Title: A Phase Ib/II Trial To Test The Safety And Efficacy Of Vaccination With HPV16-E711-19 Nanomer For The Treatment Of Incurable HPV 16-Related Oropharyngeal, Cervical And Anal Cancer In HLA-A*02 Positive Patients1

Principal Investigators: Jochen Lorch, MD, Dana-Farber Cancer Institute

Description: For this single group, phase 1b/2 trial, researchers are evaluating whether DPX-E7 vaccination is safe and will improve outcomes among patients with HPV-positive head and neck, cervical, or anal cancer.

Enrolled patients will receive DPX-E7 and low-dose cyclophosphamide; patients must be positive for HLA-A*02.

The primary outcome is the number of patients with treatment-related adverse events; secondary outcomes include overall response rate, overall survival, and progression-free survival.

For more study information, including inclusion and exclusion criteria, study locations, and contact information, visit https://clinicaltrials.gov/ct2/show/NCT02865135.

Status: This study is open and recruiting patients as of April 11, 2017.

This study is sponsored by Dana-Farber Cancer Institute in collaboration with Stand Up To Cancer.

DPX-E7 is an investigational vaccine not yet approved by the US Food and Drug Administration for the treatment of any disease.

Reference

  1. Clinicaltrials.gov. Trial to test safety and efficacy of vaccination for incurable HPV 16-related oropharyngeal, cervical and anal cancer. NCT02865135. https://clinicaltrials.gov/ct2/show/NCT02865135. Accessed April 11, 2017.