TriangleNCT03241173 · OUTCOME
Phase 1: Duration of Disease Control
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 15.4 months
What was measured
Duration of disease control (CR, PR, and SD) was measured from the first report of SD or better until PD or death from any cause, if occurring sooner than progression, 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. PD: progression of a target or non-target lesion or presence of a new lesion.
Analysis population: FAS. The confidence interval was calculated based on the exact method for binomial distributions. Only participants with a confirmed CR, PR, or SD 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 | 1 |
| Phase 1, Dose Escalation: INCAGN01949 200 mg + Nivolumab 240 mg | 1 |
| Phase 1, Dose Escalation: INCAGN01949 350 mg + Nivolumab 240 mg | 2 |
| Phase 1, Dose Escalation: INCAGN01949 700 mg + Nivolumab 240 mg | 0 |
| Phase 1, Dose Escalation: INCAGN01949 70 mg + Ipilimumab 1 mg/kg | 3 |
| Phase 1, Dose Escalation: INCAGN01949 200 mg + Ipilimumab 1 mg/kg | 0 |
| Phase 1, Dose Escalation: INCAGN01949 350 mg + Ipilimumab 1 mg/kg | 2 |
| Phase 1, Dose Escalation: INCAGN01949 700 mg + Ipilimumab 1 mg/kg | 1 |
| Phase 1, Safety Expansion: INCAGN01949 70 mg + Nivolumab 240 mg | 2 |
| Phase 1, Safety Expansion: INCAGN01949 200 mg + Nivolumab 240 mg | 2 |
| Phase 1, Safety Expansion: INCAGN01949 350 mg + Nivolumab 240 mg | 4 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1, Dose Escalation: INCAGN01949 70 mg + Nivolumab 240 mg | 97.0 | Not reported | NA | NA | The upper and lower limits of the confidence interval were not estimable because too few participants had disease progression or died. |
| Phase 1, Dose Escalation: INCAGN01949 200 mg + Nivolumab 240 mg | NA | Not reported | NA | NA | The median and upper and lower limits of the confidence interval were not estimable because too few participants had disease progression or died. |
| Phase 1, Dose Escalation: INCAGN01949 350 mg + Nivolumab 240 mg | 120.0 | Not reported | 61.0 | 179.0 | Not reported |
| Phase 1, Dose Escalation: INCAGN01949 70 mg + Ipilimumab 1 mg/kg | 58.0 | Not reported | 43.0 | 113.0 | Not reported |
| Phase 1, Dose Escalation: INCAGN01949 350 mg + Ipilimumab 1 mg/kg | 298.5 | Not reported | 169.0 | 428.0 | Not reported |
| Phase 1, Dose Escalation: INCAGN01949 700 mg + Ipilimumab 1 mg/kg | 100.0 | Not reported | NA | NA | The upper and lower limits of the confidence interval were not estimable because too few participants had disease progression or died. |
| Phase 1, Safety Expansion: INCAGN01949 70 mg + Nivolumab 240 mg | 252.0 | Not reported | NA | NA | The upper and lower limits of the confidence interval were not estimable because too few participants had disease progression or died. |
| Phase 1, Safety Expansion: INCAGN01949 200 mg + Nivolumab 240 mg | 117.0 | Not reported | 86.0 | 148.0 | Not reported |
| Phase 1, Safety Expansion: INCAGN01949 350 mg + Nivolumab 240 mg | 115.0 | Not reported | 52.0 | 418.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- The upper and lower limits of the confidence interval were not estimable because too few participants had disease progression or died.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- 97.0
- comment
- The median and upper and lower limits of the confidence interval were not estimable because too few participants had disease progression or died.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- group Id
- OG002
- lower Limit
- 61.0
- upper Limit
- 179.0
- value
- 120.0
- group Id
- OG004
- lower Limit
- 43.0
- upper Limit
- 113.0
- value
- 58.0
- group Id
- OG006
- lower Limit
- 169.0
- upper Limit
- 428.0
- value
- 298.5
- comment
- The upper and lower limits of the confidence interval were not estimable because too few participants had disease progression or died.
- group Id
- OG007
- lower Limit
- NA
- upper Limit
- NA
- value
- 100.0
- comment
- The upper and lower limits of the confidence interval were not estimable because too few participants had disease progression or died.
- group Id
- OG008
- lower Limit
- NA
- upper Limit
- NA
- value
- 252.0
- group Id
- OG009
- lower Limit
- 86.0
- upper Limit
- 148.0
- value
- 117.0
- group Id
- OG010
- lower Limit
- 52.0
- upper Limit
- 418.0
- value
- 115.0
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 2
- group Id
- OG007
- value
- 1
- group Id
- OG008
- value
- 2
- group Id
- OG009
- value
- 2
- group Id
- OG010
- value
- 4
- units
- Participants
- description
- Duration of disease control (CR, PR, and SD) was measured from the first report of SD or better until PD or death from any cause, if occurring sooner than progression, 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. PD: progression of a target or non-target lesion or presence of a new lesion.
- 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. The confidence interval was calculated based on the exact method for binomial distributions. Only participants with a confirmed CR, PR, or SD were analyzed.
- reporting Status
- POSTED
- time Frame
- up to 15.4 months
- title
- Phase 1: Duration of Disease Control
- type
- SECONDARY
- unit Of Measure
- days
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice