The purpose of this study is to assess the safety and tolerability and to determine the recommended Phase 2 dose of INCMGA00012 in combination with common standard-of-care chemotherapy regimens in participants with advanced solid tumors.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
INCMGA00012 administered intravenously every 3 weeks.
Gemcitabine administered intravenously on Days 1 and 8 of 21-day cycles.
Cisplatin administered intravenously on Day 1 of 21-day cycles.
Number of treatment-emergent adverse events with INCMGA00012 in combination with chemotherapy
Adverse events reported for the first time or worsening of a pre-existing event after the first dose of study treatment.
Time frame: Up to approximately 27 months
Objective response rate (ORR)
Defined as the percentage of participants having complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as determined by investigator assessment.
Time frame: Through study completion, up to approximately 31 months
Duration of response (DOR)
Defined as the time from an initial objective response (CR or PR) according to RECIST v1.1 until disease progression as determined by investigator assessment or death due to any cause.
Time frame: Through study completion, up to approximately 31 months
Disease control rate (DCR)
Defined as the number of participants with CR or PR as best response or stable disease that was maintained for at least 12 weeks.
Time frame: Through study completion, up to approximately 31 months
Cmax of INCMGA00012 when given in combination with chemotherapy agents
Maximum observed plasma or serum concentration.
Time frame: Through post-induction Cycle 5 Day 1, up to 15 weeks
Tmax of INCMGA00012 when given in combination with chemotherapy agents
Time to maximum concentration.
Time frame: Through post-induction Cycle 5 Day 1, up to 15 weeks
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Pemetrexed administered intravenously on Day 1 of 21-day cycles.
Carboplatin AUC5 or AUC6 administered intravenously on Day 1 of 21-day cycles.
Paclitaxel administered intravenously on Day 1 of 21-day cycles.
Cmin of INCMGA00012 when given in combination with chemotherapy agents
Minimum observed plasma or serum concentration over the dose interval.
Time frame: Through post-induction Cycle 5 Day 1, up to 15 weeks
AUC0-t of INCMGA00012 when given in combination with chemotherapy agents
Area under the plasma or serum concentration-time curve from time = 0 to the last measurable concentration at time = t.
Time frame: Through post-induction Cycle 5 Day 1, up to 15 weeks