NCT02872116|CompletedPhase 3ResultsDMCFDA Drug

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

CheckMate649

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 ClinicalTrials.gov

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2 other identifiers

CA209-6492016-001018-76

Study Type

interventional

Target

2,031

Locations

29 countries

Sites

179

Timeline

RegisteredAug 2016

StartedOct 2016

CompletionJun 2024

Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

2,031

participants targeted

Target at P75+ for phase_3 gastric-cancer

Timeline

Completed

Started Oct 2016

Longer than P75 for phase_3 gastric-cancer

Geographic Reach

29 countries

179 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

7.7 years study duration

First Submitted

Initial submission to the registry

August 16, 2016

Completed

3 days until next milestone

First Posted

Study publicly available on registry

August 19, 2016

Completed

2 months until next milestone

Study Start

First participant enrolled

October 12, 2016

Completed

3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 27, 2020

Completed

2.1 years until next milestone

Results Posted

Study results publicly available

June 28, 2022

Completed

1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 6, 2024

Completed

Last Updated

August 7, 2025

Status Verified

July 1, 2025

Enrollment Period

3.6 years

First QC Date

August 16, 2016

Results QC Date

May 18, 2022

Last Update Submit

July 21, 2025

Conditions

Gastric Cancer Gastroesophageal Junction Cancer Esophageal Adenocarcinoma

Outcome Measures

Primary Outcomes (2)

Overall Survival (OS) in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy With PD-L1 CPS ≥ 5
Overall survival (OS), defined as the time from randomization to the time of death, in participants treated with Nivolumab plus Chemotherapy vs Chemotherapy with PD-L1 CPS (combined positive score) ≥ 5. CPS is defined as the number of PD-L1 staining cells (tumor cells, lymphocytes, macrophages) divided by the total number of viable tumor cells, multiplied by 100.
From the date of randomization up to the date of death, up to approximately 17 months
Progression Free Survival (PFS) in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy With PD-L1 CPS ≥ 5
Progression Free Survival (PFS) is defined as the time from randomization to the date of the first documented PD or death due to any cause. PD is determined by blinded independent committee review (BICR) per RECIST1.1 criteria in participants treated with Nivolumab plus Chemotherapy vs Chemotherapy with PD-L1 CPS ≥ 5. Progressive disease (PD) is defined as at least a 20% increase in the sum of diameters of target lesions, taking in reference the smallest sum on study that also demonstrated an absolute increase of at least 5 mm. CPS is defined as the number of PD-L1 staining cells (tumor cells, lymphocytes, macrophages) divided by the total number of viable tumor cells, multiplied by 100.
From randomization to the date of the first documented progressive disease (PD) per BICR or death due to any cause (up to approximately 10 months)

Secondary Outcomes (7)

OS in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy
From the date of randomization up to the date of death, up to approximately 17 months
PFS in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy
From randomization to the date of the first documented progressive disease (PD) per BICR or death due to any cause (up to approximately 10 months)
Objective Response Rate in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy
From randomization to the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (up to approximately 43 months)
Time to Symptom Deterioration (TTSD) in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy
From randomization until a clinically meaningful decline from baseline in GaCS score (approximately 10 months)
OS in Participants Treated With Nivolumab Plus Ipilimumab vs Chemotherapy
From the date of randomization up to the date of death, up to approximately 14 months
+2 more secondary outcomes

Study Arms (5)

Nivolumab + Ipilimumab

EXPERIMENTAL

Nivolumab + Ipilimumab for 4 doses, followed by Nivolumab monotherapy Enrollment is closed for this arm

Drug: NivolumabDrug: Ipilimumab

XELOX (Oxaliplatin + Capecitabine)

ACTIVE COMPARATOR

Drug: OxaliplatinDrug: Capecitabine

FOLFOX (Oxaliplatin + Leucovorin + Fluorouracil)

ACTIVE COMPARATOR

Drug: OxaliplatinDrug: LeucovorinDrug: Fluorouracil

Nivolumab + XELOX

EXPERIMENTAL

Drug: NivolumabDrug: OxaliplatinDrug: Capecitabine

Nivolumab + FOLFOX

EXPERIMENTAL

Drug: NivolumabDrug: OxaliplatinDrug: LeucovorinDrug: Fluorouracil