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.
- 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.