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

NCT03704077 | Withdrawn Phase 2 FDA Drug

• 2 other identifiers: CA224-0612018-001070-20
• Study Type: interventional
• Target: N/A
• Locations: 14 countries
• Sites: 84

Brief Summary

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.

Conditions

Gastric Cancer; Cancer of the Stomach; Stomach Cancer; Gastroesophageal Junction

Outcome Measures

Primary Outcomes (1)

• Overall response rate (ORR)

  Approximately 31 months

Secondary Outcomes (9)

• Incidence of adverse events (AEs)

  Approximately 5 years

• Incidence of serious adverse events (SAEs)

  Approximately 5 years

• Incidence of AEs leading to discontinuation

  Approximately 5 years

• Incidence of deaths

  Approximately 5 years

• Incidence of laboratory abnormalities

  Approximately 5 years

Study Arms (6)

Cohort A: relatlimab + nivolumab + paclitaxel

EXPERIMENTAL

Biological: Relatlimab + Nivolumab; Biological: Nivolumab; Drug: Paclitaxel

Cohort A: nivolumab + paclitaxel

EXPERIMENTAL

Biological: Nivolumab; Drug: Paclitaxel

Cohort A: ramucirumab + paclitaxel

ACTIVE COMPARATOR

Standard-of-care

Drug: Paclitaxel; Drug: Ramucirumab

Cohort B: relatlimab + nivolumab

EXPERIMENTAL

Biological: Relatlimab + Nivolumab; Biological: Nivolumab

Cohort B: nivolumab

ACTIVE COMPARATOR

Standard-of-care

Biological: Nivolumab

Cohort C: relatlimab + nivolumab

EXPERIMENTAL

Biological: Relatlimab + Nivolumab; Biological: Nivolumab

Interventions

Relatlimab + Nivolumab BIOLOGICAL

Specified dose on specified days

Also known as: BMS-986213

Cohort A: relatlimab + nivolumab + paclitaxel; Cohort B: relatlimab + nivolumab; Cohort C: relatlimab + nivolumab

Nivolumab BIOLOGICAL

Specified dose on specified days

Also known as: Opdivo

Cohort A: nivolumab + paclitaxel; Cohort A: relatlimab + nivolumab + paclitaxel; Cohort B: nivolumab; Cohort B: relatlimab + nivolumab; Cohort C: relatlimab + nivolumab

Paclitaxel DRUG

Specified dose on specified days

Also known as: Taxol, Onxal

Cohort A: nivolumab + paclitaxel; Cohort A: ramucirumab + paclitaxel; Cohort A: relatlimab + nivolumab + paclitaxel

Ramucirumab DRUG

Specified dose on specified days

Also known as: Cyramza

Cohort A: ramucirumab + paclitaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Must not have squamous cell or undifferentiated GC or GEJ
• Untreated known central nervous system (CNS) metastases
• Uncontrolled or significant cardiovascular disease

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (84)

Local Institution

Daphne, Alabama, 36526, United States

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Bakersfield, California, 93309, United States

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Fullerton, California, 92835, United States

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Los Angeles, California, 90095, United States

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Redondo Beach, California, 90277, United States

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Santa Barbara, California, 93105, United States

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Aurora, Colorado, 80045, United States

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Lakewood, Colorado, 80228, United States

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Miami, Florida, 33176, United States

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Tampa, Florida, 33612, United States

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Marietta, Georgia, 30060, United States

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Boston, Massachusetts, 02215, United States

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St Louis, Missouri, 63110, United States

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New Brunswick, New Jersey, 08009, United States

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Chapel Hill, North Carolina, 27599, United States

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Charlotte, North Carolina, 28204, United States

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Fargo, North Dakota, 58102, United States

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Allentown, Pennsylvania, 18103, United States

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Sioux Falls, South Dakota, 57104, United States

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Vancouver, Washington, 98684, United States

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Viedma, Río Negro Province, 8500, Argentina

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Buenos Aires, 1093, Argentina

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Buenos Aires, 1426, Argentina

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CABA, 1199, Argentina

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Córdoba, 5000, Argentina

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Westmead, New South Wales, 2145, Australia

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Heidelberg, Victoria, 3084, Australia

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Malvern, Victoria, 3144, Australia

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Melbourne, Victoria, 3000, Australia

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Bedford Park, 5024, Australia

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Murdoch, 6150, Australia

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Fortaleza, Ceará, 60430-230, Brazil

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Belo Horizonte, Minas Gerais, 30130-090, Brazil

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Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

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Barretos, São Paulo, 14780-070, Brazil

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Jaú, São Paulo, 17210-080, Brazil

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Rio de Janeiro, 22793-080, Brazil

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São Paulo, 01246-000, Brazil

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Halifax, Nova Scotia, B3H 2Y9, Canada

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Hamilton, Ontario, L8V 5C2, Canada

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Ottawa, Ontario, K1H 8L6, Canada

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Toronto, Ontario, M5B 1W8, Canada

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Toronto, Ontario, M5G 2M9, Canada

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Montreal, Quebec, H4J 1C5, Canada

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Sherbrooke, Quebec, J1H 5N4, Canada

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Santiago, Santiago Metropolitan, 8330024, Chile

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Santiago, Santiago Metropolitan, Chile

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Medellín, Colombia

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Berlin, 13125, Germany

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Cologne, 50937, Germany

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Erlangen, 91054, Germany

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Essen, 45147, Germany

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Frankfurt am Main, 60488, Germany

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Freiburg im Breisgau, 79106, Germany

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Hamburg, 22763, Germany

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Hanover, 30625, Germany

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Jena, 07747, Germany

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Mainz, 55131, Germany

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Mannheim, 68167, Germany

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Marburg, 35043, Germany

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Paderborn, 33098, Germany

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Reutlingen, 72764, Germany

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Wiesbaden, 65199, Germany

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Bergamo, 24127, Italy

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Milan, 20133, Italy

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Napoli, 80131, Italy

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Reggio Emilia, 42100, Italy

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Tuxtla Gutiérrez, Chiapas, 29029, Mexico

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ZONA Centro. LEON, Guanajuato, 37000, Mexico

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Mexico City, Mexico City, 14080, Mexico

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Mérida, Yucatán, 97134, Mexico

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Aguascalientes, 20230, Mexico

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Lisbon, 1649-035, Portugal

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Porto, 4200-072, Portugal

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Rio Piedras, 00935, Puerto Rico

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Bucharest, 022328, Romania

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Cluj-Napoca, 400015, Romania

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Craiova, 200347, Romania

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Floreşti, 407280, Romania

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Badajoz, 06006, Spain

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Madrid, 28007, Spain

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Madrid, 28034, Spain

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Madrid, 28050, Spain

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Valencia, 46026, Spain

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

relatlimab; Nivolumab; Paclitaxel; Ramucirumab

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2018
• First Posted: October 12, 2018
• Study Start: October 31, 2019
• Primary Completion: February 27, 2022
• Study Completion: September 30, 2024
• Last Updated: May 19, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share

Locations

DE (15); IT (4); PT (2); CA (7); US (20); AR (5); ME (5); PR (1); BR (7); RO (4); ES (5); CO (1); CL (2); AU (6)