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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
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

CA012-004

ISRCTN number

US NCT number

WHO universal trial number (UTN)

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

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

01 Sep 2021

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

02 Nov 2020

Was the trial ended prematurely?

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

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

United States: 68

Country: Number of subjects enrolled

Canada: 27

Country: Number of subjects enrolled

Israel: 2

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

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

100

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

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 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Top of page

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

Reporting group title

Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W

Reporting group description

Reporting group title

Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W

Reporting group description

Reporting group title

Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W

Reporting group description

Reporting group title

Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W

Reporting group description

Reporting group title

Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC)

Reporting group description

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

Reporting group title

Part6B:BMS40mg+Nivo240 mg+Ipi1mg/kgQ3W/BMS 40 mg+Nivo480 mgQ4W

Reporting group description

Reporting group title

Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W

Reporting group description

Reporting group title

Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W

Reporting group description

Reporting group title

Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W

Reporting group description

Reporting group title

Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W

Reporting group description

Reporting group title

Part 8: Cohort 3- BMS 80 mg Q12W + Nivo 480 mg Q4W

Reporting group description

Reporting group title

Part 8: Cohort 4- Nivo 480 mg Q4W

Reporting group description

Reporting group title

Part 9: BMS 40 mg Q4W + Nivo 480 mg Q4W + DRibble Vaccine

Reporting group description

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

Top of page

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

Reporting group title

Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W

Reporting group description

Reporting group title

Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W

Reporting group description

Reporting group title

Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W

Reporting group description

Reporting group title

Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W

Reporting group description

Reporting group title

Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC)

Reporting group description

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

Reporting group title

Part6B:BMS40mg+Nivo240 mg+Ipi1mg/kgQ3W/BMS 40 mg+Nivo480 mgQ4W

Reporting group description

Reporting group title

Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W

Reporting group description

Reporting group title

Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W

Reporting group description

Reporting group title

Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W

Reporting group description

Reporting group title

Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W

Reporting group description

Reporting group title

Part 8: Cohort 3- BMS 80 mg Q12W + Nivo 480 mg Q4W

Reporting group description

Reporting group title

Part 8: Cohort 4- Nivo 480 mg Q4W

Reporting group description

Reporting group title

Part 9: BMS 40 mg Q4W + Nivo 480 mg Q4W + DRibble Vaccine

Reporting group description

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)

Top of page

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)

Top of page

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

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

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

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 )

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

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

Units: Percent of Participants

number (confidence interval 95%)

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)

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

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

CYCLE 4 DAY 1

99999 ± 99999

8960 ± 99999

10273 ± 99999

20900 ± 99999

69922 ± 99999

117839 ± 99999

99999 ± 99999

31800 ± 99999

11261 ± 99999

99999 ± 99999

14143 ± 99999

99999 ± 99999

CYCLE 5 DAY 1

99999 ± 99999

16912 ± 99999

99999 ± 99999

CYCLE 9 DAY 1

99999 ± 99999

23200 ± 99999

61500 ± 99999

99999 ± 99999

17392 ± 99999

23097 ± 99999

72991 ± 99999

207853 ± 99999

99999 ± 99999

30922 ± 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)

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

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)

( to )

CYCLE 4 DAY 1

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)

4.03 (4.03 to 4.03)

0.517 (0.500 to 0.583)

99999 (99999 to 99999)

0.467 (0.000 to 4.00)

99999 (99999 to 99999)

( to )

CYCLE 5 DAY 1

99999 (99999 to 99999)

0.550 (0.517 to 0.583)

99999 (99999 to 99999)

( to )

CYCLE 9 DAY 1

99999 (99999 to 99999)

0.467 (0.467 to 0.467)

22.7 (22.7 to 22.7)

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)

3.94 (0.500 to 4.03)

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)

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

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

CYCLE 4 DAY 1

99999 ± 99999

773957 ± 99999

2210404 ± 99999

2400433 ± 99999

10729551 ± 99999

23851864 ± 99999

99999 ± 99999

2699238 ± 99999

1837861 ± 99999

99999 ± 99999

504998 ± 99999

99999 ± 99999

CYCLE 5 DAY 1

99999 ± 99999

2520673 ± 99999

99999 ± 99999

CYCLE 9 DAY 1

99999 ± 99999

3952990 ± 99999

13024914 ± 99999

99999 ± 99999

2971409 ± 99999

1247687 ± 99999

16483279 ± 99999

28499982 ± 99999

99999 ± 99999

4537054 ± 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)

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

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

CYCLE 4 DAY 1

99999 ± 99999

2210404 ± 99999

99999 ± 99999

12666237 ± 99999

27936423 ± 99999

99999 ± 99999

1837861 ± 99999

99999 ± 99999

3590883 ± 99999

99999 ± 99999

CYCLE 5 DAY 1

99999 ± 99999

3335668 ± 99999

99999 ± 99999

CYCLE 9 DAY 1

99999 ± 99999

3952990 ± 99999

13024914 ± 99999

99999 ± 99999

3345948 ± 99999

3307867 ± 99999

16483279 ± 99999

50254284 ± 99999

99999 ± 99999

6176469 ± 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)

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

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

CYCLE 4 DAY 1

99999 ± 99999

2527 ± 99999

99999 ± 99999

7729 ± 99999

32982 ± 99999

99999 ± 99999

1262 ± 99999

99999 ± 99999

6906 ± 99999

99999 ± 99999

CYCLE 5 DAY 1

99999 ± 99999

1412 ± 99999

99999 ± 99999

CYCLE 9 DAY 1

99999 ± 99999

6470 ± 99999

33600 ± 99999

99999 ± 99999

5510 ± 99999

5686 ± 99999

34303 ± 99999

131520 ± 99999

99999 ± 99999

13400 ± 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)

