secondary
    End point timeframe
    Cycle 1-9 timepoints can include (Pre-dose, 0.30, 4, 24, 72, 168, 336, 696 hours post dose)
    End point values
    Part 1: BMS 20 mg Q2W Part 1: BMS 40 mg Q2W Part 1: BMS 80 mg Q2W Part 1: BMS 160 mg Q2W Part 1: BMS 320 mg Q2W Part 2 BMS 20 mg + Nivo 240 mg Q2W Part 2: BMS 40 mg + Nivo 240 mg Q2W Part 2: BMS 80 mg + Nivo 240 mg Q2W Part 2: BMS 160 mg + Nivo 240 mg Q2W Part 2: BMS 320 mg + Nivo 240 mg Q2W Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC) Part 4: BMS 80 mg + Nivo 480mg Q4W Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W Part 6A:BMS40mg+Nivo 240mg+Ipi 1mg/kgQ3W/BMS 40mg+Nivo480mgQ4W Part6B:BMS40mg+Nivo240 mg+Ipi1mg/kgQ3W/BMS 40 mg+Nivo480 mgQ4W Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W Part 8: Cohort 3- BMS 80 mg Q12W + Nivo 480 mg Q4W Part 8: Cohort 4- Nivo 480 mg Q4W Part 9: BMS 40 mg Q4W + Nivo 480 mg Q4W + DRibble Vaccine
    Number of subjects analysed
    4
    4
    4
    4
    4
    7
    8
    12
    8
    8
    4
    10
    7
    8
    6
    18
    12
    6
    7
    1
    6
    9
    2
    2
    2
    2
    0 [44]
    Units: NG/ML
    geometric mean (geometric coefficient of variation)
        CYCLE 4 DAY 1
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    4379 ( 99999 )
    99999 ( 99999 )
    25131 ( 99999 )
    55386 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    3715 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    10739 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    ( )
        CYCLE 5 DAY 1
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    4964 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    ( )
        CYCLE 9 DAY 1
    99999 ( 99999 )
    99999 ( 99999 )
    11826 ( 99999 )
    45155 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    9746 ( 99999 )
    9903 ( 99999 )
    45878 ( 99999 )
    148579 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    19538 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    ( )
    Notes
    [44] - Only participants with available serum time-concentration data evaluated
    No statistical analyses for this end point

    Secondary: AI: Accumulation Index. Ratio of an exposure measure at steady state (Cmax)

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    End point title
    AI: Accumulation Index. Ratio of an exposure measure at steady state (Cmax)
    End point description
    The ratio of an exposure measure at steady state to that after the first dose was measured after dosing to assess the pharmacokinetics of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab Note: 99999 = N/A
    End point type
    Secondary
    End point timeframe
    Cycle 1-9 timepoints can include (Pre-dose, 0.30, 4, 24, 72, 168, 336, 696 hours post dose)
    End point values
    Part 1: BMS 20 mg Q2W Part 1: BMS 40 mg Q2W Part 1: BMS 80 mg Q2W Part 1: BMS 160 mg Q2W Part 1: BMS 320 mg Q2W Part 2 BMS 20 mg + Nivo 240 mg Q2W Part 2: BMS 40 mg + Nivo 240 mg Q2W Part 2: BMS 80 mg + Nivo 240 mg Q2W Part 2: BMS 160 mg + Nivo 240 mg Q2W Part 2: BMS 320 mg + Nivo 240 mg Q2W Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC) Part 4: BMS 80 mg + Nivo 480mg Q4W Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W Part 6A:BMS40mg+Nivo 240mg+Ipi 1mg/kgQ3W/BMS 40mg+Nivo480mgQ4W Part6B:BMS40mg+Nivo240 mg+Ipi1mg/kgQ3W/BMS 40 mg+Nivo480 mgQ4W Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W Part 8: Cohort 3- BMS 80 mg Q12W + Nivo 480 mg Q4W Part 8: Cohort 4- Nivo 480 mg Q4W Part 9: BMS 40 mg Q4W + Nivo 480 mg Q4W + DRibble Vaccine
    Number of subjects analysed
    4
    4
    4
    4
    4
    7
    8
    12
    8
    8
    4
    10
    7
    8
    6
    18
    12
    6
    7
    1
    6
    9
    2
    2
    2
    2
    0 [45]
    Units: NG/ML
    geometric mean (geometric coefficient of variation)
        CYCLE 4 DAY 1
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    0.793 ( 99999 )
    1.05 ( 99999 )
    1.67 ( 99999 )
    1.40 ( 99999 )
    1.52 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    1.32 ( 99999 )
    1.03 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    1.21 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    ( )
        CYCLE 5 DAY 1
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    1.02 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    ( )
        CYCLE 9 DAY 1
    99999 ( 99999 )
    99999 ( 99999 )
    1.45 ( 99999 )
    1.89 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    1.40 ( 99999 )
    1.29 ( 99999 )
    1.83 ( 99999 )
    2.56 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    1.66 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    ( )
    Notes
    [45] - Only participants with available serum time-concentration data evaluated
    No statistical analyses for this end point

