NCT02872116 · OUTCOME
Objective Response Rate in Participants Treated With Nivolumab Plus Ipilimumab vs Chemotherapy
Efficacy Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Against Chemotherapy in Stomach Cancer or Stomach/Esophagus Junction Cancer · Source last updated 2025-08-07
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of Participants
- Interval / dispersion
- 95% Confidence Interval
- 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)
What was measured
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.
Analysis population: All randomized participants in various subsets as determined by PD-L1 CPS status
Groups in this outcome
Arm 2b: Chemotherapy (XELOX or FOLFOX)
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 3.
Arm 3: Nivolumab + Ipilimumab
1 mg/kg nivolumab administered IV over 30 minutes followed by ipilimumab 3 mg/kg administered IV over 30 minutes on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1 to 4), followed by nivolumab 240 mg administered IV over 30 minutes on Day 1 of each treatment cycle every 2 weeks (Cycle 5 and beyond). Arm is closed to enrollment as of 05-June-2018.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Arm 2b: Chemotherapy (XELOX or FOLFOX) | 404 |
|---|
| Arm 3: Nivolumab + Ipilimumab | 409 |
|---|
Reported measurements
Participants with CPS ≥ 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Arm 2b: Chemotherapy (XELOX or FOLFOX) | 319 |
|---|
| Arm 3: Nivolumab + Ipilimumab | 322 |
|---|
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm 2b: Chemotherapy (XELOX or FOLFOX) | 37.3 | Not reported | 32.0 | 42.9 | Not reported |
|---|
| Arm 3: Nivolumab + Ipilimumab | 21.7 | Not reported | 17.4 | 26.6 | Not reported |
|---|
Participants with CPS ≥ 5
Analysis denominator · Participants
| Group | Source count |
|---|
| Arm 2b: Chemotherapy (XELOX or FOLFOX) | 239 |
|---|
| Arm 3: Nivolumab + Ipilimumab | 234 |
|---|
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm 2b: Chemotherapy (XELOX or FOLFOX) | 37.7 | Not reported | 31.5 | 44.1 | Not reported |
|---|
| Arm 3: Nivolumab + Ipilimumab | 23.1 | Not reported | 17.8 | 29.0 | Not reported |
|---|
Participants with CPS ≥ 10
Analysis denominator · Participants
| Group | Source count |
|---|
| Arm 2b: Chemotherapy (XELOX or FOLFOX) | 198 |
|---|
| Arm 3: Nivolumab + Ipilimumab | 181 |
|---|
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm 2b: Chemotherapy (XELOX or FOLFOX) | 35.9 | Not reported | 29.2 | 43.0 | Not reported |
|---|
| Arm 3: Nivolumab + Ipilimumab | 24.3 | Not reported | 18.3 | 31.2 | Not reported |
|---|
All randomized participants
Analysis denominator · Participants
| Group | Source count |
|---|
| Arm 2b: Chemotherapy (XELOX or FOLFOX) | 404 |
|---|
| Arm 3: Nivolumab + Ipilimumab | 409 |
|---|
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm 2b: Chemotherapy (XELOX or FOLFOX) | 34.9 | Not reported | 30.3 | 39.8 | Not reported |
|---|
| Arm 3: Nivolumab + Ipilimumab | 20.8 | Not reported | 17.0 | 25.0 | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 32.0
- upper Limit
- 42.9
- value
- 37.3
- group Id
- OG001
- lower Limit
- 17.4
- upper Limit
- 26.6
- value
- 21.7
- denoms
- counts
- group Id
- OG000
- value
- 319
- group Id
- OG001
- value
- 322
- units
- Participants
- title
- Participants with CPS ≥ 1
- categories
- measurements
- group Id
- OG000
- lower Limit
- 31.5
- upper Limit
- 44.1
- value
- 37.7
- group Id
- OG001
- lower Limit
- 17.8
- upper Limit
- 29.0
- value
- 23.1
- denoms
- counts
- group Id
- OG000
- value
- 239
- group Id
- OG001
- value
- 234
- units
- Participants
- title
- Participants with CPS ≥ 5
- categories
- measurements
- group Id
- OG000
- lower Limit
- 29.2
- upper Limit
- 43.0
- value
- 35.9
- group Id
- OG001
- lower Limit
- 18.3
- upper Limit
- 31.2
- value
- 24.3
- denoms
- counts
- group Id
- OG000
- value
- 198
- group Id
- OG001
- value
- 181
- units
- Participants
- title
- Participants with CPS ≥ 10
- categories
- measurements
- group Id
- OG000
- lower Limit
- 30.3
- upper Limit
- 39.8
- value
- 34.9
- group Id
- OG001
- lower Limit
- 17.0
- upper Limit
- 25.0
- value
- 20.8
- denoms
- counts
- group Id
- OG000
- value
- 404
- group Id
- OG001
- value
- 409
- units
- Participants
- title
- All randomized participants
- denoms
- counts
- group Id
- OG000
- value
- 404
- group Id
- OG001
- value
- 409
- units
- Participants
- 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.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- 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 3.
- id
- OG000
- title
- Arm 2b: Chemotherapy (XELOX or FOLFOX)
- description
- 1 mg/kg nivolumab administered IV over 30 minutes followed by ipilimumab 3 mg/kg administered IV over 30 minutes on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1 to 4), followed by nivolumab 240 mg administered IV over 30 minutes on Day 1 of each treatment cycle every 2 weeks (Cycle 5 and beyond). Arm is closed to enrollment as of 05-June-2018.
- id
- OG001
- title
- Arm 3: Nivolumab + Ipilimumab
- param Type
- NUMBER
- population Description
- All randomized participants in various subsets as determined by PD-L1 CPS status
- reporting Status
- POSTED
- 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)
- title
- Objective Response Rate in Participants Treated With Nivolumab Plus Ipilimumab vs Chemotherapy
- type
- SECONDARY
- unit Of Measure
- Percentage of Participants
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