NCT04375956

Study on Pembrolizumab in Recurrent, Platinum Resistant, CPS >1 Positive Ovarian, Fallopian Tube and Primary Peritoneal Cancer Patients

Prospective, Non Randomized, Phase II Study on MK-3475 in Recurrent, Platinum Resistant, CPS >1 Positive Ovarian, Fallopian Tube and Primary Peritoneal Cancer Patients.

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single arm phase II, multicenter study evaluating Pembrolizumab in recurrent platinum resistant CPS score \>1 positive ovarian, Fallopian tube and primary peritoneal cancer patients.

Detailed description

This is a single arm, phase II, multicenter study trial evaluating Pembrolizumab in recurrent platinum resistant CPS score \>1 positive ovarian, Fallopian tube and primary peritoneal cancer patients. All the eligible patients will receive Pembrolizumab 200 mg d1 q 21 iv infusion in 30 minutes, until disease progression of disease, unacceptable toxicity or patient's refusal. Pembrolizumab will be administered for a maximum of 2 years. The primary objective of the study is to assess overall survival (OS) of patients treated with Pembrolizumab single agent.

Conditions

• Ovarian Cancer
• Primary Peritoneal Carcinoma
• Fallopian Tube Cancer

Interventions

Type	Name	Description
DRUG	Pembrolizumab	Experimental

Timeline

• Start date: 2021-04-26
• Primary completion: 2025-06-15
• Completion: 2025-06-15
• First posted: 2020-05-06
• Last updated: 2021-12-20

Locations

1 site across 1 country: Italy