    Secondary: AI: Accumulation Index. Ratio of an exposure measure at steady state (AUC)

    Close Top of page
    End point title
    AI: Accumulation Index. Ratio of an exposure measure at steady state (AUC)
    End point description
    The ratio of an exposure measure at steady state to that after the first dose was measured after dosing to assess the pharmacokinetics of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab Note: 99999 = N/A
    End point type
    Secondary
    End point timeframe
    Cycle 1-9 timepoints can include (Pre-dose, 0.30, 4, 24, 72, 168, 336, 696 hours post dose)
    End point values
    Part 1: BMS 20 mg Q2W Part 1: BMS 40 mg Q2W Part 1: BMS 80 mg Q2W Part 1: BMS 160 mg Q2W Part 1: BMS 320 mg Q2W Part 2 BMS 20 mg + Nivo 240 mg Q2W Part 2: BMS 40 mg + Nivo 240 mg Q2W Part 2: BMS 80 mg + Nivo 240 mg Q2W Part 2: BMS 160 mg + Nivo 240 mg Q2W Part 2: BMS 320 mg + Nivo 240 mg Q2W Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC) Part 4: BMS 80 mg + Nivo 480mg Q4W Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W Part 6A:BMS40mg+Nivo 240mg+Ipi 1mg/kgQ3W/BMS 40mg+Nivo480mgQ4W Part6B:BMS40mg+Nivo240 mg+Ipi1mg/kgQ3W/BMS 40 mg+Nivo480 mgQ4W Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W Part 8: Cohort 3- BMS 80 mg Q12W + Nivo 480 mg Q4W Part 8: Cohort 4- Nivo 480 mg Q4W Part 9: BMS 40 mg Q4W + Nivo 480 mg Q4W + DRibble Vaccine
    Number of subjects analysed
    4
    4
    4
    4
    4
    7
    8
    12
    8
    8
    4
    10
    7
    8
    6
    18
    12
    6
    7
    1
    6
    9
    2
    2
    2
    2
    0 [46]
    Units: H*NG/ML
    geometric mean (geometric coefficient of variation)
        CYCLE 4 DAY 1
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    1.28 ( 99999 )
    99999 ( 99999 )
    1.56 ( 99999 )
    1.77 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    0.000 ( 99999 )
    1.37 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    2.13 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    ( )
        CYCLE 5 DAY 1
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    1.21 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    ( )
        CYCLE 9 DAY 1
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    2.21 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    1.85 ( 99999 )
    0.748 ( 99999 )
    2.78 ( 99999 )
    4.40 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    2.32 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    ( )
    Notes
    [46] - Only participants with available serum time-concentration data evaluated
    No statistical analyses for this end point

    Secondary: AI: Accumulation Index. Ratio of an exposure measure at steady state (Ctau)

