Trial · NCT03126110
Outcomes24
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 24
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Phase 1: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | up to approximately 27.4 months | Phase 1 Full Analysis Set (FAS): all participants enrolled in Phase 1 of the study who received at least 1 dose of INCAGN01876, nivolumab, or ipilimumab | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Phase 2: Objective Response Rate (ORR) Per RECIST v1.1 | up to approximately 44.7 months | Phase 2 Response Evaluable Population: all participants enrolled in Phase 2 who received at least 1 dose of INCAGN01876, nivolumab, or ipilimumab; completed a Baseline scan; and met at least 1 of the following criteria: (a) ≥1 post-Baseline scan (b) the participant has been in the study for a minimum of 64 days of follow-up; or (c) the participant had discontinued from treatment | Percentage of Participants | NUMBER |
| SECONDARY | Phase 1: ORR Per RECIST v1.1 | up to approximately 44.7 months | Phase 1 Response Evaluable Population: all participants enrolled in Phase 1 who received at least 1 dose of INCAGN01876, nivolumab, or ipilimumab; completed a Baseline scan; and met at least 1 of the following criteria: (a) ≥1 post-Baseline scan (b) the participant has been in the study for a minimum of 64 days of follow-up; or (c) the participant had discontinued from treatment | Percentage of Participants | NUMBER |
| SECONDARY | Phase 1: ORR Per Modified RECIST (mRECIST) v1.1 | up to approximately 44.7 months | Phase 1 Response Evaluable Population | Percentage of Participants | NUMBER |
| SECONDARY | Phase 2: ORR Per mRECIST v1.1 | up to approximately 44.7 months | Phase 2 Response Evaluable Population | Percentage of Participants | NUMBER |
| SECONDARY | Phase 1: Duration of Response (DOR) Per RECIST v1.1 | up to approximately 44.7 months | Phase 1 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. | Days | MEDIAN |
| SECONDARY | Phase 2: DOR Per RECIST v1.1 | up to approximately 44.7 months | 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. | Days | MEDIAN |
| SECONDARY | Phase 1: DOR Per mRECIST v1.1 | up to approximately 44.7 months | Phase 1 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. | Days | MEDIAN |
| SECONDARY | Phase 2: DOR Per mRECIST v1.1 | up to approximately 44.7 months | 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. | Days | MEDIAN |
| SECONDARY | Phase 1: Disease Control Rate (DCR) Per RECIST v1.1 | up to approximately 44.7 months | Phase 1 Response Evaluable Population | Percentage of Participants | NUMBER |
| SECONDARY | Phase 2: DCR Per RECIST v1.1 | up to approximately 44.7 months | Phase 2 Response Evaluable Population | Percentage of Participants | NUMBER |
| SECONDARY | Phase 1: DCR Per mRECIST v1.1 | up to approximately 44.7 months | Phase 1 Response Evaluable Population | Percentage of Participants | NUMBER |
| SECONDARY | Phase 2: DCR Per mRECIST v1.1 | up to approximately 44.7 months | Phase 2 Response Evaluable Population | Percentage of Participants | NUMBER |
| SECONDARY | Phase 1: Duration of Disease Control Per RECIST v1.1 | up to approximately 44.7 months | Phase 1 Response Evaluable Population. The confidence intervals was calculated based on the exact method for binomial distributions. Only those participants with a response of SD, CR, or PR were analyzed. | Days | MEAN |
| SECONDARY | Phase 2: Duration of Disease Control Per RECIST v1.1 | up to approximately 44.7 months | Phase 2 Response Evaluable Population. The confidence intervals was calculated based on the exact method for binomial distributions. Only those participants with a response of SD, CR, or PR were analyzed. | Days | MEDIAN |
| SECONDARY | Phase 1: Duration of Disease Control Per mRECIST v1.1 | up to approximately 44.7 months | Phase 1 Response Evaluable Population. The confidence intervals was calculated based on the exact method for binomial distributions. Only those participants with a response of SD, CR, or PR were analyzed. | Days | MEAN |
| SECONDARY | Phase 2: Duration of Disease Control Per mRECIST v1.1 | up to approximately 44.7 months | Phase 2 Response Evaluable Population. The confidence intervals was calculated based on the exact method for binomial distributions. Only those participants with a response of SD, CR, or PR were analyzed. | Days | MEDIAN |
| SECONDARY | Phase 1: Progression-free Survival (PFS) Per RECIST v1.1 | up to approximately 44.7 months | Phase 1 FAS. Median survival time was estimated using the Kaplan-Meier method. The confidence interval for median survival time was calculated using the method of Brookmeyer and Crowley. | Days | MEDIAN |
| SECONDARY | Phase 2: PFS Per RECIST v1.1 | up to approximately 44.7 months | Phase 2 FAS. Median survival time was estimated using the Kaplan-Meier method. The confidence interval for median survival time was calculated using the method of Brookmeyer and Crowley. | Days | MEDIAN |
| SECONDARY | Phase 1: PFS Per mRECIST v1.1 | up to approximately 44.7 months | Phase 1 FAS. Median survival time was estimated using the Kaplan-Meier method. The confidence interval for median survival time was calculated using the method of Brookmeyer and Crowley. | Days | MEDIAN |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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