TriangleNCT02327078 · OUTCOME
Phase 2: Duration of Disease Control, Defined as CR, PR, and Stable Disease (SD)
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
Duration of disease control is the time from the first dose to the first objective response of PD, or death, whichever occurs first, for participants who reported a best overall response of SD or better. PD was defined as at least a 20% increase in the SOD of target lesions. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the Baseline sum diameters.
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 per cancer type in this outcome measure. Overall number analyzed are the participants who had best overall response of stable disease or better.
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 | 4 |
| Phase 2: Epacadostat 300 mg + Nivolumab 240 mg in DLBCL | 4 |
| Phase 2: Epacadostat 100/300 mg + Nivolumab 240 mg in Melanoma(I/O Naive) | 39 |
| Phase 2 Epacadostat 100mg + Nivolumab 480 mg in Melanoma (I/O Relapsed) | 2 |
| Phase 2 Epacadostat 100mg + Nivolumab 480 mg in Melanoma (I/O Refractory) | 3 |
| Phase 2 Epacadostat 100/300 mg + Nivolumab 240 mg in NSCLC | 19 |
| Phase 2 Epacadostat 100/300 mg + Nivolumab 240 mg in Ovarian Cancer | 9 |
| Phase 2 Epacadostat 100/300 mg + Nivolumab 240 mg in SCCHN | 17 |
| Phase 2 Epacadostat 100/300 mg + Nivolumab 240 mg in Glioblastoma | 8 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2: Epacadostat 100 mg + Nivolumab 240 in Colorectal Cancer | 3.72 | Not reported | 2.86 | NA | Upper limit of 95% CI was not estimable due to low number of participants with events. |
| Phase 2: Epacadostat 300 mg + Nivolumab 240 mg in DLBCL | 4.57 | Not reported | 3.52 | 10.26 | Not reported |
| 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 due to low number of participants with events. |
| Phase 2 Epacadostat 100mg + Nivolumab 480 mg in Melanoma (I/O Refractory) | NA | Not reported | 3.19 | 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 NSCLC | NA | Not reported | 9.11 | 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 | 5.86 | Not reported | 3.52 | 7.47 | Not reported |
| Phase 2 Epacadostat 100/300 mg + Nivolumab 240 mg in SCCHN | 10.89 | Not reported | 4.84 | NA | 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 Glioblastoma | 3.72 | Not reported | 3.49 | 5.59 | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- Upper limit of 95% CI was not estimable due to low number of participants with events.
- group Id
- OG000
- lower Limit
- 2.86
- upper Limit
- NA
- value
- 3.72
- group Id
- OG001
- lower Limit
- 3.52
- upper Limit
- 10.26
- value
- 4.57
- 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 due to low number of participants with events.
- group Id
- OG003
- 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
- OG004
- lower Limit
- 3.19
- 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
- 9.11
- upper Limit
- NA
- value
- NA
- group Id
- OG006
- lower Limit
- 3.52
- upper Limit
- 7.47
- value
- 5.86
- comment
- Upper limit of 95% CI was not estimable due to low number of participants with events.
- group Id
- OG007
- lower Limit
- 4.84
- upper Limit
- NA
- value
- 10.89
- group Id
- OG008
- lower Limit
- 3.49
- upper Limit
- 5.59
- value
- 3.72
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 39
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 19
- group Id
- OG006
- value
- 9
- group Id
- OG007
- value
- 17
- group Id
- OG008
- value
- 8
- units
- Participants
- description
- Duration of disease control is the time from the first dose to the first objective response of PD, or death, whichever occurs first, for participants who reported a best overall response of SD or better. PD was defined as at least a 20% increase in the SOD of target lesions. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the Baseline sum diameters.
- 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 per cancer type in this outcome measure. Overall number analyzed are the participants who had best overall response of stable disease or better.
- reporting Status
- POSTED
- time Frame
- From first dose up end of the study (up to approximately 6 years)
- title
- Phase 2: Duration of Disease Control, Defined as CR, PR, and Stable Disease (SD)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice