TriangleNCT02060188 · OUTCOME
Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Per Independent Review Committee (IRC)
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 date of randomization to the date of objectively documented progression or the date of subsequent systemic cancer therapy, whichever occurs first (Up to approximately 127 months)
What was measured
Objective Response Rate (ORR) is defined as the number of randomized participants who achieve a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), based on IRC\\\[using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1\\\], divided by the number of all randomized participants. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\\<10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Analysis population: All treated participants. As pre-specified only applicable for Cohort 1, 2, 3, 4, 5 and 6
Groups in this outcome
Cohort 1: Nivolumab Monotherapy
Nivolumab 3 mg/kg
Cohort 2: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg
Cohort 3: Nivolumab 3 mg/kg Q2W with Ipilimumab 1 mg/kg Q6W
Nivolumab 3 mg/kg Q2W with Ipilimumab 1 mg/kg twice in six weeks Q6W
Cohort 4: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg + Cobimetinib 60 mg
Cohort 4: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg + Cobimetinib 60 mg
Cohort 5: Nivolumab 240 mg + BMS-986016 80 mg
Nivolumab 240 mg + BMS-986016 80 mg
Cohort 6: Nivolumab FD + Daratumumab 16 mg/kg
Nivolumab FD + Daratumumab 16 mg/kg
| Group | Source count |
|---|---|
| Cohort 1: Nivolumab Monotherapy | 74 |
| Cohort 2: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg | 119 |
| Cohort 3: Nivolumab 3 mg/kg Q2W with Ipilimumab 1 mg/kg Q6W | 45 |
| Cohort 4: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg + Cobimetinib 60 mg | 30 |
| Cohort 5: Nivolumab 240 mg + BMS-986016 80 mg | 50 |
| Cohort 6: Nivolumab FD + Daratumumab 16 mg/kg | 44 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1: Nivolumab Monotherapy | 37.8 | Not reported | 26.8 | 49.9 | Not reported |
| Cohort 2: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg | 61.3 | Not reported | 52.0 | 70.1 | Not reported |
| Cohort 3: Nivolumab 3 mg/kg Q2W with Ipilimumab 1 mg/kg Q6W | 62.2 | Not reported | 46.5 | 76.2 | Not reported |
| Cohort 4: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg + Cobimetinib 60 mg | 6.7 | Not reported | 0.8 | 22.1 | Not reported |
| Cohort 5: Nivolumab 240 mg + BMS-986016 80 mg | 50.0 | Not reported | 35.5 | 64.5 | Not reported |
| Cohort 6: Nivolumab FD + Daratumumab 16 mg/kg | 0 | Not reported | 0.0 | 8.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 26.8
- upper Limit
- 49.9
- value
- 37.8
- group Id
- OG001
- lower Limit
- 52.0
- upper Limit
- 70.1
- value
- 61.3
- group Id
- OG002
- lower Limit
- 46.5
- upper Limit
- 76.2
- value
- 62.2
- group Id
- OG003
- lower Limit
- 0.8
- upper Limit
- 22.1
- value
- 6.7
- group Id
- OG004
- lower Limit
- 35.5
- upper Limit
- 64.5
- value
- 50.0
- group Id
- OG005
- lower Limit
- 0.0
- upper Limit
- 8.0
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 74
- group Id
- OG001
- value
- 119
- group Id
- OG002
- value
- 45
- group Id
- OG003
- value
- 30
- group Id
- OG004
- value
- 50
- group Id
- OG005
- value
- 44
- units
- Participants
- description
- Objective Response Rate (ORR) is defined as the number of randomized participants who achieve a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), based on IRC\\\[using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1\\\], divided by the number of all randomized participants. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\\<10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Nivolumab 3 mg/kg
- id
- OG000
- title
- Cohort 1: Nivolumab Monotherapy
- description
- Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg
- id
- OG001
- title
- Cohort 2: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg
- description
- Nivolumab 3 mg/kg Q2W with Ipilimumab 1 mg/kg twice in six weeks Q6W
- id
- OG002
- title
- Cohort 3: Nivolumab 3 mg/kg Q2W with Ipilimumab 1 mg/kg Q6W
- description
- Cohort 4: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg + Cobimetinib 60 mg
- id
- OG003
- title
- Cohort 4: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg + Cobimetinib 60 mg
- description
- Nivolumab 240 mg + BMS-986016 80 mg
- id
- OG004
- title
- Cohort 5: Nivolumab 240 mg + BMS-986016 80 mg
- description
- Nivolumab FD + Daratumumab 16 mg/kg
- id
- OG005
- title
- Cohort 6: Nivolumab FD + Daratumumab 16 mg/kg
- param Type
- NUMBER
- population Description
- All treated participants. As pre-specified only applicable for Cohort 1, 2, 3, 4, 5 and 6
- reporting Status
- POSTED
- time Frame
- From date of randomization to the date of objectively documented progression or the date of subsequent systemic cancer therapy, whichever occurs first (Up to approximately 127 months)
- title
- Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Per Independent Review Committee (IRC)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice