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An Investigational Study of Immunotherapy Combinations With Chemotherapy in Patients With Gastric or Gastroesophageal Junction (GEJ) Cancers

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03662659
Collaborator
(none)
274
Enrollment
78
Locations
2
Arms
73.5
Anticipated Duration (Months)
3.5
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the efficacy and safety of investigational drug relatlimab plus nivolumab in combination with chemotherapy in participants with unresectable, untreated, locally advanced or metastatic gastric or GEJ cancer.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
274 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized, Open-label, Phase II Clinical Trial of Relatlimab (Anti-LAG-3) and Nivolumab in Combination With Chemotherapy Versus Nivolumab in Combination With Chemotherapy as First-Line Treatment in Patients With Gastric or Gastroesophageal Junction Adenocarcinoma
Actual Study Start Date :
Oct 16, 2018
Actual Primary Completion Date :
Aug 27, 2020
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: BMS-986213 + investigator's choice chemotherapy

BMS-986213 + XELOX or BMS-986213 + FOLFOX or BMS-986213 + SOX

Biological: BMS-986213
Relatlimab + Nivolumab specified dose on specified days

Biological: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
  • BMS-936558

    • Drug: XELOX
    Oxaliplatin + capecitabine

    Drug: FOLFOX
    Oxaliplatin + leucovorin + fluorouracil

    Drug: SOX
    Oxaliplatin + tegafur/gimeracil/oteracil potassium
    Experimental: Nivolumab + investigator's choice chemotherapy

    Nivolumab + XELOX or Nivolumab + FOLFOX or Nivolumab + SOX

    Biological: Nivolumab
    Specified dose on specified days
    Other Names:
  • Opdivo
  • BMS-936558

    • Drug: XELOX
    Oxaliplatin + capecitabine

    Drug: FOLFOX
    Oxaliplatin + leucovorin + fluorouracil

    Drug: SOX
    Oxaliplatin + tegafur/gimeracil/oteracil potassium

    Outcome Measures

    Primary Outcome Measures

    1. BICR-Assessed Objective Response Rate (ORR) in Randomized LAG-3 Positive (>=1 %) Participants [Up to 25 months]

      The number of LAG-3 Positive (>=1%) participants with a Best Overall Response (BOR) of confirmed Complete Response (CR) or Partial Response (PR) divided by the number of randomized LAG-3 positive (>=1%) participants in each arm; recorded between randomization date and the date of objectively documented progression [per RECISIT 1.1], death due to any cause, or date of subsequent anticancer therapy, whichever occurs first. CR= Disappearance of all target lesions PR= At least a 30% decrease in the sum of diameters of target lesions

    Secondary Outcome Measures

    1. Objective Response Rate (ORR) [Up to 25 months]

      Objective response rate (ORR) based on Blinded Independent Central Review (BICR) and Investigator assessments is defined as the number of participants with a Best Overall Response (BOR) of confirmed Complete Response (CR) or Partial Response (PR) divided by the number of randomized participants in each arm; recorded between randomization date and the date of objectively documented progression [per RECISIT 1.1], death due to any cause, or date of subsequent anticancer therapy, whichever occurs first.

    2. Duration of Response (DOR) [Up to 25 months]

      Duration of Response (DOR) based on Blinded Independent Central Review (BICR) and investigator is defined as the time between the date of first documented response (complete response or partial response) and the date of the first disease progression, per RECIST 1.1, or death due to any cause, or date of subsequent anticancer therapy, whichever occurs first.

    3. Overall Survival (OS) [Up to 25 months]

      Overall Survival (OS) is defined as the time between the date of randomization and the date of death due to any cause. For those without documentation of death, OS will be censored on the last date the participant was known to be alive.

    4. Progression-Free Survival (PFS) [Up to 25 months]

      Progression-Free Survival (PFS) per Blinded Independent Central Review (BICR) and Investigator is defined as the time between the date of randomization and the first date of documented progression, or death due to any cause, or date of subsequent anticancer therapy, whichever occurs first. Participants who die without a reported prior progression (and die without start of subsequent therapy) will be considered to have progressed on the date of death.

    5. Number of Participants With Adverse Events (AEs) [From first dose to 30 days post last dose (Up to 23 months)]

      Number of participants with any grade adverse events (AEs), serious adverse events (SAE), and adverse events leading to discontinuation using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v 5.0) to assess the overall safety and tolerability of BMS-986213 in combination with chemotherapy vs. Nivolumab in combination with chemotherapy.

    6. Number of Deaths [Up to 25 months]

      Number of deaths in each arm to assess the overall safety and tolerability of BMS-986213 in combination with chemotherapy vs. Nivolumab in combination with chemotherapy.

    7. Number of Participants With Laboratory Abnormalities in Specific Liver Tests [From first dose to up to 30 days post last dose (Up to 23 months)]

      Number of participants with laboratory abnormalities in specific liver tests based on US conventional units to assess the overall safety and tolerability of BMS-986213 in combination with chemotherapy vs. Nivolumab in combination with chemotherapy. The number of participants with the following laboratory abnormalities from on-treatment evaluations will be summarized: ALT or AST > 3 x ULN, > 5 x ULN, > 10 x ULN and > 20 x ULN Total bilirubin > 2 x ULN ALP > 1.5 x ULN Concurrent (within 1 day) ALT or AST > 3 x ULN and total bilirubin > 1.5 x ULN Concurrent (within 30 days) ALT or AST > 3 x ULN and total bilirubin > 1.5 x ULN Concurrent (within 1 day) ALT or AST > 3 x ULN and total bilirubin > 2 x ULN Concurrent (within 30 days) ALT or AST > 3 x ULN and total bilirubin > 2 x ULN

    8. Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests [From first dose to up to 30 days post last dose (Up to 23 months)]

      Number of participants with laboratory abnormalities in specific thyroid tests based on US conventional units. The number of participants with the following laboratory abnormalities from on-treatment evaluations will be summarized: TSH value > ULN and with baseline TSH value <= ULN with at least one FT3/FT4 test value < LLN within 2-week window after the abnormal TSH test with all FT3/FT4 test values >= LLN within 2-week window after the abnormal TSH test with FT3/FT4 missing within 2-week window after the abnormal TSH test. TSH < LLN and with baseline TSH value >= LLN with at least one FT3/FT4 test value > ULN within 2-week window after the abnormal TSH test with all FT3/FT4 test values <= ULN within 2-week window after the abnormal TSH test with FT3/FT4 missing within 2-week window after the abnormal TSH test

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

    Inclusion Criteria:

    • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

    • Histologically- or cytologically-confirmed diagnosis of unresectable and either locally advanced, or metastatic gastric cancer or GEJ adenocarcinoma

    • No prior treatment with systemic treatment (including HER 2 inhibitors) given as primary therapy for unresectable and either locally advanced, or metastatic GC or GEJ adenocarcinoma

    • Tumor tissue must be provided for biomarker analyses

    Exclusion Criteria:

    • Participants with HER2 positive status

    • Participants with known untreated central nervous system (CNS) metastases

    • Uncontrolled or significant cardiovascular disease

    Other protocol defined inclusion/exclusion criteria could apply

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Local Institution - 0049 Clovis California United States 93611
    2 City Of Hope National Medical Center Duarte California United States 91010
    3 Scripps Clinic La Jolla California United States 92037
    4 Local Institution - 0040 Los Angeles California United States 90033
    5 Hoag Memorial Hospital Presbyterian Newport Beach California United States 92663
    6 Local Institution - 0041 Orange California United States 92868
    7 Ucla Santa Monica California United States 90404
    8 Local Institution - 0056 Aurora Colorado United States 80045
    9 Yale University School Of Medicine New Haven Connecticut United States 06520
    10 Local Institution - 0050 Hackensack New Jersey United States 07601
    11 Local Institution - 0054 Dallas Texas United States 75216
    12 Local Institution Richmond Virginia United States 23230
    13 Local Institution - 0052 Seattle Washington United States 98109
    14 Hospital Britanico De Buenos Aires Ciudad Autónoma de Buenos Aires Buenos Aires Argentina 1280
    15 Local Institution - 0009 Buenos Aires Argentina 1093
    16 Instituto Medico Especialazado Alexander Fleming Caba Argentina 1426
    17 Centro Medico San Roque Tucuman Argentina 4000
    18 Local Institution - 0027 Westmead New South Wales Australia 2145
    19 Local Institution - 0007 Herston Queensland Australia 4029
    20 Local Institution - 0003 Heidelberg Victoria Australia 3084
    21 Local Institution Malvern Victoria Australia 3144
    22 St John of God Murdoch Hospital Murdoch Western Australia Australia 6150
    23 Local Institution Bedford Park Australia 5024
    24 Local Institution Graz Austria 8036
    25 Medizinische Universtaet Wien Wien Austria 1090
    26 Local Institution Bruxelles Belgium 1200
    27 Local Institution - 0092 Leuven Belgium 3000
    28 Local Institution Kelowna British Columbia Canada V1Y 5L3
    29 Local Institution Halifax Nova Scotia Canada B3H 2Y9
    30 Local Institution Toronto Ontario Canada M5G 2M9
    31 Local Institution Trois-Rivieres Quebec Canada G8Z 3R9
    32 Local Institution Quebec Canada G1R 2J6
    33 Local Institution Rancagua L.g.bernardoohiggins Chile
    34 Local Institution Santiago Metropolitana Chile
    35 Oncocentro Apys Vina del Mar Valparaiso Chile 2520598
    36 Clinica San Carlos de Apoquindo Santiago Chile
    37 Klinika komplexni onkologicke pece Brno Czechia 656 53
    38 Onkologicka klinika Olomouc Czechia 779 00
    39 Institut Sainte Catherine Avignon Cedex 9 France 84918
    40 Chu Jean Minjoz Besancon Cedex France 25030
    41 Centre Georges-Francois Leclerc Dijon France 21000
    42 Institut du Cancer de Montpellier Montpellier France 34090
    43 Hopital Saint Louis Paris France 75010
    44 Local Institution - 0072 Paris France 75012
    45 Hopital Charles Nicolle C H U Rouen Rouen Cedex France 76031
    46 Local Institution Cologne Germany 50937
    47 Universitatsklinikum Carl Gustav Carus Dresden Dresden Germany 01307
    48 Klinik Essen-Mitte Essen Germany 45136
    49 University Hospital Essen Essen Germany 45147
    50 Krankenhaus Nordwest Frankfurt Germany 60488
    51 Local Institution - 0018 Hamburg Germany 20249
    52 Medizinische Hochschule Hannover Hannover Germany 30625
    53 Local Institution - 0013 Heidelberg Germany 69120
    54 Local Institution - 0015 Mannheim Germany 68167
    55 Universitaets-Klinikum Marburg Marburg Germany 35043
    56 Local Institution Milano Italy 20132
    57 Local Institution Milano Italy 20133
    58 Local Institution Roma Italy 00168
    59 Local Institution Bergen Norway 5021
    60 Local Institution Oslo Norway 0450
    61 Local Institution Trondheim Norway 7030
    62 Local Institution - 0093 Warszawa Poland 02-034
    63 Local Institution San Juan Puerto Rico 00927
    64 Local Institution Singapore Singapore 169610
    65 Hospital Infanta Cristina Badajoz Spain 06080
    66 Local Institution Barcelona Spain 08035
    67 Local Institution Barcelona Spain 08036
    68 Local Institution Bilbao Spain 48013
    69 Local Institution Madrid Spain 28007
    70 Local Institution Madrid Spain 28046
    71 Hospital Univ. Miguel Servet Zaragoza Spain 50009
    72 Local Institution Manchester Greater Manchester United Kingdom M20 4BX
    73 Local Institution Nottingham Nottinghamshire United Kingdom NG5 1PB
    74 Local Institution Coventry West Midlands United Kingdom CV2 2DX
    75 Local Institution Lancaster United Kingdom LA1 4RP
    76 Local Institution London United Kingdom SE1 9RT
    77 Local Institution Northwood United Kingdom HA6 2RN
    78 Local Institution Southampton United Kingdom SO16 6YD

