TriangleNCT03126110 · OUTCOME
Phase 2: ORR 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
ORR was defined as the percentage of participants with a best overall response of confirmed CR or PR, determined by investigator assessment of radiographic disease assessments per mRECIST v1.1. The response of target lesions was evaluated from the percentage change in the sum of the diameters of the viable portions (portions enhanced during the arterial phase). CR: Disappearance of any intratumoral arterial enhancement during in target lesions, disappearance of all non-target lesions, and no appearance of any new lesions. PR: ≥30% of the sum of the diameters of viable portions (enhancement on arterial phase) of target lesions taking as reference the Baseline sum, no new lesions, and no progression of non-target lesions.
Analysis population: Phase 2 Response Evaluable Population
Groups in this outcome
Phase 2 Group C2 PD-1/PD-L1 RM: INCAGN01876 300 mg + Ipilimumab 1 mg/kg
Participants with programmed cell death protein/programmed cell death ligand 1 (PD-1/PD-L1) relapsed melanoma (RM) received INCAGN01876 300 mg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
Phase 2 Group F GC: INCAGN01876 300 mg + Nivolumab 240 mg
Participants with gastric cancer (GC) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
Phase 2 Group F SCCHN INCAGN01876 300 mg + Nivolumab 240 mg
Participants with squamous cell carcinoma of the head and neck (SCCHN) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
Phase 2 Group F CC: INCAGN01876 300 mg + Nivolumab 240 mg
Participants with cervical cancer (CC) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
Phase 2 Group F PD-1/PD-L1 RM: INCAGN01876 300 mg + Nivolumab 240 mg
Participants with PD-1/PD-L1 relapsed melanoma received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
Phase 2 Group F Biopsy: INCAGN01876 300 mg + Nivolumab 240 mg
Participants with gastric cancer, squamous cell carcinoma of the head and neck, cervical cancer, or PD-1/PD-L1 relapsed melanoma who had tumor lesions that were amenable to percutaneous biopsy received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
| Group | Source count |
|---|---|
| Phase 2 Group C2 PD-1/PD-L1 RM: INCAGN01876 300 mg + Ipilimumab 1 mg/kg | 8 |
| Phase 2 Group F GC: INCAGN01876 300 mg + Nivolumab 240 mg | 16 |
| Phase 2 Group F SCCHN INCAGN01876 300 mg + Nivolumab 240 mg | 46 |
| Phase 2 Group F CC: INCAGN01876 300 mg + Nivolumab 240 mg | 18 |
| Phase 2 Group F PD-1/PD-L1 RM: INCAGN01876 300 mg + Nivolumab 240 mg | 4 |
| Phase 2 Group F Biopsy: INCAGN01876 300 mg + Nivolumab 240 mg | 2 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2 Group C2 PD-1/PD-L1 RM: INCAGN01876 300 mg + Ipilimumab 1 mg/kg | 0.0 | Not reported | Not reported | Not reported | Not reported |
| Phase 2 Group F GC: INCAGN01876 300 mg + Nivolumab 240 mg | 0.0 | Not reported | Not reported | Not reported | Not reported |
| Phase 2 Group F SCCHN INCAGN01876 300 mg + Nivolumab 240 mg | 26.1 | Not reported | Not reported | Not reported | Not reported |
| Phase 2 Group F CC: INCAGN01876 300 mg + Nivolumab 240 mg | 16.7 | Not reported | Not reported | Not reported | Not reported |
| Phase 2 Group F PD-1/PD-L1 RM: INCAGN01876 300 mg + Nivolumab 240 mg | 0.0 | Not reported | Not reported | Not reported | Not reported |
| Phase 2 Group F Biopsy: INCAGN01876 300 mg + Nivolumab 240 mg | 0.0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0.0
- group Id
- OG001
- value
- 0.0
- group Id
- OG002
- value
- 26.1
- group Id
- OG003
- value
- 16.7
- group Id
- OG004
- value
- 0.0
- group Id
- OG005
- value
- 0.0
- denoms
- counts
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 16
- group Id
- OG002
- value
- 46
- group Id
- OG003
- value
- 18
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 2
- units
- Participants
- description
- ORR was defined as the percentage of participants with a best overall response of confirmed CR or PR, determined by investigator assessment of radiographic disease assessments per mRECIST v1.1. The response of target lesions was evaluated from the percentage change in the sum of the diameters of the viable portions (portions enhanced during the arterial phase). CR: Disappearance of any intratumoral arterial enhancement during in target lesions, disappearance of all non-target lesions, and no appearance of any new lesions. PR: ≥30% of the sum of the diameters of viable portions (enhancement on arterial phase) of target lesions taking as reference the Baseline sum, no new lesions, and no progression of non-target lesions.
- groups
- description
- Participants with programmed cell death protein/programmed cell death ligand 1 (PD-1/PD-L1) relapsed melanoma (RM) received INCAGN01876 300 mg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
- id
- OG000
- title
- Phase 2 Group C2 PD-1/PD-L1 RM: INCAGN01876 300 mg + Ipilimumab 1 mg/kg
- description
- Participants with gastric cancer (GC) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
- id
- OG001
- title
- Phase 2 Group F GC: INCAGN01876 300 mg + Nivolumab 240 mg
- description
- Participants with squamous cell carcinoma of the head and neck (SCCHN) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
- id
- OG002
- title
- Phase 2 Group F SCCHN INCAGN01876 300 mg + Nivolumab 240 mg
- description
- Participants with cervical cancer (CC) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
- id
- OG003
- title
- Phase 2 Group F CC: INCAGN01876 300 mg + Nivolumab 240 mg
- description
- Participants with PD-1/PD-L1 relapsed melanoma received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
- id
- OG004
- title
- Phase 2 Group F PD-1/PD-L1 RM: INCAGN01876 300 mg + Nivolumab 240 mg
- description
- Participants with gastric cancer, squamous cell carcinoma of the head and neck, cervical cancer, or PD-1/PD-L1 relapsed melanoma who had tumor lesions that were amenable to percutaneous biopsy received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
- id
- OG005
- title
- Phase 2 Group F Biopsy: INCAGN01876 300 mg + Nivolumab 240 mg
- param Type
- NUMBER
- population Description
- Phase 2 Response Evaluable Population
- reporting Status
- POSTED
- time Frame
- up to approximately 44.7 months
- title
- Phase 2: ORR 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