Extrait

Co-primary objectives of the Phase I segment: To characterize •The occurrence of dose-limiting toxicity. •The anti-PRAME humoral immune response Co-primary objectives of Phase II segment: To characterize •The clinical activity in terms of objective response. •The occurrence of dose-limiting toxicity As of Amendment 3, there will no longer be an active follow-up of patients after discontinuation or completion of study treatment. The study will end approximately 30 days after the last dose will be administered. In addition, no more biological samples will be collected for protocol research purposes. For each biological sample already collected in the scope of the study and not tested yet, testing will not be performed by default, except if a scientific rationale remains relevant. Sampling for safety monitoring will continue.

Critère d'inclusion

• First-line treatment of patients with PRAME-positive unresectable stage III or IV metastatic melanoma

Liens

• euctr
• ictrp
• ictrp
• ictrp
• euctr
• euctr