NCT03430700

Trial of Pembrolizumab Following Weekly Paclitaxel for Platinum-resistant Ovarian, Fallopian Tube or Peritoneal Cancer

Phase II Trial of Maintenance Pembrolizumab Following Weekly Paclitaxel for Platinum-resistant Ovarian, Fallopian Tube or Peritoneal Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: University College, London · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The overall aim of the study is to demonstrate a clinically meaningful extension of progression free survival using maintenance pembrolizumab. The aim of the translational research is to study the immune microenvironment before and during pembrolizumab therapy.

Detailed description

This study aims to investigate the effect of maintenance pembrolizumab in patients who have undergone treatment with weekly paclitaxel for platinum-resistant recurrent ovarian cancer and have either responded or have not progressed after a minimum of 4 cycles of treatment. In this study patients will receive 3 weekly pembrolizumab until progression and the investigators will monitor the immune microenvironment by tumour biopsy and blood sampling before starting pembrolizumab and again before cycle 4 of treatment. The clinical endpoint will be to demonstrate a worthwhile improvement in the 6 month median PFS and to study possible predictive markers or response to pembrolizumab. This is a non-randomised phase II study, and the population may be different from those who received paclitaxel and bevacizumab.

Conditions

• Ovarian Cancer
• Fallopian Tube Cancer
• Peritoneal Cancer

Interventions

Type	Name	Description
DRUG	Pembrolizumab	Intravenous infusion

Timeline

• Start date: 2019-05-16
• Primary completion: 2025-03-17
• Completion: 2025-03-17
• First posted: 2018-02-13
• Last updated: 2023-01-30

Locations

4 sites across 1 country: United Kingdom