Advanced melanoma refractory to prior checkpoint inhibitor therapy
Conditions
Brief summary
1. Objective response rate (ORR) as assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) criteria.
Detailed description
1. Progression-free survival (PFS), defined as the time from enrollment until disease progression or death, whichever comes first, quantified as a rate at 6 and 12 months., 2. Duration of response (DOR), defined as the time from first objective response until progression of disease or death, whichever comes first, quantified as median DOR., 3. Overall survival (OS) time, defined as the time from enrollment until death, whichever comes first, quantified as median OS.
Interventions
DRUGBOTENSILIMAB
DRUGBALSTILIMAB
Sponsors
Agenus Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Objective response rate (ORR) as assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) criteria. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Progression-free survival (PFS), defined as the time from enrollment until disease progression or death, whichever comes first, quantified as a rate at 6 and 12 months., 2. Duration of response (DOR), defined as the time from first objective response until progression of disease or death, whichever comes first, quantified as median DOR., 3. Overall survival (OS) time, defined as the time from enrollment until death, whichever comes first, quantified as median OS. | — |
Countries
Belgium, France, Germany, Italy, Spain
Outcome results
None listed