The purpose of this study is to determine the safety, tolerability, and efficacy of INCAGN01876 when given in combination with immune therapies.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
In Phase 1 subjects will receive INCAGN01876 administered intravenously (IV) at the protocol-defined dose and schedule according to cohort and treatment group enrollment. In Phase 2, subjects will be administered IV study drug at the recommended dose from Phase 1.
Epacadostat will be self-administered orally at the protocol-defined dose.
Pembrolizumab will be administered IV at the protocol-defined dose.
The Angeles Clinic and Research Institute
Los Angeles, California, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Phase 1 and Phase 2: Participants With Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability]
A TEAE is any adverse event (AE) either reported for the first time or worsening of a pre-existing event after the first dose of study treatment.
Time frame: Screening through 60 days after end of treatment, up to approximately 18 months
Phase 1 and Phase 2 : ORR Based on RECIST v1.1 and mRECIST
Defined as the percentage of participants having a CR or PR based on investigator assessment per RECIST v1.1.
Time frame: Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months
Phase 2: Complete Response Rate (CRR) Based on RECIST v1.1
Defined as the percentage of checkpoint inhibitor-naive melanoma participants who have a CR based on investigator assessment per RECIST v1.1
Time frame: Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months
Phase 1 & Phase 2: Disease Control Rate Based on RECIST v1.1 and mRECIST
Defined as the percentage of participants having CR, PR, or stable disease (SD) based on investigator assessment per RECIST v1.1.
Time frame: Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months.
Phase 1 & Phase 2: Duration of Response Based on RECIST v1.1 and mRECIST
Defined as the time from the earliest date of disease response (CR or PR) until earliest date of disease progression or death due to any cause.
Time frame: Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months
Phase 1 & Phase 2: Duration of Disease Control Based on RECIST v1.1 and mRECIST
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Defined as time from first report of SD or better until disease progression or death from any cause.
Time frame: Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months
Phase 1 & Phase 2: Progression-free Survival Based on RECIST v1.1 and mRECIST
Defined as the time from the start of combination therapy until the earliest date of disease progression or death due to any cause.
Time frame: Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months
Phase 1 & Phase 2: Overall Survival
Defined as the time from the start of combination therapy until death due to any cause.
Time frame: At 1 year and 2 years.