TriangleNCT02327078 · OUTCOME
Phase 2: Duration of Response
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 first dose up end of the study (up to approximately 6 years)
What was measured
DOR is defined as the time from the first overall response contributing to an objective response (CR or PR) to the earlier of the participant's death and first overall response of PD. CR was defined as disappearance of all target lesions. PR was defined as At least a 30% decrease in the sum of diameters (SOD) of target lesions, taking as reference the Baseline sum diameters. PD was defined as at least a 20% increase in the SOD of target lesions.
Analysis population: The Phase 2 Full Analysis Population includes all participants enrolled in the study who received at least 1 dose of study drug. The data is reported only for responders and per cancer type for this outcome measure.
Groups in this outcome
Phase 2: Epacadostat 100 mg + Nivolumab 240 in Colorectal Cancer
Participants with Colorectal Cancer received epacadostat 100 mg BID in combination with nivolumab 240 mg IV infusion Q2W on Days 1, 15, 29, and 43 of each 8-week cycle.
Phase 2: Epacadostat 300 mg + Nivolumab 240 mg in DLBCL
Participants with DLBCL received epacadostat 300 mg BID in combination with nivolumab 240 mg IV infusion Q2W on Days 1, 15, 29, and 43 of each 8-week cycle.
Phase 2: Epacadostat 100/300 mg + Nivolumab 240 mg in Melanoma(I/O Naive)
Participants with Melanoma(I/O Naive) received epacadostat 100 mg or 300 mg BID in combination with nivolumab 240 mg IV infusion Q2W on Days 1, 15, 29, and 43 of each 8-week cycle.
Phase 2 Epacadostat 100mg + Nivolumab 480 mg in Melanoma (I/O Relapsed)
Participants with Melanoma (I/O Relapsed) received epacadostat 100 mg BID in combination with nivolumab 480 mg IV infusion Q2W on Days 1, 15, 29, and 43 of each 8-week cycle.
Phase 2 Epacadostat 100mg + Nivolumab 480 mg in Melanoma (I/O Refractory)
Participants with Melanoma (I/O Refractory) received epacadostat 100 mg BID in combination with nivolumab 480 mg IV infusion Q2W on Days 1, 15, 29, and 43 of each 8-week cycle.
Phase 2 Epacadostat 100/300 mg + Nivolumab 240 mg in NSCLC
Participants with NSCLC received epacadostat 100 mg or 300 mg BID in combination with nivolumab 240 mg IV infusion Q2W on Days 1, 15, 29, and 43 of each 8-week cycle.
Phase 2 Epacadostat 100/300 mg + Nivolumab 240 mg in Ovarian Cancer
Participants with Ovarian Cancer received epacadostat 100 mg or 300 mg BID in combination with nivolumab 240 mg IV infusion Q2W on Days 1, 15, 29, and 43 of each 8-week cycle.
Phase 2 Epacadostat 100/300 mg + Nivolumab 240 mg in SCCHN
Participants with SCCHN received epacadostat 100/300 mg BID in combination with nivolumab 240 mg IV infusion Q2W on Days 1, 15, 29, and 43 of each 8-week cycle.
Phase 2 Epacadostat 100/300 mg + Nivolumab 240 mg in Glioblastoma
Participants with Glioblastoma received epacadostat 100/300 mg BID in combination with nivolumab 240 mg IV infusion Q2W on Days 1, 15, 29, and 43 of each 8-week cycle.
| Group | Source count |
|---|---|
| Phase 2: Epacadostat 100 mg + Nivolumab 240 in Colorectal Cancer | 1 |
| Phase 2: Epacadostat 300 mg + Nivolumab 240 mg in DLBCL | 0 |
| Phase 2: Epacadostat 100/300 mg + Nivolumab 240 mg in Melanoma(I/O Naive) | 31 |
| Phase 2 Epacadostat 100mg + Nivolumab 480 mg in Melanoma (I/O Relapsed) | 1 |
| Phase 2 Epacadostat 100mg + Nivolumab 480 mg in Melanoma (I/O Refractory) | 2 |
| Phase 2 Epacadostat 100/300 mg + Nivolumab 240 mg in NSCLC | 12 |
| Phase 2 Epacadostat 100/300 mg + Nivolumab 240 mg in Ovarian Cancer | 4 |
| Phase 2 Epacadostat 100/300 mg + Nivolumab 240 mg in SCCHN | 8 |
| Phase 2 Epacadostat 100/300 mg + Nivolumab 240 mg in Glioblastoma | 0 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2: Epacadostat 100 mg + Nivolumab 240 in Colorectal Cancer | NA | Not reported | NA | NA | Median, lower and upper limit of 95% CI was not estimable for 1 participant. |
| Phase 2: Epacadostat 100/300 mg + Nivolumab 240 mg in Melanoma(I/O Naive) | NA | Not reported | NA | NA | Median, lower and upper limit of 95% CI was not estimable due to low number of participants with events. |
| Phase 2 Epacadostat 100mg + Nivolumab 480 mg in Melanoma (I/O Relapsed) | NA | Not reported | NA | NA | Median, lower and upper limit of 95% CI was not estimable for 1 participant. |
| Phase 2 Epacadostat 100mg + Nivolumab 480 mg in Melanoma (I/O Refractory) | NA | Not reported | NA | NA | Median and 95% CI was not estimable due to low number of participants with events. |
| Phase 2 Epacadostat 100/300 mg + Nivolumab 240 mg in NSCLC | NA | Not reported | 1.94 | NA | Median and upper limit of 95% CI was not estimable due to low number of participants with events. |
| Phase 2 Epacadostat 100/300 mg + Nivolumab 240 mg in Ovarian Cancer | 3.93 | Not reported | 3.13 | 5.53 | Not reported |
| Phase 2 Epacadostat 100/300 mg + Nivolumab 240 mg in SCCHN | NA | Not reported | 7.37 | NA | Median and upper limit of 95% CI was not estimable due to low number of participants with events. |
Complete source fields
- classes
- categories
- measurements
- comment
- Median, lower and upper limit of 95% CI was not estimable for 1 participant.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- Median, lower and upper limit of 95% CI was not estimable due to low number of participants with events.
- group Id
- OG002
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- Median, lower and upper limit of 95% CI was not estimable for 1 participant.
- group Id
- OG003
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- Median and 95% CI was not estimable due to low number of participants with events.
- group Id
- OG004
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- Median and upper limit of 95% CI was not estimable due to low number of participants with events.
- group Id
- OG005
- lower Limit
- 1.94
- upper Limit
- NA
- value
- NA
- group Id
- OG006
- lower Limit
- 3.13
- upper Limit
- 5.53
- value
- 3.93
- comment
- Median and upper limit of 95% CI was not estimable due to low number of participants with events.
- group Id
- OG007
- lower Limit
- 7.37
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 31
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 12
- group Id
- OG006
- value
- 4
- group Id
- OG007
- value
- 8
- group Id
- OG008
- value
- 0
- units
- Participants
- description
- DOR is defined as the time from the first overall response contributing to an objective response (CR or PR) to the earlier of the participant's death and first overall response of PD. CR was defined as disappearance of all target lesions. PR was defined as At least a 30% decrease in the sum of diameters (SOD) of target lesions, taking as reference the Baseline sum diameters. PD was defined as at least a 20% increase in the SOD of target lesions.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with Colorectal Cancer received epacadostat 100 mg BID in combination with nivolumab 240 mg IV infusion Q2W on Days 1, 15, 29, and 43 of each 8-week cycle.
- id
- OG000
- title
- Phase 2: Epacadostat 100 mg + Nivolumab 240 in Colorectal Cancer
- description
- Participants with DLBCL received epacadostat 300 mg BID in combination with nivolumab 240 mg IV infusion Q2W on Days 1, 15, 29, and 43 of each 8-week cycle.
- id
- OG001
- title
- Phase 2: Epacadostat 300 mg + Nivolumab 240 mg in DLBCL
- description
- Participants with Melanoma(I/O Naive) received epacadostat 100 mg or 300 mg BID in combination with nivolumab 240 mg IV infusion Q2W on Days 1, 15, 29, and 43 of each 8-week cycle.
- id
- OG002
- title
- Phase 2: Epacadostat 100/300 mg + Nivolumab 240 mg in Melanoma(I/O Naive)
- description
- Participants with Melanoma (I/O Relapsed) received epacadostat 100 mg BID in combination with nivolumab 480 mg IV infusion Q2W on Days 1, 15, 29, and 43 of each 8-week cycle.
- id
- OG003
- title
- Phase 2 Epacadostat 100mg + Nivolumab 480 mg in Melanoma (I/O Relapsed)
- description
- Participants with Melanoma (I/O Refractory) received epacadostat 100 mg BID in combination with nivolumab 480 mg IV infusion Q2W on Days 1, 15, 29, and 43 of each 8-week cycle.
- id
- OG004
- title
- Phase 2 Epacadostat 100mg + Nivolumab 480 mg in Melanoma (I/O Refractory)
- description
- Participants with NSCLC received epacadostat 100 mg or 300 mg BID in combination with nivolumab 240 mg IV infusion Q2W on Days 1, 15, 29, and 43 of each 8-week cycle.
- id
- OG005
- title
- Phase 2 Epacadostat 100/300 mg + Nivolumab 240 mg in NSCLC
- description
- Participants with Ovarian Cancer received epacadostat 100 mg or 300 mg BID in combination with nivolumab 240 mg IV infusion Q2W on Days 1, 15, 29, and 43 of each 8-week cycle.
- id
- OG006
- title
- Phase 2 Epacadostat 100/300 mg + Nivolumab 240 mg in Ovarian Cancer
- description
- Participants with SCCHN received epacadostat 100/300 mg BID in combination with nivolumab 240 mg IV infusion Q2W on Days 1, 15, 29, and 43 of each 8-week cycle.
- id
- OG007
- title
- Phase 2 Epacadostat 100/300 mg + Nivolumab 240 mg in SCCHN
- description
- Participants with Glioblastoma received epacadostat 100/300 mg BID in combination with nivolumab 240 mg IV infusion Q2W on Days 1, 15, 29, and 43 of each 8-week cycle.
- id
- OG008
- title
- Phase 2 Epacadostat 100/300 mg + Nivolumab 240 mg in Glioblastoma
- param Type
- MEDIAN
- population Description
- The Phase 2 Full Analysis Population includes all participants enrolled in the study who received at least 1 dose of study drug. The data is reported only for responders and per cancer type for this outcome measure.
- reporting Status
- POSTED
- time Frame
- From first dose up end of the study (up to approximately 6 years)
- title
- Phase 2: Duration of Response
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice