NCT05737199

Assessment of the Efficacy and Safety of Pembrolizumab for Ovarian Squamous Cell Carcinoma

A Single-arm Open-label Phase II Trial to Assess the Efficacy and Safety of Pembrolizumab for Unresectable Advanced or Recurrent Ovarian Squamous Cell Carcinoma

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (estimated)
• Sponsor: Niigata University Medical & Dental Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase II, non-randomized, open-label, single-arm, multicenter study to evaluate the efficacy and safety of MK-3475 in patients with ovarian squamous cell carcinoma.

Detailed description

This study includes female patients 18 years of age or older with advanced or recurrent unresectable squamous cell carcinoma of the ovary. Pembrolizumab will be given for a maximum of 2 years i.e. a total of 35 cycles of pembrolizumab with the q3 week dosing.

Conditions

• Ovarian Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	MK-3475 (pembrolizumab)	MK-3475 (pembrolizumab) 200mg IV every 3 weeks \[Q3W\] Treated for 2 years (35 cycles), or until PD, unacceptable toxicity, or study withdrawal.

Timeline

• Start date: 2023-05-01
• Primary completion: 2028-05-31
• Completion: 2028-05-31
• First posted: 2023-02-21
• Last updated: 2026-02-05

Locations

1 site across 1 country: Japan

Regulatory

• FDA-regulated drug study