Primary Outcome Measures
Part 1: Number of participants with treatment emergent AEs (TEAEs) [Time Frame: Up to 2 years] [Designated as safety issue: ]
Part 1: Number of participants with immune related AEs of interest [Time Frame: Up to 2 years] [Designated as safety issue: ]
Part 1: Number of participants with abnormal hematology parameters [Time Frame: Up to 2 years] [Designated as safety issue: ]
Part 1: Number of participants with abnormal clinical chemistry parameters [Time Frame: Up to 2 years] [Designated as safety issue: ]
Part 1: Number of participants with abnormal thyroid function [Time Frame: Up to 2 years] [Designated as safety issue: ]
Part 1: Number of participants with abnormal urine parameters [Time Frame: Up to 2 years] [Designated as safety issue: ]
Part 1: Number of participants with abnormal vital signs [Time Frame: Up to 2 years] [Designated as safety issue: ]
Part 1: Number of participants with abnormal electrocardiogram (ECG) parameters [Time Frame: Up to 2 years] [Designated as safety issue: ]
Part 1: Number of participants with abnormal physical examination. [Time Frame: Up to 2 years] [Designated as safety issue: ]
Part 1: Number of participants receiving concomitant medications [Time Frame: Up to 2 years] [Designated as safety issue: ]
Part 2A: Number of participants with TEAEs [Time Frame: Up to 2 years] [Designated as safety issue: ]
Part 2A: Number of participants with immune related AEs of interest [Time Frame: Up to 2 years] [Designated as safety issue: ]
Part 2A: Number of participants with abnormal hematology parameters [Time Frame: Up to 2 years] [Designated as safety issue: ]
Part 2A: Number of participants with abnormal clinical chemistry parameters [Time Frame: Up to 2 years] [Designated as safety issue: ]
Part 2A: Number of participants with abnormal thyroid function [Time Frame: Up to 2 years] [Designated as safety issue: ]
Part 2A: Number of participants with abnormal urine parameters [Time Frame: Up to 2 years] [Designated as safety issue: ]
Part 2A: Number of participants with abnormal vital signs [Time Frame: Up to 2 years] [Designated as safety issue: ]
Part 2A: Number of participants with abnormal ECG [Time Frame: Up to 2 years] [Designated as safety issue: ]
Part 2A: Number of participants with abnormal physical examination [Time Frame: Up to 2 years] [Designated as safety issue: ]
Part 2A: Number of participants receiving concomitant medications [Time Frame: Up to 2 years] [Designated as safety issue: ]
Part 2B: Number of participants with TEAEs [Time Frame: Up to 2 years] [Designated as safety issue: ]
Part 2B: Number of participants with immune related AEs of interest [Time Frame: Up to 2 years] [Designated as safety issue: ]
Part 2B: Number of participants with abnormal hematology parameters [Time Frame: Up to 2 years] [Designated as safety issue: ]
Part 2B: Number of participants with abnormal clinical chemistry parameters [Time Frame: Up to 2 years] [Designated as safety issue: ]
Part 2B: Number of participants with abnormal thyroid function [Time Frame: Up to 2 years] [Designated as safety issue: ]
Part 2B: Number of participants with abnormal urine parameters [Time Frame: Up to 2 years] [Designated as safety issue: ]
Part 2B: Number of participants with abnormal vital signs [Time Frame: Up to 2 years] [Designated as safety issue: ]
Part 2B: Number of participants with abnormal ECG parameters [Time Frame: Up to 2 years] [Designated as safety issue: ]
Part 2B: Number of participants with abnormal physical examination [Time Frame: Up to 2 years] [Designated as safety issue: ]
Part 2B: Number of participants receiving concomitant medications [Time Frame: Up to 2 years] [Designated as safety issue: ]
Part 2B: Cohort A1 Overall Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 [Time Frame: Up to 2 years] [Designated as safety issue: ]
Part 2B: Cohort F ORR by RECIST version 1.1 [Time Frame: Up to 2 years] [Designated as safety issue: ]
Part 2B: Cohort A2 ORR by RECIST version 1.1 [Time Frame: Up to 2 years] [Designated as safety issue: ]
Part 2B: Cohort G ORR by RECIST version 1.1 [Time Frame: Up to 2 years] [Designated as safety issue: ]
Part 2B: Cohort E ORR by immune related Response Evaluation Criteria in Solid Tumors per irRECIST [Time Frame: Up to 2 years] [Designated as safety issue: ]
Part 2B: Cohort A1 Duration of response (DOR) [Time Frame: Up to 2 years] [Designated as safety issue: ]
Part 2B: Cohort F Duration of response (DOR) [Time Frame: Up to 2 years] [Designated as safety issue: ]
Part 2B: Cohort A2 Duration of response (DOR) [Time Frame: Up to 2 years] [Designated as safety issue: ]
Secondary Outcome Measures
Part 2B: Cohort A1 ORR by independent blinded central review using RECIST version 1.1 [Time Frame: Up to 2 years] [Designated as safety issue: ]
Part 2B: Cohort F ORR by independent blinded central review using RECIST version 1.1 [Time Frame: Up to 2 years] [Designated as safety issue: ]
Part 2B: Cohort A1 Immune-related objective response rate (irORR) by irRECIST [Time Frame: Up to 2 years] [Designated as safety issue: ]
Part 2B: Cohort A2 irORR by irRECIST [Time Frame: Up to 2 years] [Designated as safety issue: ]
Part 2B: Cohort F irORR by irRECIST [Time Frame: Up to 2 years] [Designated as safety issue: ]
Part 2B: Cohort G irORR by irRECIST [Time Frame: Up to 2 years] [Designated as safety issue: ]
Part 2B: Cohort A1 Duration of response (DOR) based on independent blinded central review using RECIST version 1.1 [Time Frame: Up to 2 years] [Designated as safety issue: ]
Part 2B: Cohort F DOR based on independent blinded central review using RECIST version 1.1 [Time Frame: Up to 2 years] [Designated as safety issue: ]
Part 2B: Cohort G DOR based on independent blinded central review using RECIST version 1.1 [Time Frame: Up to 2 years] [Designated as safety issue: ]
Part 2B: Cohort A1 Disease control rate [Time Frame: Up to 2 years] [Designated as safety issue: ]
Part 2B: Cohort A2 Disease control rate [Time Frame: Up to 2 years] [Designated as safety issue: ]
Part 2B: Cohort F Disease control rate [Time Frame: Up to 2 years] [Designated as safety issue: ]
Part 2B: Cohort G Disease control rate [Time Frame: Up to 2 years] [Designated as safety issue: ]
Part 2B: Immune related disease control rate [Time Frame: Up to 2 years] [Designated as safety issue: ]
Part 2B: Immune related duration of response [Time Frame: Up to 2 years] [Designated as safety issue: ]
Part 2B: Progression free survival [Time Frame: Up to 2 years] [Designated as safety issue: ]
Part 2B: Overall survival [Time Frame: Up to 2 years] [Designated as safety issue: ]
Part 1: Area under the concentration-time curve from time 0 to last (AUC,0-last) assessment of dostarlimab [Time Frame: Predose, 0.25, 0.5, 1.5, 3, 24, 48, 96, 168, 336, 504 and 672 hours post dose] [Designated as safety issue: ]
Part 1: Area under the concentration-time curve from time 0 to infinity (AUC, 0-infinity) of dostarlimab [Time Frame: Predose, 0.25, 0.5, 1.5, 3, 24, 48, 96, 168, 336, 504,672 hours post dose] [Designated as safety issue: ]
Part 1: Minimum concentration (Cmin) of dostarlimab [Time Frame: Predose, 0.25, 0.5, 1.5, 3, 24, 48, 96, 168, 336, 504,672 hours post dose] [Designated as safety issue: ]
Part 1: Maximum concentration (Cmax) of dostarlimab [Time Frame: Predose, 0.25, 0.5, 1.5, 3, 24, 48, 96, 168, 336, 504,672 hours post dose] [Designated as safety issue: ]
Part 1: Clearance (CL) of dostarlimab [Time Frame: Predose, 0.25, 0.5, 1.5, 3, 24, 48, 96, 168, 336, 504,672 hours post dose] [Designated as safety issue: ]
Part 1: Volume of distribution (Vz) of dostarlimab [Time Frame: Predose, 0.25, 0.5, 1.5, 3, 24, 48, 96, 168, 336, 504,672 hours post dose] [Designated as safety issue: ]
Part 1: Area under the concentration-time curve at steady state (AUC,ss) of dostarlimab [Time Frame: Predose, 0.25, 0.5, 1.5, 3, 24, 48, 96, 168, 336, 504,672 hours post dose] [Designated as safety issue: ]
Part 1: Minimum concentration at steady state (Cmin,ss) of dostarlimab [Time Frame: Predose, 0.25, 0.5, 1.5, 3, 24, 48, 96, 168, 336, 504,672 hours post dose.] [Designated as safety issue: ]
Part 1: Maximum concentration at steady state (Cmax,ss) of dostarlimab [Time Frame: Predose, 0.25, 0.5, 1.5, 3, 24, 48, 96, 168, 336, 504,672 hours post dose] [Designated as safety issue: ]
Part 2A : AUC,0-last assessment of dostarlimab [Time Frame: Predose, 0.25, 0.5, 1.5, 3, 24, 48, 96, 168, 336, and 504 hours post dose Q3W upto 2 years] [Designated as safety issue: ]
Part 2A: AUC, 0-infinity of dostarlimab [Time Frame: Predose, 0.25, 0.5, 1.5, 3, 24, 48, 96, 168, 336, and 504 hours post dose Q3W upto 2 years] [Designated as safety issue: ]
Part 2A: Cmin of dostarlimab [Time Frame: Predose, 0.25, 0.5, 1.5, 3, 24, 48, 96, 168, 336, and 504,hours post dose Q3W upto 2 years] [Designated as safety issue: ]
Part 2A: Cmax of dostarlimab [Time Frame: Predose, 0.25, 0.5, 1.5, 3, 24, 48, 96, 168, 336, and 504,hours post dose Q3W upto 2 years] [Designated as safety issue: ]
Part 2A: CL of dostarlimab [Time Frame: Predose, 0.25, 0.5, 1.5, 3, 24, 48, 96, 168, 336, and 504,hours post dose Q3W upto 2 years] [Designated as safety issue: ]
Part 2A: Vz of dostarlimab [Time Frame: Predose, 0.25, 0.5, 1.5, 3, 24, 48, 96, 168, 336, and 504 hours post dose Q3W upto 2 years.] [Designated as safety issue: ]
Part 2A: AUC,ss of dostarlimab [Time Frame: Predose, 0.25, 0.5, 1.5, 3, 24, 48, 96, 168, 336, and 504 hours post dose Q3W upto 2 years] [Designated as safety issue: ]
Part 2A: Cmin,ss of dostarlimab [Time Frame: Predose, 0.25, 0.5, 1.5, 3, 24, 48, 96, 168, 336, and 504 hours post dose Q3W upto 2 years] [Designated as safety issue: ]
Part 2A: Cmax,ss of dostarlimab [Time Frame: Predose, 0.25, 0.5, 1.5, 3, 24, 48, 96, 168, 336, and 504 hours post dose Q3W upto 2 years] [Designated as safety issue: ]
Part 2A : AUC,0-last assessment of dostarlimab [Time Frame: Predose, 0.25, 0.5, 1.5, 3, 24, 48, 96, 168, 336, 504, 672, 840, and 1008 hours post dose Q6W upto 2 years] [Designated as safety issue: ]
Part 2A: AUC, 0-infinity of dostarlimab [Time Frame: Predose, 0.25, 0.5, 1.5, 3, 24, 48, 96, 168, 336, 504, 672, 840, and 1008 hours post dose Q6W upto 2 years] [Designated as safety issue: ]
Part 2A: Cmin of dostarlimab [Time Frame: Predose, 0.25, 0.5, 1.5, 3, 24, 48, 96, 168, 336, 504, 672, 840, and 1008 hours post dose Q6W upto 2 years] [Designated as safety issue: ]
Part 2A: Cmax of dostarlimab [Time Frame: Predose, 0.25, 0.5, 1.5, 3, 24, 48, 96, 168, 336, 504, 672, 840, and 1008 hours post dose Q6W upto 2 years] [Designated as safety issue: ]
Part 2A: CL of dostarlimab [Time Frame: Predose, 0.25, 0.5, 1.5, 3, 24, 48, 96, 168, 336, 504, 672, 840, and 1008 hours post dose Q6W upto 2 years] [Designated as safety issue: ]
Part 2A: Vz of dostarlimab [Time Frame: Predose, 0.25, 0.5, 1.5, 3, 24, 48, 96, 168, 336, 504, 672, 840, and 1008 hours post dose Q6W upto 2 years] [Designated as safety issue: ]
Part 2A: AUC,ss of dostarlimab [Time Frame: Predose, 0.25, 0.5, 1.5, 3, 24, 48, 96, 168, 336, 504, 672, 840, and 1008 hours post dose Q6W upto 2 years] [Designated as safety issue: ]
Part 2A: Cmin,ss of dostarlimab [Time Frame: Predose, 0.25, 0.5, 1.5, 3, 24, 48, 96, 168, 336, 504, 672, 840, and 1008 hours post dose Q6W upto 2 years] [Designated as safety issue: ]
Part 2A: Cmax,ss of dostarlimab [Time Frame: Predose, 0.25, 0.5, 1.5, 3, 24, 48, 96, 168, 336, 504, 672, 840 and 1008 hours post dose Q6W upto 2 years] [Designated as safety issue: ]
Part 2B : AUC,0-last assessment of dostarlimab [Time Frame: Predose, 0.5 and 1.5 hours post dose] [Designated as safety issue: ]
Part 2B: AUC, 0-infinity of dostarlimab [Time Frame: Predose, 0.5 and 1.5 hours post dose] [Designated as safety issue: ]
Part 2B: Cmin of dostarlimab [Time Frame: Predose, 0.5 and 1.5 hours post dose] [Designated as safety issue: ]
Part 2B: Cmax of dostarlimab [Time Frame: Predose, 0.5 and 1.5 hours post dose] [Designated as safety issue: ]
Part 2B: CL of dostarlimab [Time Frame: Predose, 0.5 and 1.5 hours post dose] [Designated as safety issue: ]
Part 2B: Vz of dostarlimab [Time Frame: Predose, 0.5 and 1.5 hours post dose] [Designated as safety issue: ]
Part 2B: AUC,ss of dostarlimab [Time Frame: Predose, 0.5 and 1.5 hours post dose] [Designated as safety issue: ]
Part 2B: Cmin,ss of dostarlimab [Time Frame: Predose, 0.5 and 1.5 hours post dose] [Designated as safety issue: ]
Part 2B: Cmax,ss of dostarlimab [Time Frame: Predose, 0.5 and 1.5 hours post dose] [Designated as safety issue: ]