BRAF V600 mutation–positive unresectable or metastatic melanoma
Conditions
Brief summary
Progression-free survival (PFS): defined as the time from the date of randomization until the first date of progression, or until date of death (whatever the cause), whichever occurs first. For patients who remain alive and whose disease has not progressed, PFS will be censored on the date of last visit/contact when a disease assessment was performed. PFS will be based on the disease assessment or date of death provided by the local investigator
Detailed description
Overall survival (OS): defined as the time from the date of randomization to the date of death, whatever the cause. The follow-up of patients still alive will be censored at the moment of last visit/contact, CR rate, time to CR and duration of CR, Best overall objective response (CR+PR) rate (ORR), time to best objective reponse (OR) and duration of OR
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS): defined as the time from the date of randomization until the first date of progression, or until date of death (whatever the cause), whichever occurs first. For patients who remain alive and whose disease has not progressed, PFS will be censored on the date of last visit/contact when a disease assessment was performed. PFS will be based on the disease assessment or date of death provided by the local investigator | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS): defined as the time from the date of randomization to the date of death, whatever the cause. The follow-up of patients still alive will be censored at the moment of last visit/contact, CR rate, time to CR and duration of CR, Best overall objective response (CR+PR) rate (ORR), time to best objective reponse (OR) and duration of OR | — |
Countries
France, Germany, Italy, Netherlands, Poland, Spain