TriangleNCT03126110 · OUTCOME
Phase 2: DOR Per mRECIST v1.1
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 approximately 44.7 months
What was measured
DOR was defined as the time from the first overall response contributing to a confirmed objective response (CR or PR) to the earlier of the participant's death from any cause or the first assessment of PD, determined by investigator assessment of radiographic disease assessment per mRECIST 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. PD: progression of a target or non-target lesion or presence of a new lesion.
Analysis population: Phase 2 Response Evaluable Population. Only those participants with a response of CR or PR were analyzed. The confidence interval for median survival time was calculated using the method of Brookmeyer and Crowley.
Groups in this outcome
Phase 2 Group C2: PD-1/PD-L1 RM: INCAGN01876 300 mg + Ipilimumab 1 mg/kg
Participants with programmed cell death protein/programmed cell death ligand 1 (PD-1/PD-L1) relapsed melanoma (RM) received INCAGN01876 300 mg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
Phase 2 Group F GC: INCAGN01876 300 mg + Nivolumab 240 mg
Participants with gastric cancer (GC) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
Phase 2 Group F SCCHN INCAGN01876 300 mg + Nivolumab 240 mg
Participants with squamous cell carcinoma of the head and neck (SCCHN) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
Phase 2 Group F CC: INCAGN01876 300 mg + Nivolumab 240 mg
Participants with cervical cancer (CC) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
Phase 2 Group F PD-1/PD-L1 RM: INCAGN01876 300 mg + Nivolumab 240 mg
Participants with PD-1/PD-L1 relapsed melanoma received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
Phase 2 Group F: Biopsy: INCAGN01876 300 mg + Nivolumab 240 mg
Participants with gastric cancer, squamous cell carcinoma of the head and neck, cervical cancer, or PD-1/PD-L1 relapsed melanoma who had tumor lesions that were amenable to percutaneous biopsy received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
| Group | Source count |
|---|---|
| Phase 2 Group C2: PD-1/PD-L1 RM: INCAGN01876 300 mg + Ipilimumab 1 mg/kg | 0 |
| Phase 2 Group F GC: INCAGN01876 300 mg + Nivolumab 240 mg | 0 |
| Phase 2 Group F SCCHN INCAGN01876 300 mg + Nivolumab 240 mg | 12 |
| Phase 2 Group F CC: INCAGN01876 300 mg + Nivolumab 240 mg | 3 |
| Phase 2 Group F PD-1/PD-L1 RM: INCAGN01876 300 mg + Nivolumab 240 mg | 0 |
| Phase 2 Group F: Biopsy: INCAGN01876 300 mg + Nivolumab 240 mg | 0 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2 Group F SCCHN INCAGN01876 300 mg + Nivolumab 240 mg | NA | Not reported | NA | NA | The median and the upper and lower limits of the confidence interval were not estimable because too few participants had disease progression or died. |
| Phase 2 Group F CC: INCAGN01876 300 mg + Nivolumab 240 mg | NA | Not reported | 113.0 | NA | The median and the upper limit of the confidence interval were not estimable because too few participants had disease progression or died. |
Complete source fields
- classes
- categories
- measurements
- comment
- The median and the upper and lower limits of the confidence interval were not estimable because too few participants had disease progression or died.
- group Id
- OG002
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- The median and the upper limit of the confidence interval were not estimable because too few participants had disease progression or died.
- group Id
- OG003
- lower Limit
- 113.0
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 12
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- units
- Participants
- description
- DOR was defined as the time from the first overall response contributing to a confirmed objective response (CR or PR) to the earlier of the participant's death from any cause or the first assessment of PD, determined by investigator assessment of radiographic disease assessment per mRECIST 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. PD: progression of a target or non-target lesion or presence of a new lesion.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with programmed cell death protein/programmed cell death ligand 1 (PD-1/PD-L1) relapsed melanoma (RM) received INCAGN01876 300 mg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
- id
- OG000
- title
- Phase 2 Group C2: PD-1/PD-L1 RM: INCAGN01876 300 mg + Ipilimumab 1 mg/kg
- description
- Participants with gastric cancer (GC) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
- id
- OG001
- title
- Phase 2 Group F GC: INCAGN01876 300 mg + Nivolumab 240 mg
- description
- Participants with squamous cell carcinoma of the head and neck (SCCHN) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
- id
- OG002
- title
- Phase 2 Group F SCCHN INCAGN01876 300 mg + Nivolumab 240 mg
- description
- Participants with cervical cancer (CC) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
- id
- OG003
- title
- Phase 2 Group F CC: INCAGN01876 300 mg + Nivolumab 240 mg
- description
- Participants with PD-1/PD-L1 relapsed melanoma received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
- id
- OG004
- title
- Phase 2 Group F PD-1/PD-L1 RM: INCAGN01876 300 mg + Nivolumab 240 mg
- description
- Participants with gastric cancer, squamous cell carcinoma of the head and neck, cervical cancer, or PD-1/PD-L1 relapsed melanoma who had tumor lesions that were amenable to percutaneous biopsy received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
- id
- OG005
- title
- Phase 2 Group F: Biopsy: INCAGN01876 300 mg + Nivolumab 240 mg
- param Type
- MEDIAN
- population Description
- Phase 2 Response Evaluable Population. Only those participants with a response of CR or PR were analyzed. The confidence interval for median survival time was calculated using the method of Brookmeyer and Crowley.
- reporting Status
- POSTED
- time Frame
- up to approximately 44.7 months
- title
- Phase 2: DOR Per mRECIST v1.1
- type
- SECONDARY
- unit Of Measure
- Days
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice