Trial · NCT02872116
Efficacy Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Against Chemotherapy in Stomach Cancer or Stomach/Esophagus Junction Cancer
NCT02872116, Phase 3, Completed, Bristol-Myers Squibb; results first posted 2022-06-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Against Chemotherapy in Stomach Cancer or Stomach/Esophagus Junction Cancer. Trials, record NCT02872116. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02872116
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Against Chemotherapy in Stomach Cancer or Stomach/Esophagus Junction Cancer
- NCT number
- NCT02872116
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,031 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Gastric Cancer, Gastroesophageal Junction Cancer, Esophageal Adenocarcinoma
- Interventions
- Nivolumab, Ipilimumab, Oxaliplatin, Capecitabine, Leucovorin, Fluorouracil
- First posted
- 2016-08-19
- Last updated
- 2025-08-07
- Other registries' IDs
- eudract:2016-001018-76
- Results first posted
- 2022-06-28
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy With PD-L1 CPS ≥ 5 | From the date of randomization up to the date of death, up to approximately 17 months | 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. |
| Primary | Progression Free Survival (PFS) in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy With PD-L1 CPS ≥ 5 | 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) | 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. |
| Secondary | 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 | 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. |
| Secondary | 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) | 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. |
| Secondary | 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) | 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. |
| Secondary | 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) | 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. |
| Secondary | 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 | 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. |
| Secondary | PFS in Participants Treated With Nivolumab Plus Ipilimumab 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 9 months) | 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. |
| Secondary | Objective Response Rate in Participants Treated With Nivolumab Plus Ipilimumab 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) | 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. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy With PD-L1 CPS ≥ 5 | From the date of randomization up to the date of death, up to approximately 17 months | All randomized participants with PD-L1 CPS ≥ 5 | Months | MEDIAN |
| PRIMARY | Progression Free Survival (PFS) in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy With PD-L1 CPS ≥ 5 | 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) | All randomized participants with PD-L1 CPS ≥ 5 | Months | MEDIAN |
| SECONDARY | 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 | All randomized participants with available OS measurements in various subsets | Months | MEDIAN |
| SECONDARY | 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) | All randomized participants with available PFS measurements in various subsets | Months | MEDIAN |
| SECONDARY | 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) | All randomized participants in various subsets as determined by PD-L1 CPS status | Percentage of Participants | NUMBER |
| SECONDARY | 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) | All Treated participants with TTSD measurements | Months | MEDIAN |
| SECONDARY | 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 | All randomized participants with available measurements in various subsets as determined by PD-L1 CPS status | Months | MEDIAN |
| SECONDARY | PFS in Participants Treated With Nivolumab Plus Ipilimumab 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 9 months) | All randomized participants with available measurements in various subsets as determined by PD-L1 CPS status | Months | MEDIAN |
| SECONDARY | Objective Response Rate in Participants Treated With Nivolumab Plus Ipilimumab 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) | All randomized participants in various subsets as determined by PD-L1 CPS status | Percentage of Participants | NUMBER |
Source ClinicalTrials.gov
Results by group54
