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

January 14, 2025 updated by: Bristol-Myers Squibb

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

274

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Caba, Argentina, 1426
        • Local Institution - 0078
    • Buenos Aires
      • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, 1280
        • Local Institution - 0010
    • Ciudad Autónoma De Buenos Aires
      • Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina, C1093AAS
        • Local Institution - 0009
    • Tucumán
      • San Miguel de Tucumán, Tucumán, Argentina, T4000IAK
        • Local Institution - 0011
  • Australia
      • Bedford Park, Australia, 5024
        • Local Institution - 0028
    • New South Wales
      • Westmead, New South Wales, Australia, 2145
        • Local Institution - 0027
    • Queensland
      • Herston, Queensland, Australia, 4029
        • Local Institution - 0007
    • Victoria
      • Heidelberg, Victoria, Australia, 3084
        • Local Institution - 0003
      • Malvern, Victoria, Australia, 3144
        • Local Institution - 0029
      • Shepparton, Victoria, Australia, 3630
        • Local Institution - 0008
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Local Institution - 0005
  • Austria
      • Graz, Austria, 8036
        • Local Institution - 0090
      • Wien, Austria, 1090
        • Local Institution - 0089
  • Belgium
      • Bruxelles, Belgium, 1200
        • Local Institution - 0091
      • Leuven, Belgium, 3000
        • Local Institution - 0092
  • Canada
      • Quebec, Canada, G1R 2J6
        • Local Institution - 0095
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 5L3
        • Local Institution - 0024
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • Local Institution - 0063
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Local Institution - 0070
    • Quebec
      • Trois-Rivieres, Quebec, Canada, G8Z 3R9
        • Local Institution - 0055
  • Chile
      • Santiago, Chile
        • Local Institution - 0079
    • L.g.bernardoohiggins
      • Rancagua, L.g.bernardoohiggins, Chile
        • Local Institution - 0002
    • Metropolitana
      • Santiago, Metropolitana, Chile
        • Local Institution - 0080
    • Valparaiso
      • Vina del Mar, Valparaiso, Chile, 2520598
        • Local Institution - 0001
  • Czechia
      • Brno, Czechia, 656 53
        • Local Institution - 0031
      • Olomouc, Czechia, 779 00
        • Local Institution - 0030
  • France
      • Avignon Cedex 9, France, 84918
        • Local Institution - 0047
      • Besancon Cedex, France, 25030
        • Local Institution - 0073
      • Dijon, France, 21000
        • Local Institution - 0045
      • Montpellier, France, 34090
        • Local Institution - 0071
      • Paris, France, 75012
        • Local Institution - 0072
      • Paris, France, 75010
        • Local Institution - 0043
      • Rouen Cedex, France, 76031
        • Local Institution - 0046
  • Germany
      • Cologne, Germany, 50937
        • Local Institution - 0083
      • Dresden, Germany, 01307
        • Local Institution - 0082
      • Essen, Germany, 45147
        • Local Institution - 0081
      • Essen, Germany, 45136
        • Local Institution - 0017
      • Frankfurt, Germany, 60488
        • Local Institution - 0014
      • Hamburg, Germany, 20249
        • Local Institution - 0018
      • Hannover, Germany, 30625
        • Local Institution - 0012
      • Heidelberg, Germany, 69120
        • Local Institution - 0013
      • Mannheim, Germany, 68167
        • Local Institution - 0015
      • Marburg, Germany, 35043
        • Local Institution - 0016
  • Italy
      • Milan, Italy, 20132
        • Local Institution - 0020
      • Milano, Italy, 20133
        • IRCCS Istituto Nazionale Tumori Milano
      • Roma, Italy, 00168
        • Local Institution - 0021
  • Norway
      • Bergen, Norway, 5021
        • Local Institution - 0088
      • Oslo, Norway, 0450
        • Local Institution - 0086
      • Trondheim, Norway, 7030
        • Local Institution - 0087
  • Poland
      • Warszawa, Poland, 02-034
        • Local Institution - 0093
  • Puerto Rico
      • San Juan, Puerto Rico, 00927
        • Local Institution - 0067
  • Singapore
      • Singapore, Singapore, 168583
        • Local Institution - 0038
  • Spain
      • Badajoz, Spain, 06080
        • Local Institution - 0099
      • Barcelona, Spain, 08035
        • Local Institution - 0098
      • Barcelona, Spain, 08036
        • Local Institution - 0061
      • Bilbao, Spain, 48013
        • Local Institution - 0059
      • Madrid, Spain, 28007
        • Local Institution - 0057
      • Zaragoza, Spain, 50009
        • Local Institution - 0060
    • M
      • Madrid, M, Spain, 28046
        • Local Institution - 0058
  • United Kingdom
      • Lancaster, United Kingdom, LA1 4RP
        • Local Institution - 0036
      • London, United Kingdom, SE1 9RT
        • Local Institution - 0034
      • Northwood, United Kingdom, HA6 2RN
        • Local Institution - 0069
      • Southampton, United Kingdom, SO16 6YD
        • Local Institution - 0033
    • Greater Manchester
      • Manchester, Greater Manchester, United Kingdom, M20 4BX
        • Local Institution - 0075
    • Nottinghamshire
      • Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
        • Local Institution - 0035
    • West Midlands
      • Coventry, West Midlands, United Kingdom, CV2 2DX
        • Local Institution - 0032
  • United States
    • California
      • Clovis, California, United States, 93611
        • Local Institution - 0049
      • Duarte, California, United States, 91010-3012
        • Local Institution - 0064
      • La Jolla, California, United States, 92037
        • Scripps Clinic
      • Los Angeles, California, United States, 90033
        • Local Institution - 0040
      • Newport Beach, California, United States, 92663
        • Hoag Memorial Hospital Presbyterian
      • Orange, California, United States, 92868
        • Local Institution - 0041
      • Santa Monica, California, United States, 90404
        • Local Institution - 0077
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Local Institution - 0056
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Local Institution - 0062
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Local Institution - 0050
    • Texas
      • Dallas, Texas, United States, 75216
        • Local Institution - 0054
    • Virginia
      • Richmond, Virginia, United States, 23230
        • Virginia Cancer Institute
    • Washington
      • Seattle, Washington, United States, 98109
        • Local Institution - 0052

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BMS-986213 + investigator's choice chemotherapy
BMS-986213 + XELOX or BMS-986213 + FOLFOX or BMS-986213 + SOX
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
Biological: BMS-986213
Relatlimab + Nivolumab specified dose on specified days
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:
  • BMS-936558
  • Opdivo
Drug: XELOX
Oxaliplatin + capecitabine
Drug: FOLFOX
Oxaliplatin + leucovorin + fluorouracil
Drug: SOX
Oxaliplatin + tegafur/gimeracil/oteracil potassium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BICR-Assessed Objective Response Rate (ORR) in Randomized LAG-3 Positive (>=1 %) Participants
Time Frame: 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
Up to 25 months
BICR-Assessed Objective Response Rate (ORR) in Randomized LAG-3 Positive (>=1 %) Participants - Extended Collection
Time Frame: From randomization date to the date of objectively documented progression, death due to any cause, or date of subsequent anticancer therapy, whichever occurs first (Up to 63 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 Progression=At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study and the sum must also demonstrate an absolute increase of at least 5 mm.
From randomization date to the date of objectively documented progression, death due to any cause, or date of subsequent anticancer therapy, whichever occurs first (Up to 63 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: From randomization date to the date of objectively documented progression, death due to any cause, or date of subsequent anticancer therapy, whichever occurs first (Up to 63 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.

CR= Disappearance of all target lesions PR= At least a 30% decrease in the sum of diameters of target lesions Progression=At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study and the sum must also demonstrate an absolute increase of at least 5 mm.
From randomization date to the date of objectively documented progression, death due to any cause, or date of subsequent anticancer therapy, whichever occurs first (Up to 63 months)
Duration of Response (DOR)
Time Frame: From the date of first dose to the date of the first disease progression or death due to any cause, or date of subsequent anticancer therapy, whichever occurs first (Up to 63 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 complete response (CR) or partial response (PR) 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.

CR= Disappearance of all target lesions PR= At least a 30% decrease in the sum of diameters of target lesions
From the date of first dose to the date of the first disease progression or death due to any cause, or date of subsequent anticancer therapy, whichever occurs first (Up to 63 months)
Overall Survival (OS)
Time Frame: From the date of randomization to the date of death due to any cause (Up to 63 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.
From the date of randomization to the date of death due to any cause (Up to 63 months)
Progression-Free Survival (PFS)
Time Frame: From the date of randomization to the first date of documented progression, or death due to any cause, or date of subsequent anticancer therapy, whichever occurs first (Up to 63 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.

Progression=At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study and the sum must also demonstrate an absolute increase of at least 5 mm.
From the date of randomization to the first date of documented progression, or death due to any cause, or date of subsequent anticancer therapy, whichever occurs first (Up to 63 months)
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: From first dose to 30 days post last dose (Up to 60 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). An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires inpatient hospitalization, results in significant disability, is a birth defect, or is an important medical event.
From first dose to 30 days post last dose (Up to 60 months)
Number of Participants Who Died
Time Frame: Up to 60 months
Number of participants who died in each arm.
Up to 60 months
Number of Participants With Laboratory Abnormalities in Specific Liver Tests
Time Frame: From first dose to 30 days post last dose (Up to 60 months)

Number of participants with laboratory abnormalities in specific liver tests based on US conventional units. 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
From first dose to 30 days post last dose (Up to 60 months)
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
Time Frame: From first dose to 30 days post last dose (Up to 60 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
From first dose to 30 days post last dose (Up to 60 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 16, 2018

Primary Completion (Actual)

August 27, 2020

Study Completion (Actual)

January 18, 2024

Study Registration Dates

First Submitted

September 6, 2018

First Submitted That Met QC Criteria

September 6, 2018

First Posted (Actual)

September 7, 2018

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 14, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA224-060
  • 2018-001069-18 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Gastric Cancer

Clinical Trials on Nivolumab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ireland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe