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 the Informed Consent Form and Disease Group Cover Letter. In addition, we 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. We submitted the protocol to Clinical Research Committee (CRC) for approval. After two cycles of review, we have submitted the responses again, which will not have to undergo full review by the committee. We will be submitting the protocol to the Institutional Review Board (IRB) after we get final CRC approval. We expect that we will be able to recruit patients for the trial in second quarter of 2022.
Document Details
- Document Type
- Technical Report
- Publication Date
- Aug 01, 2021
- Accession Number
- AD1166803
Entities
People
- Samir N. Khleif
Organizations
- Georgetown University