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

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Overall response rate (ORR)
Time Frame: Approximately 31 months
Approximately 31 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 31, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 27, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 9, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 9, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 12, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 19, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 17, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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