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    End point title
    AI: Accumulation Index. Ratio of an exposure measure at steady state (Ctau)
    End point description
    The ratio of an exposure measure at steady state to that after the first dose was measured after dosing to assess the pharmacokinetics of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab Note: 99999 = N/A
    End point type
    Secondary
    End point timeframe
    Cycle 1-9 timepoints can include (Pre-dose, 0.30, 4, 24, 72, 168, 336, 696 hours post dose)
    End point values
    Part 1: BMS 20 mg Q2W Part 1: BMS 40 mg Q2W Part 1: BMS 80 mg Q2W Part 1: BMS 160 mg Q2W Part 1: BMS 320 mg Q2W Part 2 BMS 20 mg + Nivo 240 mg Q2W Part 2: BMS 40 mg + Nivo 240 mg Q2W Part 2: BMS 80 mg + Nivo 240 mg Q2W Part 2: BMS 160 mg + Nivo 240 mg Q2W Part 2: BMS 320 mg + Nivo 240 mg Q2W Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC) Part 4: BMS 80 mg + Nivo 480mg Q4W Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W Part 6A:BMS40mg+Nivo 240mg+Ipi 1mg/kgQ3W/BMS 40mg+Nivo480mgQ4W Part6B:BMS40mg+Nivo240 mg+Ipi1mg/kgQ3W/BMS 40 mg+Nivo480 mgQ4W Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W Part 8: Cohort 3- BMS 80 mg Q12W + Nivo 480 mg Q4W Part 8: Cohort 4- Nivo 480 mg Q4W Part 9: BMS 40 mg Q4W + Nivo 480 mg Q4W + DRibble Vaccine
    Number of subjects analysed
    4
    4
    4
    4
    4
    7
    8
    12
    8
    8
    4
    10
    7
    8
    6
    18
    12
    6
    7
    1
    6
    9
    2
    2
    2
    2
    0 [47]
    Units: NG/ML
    geometric mean (geometric coefficient of variation)
        CYCLE 4 DAY 1
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    1.90 ( 99999 )
    99999 ( 99999 )
    1.22 ( 99999 )
    1.89 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    0.000 ( 99999 )
    2.47 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    2.72 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    ( )
        CYCLE 5 DAY 1
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    1.05 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    ( )
        CYCLE 9 DAY 1
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    2.33 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    2.40 ( 99999 )
    1.22 ( 99999 )
    2.61 ( 99999 )
    7.55 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    3.49 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    ( )
    Notes
    [47] - Only participants with available serum time-concentration data evaluated
    No statistical analyses for this end point

    Secondary: T-HALFeff: Effective elimination half-life that explains the degree of accumulation observed for a specific exposure measure (exposure measure includes AUC(TAU), Cmax)

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    End point title
    T-HALFeff: Effective elimination half-life that explains the degree of accumulation observed for a specific exposure measure (exposure measure includes AUC(TAU), Cmax)
    End point description
    The effective elimination half-life that explains the degree of accumulation observed for a specific exposure measure was measured after dosing to assess the pharmacokinetics of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab Note: 99999 = N/A
    End point type
    Secondary
    End point timeframe
    Cycle 1-9 timepoints can include (Pre-dose, 0.30, 4, 24, 72, 168, 336, 696 hours post dose)
    End point values
    Part 1: BMS 20 mg Q2W Part 1: BMS 40 mg Q2W Part 1: BMS 80 mg Q2W Part 1: BMS 160 mg Q2W Part 1: BMS 320 mg Q2W Part 2 BMS 20 mg + Nivo 240 mg Q2W Part 2: BMS 40 mg + Nivo 240 mg Q2W Part 2: BMS 80 mg + Nivo 240 mg Q2W Part 2: BMS 160 mg + Nivo 240 mg Q2W Part 2: BMS 320 mg + Nivo 240 mg Q2W Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC) Part 4: BMS 80 mg + Nivo 480mg Q4W Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W Part 6A:BMS40mg+Nivo 240mg+Ipi 1mg/kgQ3W/BMS 40mg+Nivo480mgQ4W Part6B:BMS40mg+Nivo240 mg+Ipi1mg/kgQ3W/BMS 40 mg+Nivo480 mgQ4W Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W Part 8: Cohort 3- BMS 80 mg Q12W + Nivo 480 mg Q4W Part 8: Cohort 4- Nivo 480 mg Q4W Part 9: BMS 40 mg Q4W + Nivo 480 mg Q4W + DRibble Vaccine
    Number of subjects analysed
    4
    4
    4
    4
    4
    7
    8
    12
    8
    8
    4
    10
    7
    8
    6
    18
    12
    6
    7
    1
    6
    9
    2
    2
    2
    2
    0 [48]
    Units: Hr
    arithmetic mean (standard deviation)
        CYCLE 4 DAY 1
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    229 ( 40 )
    99999 ( 99999 )
    345 ( 111 )
    429 ( 182 )
    99999 ( 99999 )
    99999 ( 99999 )
    0.000 ( 99999 )
    261 ( 58 )
    99999 ( 99999 )
    99999 ( 99999 )
    146 ( 200 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    ( )
        CYCLE 5 DAY 1
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    447 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    ( )
        CYCLE 9 DAY 1
    99999 ( 99999 )
    99999 ( 99999 )
    0.000 ( 99999 )
    331 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    315 ( 119 )
    0.000 ( 0.000 )
    593 ( 308 )
    607 ( 527 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    312 ( 180 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    ( )
    Notes
    [48] - Only participants with available serum time-concentration data evaluated
    No statistical analyses for this end point

    Secondary: Ctrough: Trough observed plasma concentration

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    End point title
    Ctrough: Trough observed plasma concentration
    End point description
    Trough observed plasma concentration (this includes predose concentrations and Ctau concentrations) was measured after dosing to assess the pharmacokinetics of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab Note: 99999 = N/A
    End point type
    Secondary
    End point timeframe
    Cycle 1-17 timepoints can include (Pre-dose, 336, 504, 672 hours post dose)
    End point values
    Part 1: BMS 20 mg Q2W Part 1: BMS 40 mg Q2W Part 1: BMS 80 mg Q2W Part 1: BMS 160 mg Q2W Part 1: BMS 320 mg Q2W Part 2 BMS 20 mg + Nivo 240 mg Q2W Part 2: BMS 40 mg + Nivo 240 mg Q2W Part 2: BMS 80 mg + Nivo 240 mg Q2W Part 2: BMS 160 mg + Nivo 240 mg Q2W Part 2: BMS 320 mg + Nivo 240 mg Q2W Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC) Part 4: BMS 80 mg + Nivo 480mg Q4W Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W Part 6A:BMS40mg+Nivo 240mg+Ipi 1mg/kgQ3W/BMS 40mg+Nivo480mgQ4W Part6B:BMS40mg+Nivo240 mg+Ipi1mg/kgQ3W/BMS 40 mg+Nivo480 mgQ4W Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W Part 8: Cohort 3- BMS 80 mg Q12W + Nivo 480 mg Q4W Part 8: Cohort 4- Nivo 480 mg Q4W Part 9: BMS 40 mg Q4W + Nivo 480 mg Q4W + DRibble Vaccine
    Number of subjects analysed
    4
    4
    4
    4
    4
    7
    8
    12
    8
    8
    4
    10
    7
    8
    6
    18
    12
    6
    7
    1
    6
    9
    2
    2
    2
    2
    0 [49]
    Units: ng/mL
    geometric mean (geometric coefficient of variation)
        CYCLE 1 DAY 29 0 h
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    ( )
        CYCLE 1 DAY 15 336 h
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    ( )
        CYCLE 2 DAY 1 0 h
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    ( )
        CYCLE 2 DAY 1 336 h
    657 ( 99999 )
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    ( )
        CYCLE 2 DAY 1 504 h
    99999 ( 99999 )
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    ( )
        CYCLE 2 DAY 1 672 h
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    ( )
        CYCLE 3 DAY 1 0 h
    1290 ( 99999 )
    4244 ( 99999 )
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    16974 ( 99999 )
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    614 ( 99999 )
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    5055 ( 99999 )
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    62.5 ( 99999 )
    689 ( 2006 )
    99999 ( 99999 )
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    ( )
        CYCLE 4 DAY 1 0 h
    3420 ( 99999 )
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    ( )
        CYCLE 4 DAY 29 0
    99999 ( 99999 )
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    ( )
        CYCLE 4 DAY 15 336 h
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