Efficacy and Safety of Pembrolizumab in Combination With Lenvatinib in Metastatic Uveal MElanoma Patients (PLUME)

Because we suspect that the benefit of anti-PD-1 in metastatic UM patients could vary according to previous exposure to Tebentafusp (better efficacy of anti-PD-1 after Tebentafusp), the combination of pembrolizumab and lenvatinib will be assessed in two independent cohorts: cohort 1 with Tebentafusp-naive patients, and cohort 2 with patients previously treated by Tebentafusp. The study is a monocentric, phase II trial with a single-arm of treatment in each cohort. Liver MRI and chest-abdomen-pelvis CT will be performed every 9 weeks until progressive disease (PD), followed by a Follow-up visit within 28 days after last treatment intake. Survival status will be registered after patient discontinuation.

NCT Number	NCT05282901
Lead Sponsor	Institut Curie Collaborators: Merck Sharp & Dohme LLC
Conditions	Metastatic Uveal Melanoma
Enrollment	51 participants
Start Date	2022-07-07
Primary Completion	2025-04-28 (estimated)
Study Completion	2026-07-09 (estimated)
Updated on ClinicalTrials.gov	2026-07-28