NCT03596281

Pembrolizumab in Combination with Bevacizumab and Pegylated Liposomal Doxorubicin in Patients with Ovarian Cancer

An Open-label Phase 1 of Pembrolizumab in Combination with Bevacizumab and Pegylated Liposomal Doxorubicin in Patients with Platinum Resistant Epithelial Ovarian Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

French multicenter, open-label, phase 1b, evaluating via the mTPI design the paired treatment of pembrolizumab and PLD (cohort A), pembrolizumab and bevacizumab (cohort B) and finally the combination treatment of the three drugs PLD plus bevacizumab and pembrolizumab (cohort C). Thanks to an expansion cohort C+ the ORR will be evaluated in a total of 19 patients at the RP2 D using an exact binomial one-step Fleming-type design. Cohort A and B will be opened for inclusions at the same time. Once safety of the dual combinations confirmed in cohorts A and B,cohort C will be opened for inclusions.

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	Pembrolizumab	200mg Q3W IV
DRUG	Bevacizumab	400 or 300 mg Q3W IV
DRUG	pegylated liposomal doxorubicin (PLD)	15 or 20 or 30 mg/m² Q3W IV

Timeline

• Start date: 2018-12-05
• Primary completion: 2021-03-11
• Completion: 2023-04-11
• First posted: 2018-07-23
• Last updated: 2024-10-18

Locations

1 site across 1 country: France