NCT04602377

Addition of Pembrolizumab to the Standard of Care Chemotherapy in Patient With SCCOHT

Multicentric Non-randomized Phase II of Pembrolizumab in Combination With Etoposide-cisplatin-based Chemotherapy in First-line Small Cell Ovarian Carcinoma of Hypercalcemic Type

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (estimated)
• Sponsor: ARCAGY/ GINECO GROUP · Academic / Other
• Sex: Female
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Small Cell Ovarian Carcinoma

Interventions

Type	Name	Description
DRUG	Pembrolizumab 25 MG/ML [Keytruda]	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.

Timeline

• Start date: 2021-08-04
• Primary completion: 2026-06-01
• Completion: 2030-02-01
• First posted: 2020-10-26
• Last updated: 2025-11-28

Locations

13 sites across 1 country: France