Advanced solid tumor
Conditions
Brief summary
Number of participants who experience one or more dose-limiting toxicities (DLTs), Number of participants who experience one or more adverse events (AEs), Number of participants who discontinue study intervention due to an AE
Detailed description
Objective response rate (ORR) per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR), ORR per RECIST 1.1 as assessed by investigator, Area under the curve (AUC) of MK-1200, Minimum concentration (Cmin) of MK-1200, Maximum concentration (Cmax) of MK-1200, Duration of response (DOR) per RECIST 1.1 as assessed by BICR, DOR per RECIST 1.1 as assessed by investigator, Progression-free survival (PFS) per RECIST 1.1 as assessed by BICR, PFS per RECIST 1.1 as assessed by investigator, Overall Survival (OS)
Interventions
DRUG-
DRUGMK-1200
Sponsors
Merck Sharp & Dohme LLC
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants who experience one or more dose-limiting toxicities (DLTs), Number of participants who experience one or more adverse events (AEs), Number of participants who discontinue study intervention due to an AE | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR) per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR), ORR per RECIST 1.1 as assessed by investigator, Area under the curve (AUC) of MK-1200, Minimum concentration (Cmin) of MK-1200, Maximum concentration (Cmax) of MK-1200, Duration of response (DOR) per RECIST 1.1 as assessed by BICR, DOR per RECIST 1.1 as assessed by investigator, Progression-free survival (PFS) per RECIST 1.1 as assessed by BICR, PFS per RECIST 1.1 as assessed by investigator, Overall Survival (OS) | — |
Countries
France, Italy, Poland, Spain
Outcome results
None listed