TriangleNCT03241173 · OUTCOME
Phase 1: Progression-free Survival (PFS)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- days
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- up to 15.6 months
What was measured
PFS was defined as the length of time between the Baseline visit (Day 1) and the earlier of death or the first assessment of PD, as determined by investigator assessment of objective radiographic disease assessments per RECIST v1.1.
Analysis population: FAS. Median survival time was estimated using the Kaplan-Meier method. The confidence interval was calculated using the method of Brookmeyer and Crowley. Only participants with events of disease progression or death were analyzed.
Groups in this outcome
Phase 1, Dose Escalation: INCAGN01949 70 mg + Nivolumab 240 mg
Participants with advanced or metastatic select solid tumors received INCAGN01949 70 milligrams (mg) every 2 weeks (Q2W) beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 1 Day 1, administered as intravenous (IV) infusions.
Phase 1, Dose Escalation: INCAGN01949 200 mg + Nivolumab 240 mg
Participants with advanced or metastatic select solid tumors received INCAGN01949 200 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 1 Day 1, administered as IV infusions.
Phase 1, Dose Escalation: INCAGN01949 350 mg + Nivolumab 240 mg
Participants with advanced or metastatic select solid tumors received INCAGN01949 350 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 1 Day 1, administered as IV infusions.
Phase 1, Dose Escalation: INCAGN01949 700 mg + Nivolumab 240 mg
Participants with advanced or metastatic select solid tumors received INCAGN01949 700 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 1 Day 1, administered as IV infusions.
Phase 1, Dose Escalation: INCAGN01949 70 mg + Ipilimumab 1 mg/kg
Participants with advanced or metastatic select solid tumors received INCAGN01949 70 mg Q2W beginning on Cycle 1 Day 1, followed by ipilimumab 1 mg/kilogram (kg) every 6 weeks (Q6W) beginning on Cycle 1 Day 1, administered as IV infusions.
Phase 1, Dose Escalation: INCAGN01949 200 mg + Ipilimumab 1 mg/kg
Participants with advanced or metastatic select solid tumors received INCAGN01949 200 mg Q2W beginning on Cycle 1 Day 1, followed by ipilimumab 1 mg/kg Q6W beginning on Cycle 1 Day 1, administered as IV infusions.
Phase 1, Dose Escalation: INCAGN01949 350 mg + Ipilimumab 1 mg/kg
Participants with advanced or metastatic select solid tumors received INCAGN01949 350 mg Q2W beginning on Cycle 1 Day 1, followed by ipilimumab 1 mg/kg Q6W beginning on Cycle 1 Day 1, administered as IV infusions.
Phase 1, Dose Escalation: INCAGN01949 700 mg + Ipilimumab 1 mg/kg
Participants with advanced or metastatic select solid tumors received INCAGN01949 700 mg Q2W beginning on Cycle 1 Day 1, followed by ipilimumab 1 mg/kg Q6W beginning on Cycle 1 Day 1, administered as IV infusions.
Phase 1, Safety Expansion: INCAGN01949 70 mg + Nivolumab 240 mg
Participants with advanced or metastatic select solid tumors received INCAGN01949 70 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 3 Day 1, administered as IV infusions.
Phase 1, Safety Expansion: INCAGN01949 200 mg + Nivolumab 240 mg
Participants with advanced or metastatic select solid tumors received INCAGN01949 200 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 3 Day 1, administered as IV infusions.
Phase 1, Safety Expansion: INCAGN01949 350 mg + Nivolumab 240 mg
Participants with advanced or metastatic select solid tumors received INCAGN01949 350 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 3 Day 1, administered as IV infusions.
