TriangleNCT03126110 · OUTCOME
Phase 1: DCR Per mRECIST v1.1
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
- Not reported
- Time frame
- up to approximately 44.7 months
What was measured
DCR was defined as the percentage of participants with a best overall response of unconfirmed CR, unconfirmed PR, or stable disease (SD; ≥49 days), determined by investigator assessment of radiographic disease assessments per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD.
Analysis population: Phase 1 Response Evaluable Population
Groups in this outcome
Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2W
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + Nivolumab 240 mg Q2W
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2W
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2W
Participants received INCAGN01876 10.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
Phase 1 Group C: INCAGN01876 1.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV every 6 weeks (Q6W).
Phase 1 Group C: INCAGN01876 3.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
Phase 1 Group C: INCAGN01876 5.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
Phase 1 Group D: INCAGN01876 1.0 mg/kg + Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with nivolumab 3 mg/kg administered IV Q2W and ipilimumab 1 mg/kg administered IV Q6W.
| Group | Source count |
|---|---|
| Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2W | 4 |
| Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + Nivolumab 240 mg Q2W | 4 |
| Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2W | 5 |
| Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2W | 4 |
| Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W | 5 |
| Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W | 4 |
| Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W | 4 |
| Phase 1 Group C: INCAGN01876 1.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W | 4 |
| Phase 1 Group C: INCAGN01876 3.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W | 8 |
| Phase 1 Group C: INCAGN01876 5.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W | 3 |
| Phase 1 Group D: INCAGN01876 1.0 mg/kg + Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg | 6 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2W | 25.0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + Nivolumab 240 mg Q2W | 50.0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2W | 20.0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2W | 50.0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W | 0.0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W | 25.0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W | 50.0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Group C: INCAGN01876 1.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W | 25.0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Group C: INCAGN01876 3.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W | 50.0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Group C: INCAGN01876 5.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W | 0.0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Group D: INCAGN01876 1.0 mg/kg + Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg | 0.0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 25.0
- group Id
- OG001
- value
- 50.0
- group Id
- OG002
- value
- 20.0
- group Id
- OG003
- value
- 50.0
- group Id
- OG004
- value
- 0.0
- group Id
- OG005
- value
- 25.0
- group Id
- OG006
- value
- 50.0
- group Id
- OG007
- value
- 25.0
- group Id
- OG008
- value
- 50.0
- group Id
- OG009
- value
- 0.0
- group Id
- OG010
- value
- 0.0
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 5
- group Id
- OG005
- value
- 4
- group Id
- OG006
- value
- 4
- group Id
- OG007
- value
- 4
- group Id
- OG008
- value
- 8
- group Id
- OG009
- value
- 3
- group Id
- OG010
- value
- 6
- units
- Participants
- description
- DCR was defined as the percentage of participants with a best overall response of unconfirmed CR, unconfirmed PR, or stable disease (SD; ≥49 days), determined by investigator assessment of radiographic disease assessments per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD.
- groups
- description
- Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
- id
- OG000
- title
- Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2W
- description
- Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
- id
- OG001
- title
- Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + Nivolumab 240 mg Q2W
- description
- Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
- id
- OG002
- title
- Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2W
- description
- Participants received INCAGN01876 10.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
- id
- OG003
- title
- Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2W
- description
- Participants received INCAGN01876 1.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
- id
- OG004
- title
- Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
- description
- Participants received INCAGN01876 3.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
- id
- OG005
- title
- Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
- description
- Participants received INCAGN01876 5.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
- id
- OG006
- title
- Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
- description
- Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV every 6 weeks (Q6W).
- id
- OG007
- title
- Phase 1 Group C: INCAGN01876 1.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
- description
- Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
- id
- OG008
- title
- Phase 1 Group C: INCAGN01876 3.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
- description
- Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
- id
- OG009
- title
- Phase 1 Group C: INCAGN01876 5.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
- description
- Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with nivolumab 3 mg/kg administered IV Q2W and ipilimumab 1 mg/kg administered IV Q6W.
- id
- OG010
- title
- Phase 1 Group D: INCAGN01876 1.0 mg/kg + Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg
- param Type
- NUMBER
- population Description
- Phase 1 Response Evaluable Population
- reporting Status
- POSTED
- time Frame
- up to approximately 44.7 months
- title
- Phase 1: DCR Per mRECIST v1.1
- type
- SECONDARY
- unit Of Measure
- Percentage of Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice