OSE2101 Alone or in Combination With Pembrolizumab vs BSC in Patient With Platinum-sensitive Recurrent OC
Status:
Recruiting
Trial end date:
2025-03-01
Target enrollment:
Participant gender:
Summary
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 1 to 2 lines of 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).