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy With PD-L1 CPS ≥ 5 | Arm 1: Nivolumab + Chemotherapy (XELOX or FOLFOX) | 14.39 | 95% Confidence Interval 13.11 to 16.23 | Months | |
| Overall Survival (OS) in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy With PD-L1 CPS ≥ 5 | Arm 2a: Chemotherapy (XELOX or FOLFOX) | 11.10 | 95% Confidence Interval 10.02 to 12.09 | Months | |
| Progression Free Survival (PFS) in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy With PD-L1 CPS ≥ 5 | Arm 1: Nivolumab + Chemotherapy (XELOX or FOLFOX) | 7.69 | 95% Confidence Interval 7.03 to 9.17 | Months | |
| Progression Free Survival (PFS) in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy With PD-L1 CPS ≥ 5 | Arm 2a: Chemotherapy (XELOX or FOLFOX) | 6.05 | 95% Confidence Interval 5.55 to 6.90 | Months | |
| OS in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy | Arm 1: Nivolumab + Chemotherapy (XELOX or FOLFOX) | All randomized participants | 13.73 | 95% Confidence Interval 12.42 to 14.49 | Months |
| OS in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy | Arm 2a: Chemotherapy (XELOX or FOLFOX) | All randomized participants | 11.63 | 95% Confidence Interval 10.94 to 12.52 | Months |
| OS in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy | Arm 1: Nivolumab + Chemotherapy (XELOX or FOLFOX) | Participants with PD-LI CPS ≥ 1 | 13.80 | 95% Confidence Interval 12.42 to 14.82 | Months |
| OS in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy | Arm 2a: Chemotherapy (XELOX or FOLFOX) | Participants with PD-LI CPS ≥ 1 | 11.37 | 95% Confidence Interval 10.74 to 12.25 | Months |
| OS in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy | Arm 1: Nivolumab + Chemotherapy (XELOX or FOLFOX) | Participants with PD-L1 CPS ≥ 5 | 14.39 | 95% Confidence Interval 13.11 to 16.23 | Months |
| OS in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy | Arm 2a: Chemotherapy (XELOX or FOLFOX) | Participants with PD-L1 CPS ≥ 5 | 11.14 | 95% Confidence Interval 10.05 to 12.12 | Months |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Pre-Treatment | STARTED | Arm 1: Nivolumab + Chemotherapy (XELOX or FOLFOX) | 789 | |
| Pre-Treatment | STARTED | Arm 2: Chemotherapy (XELOX or FOLFOX) | 833 | |
| Pre-Treatment | STARTED | Arm 3: Nivolumab + Ipilimumab | 409 | |
| Pre-Treatment | COMPLETED | Arm 1: Nivolumab + Chemotherapy (XELOX or FOLFOX) | 782 | |
| Pre-Treatment | COMPLETED | Arm 2: Chemotherapy (XELOX or FOLFOX) | 806 | |
| Pre-Treatment | COMPLETED | Arm 3: Nivolumab + Ipilimumab | 403 | |
| Pre-Treatment | NOT COMPLETED | Arm 1: Nivolumab + Chemotherapy (XELOX or FOLFOX) | 7 | |
| Pre-Treatment | NOT COMPLETED | Arm 2: Chemotherapy (XELOX or FOLFOX) | 27 | |
| Pre-Treatment | NOT COMPLETED | Arm 3: Nivolumab + Ipilimumab | 6 | |
| Treatment | STARTED | Arm 1: Nivolumab + Chemotherapy (XELOX or FOLFOX) | 782 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events3,312
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Nivo + Chemo | 312 | 782 | |
| other | Anaemia | Blood and lymphatic system disorders | Chemo | 276 | 806 | |
| other | Anaemia | Blood and lymphatic system disorders | Nivo + Ipi | 132 | 403 | |
| other | Leukopenia | Blood and lymphatic system disorders | Nivo + Chemo | 75 | 782 | |
| other | Leukopenia | Blood and lymphatic system disorders | Chemo | 64 | 806 | |
| other | Leukopenia | Blood and lymphatic system disorders | Nivo + Ipi | 9 | 403 | |
| other | Neutropenia | Blood and lymphatic system disorders | Nivo + Chemo | 218 | 782 | |
| other | Neutropenia | Blood and lymphatic system disorders | Chemo | 203 | 806 | |
| other | Neutropenia | Blood and lymphatic system disorders | Nivo + Ipi | 18 | 403 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Nivo + Chemo | 173 | 782 |
1 to 10 of 3,312Source ClinicalTrials.gov
See all 3,312 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Nivo + Chemo | 691 | 782 |
| Total, all-cause mortality | Chemo | 741 | 806 |
| Total, all-cause mortality | Nivo + Ipi | 361 | 403 |
| Total, other adverse events | Nivo + Chemo | 763 | 782 |
| Total, other adverse events | Chemo | 756 | 806 |
| Total, other adverse events | Nivo + Ipi | 369 | 403 |
| Total, serious adverse events | Nivo + Chemo | 529 | 782 |
| Total, serious adverse events | Chemo | 474 | 806 |
| Total, serious adverse events | Nivo + Ipi | 307 | 403 |
Source ClinicalTrials.gov
Papers6
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02872116
GET https://conductscience.org/api/trials/v1/NCT02872116/results?page=2