A Combination Therapy Strategy to Reverse Anti-PD-1 Therapy Resistance in Metastatic Ovarian Cancer Patients
Abstract
The purpose of this phase II clinical study is to investigate if administration of a vaccine (NY-ESO-179-108 peptide) beforeanti-PD-1 would be able to reverse the anti-PD-1 therapy resistance and increase the response in patients with platinumresistant ovarian cancer (OC) and to correlate the presence of dysfunctional PD-1+CD38hi CD8+ T cells with the treatmentoutcome.We have developed the clinical protocol based on the grant proposal submitted to DoD and prepared other regulatorydocuments. We have received approval of the protocol from the Clinical Research Committee (CRC), the Food and DrugAdministration (FDA), the Institutional Review Board (IRB), and the USAMRDC OHARO OHRO. We have acquired supportfrom Bristol Myers Squibb (BMS) to supply nivolumab for the trial at no cost. In addition, University of Virginia has provided thevaccine for this trial. The trial is registered with ClinicalTrials.gov and is now open. We expect to recruit the first patient in thenext couple of months.
Document Details
- Document Type
- Technical Report
- Publication Date
- Aug 01, 2023
- Accession Number
- AD1216448
Entities
People
- Samir N. Khleif
Organizations
- Georgetown University