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

0 ^[43]

Units: L/H

geometric mean (geometric coefficient of variation)

CYCLE 4 DAY 1

99999 ± 99999

0.018 ± 99999

99999 ± 99999

0.013 ± 99999

0.011 ± 99999

99999 ± 99999

0.022 ± 99999

99999 ± 99999

0.011 ± 99999

99999 ± 99999

CYCLE 5 DAY 1

99999 ± 99999

0.024 ± 99999

99999 ± 99999

CYCLE 9 DAY 1

99999 ± 99999

0.020 ± 99999

0.012 ± 99999

99999 ± 99999

0.012 ± 99999

0.024 ± 99999

0.010 ± 99999

0.006 ± 99999

99999 ± 99999

0.013 ± 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)

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

0 ^[44]

Units: NG/ML

geometric mean (geometric coefficient of variation)

CYCLE 4 DAY 1

99999 ± 99999

4379 ± 99999

99999 ± 99999

25131 ± 99999

55386 ± 99999

99999 ± 99999

3715 ± 99999

99999 ± 99999

10739 ± 99999

99999 ± 99999

CYCLE 5 DAY 1

99999 ± 99999

4964 ± 99999

99999 ± 99999

CYCLE 9 DAY 1

99999 ± 99999

11826 ± 99999

45155 ± 99999

99999 ± 99999

9746 ± 99999

9903 ± 99999

45878 ± 99999

148579 ± 99999

99999 ± 99999

19538 ± 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)

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

0 ^[45]

Units: NG/ML

geometric mean (geometric coefficient of variation)

CYCLE 4 DAY 1

99999 ± 99999

0.793 ± 99999

1.05 ± 99999

1.67 ± 99999

1.40 ± 99999

1.52 ± 99999

99999 ± 99999

1.32 ± 99999

1.03 ± 99999

99999 ± 99999

1.21 ± 99999

99999 ± 99999

CYCLE 5 DAY 1

99999 ± 99999

1.02 ± 99999

99999 ± 99999

CYCLE 9 DAY 1

99999 ± 99999

1.45 ± 99999

1.89 ± 99999

99999 ± 99999

1.40 ± 99999

1.29 ± 99999

1.83 ± 99999

2.56 ± 99999

99999 ± 99999

1.66 ± 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)

Top of page

End point title

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

End point description

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)

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

0 ^[46]

Units: H*NG/ML

geometric mean (geometric coefficient of variation)

CYCLE 4 DAY 1

99999 ± 99999

1.28 ± 99999

99999 ± 99999

1.56 ± 99999

1.77 ± 99999

99999 ± 99999

0.000 ± 99999

1.37 ± 99999

99999 ± 99999

2.13 ± 99999

99999 ± 99999

CYCLE 5 DAY 1

99999 ± 99999

1.21 ± 99999

99999 ± 99999

CYCLE 9 DAY 1

99999 ± 99999

2.21 ± 99999

99999 ± 99999

1.85 ± 99999

0.748 ± 99999

2.78 ± 99999

4.40 ± 99999

99999 ± 99999

2.32 ± 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)

Top of page

End point title

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

End point description

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)

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

0 ^[47]

Units: NG/ML

geometric mean (geometric coefficient of variation)

CYCLE 4 DAY 1

99999 ± 99999

1.90 ± 99999

99999 ± 99999

1.22 ± 99999

1.89 ± 99999

99999 ± 99999

0.000 ± 99999

2.47 ± 99999

99999 ± 99999

2.72 ± 99999

99999 ± 99999

CYCLE 5 DAY 1

99999 ± 99999

1.05 ± 99999

99999 ± 99999

CYCLE 9 DAY 1

99999 ± 99999

2.33 ± 99999

99999 ± 99999

2.40 ± 99999

1.22 ± 99999

2.61 ± 99999

7.55 ± 99999

99999 ± 99999

3.49 ± 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)

Top of page

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)

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

0 ^[48]

Units: Hr

arithmetic mean (standard deviation)

CYCLE 4 DAY 1

99999 ± 99999

229 ± 40

99999 ± 99999

345 ± 111

429 ± 182

99999 ± 99999

0.000 ± 99999

261 ± 58

99999 ± 99999

146 ± 200

99999 ± 99999

CYCLE 5 DAY 1

99999 ± 99999

447 ± 99999

99999 ± 99999

CYCLE 9 DAY 1

99999 ± 99999

0.000 ± 99999

331 ± 99999

99999 ± 99999

315 ± 119

0.000 ± 0.000

593 ± 308

607 ± 527

99999 ± 99999

312 ± 180

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

Top of page

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)

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

0 ^[49]

Units: ng/mL

geometric mean (geometric coefficient of variation)

CYCLE 1 DAY 29 0 h

99999 ± 99999

1354 ± 99999

1108 ± 99999

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Clinical trials

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

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Primary: The Number of Participant Deaths

Primary: The Number of Participant Deaths

Secondary: Objective Response Rate (ORR)

Secondary: Objective Response Rate (ORR)

Secondary: Duration of Response (DOR)

Secondary: Duration of Response (DOR)

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

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

Secondary: Cmax: Maximum observed serum concentration

Secondary: Cmax: Maximum observed serum concentration

Secondary: Tmax: Time of maximum observed serum concentration

Secondary: Tmax: Time of maximum observed serum concentration

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

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

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

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

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

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

Secondary: CLT: Total body clearance

Secondary: CLT: Total body clearance

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

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

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

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

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

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

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

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

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)

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)

Secondary: Ctrough: Trough observed plasma concentration

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