Study to compare how long subjects with gastric or gastroesophageal junction cancer live after receiving nivolumab and ipilimumab compared with subjects receiving chemotherapy standard of care, oxaliplatin plus fluoropyrimidine.

A Randomized, Multicenter, Open-Label, Phase 3 Study of Nivolumab Plus Ipilimumab versus Oxaliplatin plus Fluoropyrimidine in Subjects with Previously Untreated Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer (CheckMate 649: CHECKpoint pathway and nivoluMab clinical Trial Evaluation 649) - CheckMate 649

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-001018-76-ES

Enrollment

1000

Registered

2016-08-05

Start date

2016-10-10

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric or Gastroesophageal Junction Cancer MedDRA version: 19.0 Level: PT Classification code 10017758 Term: Gastric cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 19.0 Level: LLT Classification code 10056267 Term: Gastroesophageal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Product Name: NIVOLUMAB - 10ml vial Product Code: BMS-936558 Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: NIVOLUMAB CAS Number: 946414-94-4 Current Sponsor code: BMS-93655

Eligibility

Sex/Gender

All

Inclusion criteria

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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 700 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 300

Exclusion criteria

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 (HIV) or known acquired immunodeficiency syndrome (AIDS) - Any positive test result for hepatitis B or C indicating acute or chronic infection

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare OS of nivolumab plus ipilimumab versus oxaliplatin plus fluoropyrimidine in subjects with advanced or metastatic GC or GEJ cancer whose tumors express PD-L1.;Secondary Objective: - To compare OS of nivolumab plus ipilimumab versus oxaliplatin plus fluoropyrimidine in all randomized subjects with advanced or metastatic GC or GEJ cancer - To compare PFS of nivolumab plus ipilimumab versus oxaliplatin plus fluoropyrimidine in subjects with advanced or metastatic GC or GEJ cancer whose tumors express PD-L1 - To compare PFS of nivolumab plus ipilimumab versus oxaliplatin plus fluoropyrimidine in all randomized subjects with advanced or metastatic GC or GEJ cancer - To compare TTSD as assessed using the Gastric Cancer Subscale (GaCS) of the Functional Assessment of Cancer Therapy-Gastric (FACT-Ga) of nivolumab plus ipilimumab vs oxaliplatin plus fluoropyrimidine in subjects with advanced or metastatic GC or GEJ cancer whose tumors express PD-L1 - To compare TTSD as assessed using GaCS of FACT-Ga of nivolumab plus ipilimumab vs oxaliplatin plus fluoropyrimidine in all randomized subjects with advanced or metastatic GC or GEJ cancer.;Primary end point(s): Overall survival (OS) of nivolumab + ipilimumab versus oxaliplatin + fluoropyrimidine in subjects with PDL1 expressing tumors;Timepoint(s) of evaluation of this end point: Approximately 35 months after the first patient is randomized	—

Measure

Time frame

Main Objective: To compare OS of nivolumab plus ipilimumab versus oxaliplatin plus fluoropyrimidine in subjects with advanced or metastatic GC or GEJ cancer whose tumors express PD-L1.;Secondary Objective: - To compare OS of nivolumab plus ipilimumab versus oxaliplatin plus fluoropyrimidine in all randomized subjects with advanced or metastatic GC or GEJ cancer - To compare PFS of nivolumab plus ipilimumab versus oxaliplatin plus fluoropyrimidine in subjects with advanced or metastatic GC or GEJ cancer whose tumors express PD-L1 - To compare PFS of nivolumab plus ipilimumab versus oxaliplatin plus fluoropyrimidine in all randomized subjects with advanced or metastatic GC or GEJ cancer - To compare TTSD as assessed using the Gastric Cancer Subscale (GaCS) of the Functional Assessment of Cancer Therapy-Gastric (FACT-Ga) of nivolumab plus ipilimumab vs oxaliplatin plus fluoropyrimidine in subjects with advanced or metastatic GC or GEJ cancer whose tumors express PD-L1 - To compare TTSD as assessed using GaCS of FACT-Ga of nivolumab plus ipilimumab vs oxaliplatin plus fluoropyrimidine in all randomized subjects with advanced or metastatic GC or GEJ cancer.;Primary end point(s): Overall survival (OS) of nivolumab + ipilimumab versus oxaliplatin + fluoropyrimidine in subjects with PDL1 expressing tumors;Timepoint(s) of evaluation of this end point: Approximately 35 months after the first patient is randomized

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Secondary

Measure	Time frame
Secondary end point(s): - OS of nivolumab + ipilimumab versus oxaliplatin + fluoropyrimidine in all randomized subjects - Progressionfree Survival (PFS) of nivolumab + ipilimumab versus oxaliplatin + fluoropyrimidine in subjects with PDL1 expressing tumors and all randomized subjects. -Time to Symptom Deterioration in a patient reported outcomes questionnaire (GaCS), in subjects with PDL1 expressing tumors and all randomized subjects;Timepoint(s) of evaluation of this end point: Approximately 35 months after the first patient is randomized	—

Measure

Time frame

Secondary end point(s): - OS of nivolumab + ipilimumab versus oxaliplatin + fluoropyrimidine in all randomized subjects - Progressionfree Survival (PFS) of nivolumab + ipilimumab versus oxaliplatin + fluoropyrimidine in subjects with PDL1 expressing tumors and all randomized subjects. -Time to Symptom Deterioration in a patient reported outcomes questionnaire (GaCS), in subjects with PDL1 expressing tumors and all randomized subjects;Timepoint(s) of evaluation of this end point: Approximately 35 months after the first patient is randomized

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Countries

Argentina, Australia, Brazil, Canada, Chile, China, Colombia, France, Germany, Greece, Hungary, Italy, Japan, Korea, Republic of, Peru, Poland, Portugal, Romania, Russian Federation, Spain, Taiwan, United Kingdom, United States

Contacts

Public ContactGCT-SU

Bristol-Myers Squibb International Corporation

clinical.trials@bms.com900150160

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026