drugset / Trial / NCT05479045
A Combination Therapy Strategy to Prevent Anti-PD-1 Therapy Resistance in Metastatic Ovarian Cancer Patients
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
Outcome
Outcome not reported
Stopped (Business): “Sponsor Decision”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | NY-ESO-1 peptide | Vaccine | 300 ug | Subcutaneous |
| Subject | Toripalimab | Monoclonal antibody | 240 mg | Intravenous |
| Background | GM-CSF | Protein / enzyme biologic | 100 ug | Subcutaneous |
| Background | incomplete Freund's adjuvant | Other / unclassified | 1 ml | Subcutaneous |