NCT02872116 · CITED IN SOURCE DOCUMENTS

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

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase: PHASE3
Status at capture: COMPLETED
Registry last update: 2025-08-07

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Overall Survival (OS) in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy With PD-L1 CPS ≥ 5

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outcome · POSTED

Progression Free Survival (PFS) in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy With PD-L1 CPS ≥ 5

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outcome · POSTED

OS in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy

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outcome · POSTED

PFS in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy

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outcome · POSTED

Objective Response Rate in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy

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outcome · POSTED

Time to Symptom Deterioration (TTSD) in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy

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outcome · POSTED

OS in Participants Treated With Nivolumab Plus Ipilimumab vs Chemotherapy

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outcome · POSTED

PFS in Participants Treated With Nivolumab Plus Ipilimumab vs Chemotherapy

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outcome · POSTED

Objective Response Rate in Participants Treated With Nivolumab Plus Ipilimumab vs Chemotherapy

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility 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 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 Other protocol-defined inclusion/exclusion criteria apply
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Nivolumab + Ipilimumab for 4 doses, followed by Nivolumab monotherapy Enrollment is closed for this arm
intervention Names
Drug: Nivolumab
Drug: Ipilimumab
label
Nivolumab + Ipilimumab
type
EXPERIMENTAL
intervention Names
Drug: Oxaliplatin
Drug: Capecitabine
label
XELOX (Oxaliplatin + Capecitabine)
type
ACTIVE_COMPARATOR
intervention Names
Drug: Oxaliplatin
Drug: Leucovorin
Drug: Fluorouracil
label
FOLFOX (Oxaliplatin + Leucovorin + Fluorouracil)
type
ACTIVE_COMPARATOR
intervention Names
Drug: Nivolumab
Drug: Oxaliplatin
Drug: Capecitabine
label
Nivolumab + XELOX
type
EXPERIMENTAL
intervention Names
Drug: Nivolumab
Drug: Oxaliplatin
Drug: Leucovorin
Drug: Fluorouracil
label
Nivolumab + FOLFOX
type
EXPERIMENTAL

interventions

arm Group Labels
Nivolumab + FOLFOX
Nivolumab + Ipilimumab
Nivolumab + XELOX
description
Specified dose on specified days
name
Nivolumab
other Names
Opdivo
BMS-936558
type
DRUG
arm Group Labels
Nivolumab + Ipilimumab
description
Specified dose on specified days
name
Ipilimumab
other Names
Yervoy
BMS-734016
type
DRUG
arm Group Labels
FOLFOX (Oxaliplatin + Leucovorin + Fluorouracil)
Nivolumab + FOLFOX
Nivolumab + XELOX
XELOX (Oxaliplatin + Capecitabine)
description
Specified dose on specified days
name
Oxaliplatin
type
DRUG
arm Group Labels
Nivolumab + XELOX
XELOX (Oxaliplatin + Capecitabine)
description
Specified dose on specified days
name
Capecitabine
type
DRUG
arm Group Labels
FOLFOX (Oxaliplatin + Leucovorin + Fluorouracil)
Nivolumab + FOLFOX
description
Specified dose on specified days
name
Leucovorin
type
DRUG
arm Group Labels
FOLFOX (Oxaliplatin + Leucovorin + Fluorouracil)
Nivolumab + FOLFOX
description
Specified dose on specified days
name
Fluorouracil
type
DRUG

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 2031
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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.
measure
Overall Survival (OS) in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy With PD-L1 CPS ≥ 5
time Frame
From the date of randomization up to the date of death, up to approximately 17 months
description
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.
measure
Progression Free Survival (PFS) in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy With PD-L1 CPS ≥ 5
time Frame
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

description
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 ≥ 1, 10, and all randomized participants. 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.
measure
OS in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy
time Frame
From the date of randomization up to the date of death, up to approximately 17 months
description
Progression free survival (PFS), defined as the time from randomization to the date of the first documented progressive disease (PD) or death due to any cause, in participants treated with Nivolumab plus Chemotherapy vs Chemotherapy by BICR per RECIST1.1 in participants with PD-L1 CPS ≥ 10, 1, or all randomized subjects. Progreessive 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.
measure
PFS in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy
time Frame
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)
description
Objective response rate (ORR) as assessed by BICR in participants with PD-L1 CPS ≥ 10, 5, 1, or all randomized participants. ORR is a percentage of participants determined by the number of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of measurable participants with target lesion at baseline. BOR is defined as the best response designation as determined by the BICR, recorded between the date of randomization and the date of objectively documented progression (per RECIST 1.1 as determined by the BICR) or the date of subsequent anti-cancer therapy, whichever occurs first. CR is defined as the disappearance of all target lesions. PR is define as at 30% decrease in the sum of diameters of target lesions. The 806 chemotherapy treated participants are split into two separate arms (Arm 2a and Arm 2b) to act as comparison groups to the other treatment arms.
measure
Objective Response Rate in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy
time Frame
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)
description
TTSD is defined as the the time from randomization until a clinically meaningful decline from baseline in Gastric Cancer Subscale (GaCS) score. A clinically meaningful deterioration is defined as a reduction of 8.2 points in the GaCS score. Subjects who do not deteriorate will be censored at the time of their last GACS assessment. Subjects without baseline GaCS assessment will be censored on the randomization date. Those with baseline GaCS, who do not have any GaCS assessments after randomization will be censored on the day after randomization.
measure
Time to Symptom Deterioration (TTSD) in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy
time Frame
From randomization until a clinically meaningful decline from baseline in GaCS score (approximately 10 months)
description
Overall survival (OS), defined as the time from randomization to the time of death, in participants treated with Nivolumab plus Ipilimumab vs Chemotherapy with PD-L1 CPS (combined positive score) ≥ 1, 5, 10, and all randomized participants. 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.
measure
OS in Participants Treated With Nivolumab Plus Ipilimumab vs Chemotherapy
time Frame
From the date of randomization up to the date of death, up to approximately 14 months
description
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 Ipilumab vs Chemotherapy with PD-L1 CPS ≥ 10, 5, 1 or all randomized participants. 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.
measure
PFS in Participants Treated With Nivolumab Plus Ipilimumab vs Chemotherapy
time Frame
From randomization to the date of the first documented progressive disease (PD) per BICR or death due to any cause (up to approximately 9 months)
description
Objective response rate (ORR) as assessed by BICR in participants with PD-L1 CPS ≥ 10, 5, 1, or all randomized participants. ORR is a percentage of participants determined by the number of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of measurable participants with target lesion at baseline. BOR is defined as the best response designation as determined by the BICR, recorded between the date of randomization and the date of objectively documented progression (per RECIST 1.1 as determined by the BICR) or the date of subsequent anti-cancer therapy, whichever occurs first. CR is defined as the disappearance of all target lesions. PR is define as at 30% decrease in the sum of diameters of target lesions. The 806 chemotherapy treated participants are split into two separate arms (Arm 2a and Arm 2b) to act as comparison groups to the other treatment arms.
measure
Objective Response Rate in Participants Treated With Nivolumab Plus Ipilimumab vs Chemotherapy
time Frame
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)

Full study description

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.

Source references

references

citation
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