At a glance
ClinicalIndex Comparison Record- ✓Patients ≥12 years old with previously untreated, pathologically confirmed small cell carcinoma of the ovary
- ✓Patients may be included after one cycle of chemotherapy if treatment starts within 4 weeks
- ✓FIGO stage I to IV
- ✓ECOG performance status 0 or 1
- ✕Prior therapy with chemotherapy or anti-PD-1, anti-PD-L1, anti-PD-L2 agents or T-cell receptor agents (CTLA-4, OX-40, CD137)
- ✕Live vaccine within 30 days prior to first study drug dose
- ✕Prior allogeneic tissue or solid organ transplant
- ✕More than one cycle of platinum-based chemotherapy or prior systemic anti-cancer therapy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
NCT04602377Phase 2RecruitingMonitorUpdated 7mo ago · Completion was 1mo agoMulticentric Non-randomized Phase II of Pembrolizumab in Combination With Etoposide-cisplatin-based Chemotherapy in First-line Small Cell Ovarian Carcinoma of Hypercalcemic Type
In Brief
A Phase 2 clinical trial evaluating Pembrolizumab 25 MG/ML [Keytruda] for Small Cell Ovarian Carcinoma. Currently recruiting, targeting 27 participants across 13 sites.
Signals
Detailed Summary
Small cell ovarian carcinomas are rare and have a very poor prognosis affecting a young population. The objective of this study is to increase the efficacy of the initial chemotherapy by providing immunotherapy and to be able to offer to more patients the possibility of benefiting from an intensification of chemotherapy, which is a major prognostic factor in this population.
Study Details
Timeline
Interventions
Pembrolizumab (200mg flat dose) will be administred in combinaison with PAVEP chemotherapy for the first 6 cycles (21-day cycle) Then, Pembrolizumab (200mg flat dose) will be administred in monotherapy until one year for patients with complete response and up to two years for patients with Stable disease or Progression response after the end of first-sequence therapy (PAVEP chemotherapy +/- High dose chemotherapy) or until disease progression.