NCT02872116 · OUTCOME
PFS 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
- MEDIAN
- Unit
- Months
- Interval / dispersion
- 95% Confidence Interval
- 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)
What was measured
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.
Analysis population: All randomized participants with available measurements 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. 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
All randomized participants
Analysis denominator · Participants
| Group | Source count |
|---|
| Arm 2b: Chemotherapy (XELOX or FOLFOX) | 404 |
|---|
| Arm 3: Nivolumab + Ipilimumab | 409 |
|---|
Values in Months · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm 2b: Chemotherapy (XELOX or FOLFOX) | 7.06 | Not reported | 6.87 | 8.21 | Not reported |
|---|
| Arm 3: Nivolumab + Ipilimumab | 2.83 | Not reported | 2.63 | 3.58 | Not reported |
|---|
PD-L1 CPS ≥ 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Arm 2b: Chemotherapy (XELOX or FOLFOX) | 319 |
|---|
| Arm 3: Nivolumab + Ipilimumab | 322 |
|---|
Values in Months · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm 2b: Chemotherapy (XELOX or FOLFOX) | 6.93 | Not reported | 5.98 | 7.26 | Not reported |
|---|
| Arm 3: Nivolumab + Ipilimumab | 2.79 | Not reported | 2.60 | 3.91 | Not reported |
|---|
PD-L1 CPS ≥ 5
Analysis denominator · Participants
| Group | Source count |
|---|
| Arm 2b: Chemotherapy (XELOX or FOLFOX) | 239 |
|---|
| Arm 3: Nivolumab + Ipilimumab | 234 |
|---|
Values in Months · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm 2b: Chemotherapy (XELOX or FOLFOX) | 6.28 | Not reported | 5.59 | 7.06 | Not reported |
|---|
| Arm 3: Nivolumab + Ipilimumab | 2.83 | Not reported | 2.60 | 4.04 | Not reported |
|---|
PD-L1 CPS ≥ 10
Analysis denominator · Participants
| Group | Source count |
|---|
| Arm 2b: Chemotherapy (XELOX or FOLFOX) | 198 |
|---|
| Arm 3: Nivolumab + Ipilimumab | 181 |
|---|
Values in Months · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm 2b: Chemotherapy (XELOX or FOLFOX) | 6.28 | Not reported | 5.52 | 7.13 | Not reported |
|---|
| Arm 3: Nivolumab + Ipilimumab | 2.89 | Not reported | 2.63 | 4.24 | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 6.87
- upper Limit
- 8.21
- value
- 7.06
- group Id
- OG001
- lower Limit
- 2.63
- upper Limit
- 3.58
- value
- 2.83
- denoms
- counts
- group Id
- OG000
- value
- 404
- group Id
- OG001
- value
- 409
- units
- Participants
- title
- All randomized participants
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5.98
- upper Limit
- 7.26
- value
- 6.93
- group Id
- OG001
- lower Limit
- 2.60
- upper Limit
- 3.91
- value
- 2.79
- denoms
- counts
- group Id
- OG000
- value
- 319
- group Id
- OG001
- value
- 322
- units
- Participants
- title
- PD-L1 CPS ≥ 1
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5.59
- upper Limit
- 7.06
- value
- 6.28
- group Id
- OG001
- lower Limit
- 2.60
- upper Limit
- 4.04
- value
- 2.83
- denoms
- counts
- group Id
- OG000
- value
- 239
- group Id
- OG001
- value
- 234
- units
- Participants
- title
- PD-L1 CPS ≥ 5
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5.52
- upper Limit
- 7.13
- value
- 6.28
- group Id
- OG001
- lower Limit
- 2.63
- upper Limit
- 4.24
- value
- 2.89
- denoms
- counts
- group Id
- OG000
- value
- 198
- group Id
- OG001
- value
- 181
- units
- Participants
- title
- PD-L1 CPS ≥ 10
- denoms
- counts
- group Id
- OG000
- value
- 404
- group Id
- OG001
- value
- 409
- units
- Participants
- 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.
- 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. 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
- MEDIAN
- population Description
- All randomized participants with available measurements in various subsets as determined by PD-L1 CPS status
- reporting Status
- POSTED
- 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)
- title
- PFS in Participants Treated With Nivolumab Plus Ipilimumab vs Chemotherapy
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice
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