drugset / Trial / NCT05479045

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

NCT05479045

Phase 2 Not yet recruiting 24 enrolled Georgetown University Coherus Oncology, Inc. · collab
NaSingle-groupOpen-labelTreatment

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).

Timeline

Start
2026-09
Primary completion
2027-11
Completion
2028-11

Drugs

EvaluationDrugModalityDoseRoute
Subject NY-ESO-1 peptide Vaccine 300 ug Subcutaneous
Subject Toripalimab Monoclonal antibody 240 mg Intravenous
Background incomplete Freund's adjuvant Other / unclassified 1 ml Subcutaneous
Background sargramostim Protein / enzyme biologic 100 ug Subcutaneous