TriangleNCT03241173 · OUTCOME
Phase 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- up to 17.4 months
What was measured
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. Abnormal laboratory values or test results that occurred after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the study drug(s). A TEAE was defined as any adverse event either reported for the first time or the worsening of a pre-existing event after the first dose of study drug.
Analysis population: Full Analysis Set (FAS): all participants enrolled in the study who received ≥ 1 dose of INCAGN01949, nivolumab, or ipilimumab
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 | 4 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Dose Escalation: INCAGN01949 200 mg + Nivolumab 240 mg | 4 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Dose Escalation: INCAGN01949 350 mg + Nivolumab 240 mg | 5 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Dose Escalation: INCAGN01949 700 mg + Nivolumab 240 mg | 5 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Dose Escalation: INCAGN01949 70 mg + Ipilimumab 1 mg/kg | 4 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Dose Escalation: INCAGN01949 200 mg + Ipilimumab 1 mg/kg | 5 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Dose Escalation: INCAGN01949 350 mg + Ipilimumab 1 mg/kg | 4 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Dose Escalation: INCAGN01949 700 mg + Ipilimumab 1 mg/kg | 3 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Safety Expansion: INCAGN01949 70 mg + Nivolumab 240 mg | 6 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Safety Expansion: INCAGN01949 200 mg + Nivolumab 240 mg | 6 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Safety Expansion: INCAGN01949 350 mg + Nivolumab 240 mg | 6 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- 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
- 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
- An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. Abnormal laboratory values or test results that occurred after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the study drug(s). A TEAE was defined as any adverse event either reported for the first time or the worsening of a pre-existing event after the first dose of study drug.
- 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
- COUNT_OF_PARTICIPANTS
- population Description
- Full Analysis Set (FAS): all participants enrolled in the study who received ≥ 1 dose of INCAGN01949, nivolumab, or ipilimumab
- reporting Status
- POSTED
- time Frame
- up to 17.4 months
- title
- Phase 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice