TriangleNCT02327078 · OUTCOME
Phase 1, Part 1: ORR Per RECIST v1.1 for Participants With Solid Tumors; Per Cheson Criteria for Participants With B-cell NHL; and Per RANO and mRANO Criteria for Participants With GBM
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
- From first dose up end of the study (up to approximately 6 years)
What was measured
ORR was defined as percentage of participants having CR or PR as determined by investigator assessment of radiographic disease per RECIST v1.1. CR per RECIST v 1.1 was defined as disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters (SOD) of target lesions, taking as reference the Baseline sum diameters. Per Cheson criteria, CR: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms. PR: at least a 50% decrease in SPD of up to 6 of the largest dominant nodes or nodal masses. Per RANO criteria, CR: Complete disappearance of all enhancing measurable and non-measurable disease sustained. PR: at least ≥50% decrease compared with baseline in the SOD of all measurable enhancing lesions sustained.
Analysis population: The Phase 1, Part 1 Full Analysis Population includes all participants enrolled in the study who received at least 1 dose of study drug.
Groups in this outcome
Phase 1, Part 1: Epacadostat 25 mg + Nivolumab 3 mg
Participants received epacadostat 25 mg, orally, BID in combination of nivolumab 3 mg/kg, IV, on Days 1, 15, 29, and 43 of each 8-week cycle.
Phase 1, Part 1: Epacadostat 50 mg + Nivolumab 3 mg
Participants received epacadostat 50 mg, orally, BID in combination of nivolumab 3 mg/kg, IV, Q3W, on Days 1, 15, 29, and 43 of each 8-week cycle.
Phase 1, Part 1: Epacadostat 100 mg + Nivolumab 3 mg
Participants received epacadostat 100 mg, orally, BID in combination of nivolumab 3 mg/kg, IV, Q3W, on Days 1, 15, 29, and 43 of each 8-week cycle.
Phase 1, Part 1: Epacadostat 300 mg + Nivolumab 3 mg
Participants received epacadostat 300 mg, orally, BID in combination of nivolumab 3 mg/kg, IV, Q3W, on Days 1, 15, 29, and 43 of each 8-week cycle.
| Group | Source count |
|---|---|
| Phase 1, Part 1: Epacadostat 25 mg + Nivolumab 3 mg | 3 |
| Phase 1, Part 1: Epacadostat 50 mg + Nivolumab 3 mg | 6 |
| Phase 1, Part 1: Epacadostat 100 mg + Nivolumab 3 mg | 14 |
| Phase 1, Part 1: Epacadostat 300 mg + Nivolumab 3 mg | 13 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1, Part 1: Epacadostat 25 mg + Nivolumab 3 mg | 0.0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Part 1: Epacadostat 50 mg + Nivolumab 3 mg | 0.0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Part 1: Epacadostat 100 mg + Nivolumab 3 mg | 0.0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Part 1: Epacadostat 300 mg + Nivolumab 3 mg | 23.1 | 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
- 0.0
- group Id
- OG003
- value
- 23.1
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 14
- group Id
- OG003
- value
- 13
- units
- Participants
- description
- ORR was defined as percentage of participants having CR or PR as determined by investigator assessment of radiographic disease per RECIST v1.1. CR per RECIST v 1.1 was defined as disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters (SOD) of target lesions, taking as reference the Baseline sum diameters. Per Cheson criteria, CR: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms. PR: at least a 50% decrease in SPD of up to 6 of the largest dominant nodes or nodal masses. Per RANO criteria, CR: Complete disappearance of all enhancing measurable and non-measurable disease sustained. PR: at least ≥50% decrease compared with baseline in the SOD of all measurable enhancing lesions sustained.
- groups
- description
- Participants received epacadostat 25 mg, orally, BID in combination of nivolumab 3 mg/kg, IV, on Days 1, 15, 29, and 43 of each 8-week cycle.
- id
- OG000
- title
- Phase 1, Part 1: Epacadostat 25 mg + Nivolumab 3 mg
- description
- Participants received epacadostat 50 mg, orally, BID in combination of nivolumab 3 mg/kg, IV, Q3W, on Days 1, 15, 29, and 43 of each 8-week cycle.
- id
- OG001
- title
- Phase 1, Part 1: Epacadostat 50 mg + Nivolumab 3 mg
- description
- Participants received epacadostat 100 mg, orally, BID in combination of nivolumab 3 mg/kg, IV, Q3W, on Days 1, 15, 29, and 43 of each 8-week cycle.
- id
- OG002
- title
- Phase 1, Part 1: Epacadostat 100 mg + Nivolumab 3 mg
- description
- Participants received epacadostat 300 mg, orally, BID in combination of nivolumab 3 mg/kg, IV, Q3W, on Days 1, 15, 29, and 43 of each 8-week cycle.
- id
- OG003
- title
- Phase 1, Part 1: Epacadostat 300 mg + Nivolumab 3 mg
- param Type
- NUMBER
- population Description
- The Phase 1, Part 1 Full Analysis Population includes all participants enrolled in the study who received at least 1 dose of study drug.
- reporting Status
- POSTED
- time Frame
- From first dose up end of the study (up to approximately 6 years)
- title
- Phase 1, Part 1: ORR Per RECIST v1.1 for Participants With Solid Tumors; Per Cheson Criteria for Participants With B-cell NHL; and Per RANO and mRANO Criteria for Participants With GBM
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice