Advanced cutaneous melanoma and Advanced mucosal melanoma
Conditions
Brief summary
Centrally-assessed overall response rate (ORR) based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (Cohorts 1 and 2), Investigator-assessed ORR based on RECIST 1.1 (Cohort 3) and Cohort 4
Detailed description
Centrally-assessed duration of response (DOR), progression-free survival (PFS), and disease control rate (DCR), and time to response (TTR) based on RECIST 1.1.(Cohorts 1 and 2)., Investigator-assessed DOR, PFS, DCR, and TTR based on RECIST 1.1(Cohort 3 and Cohort 4), Safety and tolerability will be assessed on the basis of treatmentemergent adverse events (TEAEs), vital signs and weight, electrocardiograms (ECGs), and clinical laboratory parameters.
Interventions
DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion
DRUGNEMVALEUKIN ALFA
Sponsors
Mural Oncology Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Centrally-assessed overall response rate (ORR) based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (Cohorts 1 and 2), Investigator-assessed ORR based on RECIST 1.1 (Cohort 3) and Cohort 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| Centrally-assessed duration of response (DOR), progression-free survival (PFS), and disease control rate (DCR), and time to response (TTR) based on RECIST 1.1.(Cohorts 1 and 2)., Investigator-assessed DOR, PFS, DCR, and TTR based on RECIST 1.1(Cohort 3 and Cohort 4), Safety and tolerability will be assessed on the basis of treatmentemergent adverse events (TEAEs), vital signs and weight, electrocardiograms (ECGs), and clinical laboratory parameters. | — |
Countries
Italy, Spain
Outcome results
None listed