or metastatic melanoma, Previously untreated, unresectable
Conditions
Brief summary
• PFS, defined as the time from randomization to the first documented disease progression (based on Independent Review Committee (IRC) in accordance with RECIST v1.1) or death from any cause. Patients who have not progressed or died at the time of analysis will be censored at the date of assessment from their last disease assessment.
Detailed description
• Overall Response Rate (ORR) defined as the percentage of patients achieving a confirmed partial response (PR) or confirmed complete response (CR). ORR will be determined by the IRC in accordance with RECIST v1.1., • OS, defined as the time from randomization until death from any cause. Patients not known to have died will be censored at the date they were last known to be alive Etc.
Interventions
DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion
DRUGIO102-IO103
Sponsors
Io Biotech ApS
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • PFS, defined as the time from randomization to the first documented disease progression (based on Independent Review Committee (IRC) in accordance with RECIST v1.1) or death from any cause. Patients who have not progressed or died at the time of analysis will be censored at the date of assessment from their last disease assessment. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Overall Response Rate (ORR) defined as the percentage of patients achieving a confirmed partial response (PR) or confirmed complete response (CR). ORR will be determined by the IRC in accordance with RECIST v1.1., • OS, defined as the time from randomization until death from any cause. Patients not known to have died will be censored at the date they were last known to be alive Etc. | — |
Countries
Belgium, Czechia, Denmark, France, Germany, Hungary, Italy, Netherlands, Poland, Spain
Outcome results
None listed