NCT05158062

Pembrolizumab and Bevacizumab With Chemotherapy Followed by Pembrolizumab, Bevacizumab and Olaparib in Recurrent Ovarian Cancer

Phase II Study of Pembrolizumab and Bevacizumab in Combination With Platinum-based Chemotherapy Followed by Pembrolizumab, Bevacizumab and Olaparib in Patients With Platinum-sensitive Recurrent Ovarian Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Kosei Hasegawa, MD, PhD · Academic / Other
• Sex: Female
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

This trial is a multicenter, single-arm, phase II study evaluating the efficacy of pembrolizumab and bevacizumab in combination with platinum-based chemotherapy (PBC) followed by pembrolizumab, bevacizumab and olaparib as a maintenance therapy in patients with platinum-sensitive recurrent ovarian cancer.This study is planned to enroll eligible 35 patients from multiple study sites in Japan.

Conditions

• Carcinoma, Ovarian Epithelial

Interventions

Type	Name	Description
BIOLOGICAL	pembrolizumab	pembrolizumab 200 mg every three weeks (Q3W)
DRUG	olaparib	olaparib 300 mg twice daily (BID) during maintenance period
BIOLOGICAL	bevacizumab	bevacizumab 15 mg/kg Q3W
DRUG	carboplatin	carboplatin AUC=5 or 6 Q3W during treatment period
DRUG	paclitaxel	paclitaxel 175 mg/m2 Q3W during treatment period
DRUG	docetaxel	docetaxel 60 \~ 70 mg/m2 Q3W during treatment period

Timeline

• Start date: 2022-04-20
• Primary completion: 2024-11-30
• Completion: 2024-11-30
• First posted: 2021-12-15
• Last updated: 2022-04-26

Locations

1 site across 1 country: Japan

Regulatory

• FDA-regulated drug study