| Group | Source count |
|---|---|
| Phase 1, Dose Escalation: INCAGN01949 70 mg + Nivolumab 240 mg | 4 |
| Phase 1, Dose Escalation: INCAGN01949 200 mg + Nivolumab 240 mg | 3 |
| Phase 1, Dose Escalation: INCAGN01949 350 mg + Nivolumab 240 mg | 4 |
| Phase 1, Dose Escalation: INCAGN01949 700 mg + Nivolumab 240 mg | 4 |
| Phase 1, Dose Escalation: INCAGN01949 70 mg + Ipilimumab 1 mg/kg | 4 |
| Phase 1, Dose Escalation: INCAGN01949 200 mg + Ipilimumab 1 mg/kg | 5 |
| Phase 1, Dose Escalation: INCAGN01949 350 mg + Ipilimumab 1 mg/kg | 4 |
| Phase 1, Dose Escalation: INCAGN01949 700 mg + Ipilimumab 1 mg/kg | 3 |
| Phase 1, Safety Expansion: INCAGN01949 70 mg + Nivolumab 240 mg | 4 |
| Phase 1, Safety Expansion: INCAGN01949 200 mg + Nivolumab 240 mg | 6 |
| Phase 1, Safety Expansion: INCAGN01949 350 mg + Nivolumab 240 mg | 6 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1, Dose Escalation: INCAGN01949 70 mg + Nivolumab 240 mg | 1.8 | Not reported | 1.0 | 4.9 | Not reported |
| Phase 1, Dose Escalation: INCAGN01949 200 mg + Nivolumab 240 mg | 1.8 | Not reported | 1.4 | NA | The upper limit of the confidence interval was not estimable because too few participants had disease progression or died. |
| Phase 1, Dose Escalation: INCAGN01949 350 mg + Nivolumab 240 mg | 2.7 | Not reported | 1.4 | 7.5 | Not reported |
| Phase 1, Dose Escalation: INCAGN01949 700 mg + Nivolumab 240 mg | 1.8 | Not reported | 0.8 | 2.1 | Not reported |
| Phase 1, Dose Escalation: INCAGN01949 70 mg + Ipilimumab 1 mg/kg | 3.5 | Not reported | 0.7 | 5.4 | Not reported |
| Phase 1, Dose Escalation: INCAGN01949 200 mg + Ipilimumab 1 mg/kg | 1.6 | Not reported | 1.2 | 1.8 | Not reported |
| Phase 1, Dose Escalation: INCAGN01949 350 mg + Ipilimumab 1 mg/kg | 4.6 | Not reported | 1.2 | 15.7 | Not reported |
| Phase 1, Dose Escalation: INCAGN01949 700 mg + Ipilimumab 1 mg/kg | 1.8 | Not reported | 1.7 | 5.1 | Not reported |
| Phase 1, Safety Expansion: INCAGN01949 70 mg + Nivolumab 240 mg | 1.6 | Not reported | 0.1 | 9.9 | Not reported |
| Phase 1, Safety Expansion: INCAGN01949 200 mg + Nivolumab 240 mg | 2.2 | Not reported | 1.8 | 6.7 | Not reported |
| Phase 1, Safety Expansion: INCAGN01949 350 mg + Nivolumab 240 mg | 4.6 | Not reported | 1.8 | 15.5 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.0
- upper Limit
- 4.9
- value
- 1.8
- comment
- The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
- group Id
- OG001
- lower Limit
- 1.4
- upper Limit
- NA
- value
- 1.8
- group Id
- OG002
- lower Limit
- 1.4
- upper Limit
- 7.5
- value
- 2.7
- group Id
- OG003
- lower Limit
- 0.8
- upper Limit
- 2.1
- value
- 1.8
- group Id
- OG004
- lower Limit
- 0.7
- upper Limit
- 5.4
- value
- 3.5
- group Id
- OG005
- lower Limit
- 1.2
- upper Limit
- 1.8
- value
- 1.6
- group Id
- OG006
- lower Limit
- 1.2
- upper Limit
- 15.7
- value
- 4.6
- group Id
- OG007
- lower Limit
- 1.7
- upper Limit
- 5.1
- value
- 1.8
- group Id
- OG008
- lower Limit
- 0.1
- upper Limit
- 9.9
- value
- 1.6
- group Id
- OG009
- lower Limit
- 1.8
- upper Limit
- 6.7
- value
- 2.2
- group Id
- OG010
- lower Limit
- 1.8
- upper Limit
- 15.5
- value
- 4.6
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 5
- group Id
- OG006
- value
- 4
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 4
- group Id
- OG009
- value
- 6
- group Id
- OG010
- value
- 6
- units
- Participants
- description
- PFS was defined as the length of time between the Baseline visit (Day 1) and the earlier of death or the first assessment of PD, as determined by investigator assessment of objective radiographic disease assessments per RECIST v1.1.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with advanced or metastatic select solid tumors received INCAGN01949 70 milligrams (mg) every 2 weeks (Q2W) beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 1 Day 1, administered as intravenous (IV) infusions.
