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Pembrolizumab in Unresectable Advanced or Recurrent Ovarian Squamous Cell Carcinoma
NCT05737199Phase 2
Key facts
- Status
- Active, not recruiting
- Start
- May 2023
- Primary completion
- May 2028
- Countries
- 1
- Sponsor
- Niigata University Medical and Dental Hospital
- Modality
- Immune Checkpoint Inhibitors, Recombinant Proteins and Enzymes
- Drugs
- pembrolizumab
- Conditions
- ovarian squamous cell carcinoma (oSCC)
01
Overview
Phase 2, open-label, single-arm trial of pembrolizumab in ovarian squamous cell carcinoma (oSCC), sponsored by Niigata University Medical and Dental Hospital. Primary endpoint: Objective Response Rate at 2 years. Started May 2023; status: active, not recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
MK-3475 (Pembrolizumab)
Treatment with MK-3475 (pembrolizumab) 200 mg IV every 3 weeks.
03
Who it enrols
Female patients >=18 years with advanced/recurrent unresectable ovarian squamous cell carcinoma, ECOG 0-1, and adequate organ function. Excludes patients with TMB-High, MSI-High, prior immune checkpoint inhibitors, active CNS metastases, active autoimmune disease, or active infections.
04
Endpoints
Primary
Objective Response Rate
Secondary
Progression-Free Survival
Overall Survival
Duration of Response
Safety and Tolerability of MK-3475 Therapy
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