TriangleNCT03241173 · OUTCOME
Phase 1: Disease Control Rate (DCR)
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 15.6 months
What was measured
DCR was defined as the percentage of participants with a CR, PR, or stable disease (SD), determined by investigator assessment of radiographic disease assessments per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. SD: no change in target lesions to qualify for CR, PR, or PD.
Analysis population: FAS
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 | 4 |
| Phase 1, Dose Escalation: INCAGN01949 350 mg + Nivolumab 240 mg | 5 |
| Phase 1, Dose Escalation: INCAGN01949 700 mg + Nivolumab 240 mg | 5 |
| 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 | 6 |
| 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 | 25.0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Dose Escalation: INCAGN01949 200 mg + Nivolumab 240 mg | 25.0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Dose Escalation: INCAGN01949 350 mg + Nivolumab 240 mg | 40.0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Dose Escalation: INCAGN01949 700 mg + Nivolumab 240 mg | 0.0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Dose Escalation: INCAGN01949 70 mg + Ipilimumab 1 mg/kg | 75.0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Dose Escalation: INCAGN01949 200 mg + Ipilimumab 1 mg/kg | 0.0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Dose Escalation: INCAGN01949 350 mg + Ipilimumab 1 mg/kg | 50.0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Dose Escalation: INCAGN01949 700 mg + Ipilimumab 1 mg/kg | 33.3 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Safety Expansion: INCAGN01949 70 mg + Nivolumab 240 mg | 33.3 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Safety Expansion: INCAGN01949 200 mg + Nivolumab 240 mg | 33.3 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Safety Expansion: INCAGN01949 350 mg + Nivolumab 240 mg | 66.7 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 25.0
- group Id
- OG001
- value
- 25.0
- group Id
- OG002
- value
- 40.0
- group Id
- OG003
- value
- 0.0
- group Id
- OG004
- value
- 75.0
- group Id
- OG005
- value
- 0.0
- group Id
- OG006
- value
- 50.0
- group Id
- OG007
- value
- 33.3
- group Id
- OG008
- value
- 33.3
- group Id
- OG009
- value
- 33.3
- group Id
- OG010
- value
- 66.7
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 5
- group Id
- OG006
- value
- 4
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 6
- group Id
- OG009
- value
- 6
- group Id
- OG010
- value
- 6
- units
- Participants
- description
- DCR was defined as the percentage of participants with a CR, PR, or stable disease (SD), determined by investigator assessment of radiographic disease assessments per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. SD: no change in target lesions to qualify for CR, PR, or PD.
- 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
- NUMBER
- population Description
- FAS
- reporting Status
- POSTED
- time Frame
- up to 15.6 months
- title
- Phase 1: Disease Control Rate (DCR)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice