IDE196 (DAROVASERTIB) in combination with crizotinib versus investigator’s choice of treatment as first-line therapy in HLA-A2 negative metastatic uveal melanoma (DAR-UM-2)
Fase: Phase II-III clinical trials
Struttura Principale: Oncologia Medica 1 - Unità Oncologia Medica Melanomi
Farmaco: Darovasertib, Crizotinib
Nivolumab, Ipilimumab, Pembrolizumab, Dacarbazina
Patologie: Melanoma
ClinicalTrials.gov: Read the details about clinical trials
PI: Dr.ssa Lorenza Di Guardo
This is a phase 3, open label, randomized, study to evaluate the safety, tolerability, pharmacokinetics, dose-exposure relationship, and anti-tumor activity of IDE196 in combination with crizotinib compared to the comparator arm of investigator's choice of treatment (pembrolizumab, ipilimumab + nivolumab, or dacarbazine).
Study Objectives and Endpoints are:
- To evaluate the efficacy of IDE196 + crizotinib compared to standard therapies for treatment of metastatic uveal melanoma;
- To determine the optimal dose of IDE196 + crizotinib combination;
- To evaluate the safety and tolerability of IDE196 in combination with crizotinib.
Last update: 19/05/2025