OSE2101 Alone or in Combination With Pembrolizumab vs BSC in Patient With Platinum-sensitive Recurrent OC

The proposed study is an international randomized phase II, multicenter, open-label, three arms trial to assess best supportive care (BSC) vs OSE2101 and vs OSE2101 + pembrolizumab as maintenance treatment for patients with platinum sensitive relapsed ovarian cancers, previously treated with chemotherapy (regardless of the number of prior lines of platinum-based chemotherapy), bevacizumab (if eligible) and a PARP inhibitor (if eligible). Patients in Complete Response, Partial Response, or Stable Disease at the end of chemotherapy with at least 4 cycles of platinum based chemotherapy will be randomized in one of the three arms (randomization 1:1:2). They will receive one or the two study treatments or BSC until progression, or intolerance, or up to 2 years (from 1st study treatment dose).

NCT Number	NCT04713514
Lead Sponsor	ARCAGY/ GINECO GROUP Collaborators: OSE Immunotherapeutics, Merck Sharp & Dohme LLC
Conditions	Platinum-sensitive Ovarian Cancer, Relapsed Ovarian Cancer
Enrollment	180 participants
Start Date	2021-08-05
Primary Completion	2025-12 (estimated)
Study Completion	2025-12 (estimated)
Updated on ClinicalTrials.gov	2024-12-02