NCT05479045

A Combination Therapy Strategy to Prevent Anti-PD-1 Therapy Resistance in Metastatic Ovarian Cancer Patients

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Georgetown University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open label, non-randomized, 2-stage phase II, single arm study to determine the efficacy of New York esophageal squamous cell carcinoma 1 (NY-ESO-1) peptide vaccine as a priming mechanism to prevent anti-PD1 resistance in patients with platinum-refractory stage III/IV ovarian cancer (OC).

Conditions

• Ovarian Cancer Stage IV
• Ovarian Cancer Stage III
• Ovarian Cancer Stage 3

Interventions

Type	Name	Description
BIOLOGICAL	NY-ESO-1 Peptide vaccine	300 mcg of NY-ESO-1 peptide, 100 micrograms (mcg) granulocyte-macrophage colony-stimulating factor (GM-CSF) and 1 milliliter (mL) of Montanide ISA-51 adjuvant. The first two doses will be administered subcutaneously in a 2 week interval and thereafter, remaining three doses will be administered every 3 weeks.
DRUG	Toripalimab-tpzi	240 milligrams (mg), intravenously, every 3 weeks starting with the second dose of NY-ESO-1 Peptide vaccine

Timeline

• Start date: 2026-09-01
• Primary completion: 2027-11-01
• Completion: 2028-11-01
• First posted: 2022-07-29
• Last updated: 2026-03-16

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study