The purpose of this study is to assess the safety and antitumor activity of INCB001158 plus epacadostat, with or without pembrolizumab, in participants with advanced or metastatic solid tumors.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
5
Phase 1: INCB001158 administered orally twice daily at the protocol-defined dose. Phase 2: INCB001158 administered orally twice daily at the recommended dose from Phase 1.
Epacadostat at the protocol-defined dose administered orally twice daily.
Pembrolizumab at the protocol-defined dose administered intravenously every 3 weeks.
University of Alabama
Birmingham, Alabama, United States
The University of Chicago Medicine
Chicago, Illinois, United States
Phase 1 Only: Safety and Tolerability of INCB001158 in Combination With Epacadostat ± Pembrolizumab as Assessed by Number of Participants With a Treatment-emergent Adverse Event (TEAE)
TEAE defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study treatment.
Time frame: Up to approximately 12 months per subject
Phase 2 Only: Objective Response Rate (ORR) of INCB001158 in Combination With Epacadostat ± Pembrolizumab
Defined as percentage of subjects having a complete response (CR) or partial response (PR) based on investigator assessment per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
Time frame: Up to approximately 12 months per subject
Phase 2 Only: Safety and Tolerability of INCB001158 in Combination With Epacadostat ± Pembrolizumab as Assessed by Number of Participants With a TEAE
TEAE defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study treatment.
Time frame: Up to approximately 12 months per subject
Phase 1 Only: ORR With INCB001158 in Combination With Epacadostat ± Pembrolizumab
Defined as percentage of subjects having a CR or PR based on investigator assessment per RECIST v1.1.
Time frame: Up to approximately 12 months per subject
Disease Control Rate With INCB001158 in Combination With Epacadostat ± Pembrolizumab
Defined as percentage of subjects having CR, PR, or stable disease for at least 56 days based on investigator assessment per RECIST v1.1.
Time frame: Up to approximately 12 months per subject
Duration of Response With INCB001158 in Combination With Epacadostat ± Pembrolizumab
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Defined as the time from earliest date of disease response until the earliest date of disease progression per RECIST v1.1, or death due to any cause, if occurring sooner than progression.
Time frame: Up to approximately 12 months per subject
Progression-free Survival With INCB001158 in Combination With Epacadostat ± Pembrolizumab
Defined as the time from date of first dose of study treatment until the earliest date of disease progression (based on investigator assessment of per RECIST v1.1) or death due to any cause, if occurring sooner than progression.
Time frame: Up to approximately 12 months per subject
Plasma Pharmacokinetic Profile of INCB001158 and Epacadostat
Noncompartmental method of analysis will be used to analyze the plasma concentrations of INCB001158 and epacadostat.
Time frame: Up to approximately 1 month