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Efficacy Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Against Chemotherapy in Stomach Cancer or Stomach/Esophagus Junction Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Efficacy Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Against Chemotherapy in Stomach Cancer or Stomach/Esophagus Junction Cancer

A Randomized, Multicenter, Open-Label, Phase 3 Study of Nivolumab Plus Ipilimumab or Nivolumab in Combination With Oxaliplatin Plus Fluoropyrimidine Versus Oxaliplatin Plus Fluoropyrimidine in Subjects With Previously Untreated Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer

NCT02872116•Bristol-Myers Squibb

View on ClinicalTrials.gov

Summary

The main purpose of this study is to compare how long patients with gastric or gastroesophageal junction cancer live after receiving nivolumab and ipilimumab or nivolumab and chemotherapy compared with patients receiving chemotherapy alone.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or Female at least 18 years of age
•Must have gastric cancer or gastroesophageal junction cancer that cannot be operated on and that is advanced or has spread out
•Did not receive neoadjuvant or adjuvant treatment (chemotherapy, radiotherapy, or both) for their disease within the last 6 months
•Must have full activity or, if limited, must be able to walk and carry out light activities such as light house work or office work
•Must agree to provide tumor tissue sample, either from a previous surgery or biopsy within 6 months or fresh, prior to the start of treatment in this study

Exclusion Criteria

•Presence of tumor cells in the brain or spinal cord that have not been treated
•Active known or suspected autoimmune disease
•Any serious or uncontrolled medical disorder or active infection
•Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
•Any positive test result for hepatitis B or C indicating acute or chronic infection

Locations (179)

Local Institution - 0005

Los Angeles, California, United States

Local Institution - 0001

San Francisco, California, United States

Local Institution - 0066

Aurora, Colorado, United States

Local Institution - 0151

Denver, Colorado, United States

Local Institution - 0136

Washington D.C., District of Columbia, United States

Florida Cancer Specialists S.

Fort Myers, Florida, United States

Local Institution - 0147

Miami, Florida, United States

Florida Cancer Specialists

St. Petersburg, Florida, United States

Local Institution - 0179

Marietta, Georgia, United States

Local Institution - 0219

Arlington Heights, Illinois, United States

Key Dates

Start Date

October 12, 2016

Primary Completion Date

May 27, 2020

Completion Date

June 6, 2024

Last Updated

August 7, 2025

Enrollment

2,031

ACTUAL participants

Conditions

Gastric CancerGastroesophageal Junction CancerEsophageal Adenocarcinoma

Interventions

Nivolumab

DRUG

Ipilimumab

DRUG

Oxaliplatin

DRUG

Capecitabine

DRUG

Leucovorin

DRUG

Fluorouracil

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 7, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Efficacy Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Against Chemotherapy in Stomach Cancer or Stomach/Esophagus Junction Cancer

Inclusion Criteria

Exclusion Criteria

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

Resilience and Equity in Aging, Cancer, and Health (REACH)

Novel Combinations in Participants With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

Using 18F-FAPI PET to Detect Metastatic Disease in Patients That Have Gastric or Esophageal Cancer.