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    Clinical Trial Results:
    A Phase 2 Randomized Study of BMS-986207 in Combination with Nivolumab and Ipilimumab as First-line Treatment for Participants with Stage IV Non-Small Cell Lung Cancer

    Summary
    EudraCT number
    		 2021-000039-29
    Trial protocol
    		 BE   DE   ES   PL  
    Global end of trial date
    27 Dec 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    31 Dec 2023
    First version publication date
    31 Dec 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CA020-016
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05005273
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bristol-Myers Squibb
    Sponsor organisation address
    Chaussée de la Hulpe 185, Brussels, Belgium, 1170
    Public contact
    EU Study Start-Up Unit, Bristol-Myers Squibb International Corporation, Clinical.Trials@bms.com
    Scientific contact
    Bristol-Myers Squibb Study Director, Bristol-Myers Squibb, Clinical.Trials@BMS.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    27 Dec 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Dec 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the PFS of BMS-986207 in combination with nivolumab plus ipilimumab versus nivolumab plus ipilimumab.
    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 subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    26 Sep 2022
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 1
    Worldwide total number of subjects
    1
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 1 participant randomized and treated in arm 1. No enrollment in Arm 2 (nivolumab 360mg Q3W Ipilimumab 1mg/kg Q6W Placebo Q3W).

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Subject

    Arms
    Arm title
    		 Treatment 1
    Arm description
    		 nivolumab 360mg Q3W Ipilimumab 1mg/kg Q6W BMS-986207 600mg Q3W
    Arm type
    		 Experimental

    Investigational medicinal product name
    niovolumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravascular use
    Dosage and administration details
    360mg Q3W

    Investigational medicinal product name
    BMS-986207
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravascular use
    Dosage and administration details
    600mg Q3W

    Investigational medicinal product name
    ipilimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravascular use
    Dosage and administration details
    1mg/kg Q6W

    Number of subjects in period 1
    		Treatment 1
    Started
    1
    Completed
    0
    Not completed
    1
         Study Terminated
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment 1
    Reporting group description
    		 nivolumab 360mg Q3W Ipilimumab 1mg/kg Q6W BMS-986207 600mg Q3W

    Reporting group values
    		 Treatment 1 Total
    Number of subjects
    		 1 1
    Age Categorical
    Units: Participants
        <=18 years
    		 0 0
        Between 18 and 65 years
    		 0 0
        >=65 years
    		 1 1
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 65 (65 to 65) -
    Sex: Female, Male
    Units: Participants
        Female
    		 1 1
        Male
    		 0 0
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0
        Asian
    		 0 0
        Native Hawaiian or Other Pacific Islander
    		 0 0
        Black or African American
    		 0 0
        White
    		 1 1
        More than one race
    		 0 0
        Unknown or Not Reported
    		 0 0
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 0 0
        Not Hispanic or Latino
    		 1 1
        Unknown or Not Reported
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    Treatment 1
    Reporting group description
    		 nivolumab 360mg Q3W Ipilimumab 1mg/kg Q6W BMS-986207 600mg Q3W

    Primary: Progression Free Survival by BICR

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    End point title
    		 Progression Free Survival by BICR [1]
    End point description
    PFS is defined for all randomized participants as the date from randomization to the date of the documentation of disease progression by BICR or death due to any cause, whichever is earlier. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. here "99999" means NA
    End point type
    Primary
    End point timeframe
    From first dose to progression or death, 2.3 months
    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: Not enough subjects for statistical analysis
    End point values
    		 Treatment 1
    Number of subjects analysed
    1 [2]
    Units: Months
        arithmetic mean (confidence interval 95%)
    99999 (99999 to 99999)
    Notes
    [2] - no subjects with BICR analysis
    No statistical analyses for this end point

    Secondary: Overall Response Rate (ORR) by BICR

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    End point title
    		 Overall Response Rate (ORR) by BICR
    End point description
    ORR is defined as the percentage of participants with a confirmed Best overall response of Complete Response (CR) or Partial Response (PR) by RECIST v1.1. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. here "99999" means NA
    End point type
    Secondary
    End point timeframe
    From first dose to progression or death, 2.3 months
    End point values
    		 Treatment 1
    Number of subjects analysed
    1 [3]
    Units: Months
        arithmetic mean (confidence interval 95%)
    99999 (99999 to 99999)
    Notes
    [3] - no subjects with CR or PR
    No statistical analyses for this end point

    Secondary: Duration of Response (DOR) by Investigator

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    End point title
    		 Duration of Response (DOR) by Investigator
    End point description
    DOR is defined for participants who have a confirmed CR or PR as the date from first documented CR or PR per RECIST v1.1 to the date of the documentation of disease progression or death due to any cause, whichever is earlier. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. here "99999" means NA
    End point type
    Secondary
    End point timeframe
    From first dose to progression or death, 2.3 months
    End point values
    		 Treatment 1
    Number of subjects analysed
    1 [4]
    Units: Months
        arithmetic mean (confidence interval 95%)
    99999 (99999 to 99999)
    Notes
    [4] - no subjects with CR or PR
    No statistical analyses for this end point

    Secondary: Number of participants who had AEs, SAEs, AEs Leading to discontinuation and Deaths.

