An Investigational Immuno-therapy Study of Relatlimab Plus Nivolumab Compared to Various Standard-of-Care Therapies in Previously Treated Participants With Recurrent, Advanced or Metastatic Gastric Cancer or Gastroesophageal Junction Adenocarcinoma

May 17, 2020 updated by: Bristol-Myers Squibb

A Randomized, Active-Controlled, Open-Label, Phase 2 Clinical Trial of BMS-986213, in Combination With Various Standard-of-Care Therapeutic Regimens, in Participants With Recurrent, Locally Advanced, or Metastatic Gastric Cancer (GC) or Gastroesophageal Junction (GEJ) Adenocarcinoma

The purpose of this study is to determine the effectiveness of relatlimab plus nivolumab, alone or in combination with various standard-of-care treatments in participants with gastric cancer (GC) or gastroesophageal junction (GEJ) adenocarcinoma that has come back or spread to other places in the body after prior therapy.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

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
      • Buenos Aires, Argentina, 1093
        • Local Institution
      • Caba, Argentina, 1199
        • Local Institution
      • Ciudad Autonoma de Buenos Aires, Argentina, 1426
        • Local Institution
      • Cordoba, Argentina, 5000
        • Local Institution
    • RIO Negro
      • Viedma, RIO Negro, Argentina, 8500
        • Local Institution
  • Australia
      • Bedford Park, Australia, 5024
        • Local Institution
      • Murdoch, Australia, 6150
        • Local Institution
    • New South Wales
      • Westmead, New South Wales, Australia, 2145
        • Local Institution
    • Victoria
      • Heidelberg, Victoria, Australia, 3084
        • Local Institution
      • Malvern, Victoria, Australia, 3144
        • Local Institution
      • Melbourne, Victoria, Australia, 3000
        • Local Institution
  • Brazil
      • Rio de Janeiro, Brazil, 22793-080
        • Local Institution
      • Sao Paulo, Brazil, 01246-000
        • Local Institution
    • Ceara
      • Fortaleza, Ceara, Brazil, 60430-230
        • Local Institution
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30130-090
        • Local Institution
    • RIO Grande DO SUL
      • Porto Alegre, RIO Grande DO SUL, Brazil, 90035-903
        • Local Institution
    • SAO Paulo
      • Barretos, SAO Paulo, Brazil, 14780-070
        • Local Institution
      • Jau, SAO Paulo, Brazil, 17210-080
        • Local Institution
  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • Local Institution
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
        • Local Institution
      • Ottawa, Ontario, Canada, K1H 8L6
        • Local Institution
      • Toronto, Ontario, Canada, M5G 2M9
        • Local Institution
      • Toronto, Ontario, Canada, M5B 1W8
        • Local Institution
    • Quebec
      • Montreal, Quebec, Canada, H4J 1C5
        • Local Institution
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Local Institution
  • Chile
    • Metropolitana
      • Santiago, Metropolitana, Chile
        • Local Institution
      • Santiago, Metropolitana, Chile, 8330024
        • Local Institution
  • Colombia
      • Medellin, Colombia
        • Local Institution
  • Germany
      • Berlin, Germany, 13125
        • Local Institution
      • Cologne, Germany, 50937
        • Local Institution
      • Erlangen, Germany, 91054
        • Local Institution
      • Essen, Germany, 45147
        • Local Institution
      • Frankfurt am Main, Germany, 60488
        • Local Institution
      • Freiburg, Germany, 79106
        • Local Institution
      • Hamburg, Germany, 22763
        • Local Institution
      • Hannover, Germany, 30625
        • Local Institution
      • Jena, Germany, 07747
        • Local Institution
      • Mainz, Germany, 55131
        • Local Institution
      • Mannheim, Germany, 68167
        • Local Institution
      • Marburg, Germany, 35043
        • Local Institution
      • Paderborn, Germany, 33098
        • Local Institution
      • Reutlingen, Germany, 72764
        • Local Institution
      • Wiesbaden, Germany, 65199
        • Local Institution
  • Italy
      • Bergamo, Italy, 24127
        • Local Institution
      • Milano, Italy, 20133
        • Local Institution
      • Napoli, Italy, 80131
        • Local Institution
      • Reggio Emilia, Italy, 42100
        • Local Institution
  • Mexico
      • Aguascalientes, Mexico, 20230
        • Local Institution
    • Chiapas
      • Tuxtla Gutierrez, Chiapas, Mexico, 29029
        • Local Institution
    • Distrito Federal
      • Mexico City, Distrito Federal, Mexico, 14080
        • Local Institution
    • Guanajuato
      • ZONA Centro. LEON, Guanajuato, Mexico, 37000
        • Local Institution
    • Yucatan
      • Merida, Yucatan, Mexico, 97134
        • Local Institution
  • Portugal
      • Lisboa, Portugal, 1649-035
        • Local Institution
      • Porto, Portugal, 4200-072
        • Local Institution
  • Puerto Rico
      • Rio Piedras, Puerto Rico, 00935
        • Local Institution
  • Romania
      • Bucuresti, Romania, 022328
        • Local Institution
      • Cluj-Napoca, Romania, 400015
        • Local Institution
      • Craiova, Romania, 200347
        • Local Institution
      • Floresti, Romania, 407280
        • Local Institution
  • Spain
      • Badajoz, Spain, 06006
        • Local Institution
      • Madrid, Spain, 28034
        • Local Institution
      • Madrid, Spain, 28050
        • Local Institution
      • Madrid, Spain, 28007
        • Local Institution
      • Valencia, Spain, 46026
        • Local Institution
  • United States
    • Alabama
      • Daphne, Alabama, United States, 36526
        • Local Institution
    • California
      • Bakersfield, California, United States, 93309
        • Local Institution
      • Fullerton, California, United States, 92835
        • Local Institution
      • Los Angeles, California, United States, 90095
        • Local Institution
      • Redondo Beach, California, United States, 90277
        • Local Institution
      • Santa Barbara, California, United States, 93105
        • Local Institution
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Local Institution
      • Lakewood, Colorado, United States, 80228
        • Local Institution
    • Florida
      • Miami, Florida, United States, 33176
        • Local Institution
      • Tampa, Florida, United States, 33612
        • Local Institution
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Local Institution
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Local Institution
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Local Institution
    • New Jersey
      • New Brunswick, New Jersey, United States, 08009
        • Local Institution
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Local Institution
      • Charlotte, North Carolina, United States, 28204
        • Local Institution
    • North Dakota
      • Fargo, North Dakota, United States, 58102
        • Local Institution
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Local Institution
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57104
        • Local Institution
    • Washington
      • Vancouver, Washington, United States, 98684
        • Local Institution

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Inclusion Criteria:

  • Histologically or cytologically confirmed locally advanced or recurrent or metastatic GC or GEJ adenocarcinoma that is considered incurable by local therapies such as radiation or surgery
  • Evidence of progressive disease (PD) on at least one prior platinum- and fluoropyrimidine-containing chemotherapy regimen
  • Available tumor tissue for biomarker analysis

Exclusion Criteria:

  • Must not have squamous cell or undifferentiated GC or GEJ
  • Untreated known 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: Cohort A: relatlimab + nivolumab + paclitaxel
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
Drug: Paclitaxel
Specified dose on specified days
Other Names:
  • Taxol
  • Onxal
Biological: Relatlimab + Nivolumab
Specified dose on specified days
Other Names:
  • BMS-986213
Experimental: Cohort A: nivolumab + paclitaxel
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
Drug: Paclitaxel
Specified dose on specified days
Other Names:
  • Taxol
  • Onxal
Active Comparator: Cohort A: ramucirumab + paclitaxel
Standard-of-care
Drug: Paclitaxel
Specified dose on specified days
Other Names:
  • Taxol
  • Onxal
Drug: Ramucirumab
Specified dose on specified days
Other Names:
  • Cyramza
Experimental: Cohort B: relatlimab + nivolumab
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
Biological: Relatlimab + Nivolumab
Specified dose on specified days
Other Names:
  • BMS-986213
Active Comparator: Cohort B: nivolumab
Standard-of-care
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
Experimental: Cohort C: relatlimab + nivolumab
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
Biological: Relatlimab + Nivolumab
Specified dose on specified days
Other Names:
  • BMS-986213

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall response rate (ORR)
Time Frame: Approximately 31 months
Approximately 31 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of adverse events (AEs)
Time Frame: Approximately 5 years
Approximately 5 years
Incidence of serious adverse events (SAEs)
Time Frame: Approximately 5 years
Approximately 5 years
Incidence of AEs leading to discontinuation
Time Frame: Approximately 5 years
Approximately 5 years
Incidence of deaths
Time Frame: Approximately 5 years
Approximately 5 years
Incidence of laboratory abnormalities
Time Frame: Approximately 5 years
Approximately 5 years
ORR
Time Frame: Approximately 5 years
Cohort A1
Approximately 5 years
Duration of response (DOR)
Time Frame: Approximately 5 years
Approximately 5 years
Progression free survival (PFS)
Time Frame: Approximately 5 years
Approximately 5 years
Overall survival (OS)
Time Frame: Approximately 5 years
Approximately 5 years

Collaborators and Investigators

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

Sponsor

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.

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 (Anticipated)

October 31, 2019

Primary Completion (Anticipated)

February 27, 2022

Study Completion (Anticipated)

September 30, 2024

Study Registration Dates

First Submitted

October 9, 2018

First Submitted That Met QC Criteria

October 9, 2018

First Posted (Actual)

October 12, 2018

Study Record Updates

Last Update Posted (Actual)

May 19, 2020

Last Update Submitted That Met QC Criteria

May 17, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA224-061
  • 2018-001070-20 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Individual patient level data from this study may be shared with qualified researchers, upon request, following the timelines and process detailed on https://www.bms.com/researchers-and-partners/independent-research/data-sharing-request-process.html

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.

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