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 platinum resistant ovarian cancer (OC) and to correlate the presence of dysfunctional PD-1+CD38hi CD8+ T cells with the treatment outcome. We have developed the clinical protocol based on the grant proposal submitted to DoD and also prepared other regulatory documents. We have received approval of the protocol from the Clinical Research Committee (CRC) and have acquired support from Bristol Myers Squibb (BMS) to supply nivolumab for the trial at no cost. In addition, University of Virginia will be providing us the vaccine for the trial. Furthermore, we got approval from the Food and Drug Administration (FDA) to proceed with the study and recently received approval from the Institutional Review Board (IRB). Now we will be submitting the HRPO form to DoD. We expect that we will be able to recruit patients for the trial in the first quarter of 2023.
Document Details
- Document Type
- Technical Report
- Publication Date
- Aug 01, 2022
- Accession Number
- AD1190711
Entities
People
- Samir N. Khleif
Organizations
- Georgetown University