A Combination Therapy Strategy to Prevent Anti-PD-1 Therapy Resistance in Metastatic Ovarian Cancer Patients
Georgetown University
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).
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: 1. Be able and willing to provide written and signed informed consent prior to performing any protocol-related procedures, including screening evaluations. 2. Women, 18 years or older, with stage III / IV platinum-refractory Ovarian Cancer (OC) (progressed on a platinum containing regimen within 6 months of therapy and adenocarcinoma histology) that can be evaluable by RECISTv1.1 criteria who progressed on standard treatment. Participants will be recruited irrespective of if they earlier received available FDA-approved therapies (including for participants with targetable…
Interventions
- BiologicalNY-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.
- DrugToripalimab-tpzi
240 milligrams (mg), intravenously, every 3 weeks starting with the second dose of NY-ESO-1 Peptide vaccine
Locations (2)
- MedStar Georgetown University HospitalWashington D.C., District of Columbia
- John Theurer Cancer CenterHackensack, New Jersey