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The purpose of this study is to determine the safety, preliminary evidence of clinical activity, and recommended Phase 2 dose (RP2D) of INCMGA00012 in combination with other agents that may improve the therapeutic efficacy of anti-PD-1 monotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | INCMGA00012 with epacadostat. |
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| Group B | Experimental | INCMGA00012 with INCB050465. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Retifanlimab | Drug | Part 1: INCMGA00012 at the protocol-defined starting dose administered intravenously every 4 weeks, with dose escalation to determine the maximum tolerated dose. Part 2: INCMGA00012 at the recommended dose from Part 1. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of treatment-emergent adverse events | Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug. | Up to approximately 30 months |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of INCMGA00012 when given in combination with immune therapies | Defined as maximum observed plasma or serum concentration. Other pharmacokinetic measures (including Cmin and AUC0-t) will also be evaluated. | Up to approximately 4 months |
| Tmax of INCMGA00012 when given in combination with immune therapies |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Angeles Clinic and Research Institute | Los Angeles | California | 90025 | United States | ||
| Yale New Haven Hospital |
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| Epacadostat | Drug | Part 1: Epacadostat at the protocol-defined starting dose administered orally twice daily, with dose escalation to determine the maximum tolerated dose. Part 2: Epacadostat at the recommended dose from Part 1. |
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| INCB050465 | Drug | Part 1: INCB050465 at the protocol-defined starting dose administered orally once daily, with dose escalation to determine the maximum tolerated dose. Part 2: INCB050465 at the recommended dose from Part 1. |
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Defined as time to maximum concentration. Other pharmacokinetic measures (including Cmin and AUC0-t) will also be evaluated. |
| Up to approximately 4 months |
| Cmax of epacadostat when given in combination with INCMGA00012 | Defined as maximum observed plasma or serum concentration. Other pharmacokinetic measures (including Cmin and AUC0-t) will also be evaluated. | Up to approximately 4 months |
| Tmax of epacadostat when given in combination with INCMGA00012 | Defined as time to maximum concentration. Other pharmacokinetic measures (including Cmin and AUC0-t) will also be evaluated. | Up to approximately 4 months |
| Cmax of INCB050645 when given in combination with INCMGA00012 | Defined as maximum observed plasma or serum concentration. Other pharmacokinetic measures (including Cmin and AUC0-t) will also be evaluated. | Up to approximately 4 months |
| Tmax of INCB050645 when given in combination with INCMGA00012 | Defined as time to maximum concentration. Other pharmacokinetic measures (including Cmin and AUC0-t) will also be evaluated. | Up to approximately 4 months |
| Overall response rate | Defined as the percentage of participants having complete response (CR) or partial response (PR) as determined by investigator assessment of radiographic disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and modified RECIST v1.1 for immune-based therapeutics. | Up to approximately 30 months |
| Duration of response | Defined as the time from the earliest date of CR or PR until the earliest date at which progression criteria are met or date of death due to any cause, whichever occurs first. | Up to approximately 30 months |
| Progression-free survival | Defined as the time from the start of therapy until the earliest date at which progression criteria are met or date of death due to any cause, whichever occurs first. | Up to approximately 30 months |
| Overall survival | Defined as the time from randomization to death due to any cause. | Up to approximately 30 months |
| New Haven |
| Connecticut |
| 06510 |
| United States |
| University of Florida - Shands Cancer Center | Gainesville | Florida | 32610 | United States |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | United States |
| Rutgers Cancer Institute of Nj | New Brunswick | New Jersey | 08901 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Upmc Cancercenter | Pittsburgh | Pennsylvania | 15232 | United States |
| South Texas Accelerated Research Therapeutics | San Antonio | Texas | 78229 | United States |
| ID | Term |
|---|---|
| C000613752 | epacadostat |
| C000656179 | parsaclisib |
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