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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
83
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.
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.
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.
The Angeles Clinic and Research Institute
Los Angeles, California, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
University of Florida - Shands Cancer Center
Gainesville, Florida, United States
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.
Time frame: Up to approximately 30 months
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.
Time frame: Up to approximately 4 months
Tmax of INCMGA00012 when given in combination with immune therapies
Defined as time to maximum concentration. Other pharmacokinetic measures (including Cmin and AUC0-t) will also be evaluated.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to approximately 4 months
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University of Chicago Medical Center
Chicago, Illinois, United States
Rutgers Cancer Institute of Nj
New Brunswick, New Jersey, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Upmc Cancercenter
Pittsburgh, Pennsylvania, United States
South Texas Accelerated Research Therapeutics
San Antonio, Texas, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to approximately 30 months
Overall survival
Defined as the time from randomization to death due to any cause.
Time frame: Up to approximately 30 months