Metastatic or unresectable melanoma
Conditions
Brief summary
The primary endpoint of this study is Progression Free Survival PFS. (PFS) is defined as the time (in days) from the date of randomization to the first date of documented progression as determined by the BIRC, or the date of death due to any cause, whichever occurs first.
Detailed description
Objective Response Rate (ORR) The ORR is defined as the percentage of patients enrolled in each arm with a best response of confirmed CR or PR as determined by the BIRC, Overall Survival (OS) The OS is defined as the time from randomization date to the date of death due to any cause.
Interventions
DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.
DRUGTucidinostat
Sponsors
Huyabio International LLC
Eligibility
Sex/Gender
All
Age
0 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of this study is Progression Free Survival PFS. (PFS) is defined as the time (in days) from the date of randomization to the first date of documented progression as determined by the BIRC, or the date of death due to any cause, whichever occurs first. | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR) The ORR is defined as the percentage of patients enrolled in each arm with a best response of confirmed CR or PR as determined by the BIRC, Overall Survival (OS) The OS is defined as the time from randomization date to the date of death due to any cause. | — |
Countries
Belgium, Czechia, France, Germany, Italy, Spain
Outcome results
None listed