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT03662659
    Other Study ID Numbers:
    • CA224-060
    • 2018-001069-18
    First Posted:
    Sep 7, 2018
    Last Update Posted:
    Aug 16, 2022
    Last Verified:
    Aug 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Stomach Neoplasms
    Nivolumab

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail 274 participants randomized and 271 treated.
    Arm/Group Title BMS986213 + Chemotherapy Nivolumab + Chemotherapy
    Arm/Group Description BMS986213 Q3W + Investigator Choice (IC) Chemotherapy XELOX Q3W or BMS986213 Q4W + IC Chemotherapy FOLFOX Q2W or BMS986213 Q3W + IC Chemotherapy SOX Q3W Nivolumab 360 mg Q3W + Investigator Choice (IC) Chemotherapy XELOX Q3W or Nivolumab 480 mg Q4W + IC Chemotherapy FOLFOX Q2W or Nivolumab 360 mg Q3W + IC Chemotherapy SOX Q3W
    Period Title: Pre-treatment
    STARTED 138 136
    COMPLETED 136 135
    NOT COMPLETED 2 1
    Period Title: Pre-treatment
    STARTED 136 135
    COMPLETED 21 29
    NOT COMPLETED 115 106

    Baseline Characteristics

    Arm/Group Title BMS986213 + Chemotherapy Nivolumab + Chemotherapy Total
    Arm/Group Description BMS986213 Q3W + Investigator Choice (IC) Chemotherapy XELOX Q3W or BMS986213 Q4W + IC Chemotherapy FOLFOX Q2W or BMS986213 Q3W + IC Chemotherapy SOX Q3W Nivolumab 360 mg Q3W + Investigator Choice (IC) Chemotherapy XELOX Q3W or Nivolumab 480 mg Q4W + IC Chemotherapy FOLFOX Q2W or Nivolumab 360 mg Q3W + IC Chemotherapy SOX Q3W Total of all reporting groups
    Overall Participants 138 136 274
    Age (Years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Years]
    59.4
    (12.1)
    61.8
    (11.3)
    60.6
    (11.7)
    Sex: Female, Male (Count of Participants)
    Female
    44
    31.9%
    38
    27.9%
    82
    29.9%
    Male
    94
    68.1%
    98
    72.1%
    192
    70.1%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    17
    12.3%
    10
    7.4%
    27
    9.9%
    Not Hispanic or Latino
    73
    52.9%
    80
    58.8%
    153
    55.8%
    Unknown or Not Reported
    48
    34.8%
    46
    33.8%
    94
    34.3%
    Race/Ethnicity, Customized (Number) [Number]
    White
    128
    92.8%
    122
    89.7%
    250
    91.2%
    Black or African American
    0
    0%
    1
    0.7%
    1
    0.4%
    Asian
    5
    3.6%
    3
    2.2%
    8
    2.9%
    Asian Indian
    1
    0.7%
    1
    0.7%
    2
    0.7%
    Chinese
    0
    0%
    5
    3.7%
    5
    1.8%
    American Indian or Alaska Native
    1
    0.7%
    0
    0%
    1
    0.4%
    Native Hawaiian or Other Pacific Islander
    1
    0.7%
    0
    0%
    1
    0.4%
    Other
    2
    1.4%
    4
    2.9%
    6
    2.2%

    Outcome Measures

    1. Primary Outcome
    Title BICR-Assessed Objective Response Rate (ORR) in Randomized LAG-3 Positive (>=1 %) Participants
    Description The number of LAG-3 Positive (>=1%) participants with a Best Overall Response (BOR) of confirmed Complete Response (CR) or Partial Response (PR) divided by the number of randomized LAG-3 positive (>=1%) participants in each arm; recorded between randomization date and the date of objectively documented progression [per RECISIT 1.1], death due to any cause, or date of subsequent anticancer therapy, whichever occurs first. CR= Disappearance of all target lesions PR= At least a 30% decrease in the sum of diameters of target lesions
    Time Frame Up to 25 months

    Outcome Measure Data

    Analysis Population Description
    All randomized LAG-3 positive (>=1%) participants
    Arm/Group Title BMS986213 + Chemotherapy Nivolumab + Chemotherapy
    Arm/Group Description BMS986213 Q3W + Investigator Choice (IC) Chemotherapy XELOX Q3W or BMS986213 Q4W + IC Chemotherapy FOLFOX Q2W or BMS986213 Q3W + IC Chemotherapy SOX Q3W Nivolumab 360 mg Q3W + Investigator Choice (IC) Chemotherapy XELOX Q3W or Nivolumab 480 mg Q4W + IC Chemotherapy FOLFOX Q2W or Nivolumab 360 mg Q3W + IC Chemotherapy SOX Q3W
    Measure Participants 97 98
    Number (95% Confidence Interval) [Percentage of Participants]
    48.5
    35.1%
    61.2
    45%
    2. Secondary Outcome
    Title Objective Response Rate (ORR)
    Description Objective response rate (ORR) based on Blinded Independent Central Review (BICR) and Investigator assessments is defined as the number of participants with a Best Overall Response (BOR) of confirmed Complete Response (CR) or Partial Response (PR) divided by the number of randomized participants in each arm; recorded between randomization date and the date of objectively documented progression [per RECISIT 1.1], death due to any cause, or date of subsequent anticancer therapy, whichever occurs first.
    Time Frame Up to 25 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description
    3. Secondary Outcome
    Title Duration of Response (DOR)
    Description Duration of Response (DOR) based on Blinded Independent Central Review (BICR) and investigator is defined as the time between the date of first documented response (complete response or partial response) and the date of the first disease progression, per RECIST 1.1, or death due to any cause, or date of subsequent anticancer therapy, whichever occurs first.
    Time Frame Up to 25 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description
    4. Secondary Outcome
    Title Overall Survival (OS)
    Description Overall Survival (OS) is defined as the time between the date of randomization and the date of death due to any cause. For those without documentation of death, OS will be censored on the last date the participant was known to be alive.
    Time Frame Up to 25 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description
    5. Secondary Outcome
    Title Progression-Free Survival (PFS)
    Description Progression-Free Survival (PFS) per Blinded Independent Central Review (BICR) and Investigator is defined as the time between the date of randomization and the first date of documented progression, or death due to any cause, or date of subsequent anticancer therapy, whichever occurs first. Participants who die without a reported prior progression (and die without start of subsequent therapy) will be considered to have progressed on the date of death.
    Time Frame Up to 25 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description
    6. Secondary Outcome
    Title Number of Participants With Adverse Events (AEs)
    Description Number of participants with any grade adverse events (AEs), serious adverse events (SAE), and adverse events leading to discontinuation using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v 5.0) to assess the overall safety and tolerability of BMS-986213 in combination with chemotherapy vs. Nivolumab in combination with chemotherapy.
    Time Frame From first dose to 30 days post last dose (Up to 23 months)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description
    7. Secondary Outcome
    Title Number of Deaths
    Description Number of deaths in each arm to assess the overall safety and tolerability of BMS-986213 in combination with chemotherapy vs. Nivolumab in combination with chemotherapy.
    Time Frame Up to 25 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description
    8. Secondary Outcome
    Title Number of Participants With Laboratory Abnormalities in Specific Liver Tests
    Description Number of participants with laboratory abnormalities in specific liver tests based on US conventional units to assess the overall safety and tolerability of BMS-986213 in combination with chemotherapy vs. Nivolumab in combination with chemotherapy. The number of participants with the following laboratory abnormalities from on-treatment evaluations will be summarized: ALT or AST > 3 x ULN, > 5 x ULN, > 10 x ULN and > 20 x ULN Total bilirubin > 2 x ULN ALP > 1.5 x ULN Concurrent (within 1 day) ALT or AST > 3 x ULN and total bilirubin > 1.5 x ULN Concurrent (within 30 days) ALT or AST > 3 x ULN and total bilirubin > 1.5 x ULN Concurrent (within 1 day) ALT or AST > 3 x ULN and total bilirubin > 2 x ULN Concurrent (within 30 days) ALT or AST > 3 x ULN and total bilirubin > 2 x ULN
    Time Frame From first dose to up to 30 days post last dose (Up to 23 months)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description
    9. Secondary Outcome
    Title Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
    Description Number of participants with laboratory abnormalities in specific thyroid tests based on US conventional units. The number of participants with the following laboratory abnormalities from on-treatment evaluations will be summarized: TSH value > ULN and with baseline TSH value <= ULN with at least one FT3/FT4 test value < LLN within 2-week window after the abnormal TSH test with all FT3/FT4 test values >= LLN within 2-week window after the abnormal TSH test with FT3/FT4 missing within 2-week window after the abnormal TSH test. TSH < LLN and with baseline TSH value >= LLN with at least one FT3/FT4 test value > ULN within 2-week window after the abnormal TSH test with all FT3/FT4 test values <= ULN within 2-week window after the abnormal TSH test with FT3/FT4 missing within 2-week window after the abnormal TSH test
    Time Frame From first dose to up to 30 days post last dose (Up to 23 months)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description

    Adverse Events

    Time Frame From first day to 100 days post last dose (Up to 25 months)
    Adverse Event Reporting Description
    Arm/Group Title BMS986213 + Chemotherapy Nivolumab + Chemotherapy
    Arm/Group Description BMS986213 Q3W + Investigator Choice (IC) Chemotherapy XELOX Q3W or BMS986213 Q4W + IC Chemotherapy FOLFOX Q2W or BMS986213 Q3W + IC Chemotherapy SOX Q3W Nivolumab 360 mg Q3W + Investigator Choice (IC) Chemotherapy XELOX Q3W or Nivolumab 480 mg Q4W + IC Chemotherapy FOLFOX Q2W or Nivolumab 360 mg Q3W + IC Chemotherapy SOX Q3W
    All Cause Mortality
    BMS986213 + Chemotherapy Nivolumab + Chemotherapy
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 82/136 (60.3%) 72/135 (53.3%)
    Serious Adverse Events
    BMS986213 + Chemotherapy Nivolumab + Chemotherapy
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 107/136 (78.7%) 94/135 (69.6%)
    Blood and lymphatic system disorders
    Anaemia 1/136 (0.7%) 6/135 (4.4%)
    Febrile neutropenia 5/136 (3.7%) 2/135 (1.5%)
    Neutropenia 1/136 (0.7%) 1/135 (0.7%)
    Thrombocytopenia 1/136 (0.7%) 0/135 (0%)
    Thrombotic microangiopathy 2/136 (1.5%) 0/135 (0%)
    Cardiac disorders
    Acute coronary syndrome 0/136 (0%) 1/135 (0.7%)
    Angina pectoris 1/136 (0.7%) 1/135 (0.7%)
    Angina unstable 0/136 (0%) 1/135 (0.7%)
    Arrhythmia 1/136 (0.7%) 0/135 (0%)
    Arteriospasm coronary 1/136 (0.7%) 0/135 (0%)
    Atrial fibrillation 0/136 (0%) 2/135 (1.5%)
    Atrioventricular block 1/136 (0.7%) 0/135 (0%)
    Cardiac failure 0/136 (0%) 1/135 (0.7%)
    Cardiac failure acute 0/136 (0%) 1/135 (0.7%)
    Myocardial infarction 1/136 (0.7%) 0/135 (0%)
    Myocarditis 0/136 (0%) 1/135 (0.7%)
    Pericarditis 0/136 (0%) 1/135 (0.7%)
    Right ventricular failure 1/136 (0.7%) 0/135 (0%)
    Ear and labyrinth disorders
    Vestibular disorder 1/136 (0.7%) 0/135 (0%)
    Endocrine disorders
    Adrenal insufficiency 3/136 (2.2%) 0/135 (0%)
    Autoimmune thyroiditis 1/136 (0.7%) 0/135 (0%)
    Hyperthyroidism 1/136 (0.7%) 0/135 (0%)
    Hypophysitis 1/136 (0.7%) 0/135 (0%)
    Lymphocytic hypophysitis 1/136 (0.7%) 0/135 (0%)
    Eye disorders
    Diplopia 0/136 (0%) 1/135 (0.7%)
    Gastrointestinal disorders
    Abdominal hernia 1/136 (0.7%) 0/135 (0%)
    Abdominal pain 6/136 (4.4%) 8/135 (5.9%)
    Abdominal pain lower 0/136 (0%) 1/135 (0.7%)
    Abdominal pain upper 0/136 (0%) 3/135 (2.2%)
    Ascites 1/136 (0.7%) 3/135 (2.2%)
    Colitis 3/136 (2.2%) 1/135 (0.7%)
    Constipation 1/136 (0.7%) 2/135 (1.5%)
    Diarrhoea 3/136 (2.2%) 8/135 (5.9%)
    Dysphagia 4/136 (2.9%) 9/135 (6.7%)
    Enterocolitis 0/136 (0%) 1/135 (0.7%)
    Enterocolitis haemorrhagic 0/136 (0%) 1/135 (0.7%)
    Faeces discoloured 1/136 (0.7%) 0/135 (0%)
    Gastric haemorrhage 3/136 (2.2%) 0/135 (0%)
    Gastrointestinal haemorrhage 1/136 (0.7%) 3/135 (2.2%)
    Gastrointestinal inflammation 1/136 (0.7%) 0/135 (0%)
    Gastrooesophageal reflux disease 0/136 (0%) 1/135 (0.7%)
    Haematemesis 2/136 (1.5%) 3/135 (2.2%)
    Haematochezia 0/136 (0%) 1/135 (0.7%)
    Haemorrhoidal haemorrhage 0/136 (0%) 1/135 (0.7%)
    Ileus 1/136 (0.7%) 2/135 (1.5%)
    Immune-mediated enterocolitis 1/136 (0.7%) 1/135 (0.7%)
    Intestinal obstruction 1/136 (0.7%) 6/135 (4.4%)
    Intestinal perforation 1/136 (0.7%) 0/135 (0%)
    Large intestinal obstruction 0/136 (0%) 1/135 (0.7%)
    Large intestine perforation 1/136 (0.7%) 0/135 (0%)
    Melaena 3/136 (2.2%) 0/135 (0%)
    Nausea 2/136 (1.5%) 6/135 (4.4%)
    Obstruction gastric 1/136 (0.7%) 1/135 (0.7%)
    Oesophageal fistula 1/136 (0.7%) 0/135 (0%)
    Oesophageal obstruction 2/136 (1.5%) 0/135 (0%)
    Oesophageal pain 1/136 (0.7%) 0/135 (0%)
    Oesophageal perforation 2/136 (1.5%) 0/135 (0%)
    Oesophageal ulcer 1/136 (0.7%) 0/135 (0%)
    Pancreatitis acute 0/136 (0%) 1/135 (0.7%)
    Proctalgia 0/136 (0%) 1/135 (0.7%)
    Small intestinal obstruction 2/136 (1.5%) 1/135 (0.7%)
    Small intestinal stenosis 0/136 (0%) 1/135 (0.7%)
    Stomatitis 2/136 (1.5%) 0/135 (0%)
    Upper gastrointestinal haemorrhage 1/136 (0.7%) 1/135 (0.7%)
    Vomiting 2/136 (1.5%) 7/135 (5.2%)
    General disorders
    Asthenia 0/136 (0%) 1/135 (0.7%)
    Chest pain 1/136 (0.7%) 0/135 (0%)
    Fatigue 3/136 (2.2%) 2/135 (1.5%)
    General physical health deterioration 4/136 (2.9%) 6/135 (4.4%)
    Influenza like illness 1/136 (0.7%) 0/135 (0%)
    Medical device pain 0/136 (0%) 1/135 (0.7%)
    Pain 1/136 (0.7%) 1/135 (0.7%)
    Pyrexia 11/136 (8.1%) 7/135 (5.2%)
    Hepatobiliary disorders
    Autoimmune hepatitis 1/136 (0.7%) 1/135 (0.7%)
    Biliary colic 1/136 (0.7%) 0/135 (0%)
    Cholangitis 0/136 (0%) 1/135 (0.7%)
    Cholecystitis 1/136 (0.7%) 0/135 (0%)
    Gallbladder obstruction 1/136 (0.7%) 0/135 (0%)
    Hepatic failure 1/136 (0.7%) 0/135 (0%)
    Hepatitis 2/136 (1.5%) 1/135 (0.7%)
    Hepatitis acute 1/136 (0.7%) 0/135 (0%)
    Hepatobiliary disease 0/136 (0%) 1/135 (0.7%)
    Hyperbilirubinaemia 0/136 (0%) 1/135 (0.7%)
    Hypertransaminasaemia 1/136 (0.7%) 0/135 (0%)
    Immune-mediated hepatitis 0/136 (0%) 1/135 (0.7%)
    Immune system disorders
    Contrast media reaction 1/136 (0.7%) 0/135 (0%)
    Hypersensitivity 1/136 (0.7%) 0/135 (0%)
    Infections and infestations
    Acute sinusitis 1/136 (0.7%) 0/135 (0%)
    Adrenalitis 2/136 (1.5%) 0/135 (0%)
    Appendicitis 0/136 (0%) 1/135 (0.7%)
    Bronchitis 1/136 (0.7%) 1/135 (0.7%)
    COVID-19 pneumonia 1/136 (0.7%) 2/135 (1.5%)
    Cholangitis infective 1/136 (0.7%) 0/135 (0%)
    Device related infection 2/136 (1.5%) 3/135 (2.2%)
    Enterobacter sepsis 1/136 (0.7%) 0/135 (0%)
    Enterocolitis infectious 1/136 (0.7%) 1/135 (0.7%)
    Febrile infection 0/136 (0%) 1/135 (0.7%)
    Gastroenteritis 0/136 (0%) 2/135 (1.5%)
    Infection 3/136 (2.2%) 1/135 (0.7%)
    Influenza 0/136 (0%) 2/135 (1.5%)
    Kidney infection 1/136 (0.7%) 0/135 (0%)
    Oral candidiasis 1/136 (0.7%) 0/135 (0%)
    Pneumonia 7/136 (5.1%) 8/135 (5.9%)
    Pyelonephritis acute 0/136 (0%) 1/135 (0.7%)
    Rash pustular 1/136 (0.7%) 0/135 (0%)
    Sepsis 6/136 (4.4%) 2/135 (1.5%)
    Suspected COVID-19 0/136 (0%) 1/135 (0.7%)
    Upper respiratory tract infection 2/136 (1.5%) 0/135 (0%)
    Urinary tract infection 1/136 (0.7%) 1/135 (0.7%)
    Vascular device infection 1/136 (0.7%) 0/135 (0%)
    Injury, poisoning and procedural complications
    Craniocerebral injury 0/136 (0%) 1/135 (0.7%)
    Fall 1/136 (0.7%) 0/135 (0%)
    Humerus fracture 0/136 (0%) 1/135 (0.7%)
    Infusion related reaction 4/136 (2.9%) 0/135 (0%)
    Overdose 1/136 (0.7%) 1/135 (0.7%)
    Post procedural complication 1/136 (0.7%) 0/135 (0%)
    Spinal compression fracture 1/136 (0.7%) 0/135 (0%)
    Subdural haemorrhage 0/136 (0%) 1/135 (0.7%)
    Investigations
    Alanine aminotransferase increased 1/136 (0.7%) 0/135 (0%)
    Aspartate aminotransferase increased 2/136 (1.5%) 0/135 (0%)
    Blood bilirubin increased 1/136 (0.7%) 1/135 (0.7%)
    Blood creatine phosphokinase increased 1/136 (0.7%) 0/135 (0%)
    Blood creatinine increased 1/136 (0.7%) 0/135 (0%)
    General physical condition abnormal 1/136 (0.7%) 0/135 (0%)
    Haemoglobin decreased 1/136 (0.7%) 0/135 (0%)
    Hepatic enzyme increased 1/136 (0.7%) 0/135 (0%)
    Liver function test abnormal 1/136 (0.7%) 0/135 (0%)
    Liver function test increased 1/136 (0.7%) 0/135 (0%)
    Neutrophil count decreased 1/136 (0.7%) 0/135 (0%)
    Platelet count decreased 2/136 (1.5%) 0/135 (0%)
    Metabolism and nutrition disorders
    Decreased appetite 1/136 (0.7%) 5/135 (3.7%)
    Dehydration 3/136 (2.2%) 3/135 (2.2%)
    Diabetes mellitus 0/136 (0%) 1/135 (0.7%)
    Diabetes mellitus inadequate control 0/136 (0%) 1/135 (0.7%)
    Diabetic ketoacidosis 1/136 (0.7%) 0/135 (0%)
    Hyperglycaemia 1/136 (0.7%) 1/135 (0.7%)
    Hypokalaemia 0/136 (0%) 3/135 (2.2%)
    Hypophagia 0/136 (0%) 1/135 (0.7%)
    Hypophosphataemia 0/136 (0%) 1/135 (0.7%)
    Ketoacidosis 0/136 (0%) 1/135 (0.7%)
    Type 1 diabetes mellitus 2/136 (1.5%) 0/135 (0%)
    Musculoskeletal and connective tissue disorders
    Back pain 2/136 (1.5%) 1/135 (0.7%)
    Myositis 1/136 (0.7%) 0/135 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Gastric cancer 1/136 (0.7%) 1/135 (0.7%)
    Infected neoplasm 1/136 (0.7%) 0/135 (0%)
    Lymphangiosis carcinomatosa 1/136 (0.7%) 1/135 (0.7%)
    Malignant neoplasm progression 26/136 (19.1%) 22/135 (16.3%)
    Metastases to central nervous system 1/136 (0.7%) 0/135 (0%)
    Metastases to liver 2/136 (1.5%) 0/135 (0%)
    Metastases to meninges 0/136 (0%) 2/135 (1.5%)
    Metastases to skin 1/136 (0.7%) 0/135 (0%)
    Metastatic gastric cancer 0/136 (0%) 1/135 (0.7%)
    Neoplasm progression 0/136 (0%) 1/135 (0.7%)
    Neuroendocrine tumour 0/136 (0%) 1/135 (0.7%)
    Ovarian neoplasm 1/136 (0.7%) 0/135 (0%)
    Tumour haemorrhage 3/136 (2.2%) 0/135 (0%)
    Tumour pain 1/136 (0.7%) 0/135 (0%)
    Nervous system disorders
    Axonal neuropathy 1/136 (0.7%) 0/135 (0%)
    Cerebrovascular accident 2/136 (1.5%) 0/135 (0%)
    Encephalitis autoimmune 1/136 (0.7%) 0/135 (0%)
    Guillain-Barre syndrome 1/136 (0.7%) 0/135 (0%)
    Ischaemic stroke 0/136 (0%) 1/135 (0.7%)
    Presyncope 0/136 (0%) 1/135 (0.7%)
    Syncope 1/136 (0.7%) 2/135 (1.5%)
    Product Issues
    Device dislocation 0/136 (0%) 2/135 (1.5%)
    Psychiatric disorders
    Confusional state 1/136 (0.7%) 0/135 (0%)
    Renal and urinary disorders
    Acute kidney injury 5/136 (3.7%) 2/135 (1.5%)
    Hydronephrosis 1/136 (0.7%) 0/135 (0%)
    Nephropathy toxic 1/136 (0.7%) 1/135 (0.7%)
    Renal failure 0/136 (0%) 2/135 (1.5%)
    Renal tubular necrosis 0/136 (0%) 1/135 (0.7%)
    Urinary incontinence 1/136 (0.7%) 0/135 (0%)
    Urinary tract obstruction 1/136 (0.7%) 0/135 (0%)
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea 1/136 (0.7%) 4/135 (3%)
    Lung disorder 1/136 (0.7%) 0/135 (0%)
    Organising pneumonia 0/136 (0%) 1/135 (0.7%)
    Pleural effusion 6/136 (4.4%) 5/135 (3.7%)
    Pneumonia aspiration 0/136 (0%) 2/135 (1.5%)
    Pneumonitis 1/136 (0.7%) 6/135 (4.4%)
    Pulmonary embolism 3/136 (2.2%) 0/135 (0%)
    Respiratory failure 2/136 (1.5%) 1/135 (0.7%)
    Skin and subcutaneous tissue disorders
    Rash 0/136 (0%) 1/135 (0.7%)
    Vascular disorders
    Embolism 2/136 (1.5%) 1/135 (0.7%)
    Hypertension 1/136 (0.7%) 1/135 (0.7%)
    Hypotension 2/136 (1.5%) 2/135 (1.5%)
    Pelvic venous thrombosis 1/136 (0.7%) 0/135 (0%)
    Thrombosis 0/136 (0%) 1/135 (0.7%)
    Venous thrombosis 1/136 (0.7%) 0/135 (0%)
    Other (Not Including Serious) Adverse Events
    BMS986213 + Chemotherapy Nivolumab + Chemotherapy
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 130/136 (95.6%) 131/135 (97%)
    Blood and lymphatic system disorders
    Anaemia 39/136 (28.7%) 30/135 (22.2%)
    Leukopenia 5/136 (3.7%) 7/135 (5.2%)
    Neutropenia 37/136 (27.2%) 40/135 (29.6%)
    Thrombocytopenia 21/136 (15.4%) 25/135 (18.5%)
    Endocrine disorders
    Hyperthyroidism 10/136 (7.4%) 3/135 (2.2%)
    Hypothyroidism 21/136 (15.4%) 18/135 (13.3%)
