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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
176
MEDI4736 administered intravenously (IV) every two weeks (q2w)
INCB024360: Oral daily dosing
Unnamed facility
San Francisco, California, United States
Unnamed facility
Denver, Colorado, United States
Unnamed facility
Miami, Florida, United States
Unnamed facility
Phase 1 : Number of Treatment-Emergent Adverse Events (TEAE)
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment
Time frame: Duration of study treatment and up to 90 days after the last dose [approximately 3 years]
Phase 2: Objective Response Rate (ORR) as Determined by Radiographic Disease Assessments Per Modified Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
ORR was defined as the percentage of participants having a 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.
Time frame: 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
ORR was defined as the percentage of participants having a 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
Time frame: Measured every 8 weeks for duration of study treatment [approximately 6 months]
Phase 2: Number of Treatment-Emergent Adverse Events
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment
Time frame: Continuously for duration of study treatment and up to 90 days after the last dose [approximately 3 years]
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
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.
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Port Saint Lucie, Florida, United States
Unnamed facility
Sarasota, Florida, United States
Unnamed facility
Tampa, Florida, United States
Unnamed facility
Chicago, Illinois, United States
Unnamed facility
Louisville, Kentucky, United States
Unnamed facility
Durham, North Carolina, United States
Unnamed facility
Huntersville, North Carolina, United States
...and 3 more locations
Time frame: Measured every 8 weeks for duration of active study treatment [approximately 24 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
Time frame: Measured every 8 weeks for duration of active study treatment [approximately 24 months]
Phase 1 and 2: Pharmacokinetics (PK) of INCB024360 as Measured by Peak Concentration
Time frame: Pre dose, 0.5, 1,2, 4.6.& 8 hrs Post dose on C1D1,C1D8,C2D1
Phase 1 and 2: Pharmacokinetics (PK) of INCB024360 as Measured by Time to Maximal Observed Concentration
Time frame: Pre dose, 0.5, 1,2, 4.6.& 8 hrs Post dose on C1D1,C1D8,C2D1
Phase 1 and 2: Pharmacokinetics (PK) of INCB024360 as Area Under the Concentration-time Curve
Time frame: Pre dose, 0.5, 1,2, 4.6.& 8 hrs Post dose on C1D1,C1D8,C2D1
Phase 1 and 2: Immunogenicity of MEDI4736 as Measured by the Number and Percentage of Subjects Who Develop Detectable Anti-drug Antibodies (ADAs)
Time frame: Measured at defined study visits from Cycle 1 Day 1 through cycle 2 [approximately 2 weeks].