- id
- OG000
- title
- Phase 1, Dose Escalation: INCAGN01949 70 mg + Nivolumab 240 mg
- description
- Participants with advanced or metastatic select solid tumors received INCAGN01949 200 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 1 Day 1, administered as IV infusions.
- id
- OG001
- title
- Phase 1, Dose Escalation: INCAGN01949 200 mg + Nivolumab 240 mg
- description
- Participants with advanced or metastatic select solid tumors received INCAGN01949 350 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 1 Day 1, administered as IV infusions.
- id
- OG002
- title
- Phase 1, Dose Escalation: INCAGN01949 350 mg + Nivolumab 240 mg
- description
- Participants with advanced or metastatic select solid tumors received INCAGN01949 700 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 1 Day 1, administered as IV infusions.
- id
- OG003
- title
- Phase 1, Dose Escalation: INCAGN01949 700 mg + Nivolumab 240 mg
- description
- Participants with advanced or metastatic select solid tumors received INCAGN01949 70 mg Q2W beginning on Cycle 1 Day 1, followed by ipilimumab 1 mg/kilogram (kg) every 6 weeks (Q6W) beginning on Cycle 1 Day 1, administered as IV infusions.
- id
- OG004
- title
- Phase 1, Dose Escalation: INCAGN01949 70 mg + Ipilimumab 1 mg/kg
- description
- Participants with advanced or metastatic select solid tumors received INCAGN01949 200 mg Q2W beginning on Cycle 1 Day 1, followed by ipilimumab 1 mg/kg Q6W beginning on Cycle 1 Day 1, administered as IV infusions.
- id
- OG005
- title
- Phase 1, Dose Escalation: INCAGN01949 200 mg + Ipilimumab 1 mg/kg
- description
- Participants with advanced or metastatic select solid tumors received INCAGN01949 350 mg Q2W beginning on Cycle 1 Day 1, followed by ipilimumab 1 mg/kg Q6W beginning on Cycle 1 Day 1, administered as IV infusions.
- id
- OG006
- title
- Phase 1, Dose Escalation: INCAGN01949 350 mg + Ipilimumab 1 mg/kg
- description
- Participants with advanced or metastatic select solid tumors received INCAGN01949 700 mg Q2W beginning on Cycle 1 Day 1, followed by ipilimumab 1 mg/kg Q6W beginning on Cycle 1 Day 1, administered as IV infusions.
- id
- OG007
- title
- Phase 1, Dose Escalation: INCAGN01949 700 mg + Ipilimumab 1 mg/kg
- description
- Participants with advanced or metastatic select solid tumors received INCAGN01949 70 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 3 Day 1, administered as IV infusions.
- id
- OG008
- title
- Phase 1, Safety Expansion: INCAGN01949 70 mg + Nivolumab 240 mg
- description
- Participants with advanced or metastatic select solid tumors received INCAGN01949 200 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 3 Day 1, administered as IV infusions.
- id
- OG009
- title
- Phase 1, Safety Expansion: INCAGN01949 200 mg + Nivolumab 240 mg
- description
- Participants with advanced or metastatic select solid tumors received INCAGN01949 350 mg Q2W beginning on Cycle 1 Day 1, followed by nivolumab 240 mg Q2W beginning on Cycle 3 Day 1, administered as IV infusions.
- id
- OG010
- title
- Phase 1, Safety Expansion: INCAGN01949 350 mg + Nivolumab 240 mg
- param Type
- MEDIAN
- population Description
- FAS. Median survival time was estimated using the Kaplan-Meier method. The confidence interval was calculated using the method of Brookmeyer and Crowley. Only participants with events of disease progression or death were analyzed.
- reporting Status
- POSTED
- time Frame
- up to 15.6 months
- title
- Phase 1: Progression-free Survival (PFS)
- type
- SECONDARY
- unit Of Measure
- days
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice