high-risk, surgically resectable BRAF mutated and wild-type Melanoma
Conditions
Brief summary
The primary objective is to determine the pathologic complete response (pCR) rate. (Centrally/Independently determined). Pathologic complete response, which is defined as residual cancer burden 0.
Detailed description
Recurrence-Free Survival (RFS) at 2-years, 3-years and at the end of the study. RFS defined as the time from randomisation to recurrence event (local or distant disease development, or death). For patients without events at the end of the study time will be censored at the date of last follow-up., Overall Survival (OS) defined as the time from randomisation to death. For patients alive at the end of the study time will be censored at the date of last follow-up., Pathological Overall Response rate (pORR) defined as the sum of pathologic complete responses (pCRs), near pathologic complete responses (near pCRs) and pathologic partial responses (pPRs)., Safety, To determine molecular and immunophenotypic changes in tumour and peripheral blood evaluating several biomarkers.
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective is to determine the pathologic complete response (pCR) rate. (Centrally/Independently determined). Pathologic complete response, which is defined as residual cancer burden 0. | — |
Secondary
| Measure | Time frame |
|---|---|
| Recurrence-Free Survival (RFS) at 2-years, 3-years and at the end of the study. RFS defined as the time from randomisation to recurrence event (local or distant disease development, or death). For patients without events at the end of the study time will be censored at the date of last follow-up., Overall Survival (OS) defined as the time from randomisation to death. For patients alive at the end of the study time will be censored at the date of last follow-up., Pathological Overall Response rate (pORR) defined as the sum of pathologic complete responses (pCRs), near pathologic complete responses (near pCRs) and pathologic partial responses (pPRs)., Safety, To determine molecular and immunophenotypic changes in tumour and peripheral blood evaluating several biomarkers. | — |
Countries
Italy