    Gastrointestinal disorders
    Abdominal pain 23/136 (16.9%) 27/135 (20%)
    Abdominal pain upper 15/136 (11%) 7/135 (5.2%)
    Constipation 37/136 (27.2%) 31/135 (23%)
    Diarrhoea 53/136 (39%) 57/135 (42.2%)
    Dry mouth 12/136 (8.8%) 9/135 (6.7%)
    Dysphagia 20/136 (14.7%) 13/135 (9.6%)
    Gastrooesophageal reflux disease 8/136 (5.9%) 8/135 (5.9%)
    Nausea 70/136 (51.5%) 75/135 (55.6%)
    Stomatitis 14/136 (10.3%) 19/135 (14.1%)
    Vomiting 48/136 (35.3%) 45/135 (33.3%)
    General disorders
    Asthenia 15/136 (11%) 21/135 (15.6%)
    Chills 13/136 (9.6%) 7/135 (5.2%)
    Fatigue 69/136 (50.7%) 66/135 (48.9%)
    Mucosal inflammation 15/136 (11%) 11/135 (8.1%)
    Non-cardiac chest pain 9/136 (6.6%) 9/135 (6.7%)
    Oedema peripheral 14/136 (10.3%) 17/135 (12.6%)
    Pyrexia 33/136 (24.3%) 18/135 (13.3%)
    Infections and infestations
    Oral candidiasis 6/136 (4.4%) 12/135 (8.9%)
    Upper respiratory tract infection 9/136 (6.6%) 4/135 (3%)
    Urinary tract infection 11/136 (8.1%) 11/135 (8.1%)
    Injury, poisoning and procedural complications
    Infusion related reaction 14/136 (10.3%) 10/135 (7.4%)
    Investigations
    Alanine aminotransferase increased 15/136 (11%) 14/135 (10.4%)
    Aspartate aminotransferase increased 19/136 (14%) 15/135 (11.1%)
    Blood alkaline phosphatase increased 10/136 (7.4%) 7/135 (5.2%)
    Gamma-glutamyltransferase increased 9/136 (6.6%) 7/135 (5.2%)
    Neutrophil count decreased 24/136 (17.6%) 16/135 (11.9%)
    Platelet count decreased 15/136 (11%) 23/135 (17%)
    Weight decreased 11/136 (8.1%) 20/135 (14.8%)
    White blood cell count decreased 8/136 (5.9%) 6/135 (4.4%)
    Metabolism and nutrition disorders
    Decreased appetite 41/136 (30.1%) 39/135 (28.9%)
    Hyperglycaemia 8/136 (5.9%) 6/135 (4.4%)
    Hypocalcaemia 8/136 (5.9%) 3/135 (2.2%)
    Hypokalaemia 17/136 (12.5%) 13/135 (9.6%)
    Hypomagnesaemia 6/136 (4.4%) 7/135 (5.2%)
    Musculoskeletal and connective tissue disorders
    Arthralgia 13/136 (9.6%) 13/135 (9.6%)
    Back pain 11/136 (8.1%) 14/135 (10.4%)
    Muscular weakness 3/136 (2.2%) 7/135 (5.2%)
    Nervous system disorders
    Dizziness 11/136 (8.1%) 17/135 (12.6%)
    Dysgeusia 13/136 (9.6%) 16/135 (11.9%)
    Headache 13/136 (9.6%) 8/135 (5.9%)
    Neuropathy peripheral 36/136 (26.5%) 49/135 (36.3%)
    Paraesthesia 17/136 (12.5%) 14/135 (10.4%)
    Peripheral sensory neuropathy 27/136 (19.9%) 30/135 (22.2%)
    Polyneuropathy 9/136 (6.6%) 7/135 (5.2%)
    Psychiatric disorders
    Depression 2/136 (1.5%) 7/135 (5.2%)
    Insomnia 15/136 (11%) 12/135 (8.9%)
    Respiratory, thoracic and mediastinal disorders
    Cough 26/136 (19.1%) 21/135 (15.6%)
    Dyspnoea 22/136 (16.2%) 16/135 (11.9%)
    Epistaxis 5/136 (3.7%) 8/135 (5.9%)
    Pulmonary embolism 1/136 (0.7%) 7/135 (5.2%)
    Skin and subcutaneous tissue disorders
    Alopecia 8/136 (5.9%) 10/135 (7.4%)
    Palmar-plantar erythrodysaesthesia syndrome 12/136 (8.8%) 18/135 (13.3%)
    Pruritus 12/136 (8.8%) 9/135 (6.7%)
    Rash 24/136 (17.6%) 24/135 (17.8%)
    Rash maculo-papular 11/136 (8.1%) 1/135 (0.7%)
    Vascular disorders
    Hypertension 8/136 (5.9%) 15/135 (11.1%)
    Hypotension 7/136 (5.1%) 7/135 (5.2%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.

    Results Point of Contact

    Name/Title Bristol-Myers Squibb Study Director
    Organization Bristol-Myers Squibb
    Phone Please Email:
    Email Clinical.Trials@bms.com
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT03662659
    Other Study ID Numbers:
    • CA224-060
    • 2018-001069-18
    First Posted:
    Sep 7, 2018
    Last Update Posted:
    Aug 16, 2022
    Last Verified:
    Aug 1, 2022