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    End point title
    		 Number of participants who had AEs, SAEs, AEs Leading to discontinuation and Deaths.
    End point description
    End point type
    Secondary
    End point timeframe
    From first dose to progression or death, 2.3 months
    End point values
    		 Treatment 1
    Number of subjects analysed
    1
    Units: Participants
        Adverse Events
    0
        Serious Adverse Events
    1
        AEs leading to discontinuation
    0
        Deaths
    1
    No statistical analyses for this end point

    Secondary: Overall Survival (OS)

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    End point title
    		 Overall Survival (OS)
    End point description
    OS is defined as the time from randomization to the time of death due to any cause. Here "99999" means NA
    End point type
    Secondary
    End point timeframe
    From randomization to time of death, 2.3 months
    End point values
    		 Treatment 1
    Number of subjects analysed
    1
    Units: Months
        arithmetic mean (confidence interval 95%)
    2.3 (-99999 to 99999)
    No statistical analyses for this end point

    Secondary: Overall Response Rate (ORR) by Investigator

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    End point title
    		 Overall Response Rate (ORR) by Investigator
    End point description
    ORR is defined as the percentage of participants with a confirmed Best overall response of Complete Response (CR) or Partial Response (PR) by RECIST v1.1. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. here "99999" means NA
    End point type
    Secondary
    End point timeframe
    From first dose to progression or death, 2.3 months
    End point values
    		 Treatment 1
    Number of subjects analysed
    0 [5]
    Units: Months
        arithmetic mean (confidence interval 95%)
    ( to )
    Notes
    [5] - No subjects with CR or PR
    No statistical analyses for this end point

    Secondary: Progression Free Survival by Investigator

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    End point title
    		 Progression Free Survival by Investigator
    End point description
    PFS is defined for all randomized participants as the date from randomization to the date of the documentation of disease progression by BICR or death due to any cause, whichever is earlier. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. here "99999" means NA
    End point type
    Secondary
    End point timeframe
    From first dose to progression or death, 2.3 months
    End point values
    		 Treatment 1
    Number of subjects analysed
    1
    Units: Months
        arithmetic mean (confidence interval 95%)
    2.3 (-99999 to 99999)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events and Serious Adverse Events (From first dose to last dose + 100 days) and All-Cause mortality (From randomization to end of study): 2.3 Months
    Adverse event reporting additional description
    The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    MedDRA25.1
    Reporting groups
    Reporting group title
    Nivolumab 360 mg + Ipilimumab 1 mg/kg + BMS-986207 600 mg
    Reporting group description
    		 -

    Serious adverse events
    		 Nivolumab 360 mg + Ipilimumab 1 mg/kg + BMS-986207 600 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 1 (100.00%)
         number of deaths (all causes)
    1
         number of deaths resulting from adverse events
    Cardiac disorders
    Cardiac arrest
         subjects affected / exposed
    1 / 1 (100.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Infections and infestations
    Sepsis
         subjects affected / exposed
    1 / 1 (100.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Nivolumab 360 mg + Ipilimumab 1 mg/kg + BMS-986207 600 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 1 (100.00%)
    Investigations
    Blood alkaline phosphatase increased
         subjects affected / exposed
    1 / 1 (100.00%)
         occurrences all number
    1
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    1 / 1 (100.00%)
         occurrences all number
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    1 / 1 (100.00%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Eczema
         subjects affected / exposed
    1 / 1 (100.00%)
         occurrences all number
    1
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 1 (100.00%)
         occurrences all number
    2
    Metabolism and nutrition disorders
    Hypoalbuminaemia
         subjects affected / exposed
    1 / 1 (100.00%)
         occurrences all number
    1
    Hypokalaemia
         subjects affected / exposed
    1 / 1 (100.00%)
         occurrences all number
    1
    Hyponatraemia
         subjects affected / exposed
    1 / 1 (100.00%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    13 Jun 2022
    The study design has been updated from double-blind randomized assignment to single-blind randomized assignment. Investigators, site staff, and participants will be blinded to BMS-986207 treatment assignment. Data Monitoring Committee (DMC) and Sponsor will be unblinded to treatment assignment to monitor safety

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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