NCT02872116 · STUDY IN CONTEXT

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

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

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.

All randomized participants with PD-L1 CPS ≥ 5

→

primary · POSTED

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.

All randomized participants with PD-L1 CPS ≥ 5

→

secondary · POSTED

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.

All randomized participants with available OS measurements in various subsets

→

secondary · POSTED

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.

All randomized participants with available PFS measurements in various subsets

→

secondary · POSTED

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.

All randomized participants in various subsets as determined by PD-L1 CPS status

→

secondary · POSTED

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.

All Treated participants with TTSD measurements

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-gastroesophageal-junction-carcinoma
nct id: NCT02872116
trial label: Efficacy Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Against Chemotherapy in Stomach Cancer or Stomach/Esophagus Junction Cancer
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: regulator-cited
discovery note: Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count: 6
harms Count: 3
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-gastroesophageal-junction-carcinoma
nct id
NCT02872116
outcome key
om-0000
source section id
NCT02872116-om-0000
source outcome index
0
endpoint
Overall Survival (OS) in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy With PD-L1 CPS ≥ 5
endpoint definition
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.
time origin
From the date of randomization up to the date of death, up to approximately 17 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
All randomized participants with PD-L1 CPS ≥ 5
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-gastroesophageal-junction-carcinoma
nct id
NCT02872116
outcome key
om-0001
source section id
NCT02872116-om-0001
source outcome index
1
endpoint
Progression Free Survival (PFS) in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy With PD-L1 CPS ≥ 5
endpoint definition
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.
time origin
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)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
All randomized participants with PD-L1 CPS ≥ 5
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-gastroesophageal-junction-carcinoma
nct id
NCT02872116
outcome key
om-0002
source section id
NCT02872116-om-0002
source outcome index
2
endpoint
OS in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy
endpoint definition
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.
time origin
From the date of randomization up to the date of death, up to approximately 17 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All randomized participants with available OS measurements in various subsets
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-gastroesophageal-junction-carcinoma
nct id
NCT02872116
outcome key
om-0003
source section id
NCT02872116-om-0003
source outcome index
3
endpoint
PFS in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy
endpoint definition
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.
time origin
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)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All randomized participants with available PFS measurements in various subsets
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-gastroesophageal-junction-carcinoma
nct id
NCT02872116
outcome key
om-0004
source section id
NCT02872116-om-0004
source outcome index
4
endpoint
Objective Response Rate in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy
endpoint definition
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.
time origin
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)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All randomized participants in various subsets as determined by PD-L1 CPS status
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-gastroesophageal-junction-carcinoma
nct id
NCT02872116
outcome key
om-0005
source section id
NCT02872116-om-0005
source outcome index
5
endpoint
Time to Symptom Deterioration (TTSD) in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy
endpoint definition
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.
time origin
From randomization until a clinically meaningful decline from baseline in GaCS score (approximately 10 months)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All Treated participants with TTSD measurements
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-gastroesophageal-junction-carcinoma
nct id
NCT02872116
outcome key
om-0000
arm key
OG000
arm label
Arm 1: Nivolumab + Chemotherapy (XELOX or FOLFOX)
regimen
Nivolumab + Xelox: Nivolumab 360 mg IV over 30 minutes on Day 1 of each treatment cycle, every 3 weeks + Oxaliplatin 130 mg/m2 IV on Day 1 of each treatment cycle + capecitabine 1000 mg/m2 orally twice daily (ie, 1000 mg/m2 in the morning and 1000 mg/m2 in the evening) on Days 1 to 14 of each treatment cycle, every 3 weeks Nivolumab + Folfox: Nivolumab 240 mg IV over 30 minutes on Day 1 of each treatment cycle, every 2 weeks + Oxaliplatin 85 mg/m2 + leucovorin 400 mg/m2 + fluorouracil 400 mg/m2 IV on Day 1 of each treatment cycle, and fluorouracil 1200 mg/m2 IV continuous infusion over 24 hours (or per local standard) daily on Days 1 and 2 of each treatment cycle, every 2 weeks
analyzed count
473
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02872116-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-gastroesophageal-junction-carcinoma
nct id
NCT02872116
outcome key
om-0000
arm key
OG001
arm label
Arm 2a: Chemotherapy (XELOX or FOLFOX)
regimen
Chemotherapy (XELOX or FOLFOX): Xelox: Oxaliplatin 130 mg/m2 IV on Day 1 of each treatment cycle + capecitabine 1000 mg/m2 orally twice daily (ie, 1000 mg/m2 in the morning and 1000 mg/m2 in the evening) on Days 1 to 14 of each treatment cycle, every 3 weeks. Folfox: Oxaliplatin 85 mg/m2 + leucovorin 400 mg/m2 + fluorouracil 400 mg/m2 IV on Day 1 of each treatment cycle, and fluorouracil 1200 mg/m2 IV continuous infusion over 24 hours (or per local standard) daily on Days 1 and 2 of each treatment cycle, every 2 weeks. Comparison group to Arm 1.
analyzed count
482
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02872116-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-gastroesophageal-junction-carcinoma
nct id
NCT02872116
outcome key
om-0001
arm key
OG000
arm label
Arm 1: Nivolumab + Chemotherapy (XELOX or FOLFOX)
regimen
Nivolumab + Xelox: Nivolumab 360 mg IV over 30 minutes on Day 1 of each treatment cycle, every 3 weeks + Oxaliplatin 130 mg/m2 IV on Day 1 of each treatment cycle + capecitabine 1000 mg/m2 orally twice daily (ie, 1000 mg/m2 in the morning and 1000 mg/m2 in the evening) on Days 1 to 14 of each treatment cycle, every 3 weeks Nivolumab + Folfox: Nivolumab 240 mg IV over 30 minutes on Day 1 of each treatment cycle, every 2 weeks + Oxaliplatin 85 mg/m2 + leucovorin 400 mg/m2 + fluorouracil 400 mg/m2 IV on Day 1 of each treatment cycle, and fluorouracil 1200 mg/m2 IV continuous infusion over 24 hours (or per local standard) daily on Days 1 and 2 of each treatment cycle, every 2 weeks
analyzed count
473
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02872116-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-gastroesophageal-junction-carcinoma
nct id
NCT02872116
outcome key
om-0001
arm key
OG001
arm label
Arm 2a: Chemotherapy (XELOX or FOLFOX)
regimen
Chemotherapy (XELOX or FOLFOX): Xelox: Oxaliplatin 130 mg/m2 IV on Day 1 of each treatment cycle + capecitabine 1000 mg/m2 orally twice daily (ie, 1000 mg/m2 in the morning and 1000 mg/m2 in the evening) on Days 1 to 14 of each treatment cycle, every 3 weeks. Folfox: Oxaliplatin 85 mg/m2 + leucovorin 400 mg/m2 + fluorouracil 400 mg/m2 IV on Day 1 of each treatment cycle, and fluorouracil 1200 mg/m2 IV continuous infusion over 24 hours (or per local standard) daily on Days 1 and 2 of each treatment cycle, every 2 weeks. Comparison group to Arm 1.
analyzed count
482
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02872116-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-gastroesophageal-junction-carcinoma
nct id
NCT02872116
outcome key
om-0002
arm key
OG000
arm label
Arm 1: Nivolumab + Chemotherapy (XELOX or FOLFOX)
regimen
Nivolumab + Xelox: Nivolumab 360 mg IV over 30 minutes on Day 1 of each treatment cycle, every 3 weeks + Oxaliplatin 130 mg/m2 IV on Day 1 of each treatment cycle + capecitabine 1000 mg/m2 orally twice daily (ie, 1000 mg/m2 in the morning and 1000 mg/m2 in the evening) on Days 1 to 14 of each treatment cycle, every 3 weeks Nivolumab + Folfox: Nivolumab 240 mg IV over 30 minutes on Day 1 of each treatment cycle, every 2 weeks + Oxaliplatin 85 mg/m2 + leucovorin 400 mg/m2 + fluorouracil 400 mg/m2 IV on Day 1 of each treatment cycle, and fluorouracil 1200 mg/m2 IV continuous infusion over 24 hours (or per local standard) daily on Days 1 and 2 of each treatment cycle, every 2 weeks
analyzed count
697
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02872116-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-gastroesophageal-junction-carcinoma
nct id
NCT02872116
outcome key
om-0002
arm key
OG001
arm label
Arm 2a: Chemotherapy (XELOX or FOLFOX)
regimen
Chemotherapy (XELOX or FOLFOX): Xelox: Oxaliplatin 130 mg/m2 IV on Day 1 of each treatment cycle + capecitabine 1000 mg/m2 orally twice daily (ie, 1000 mg/m2 in the morning and 1000 mg/m2 in the evening) on Days 1 to 14 of each treatment cycle, every 3 weeks. Folfox: Oxaliplatin 85 mg/m2 + leucovorin 400 mg/m2 + fluorouracil 400 mg/m2 IV on Day 1 of each treatment cycle, and fluorouracil 1200 mg/m2 IV continuous infusion over 24 hours (or per local standard) daily on Days 1 and 2 of each treatment cycle, every 2 weeks. Comparison group to Arm 1.
analyzed count
727
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02872116-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-gastroesophageal-junction-carcinoma
nct id
NCT02872116
outcome key
om-0003
arm key
OG000
arm label
Arm 1: Nivolumab + Chemotherapy (XELOX or FOLFOX)
regimen
Nivolumab + Xelox: Nivolumab 360 mg IV over 30 minutes on Day 1 of each treatment cycle, every 3 weeks + Oxaliplatin 130 mg/m2 IV on Day 1 of each treatment cycle + capecitabine 1000 mg/m2 orally twice daily (ie, 1000 mg/m2 in the morning and 1000 mg/m2 in the evening) on Days 1 to 14 of each treatment cycle, every 3 weeks Nivolumab + Folfox: Nivolumab 240 mg IV over 30 minutes on Day 1 of each treatment cycle, every 2 weeks + Oxaliplatin 85 mg/m2 + leucovorin 400 mg/m2 + fluorouracil 400 mg/m2 IV on Day 1 of each treatment cycle, and fluorouracil 1200 mg/m2 IV continuous infusion over 24 hours (or per local standard) daily on Days 1 and 2 of each treatment cycle, every 2 weeks
analyzed count
614
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02872116-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-gastroesophageal-junction-carcinoma
nct id
NCT02872116
outcome key
om-0003
arm key
OG001
arm label
Arm 2a: Chemotherapy (XELOX or FOLFOX)
regimen
Chemotherapy (XELOX or FOLFOX): Xelox: Oxaliplatin 130 mg/m2 IV on Day 1 of each treatment cycle + capecitabine 1000 mg/m2 orally twice daily (ie, 1000 mg/m2 in the morning and 1000 mg/m2 in the evening) on Days 1 to 14 of each treatment cycle, every 3 weeks. Folfox: Oxaliplatin 85 mg/m2 + leucovorin 400 mg/m2 + fluorouracil 400 mg/m2 IV on Day 1 of each treatment cycle, and fluorouracil 1200 mg/m2 IV continuous infusion over 24 hours (or per local standard) daily on Days 1 and 2 of each treatment cycle, every 2 weeks. Comparison group to Arm 1.
analyzed count
598
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02872116-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-gastroesophageal-junction-carcinoma
nct id
NCT02872116
outcome key
om-0004
arm key
OG000
arm label
Arm 1: Nivolumab + Chemotherapy (XELOX or FOLFOX)
regimen
Nivolumab + Xelox: Nivolumab 360 mg IV over 30 minutes on Day 1 of each treatment cycle, every 3 weeks + Oxaliplatin 130 mg/m2 IV on Day 1 of each treatment cycle + capecitabine 1000 mg/m2 orally twice daily (ie, 1000 mg/m2 in the morning and 1000 mg/m2 in the evening) on Days 1 to 14 of each treatment cycle, every 3 weeks Nivolumab + Folfox: Nivolumab 240 mg IV over 30 minutes on Day 1 of each treatment cycle, every 2 weeks + Oxaliplatin 85 mg/m2 + leucovorin 400 mg/m2 + fluorouracil 400 mg/m2 IV on Day 1 of each treatment cycle, and fluorouracil 1200 mg/m2 IV continuous infusion over 24 hours (or per local standard) daily on Days 1 and 2 of each treatment cycle, every 2 weeks
analyzed count
789
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02872116-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-gastroesophageal-junction-carcinoma
nct id
NCT02872116
outcome key
om-0004
arm key
OG001
arm label
Arm 2a: Chemotherapy (XELOX or FOLFOX)
regimen
Chemotherapy (XELOX or FOLFOX): Xelox: Oxaliplatin 130 mg/m2 IV on Day 1 of each treatment cycle + capecitabine 1000 mg/m2 orally twice daily (ie, 1000 mg/m2 in the morning and 1000 mg/m2 in the evening) on Days 1 to 14 of each treatment cycle, every 3 weeks. Folfox: Oxaliplatin 85 mg/m2 + leucovorin 400 mg/m2 + fluorouracil 400 mg/m2 IV on Day 1 of each treatment cycle, and fluorouracil 1200 mg/m2 IV continuous infusion over 24 hours (or per local standard) daily on Days 1 and 2 of each treatment cycle, every 2 weeks. This arm is a subgroup of the chemotherapy group that acts as a comparison group to Arm 1.
analyzed count
792
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02872116-om-0004#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-gastroesophageal-junction-carcinoma
nct id
NCT02872116
outcome key
om-0005
arm key
OG000
arm label
Arm 1: Nivolumab + Chemotherapy (XELOX or FOLFOX)
regimen
Nivolumab + Xelox: Nivolumab 360 mg IV over 30 minutes on Day 1 of each treatment cycle, every 3 weeks + Oxaliplatin 130 mg/m2 IV on Day 1 of each treatment cycle + capecitabine 1000 mg/m2 orally twice daily (ie, 1000 mg/m2 in the morning and 1000 mg/m2 in the evening) on Days 1 to 14 of each treatment cycle, every 3 weeks Nivolumab + Folfox: Nivolumab 240 mg IV over 30 minutes on Day 1 of each treatment cycle, every 2 weeks + Oxaliplatin 85 mg/m2 + leucovorin 400 mg/m2 + fluorouracil 400 mg/m2 IV on Day 1 of each treatment cycle, and fluorouracil 1200 mg/m2 IV continuous infusion over 24 hours (or per local standard) daily on Days 1 and 2 of each treatment cycle, every 2 weeks
analyzed count
194
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02872116-om-0005#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-gastroesophageal-junction-carcinoma
nct id
NCT02872116
outcome key
om-0005
arm key
OG001
arm label
Arm 2a: Chemotherapy (XELOX or FOLFOX)
regimen
Chemotherapy (XELOX or FOLFOX): Xelox: Oxaliplatin 130 mg/m2 IV on Day 1 of each treatment cycle + capecitabine 1000 mg/m2 orally twice daily (ie, 1000 mg/m2 in the morning and 1000 mg/m2 in the evening) on Days 1 to 14 of each treatment cycle, every 3 weeks. Folfox: Oxaliplatin 85 mg/m2 + leucovorin 400 mg/m2 + fluorouracil 400 mg/m2 IV on Day 1 of each treatment cycle, and fluorouracil 1200 mg/m2 IV continuous infusion over 24 hours (or per local standard) daily on Days 1 and 2 of each treatment cycle, every 2 weeks. This arm is a subgroup of the chemotherapy group that acts as a comparison group to Arm 1.
analyzed count
193
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02872116-om-0005#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-gastroesophageal-junction-carcinoma
nct id
NCT02872116
harm key
EG000
source section id
NCT02872116-ae
event group key
EG000
event group label
Nivo + Chemo
serious affected
529
serious at risk
782
other affected
763
other at risk
782
frequency threshold
5
collection period
All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
event definition
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-gastroesophageal-junction-carcinoma
nct id
NCT02872116
harm key
EG001
source section id
NCT02872116-ae
event group key
EG001
event group label
Chemo
serious affected
474
serious at risk
806
other affected
756
other at risk
806
frequency threshold
5
collection period
All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
event definition
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-gastroesophageal-junction-carcinoma
nct id
NCT02872116
harm key
EG002
source section id
NCT02872116-ae
event group key
EG002
event group label
Nivo + Ipi
serious affected
307
serious at risk
403
other affected
369
other at risk
403
frequency threshold
5
collection period
All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
event definition
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice