NCT02766582

Phase II: Pembrolizumab/Carboplatin/Taxol in Epithelial Ovary Cancer

Phase II Open Label Nonrandomized Trial of the Anti PD 1 Therapy Pembrolizumab With First Line Platinum Based Chemotherapy Followed by 12 Months Pembrolizumab Monotherapy for Patients With Stage III/IV Epithelial Ovarian Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Phase II single arm, open label, nonrandomized study. The aim of our study is to assess the Progression Free Survival (PFS) in suboptimally cytoreduced epithelial ovarian/ primary peritoneal/ fallopian tube cancer patients treated with the novel combination of carboplatin every 21 days (triweekly) /weekly paclitaxel IV with pembrolizumab IV followed by maintenance pembrolizumab IV.

Detailed description

Utilization of combination standard intravenous chemotherapy with intravenous pembrolizumab (for 6 cycles) in first line treatment of patients with advanced ovarian cancer post surgery with any residual disease. This will be followed by single agent intravenous pembrolizumab (every 3 weeks) for 12 additional cycles.

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	Pembrolizumab	IV every 21 days at 200 mg
DRUG	Carboplatin	IV every 21 days
DRUG	Paclitaxel	IV infusion (80mg/m2) every 7 days for 6 cycles

Timeline

• Start date: 2016-10-01
• Primary completion: 2022-05-01
• Completion: 2023-12-30
• First posted: 2016-05-10
• Last updated: 2024-02-26
• Results posted: 2023-06-22

Locations

2 sites across 1 country: United States