At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 2,031 enrolled

Drug / intervention

Nivolumab +5 moredrug

Likely dose

Not stated in record

Key inclusion· 5

✓Age 18 years or older
✓Histologically confirmed gastric cancer or gastroesophageal junction cancer that is unresectable (advanced or metastatic)
✓No prior neoadjuvant or adjuvant chemotherapy or radiotherapy within the last 6 months
✓ECOG performance status 0-1 (able to walk and carry out light activities)

Key exclusion· 5

✕Untreated brain or spinal cord metastases
✕Active or suspected autoimmune disease
✕Serious or uncontrolled medical disorder or active infection
✕Known HIV infection or AIDS

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02872116

NCT02872116Phase 3Completed

Compare CT.gov

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

Bristol-Myers Squibb·interventional·Posted Aug 19, 2016·Updated Aug 7, 2025

In Brief

A Phase 3 clinical trial evaluating Nivolumab, Ipilimumab, and 4 other interventions for Gastric Cancer and 2 related conditions. Completed, enrolled 2,031 participants across 179 sites in 29 countries.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsGastric Cancer, Gastroesophageal Junction Cancer, Esophageal Adenocarcinoma

CountriesArgentina, Australia, Brazil, Canada, Chile, China, Colombia, Czechia, France, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Japan, Mexico, Peru, Poland, Portugal, Romania, Russia, Singapore, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom, United States

CollaboratorsOno Pharmaceutical Co., Ltd.

Timeline

Phase 3CompletedFinished

2017201820192020202120222023202420252026

First PostedAug 2016

Enrollment StartOct 2016

Primary CompletionMay 2020

Study CompletionJun 2024

TodayJul 2026

First PostedAug 19, 2016

Enrollment StartOct 12, 2016

Primary CompletionMay 27, 2020

Study CompletionJun 6, 2024

TodayJul 2, 2026

Enrollment to primary: 3.6 yearsPosted 9.9 years ago