Resectable mucosal melanomas
Conditions
Brief summary
Disease free survival, defined as the time between the inclusion in the trial and the date of the first event defined as local, regional, distant relapse or death whatever the cause.
Detailed description
Overall survival (OS), Locoregional control (Time to locoregional relapse, TTLRC), Efficacy (Objective response, according to RECIST 1.1), after neoadjuvant therapy, Pathological response after neoadjuvant therapy, Acute toxicity (CTC-NCI V4), Translational criteria o Ex vivo response to anti-PD1 o Prognostic value of biomarkers including PDL1 expression and mutational load o Variation of circulating lymphocytes (before–after treatment)
Interventions
DRUGLenvatinib
DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion
Sponsors
Institut Gustave Roussy
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease free survival, defined as the time between the inclusion in the trial and the date of the first event defined as local, regional, distant relapse or death whatever the cause. | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS), Locoregional control (Time to locoregional relapse, TTLRC), Efficacy (Objective response, according to RECIST 1.1), after neoadjuvant therapy, Pathological response after neoadjuvant therapy, Acute toxicity (CTC-NCI V4), Translational criteria o Ex vivo response to anti-PD1 o Prognostic value of biomarkers including PDL1 expression and mutational load o Variation of circulating lymphocytes (before–after treatment) | — |
Countries
France
Outcome results
None listed