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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

NCT ID: NCT03704077

Last Updated: 2020-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-31

Study Completion Date

2024-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Gastric Cancer Cancer of the Stomach Stomach Cancer Gastroesophageal Junction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort A: relatlimab + nivolumab + paclitaxel

Group Type EXPERIMENTAL

Relatlimab + Nivolumab

Intervention Type BIOLOGICAL

Specified dose on specified days

Nivolumab

Intervention Type BIOLOGICAL

Specified dose on specified days

Paclitaxel

Intervention Type DRUG

Specified dose on specified days

Cohort A: nivolumab + paclitaxel

Group Type EXPERIMENTAL

Nivolumab

Intervention Type BIOLOGICAL

Specified dose on specified days

Paclitaxel

Intervention Type DRUG

Specified dose on specified days

Cohort A: ramucirumab + paclitaxel

Standard-of-care

Group Type ACTIVE_COMPARATOR

Paclitaxel

Intervention Type DRUG

Specified dose on specified days

Ramucirumab

Intervention Type DRUG

Specified dose on specified days

Cohort B: relatlimab + nivolumab

Group Type EXPERIMENTAL

Relatlimab + Nivolumab

Intervention Type BIOLOGICAL

Specified dose on specified days

Nivolumab

Intervention Type BIOLOGICAL

Specified dose on specified days

Cohort B: nivolumab

Standard-of-care

Group Type ACTIVE_COMPARATOR

Nivolumab

Intervention Type BIOLOGICAL

Specified dose on specified days

Cohort C: relatlimab + nivolumab

Group Type EXPERIMENTAL

Relatlimab + Nivolumab

Intervention Type BIOLOGICAL

Specified dose on specified days

Nivolumab

Intervention Type BIOLOGICAL

Specified dose on specified days

Interventions

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Relatlimab + Nivolumab

Specified dose on specified days

Intervention Type BIOLOGICAL

Nivolumab

Specified dose on specified days

Intervention Type BIOLOGICAL

Paclitaxel

Specified dose on specified days

Intervention Type DRUG

Ramucirumab

Specified dose on specified days

Intervention Type DRUG

Other Intervention Names

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BMS-986213 Opdivo Taxol Onxal Cyramza

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution

Daphne, Alabama, United States

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Bakersfield, California, United States

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Fullerton, California, United States

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Los Angeles, California, United States

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Redondo Beach, California, United States

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Santa Barbara, California, United States

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Aurora, Colorado, United States

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Lakewood, Colorado, United States

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Miami, Florida, United States

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Tampa, Florida, United States

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Marietta, Georgia, United States

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Boston, Massachusetts, United States

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St Louis, Missouri, United States

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New Brunswick, New Jersey, United States

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Chapel Hill, North Carolina, United States

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Charlotte, North Carolina, United States

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Fargo, North Dakota, United States

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Allentown, Pennsylvania, United States

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Sioux Falls, South Dakota, United States

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Vancouver, Washington, United States

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Viedma, Río Negro Province, Argentina

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Buenos Aires, , Argentina

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Buenos Aires, , Argentina

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CABA, , Argentina

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Córdoba, , Argentina

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Westmead, New South Wales, Australia

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Heidelberg, Victoria, Australia

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Malvern, Victoria, Australia

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Melbourne, Victoria, Australia

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Bedford Park, , Australia

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Murdoch, , Australia

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Fortaleza, Ceará, Brazil

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Belo Horizonte, Minas Gerais, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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Barretos, São Paulo, Brazil

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Jaú, São Paulo, Brazil

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Rio de Janeiro, , Brazil

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São Paulo, , Brazil

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Halifax, Nova Scotia, Canada

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Hamilton, Ontario, Canada

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Ottawa, Ontario, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Sherbrooke, Quebec, Canada

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Santiago, Santiago Metropolitan, Chile

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Santiago, Santiago Metropolitan, Chile

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Medellín, , Colombia

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Berlin, , Germany

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Cologne, , Germany

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Erlangen, , Germany

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Essen, , Germany

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Frankfurt am Main, , Germany

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Freiburg im Breisgau, , Germany

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Hamburg, , Germany

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Hanover, , Germany

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Jena, , Germany

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Mainz, , Germany

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Mannheim, , Germany

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Marburg, , Germany

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Paderborn, , Germany

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Reutlingen, , Germany

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Wiesbaden, , Germany

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Bergamo, , Italy

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Milan, , Italy

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Napoli, , Italy

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Reggio Emilia, , Italy

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Tuxtla Gutiérrez, Chiapas, Mexico

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ZONA Centro. LEON, Guanajuato, Mexico

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Mexico City, Mexico City, Mexico

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Mérida, Yucatán, Mexico

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Aguascalientes, , Mexico

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Lisbon, , Portugal

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Porto, , Portugal

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Rio Piedras, , Puerto Rico

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Bucharest, , Romania

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Cluj-Napoca, , Romania

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Craiova, , Romania

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Floreşti, , Romania

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Badajoz, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Valencia, , Spain

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Countries

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United States Argentina Australia Brazil Canada Chile Colombia Germany Italy Mexico Portugal Puerto Rico Romania Spain

Related Links

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https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

BMS Clinical Trial Information

https://www.bmsstudyconnect.com/s/US/English/USenHome

BMS Clinical Trial Patient Recruiting

https://www.bms.com/researchers-and-partners/investigator-inquiry-form.html

Investigator Inquiry Form

https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

FDA Safety Alerts and Recalls

Other Identifiers

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2018-001070-20

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CA224-061

Identifier Type: -

Identifier Source: org_study_id

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