Advanced/Metastatic, Head and Neck Cancer, Small Cell Lung Cancer, Bladder Cancer
A Study of Epacadostat (INCB024360) in Combination With Durvalumab (MEDI4736) in Subjects With Selected Advanced Solid Tumors (ECHO-203)
Results Available
Clinical Study Purpose
The purpose of this study is to explore the safety, tolerability, pharmacokinetics, immunogenicity and preliminary efficacy of INCB024360 administered in combination with MEDI4736 in subjects with selected advanced solid tumors.
Clinical Study Summary
Clinical Study Locations
Key Inclusion and Exclusion Criteria
Inclusion Criteria
- Male or female subjects, age 18 years or older
- Histologically or cytologically confirmed diagnosis of selected locally advanced or metastatic solid tumors
Exclusion Criteria
- Laboratory and medical history parameters not within protocol-defined range
- Participation in any other study in which receipt of an investigational study drug occurred within 28 days or 5 half-lives (whichever is longer) prior to first dose
Protocol Summary
Phase 1: Incidence of Dose Limiting Toxicities and frequency, duration, and severity of Adverse Events (AEs)
Timeframe: Duration of study treatment and up to 90 days after the last dose [approximately 15 months]
Phase 2: Objective Response Rate (ORR) as determined by radiographic disease assessments per modified Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Timeframe: Measured every 8 weeks for duration of study treatment [approximately 12 months]
Phase 1: Objective Response Rate (ORR) as determined by radiographic disease assessments per modified RECIST v1.1
Timeframe: Measured every 8 weeks for duration of study treatment [approximately 6 months]
Phase 2: Frequency, duration, and severity of AEs
Timeframe: Continuously for duration of study treatment and up to 90 days after the last dose
Phase 1 and 2: Durability of response as measured by the time from the earliest date of disease response until earliest date of disease progression
Timeframe: Measured every 8 weeks for duration of active study treatment [approximately 6 months]
Phase 1 and 2: Progression-free survival as measured by the duration from the date of enrollment until the earliest date of disease progression or death
Timeframe: Measured every 8 weeks for duration of active study treatment [approximately 6 months]
Phase 1 and 2: Pharmacokinetics (PK) of INCB024360 and MEDI4736 as measured by peak concentration
Timeframe: Measured at defined study visits from Cycle 1 Day 1 through cycle 2 [approximately 2 weeks]
Phase 1 and 2: Pharmacokinetics (PK) of INCB024360 and MEDI4736 as measured by time to maximal observed concentration
Timeframe: Measured at defined study visits from Cycle 1 Day 1 through cycle 2 [approximately 2 weeks].
Phase 1 and 2: Pharmacokinetics (PK) of INCB024360 and MEDI4736 as area under the concentration-time curve
Timeframe: Measured at defined study visits from Cycle 1 Day 1 through cycle 2 [approximately 2 weeks].
Phase 1 and 2: Immunogenicity of MEDI4736 as measured by the number and percentage of subjects who develop detectable anti-drug antibodies (ADAs)
Timeframe: Measured at defined study visits from Cycle 1 Day 1 through cycle 2 [approximately 2 weeks].