An intravenous vaccine, axalimogene filolisbac, could prevent relapse of cervical cancer. Relapsed cervical cancer is frequently fatal.
Researchers are assessing the vaccine in patients at high risk of relapse. Axalimogene filolisbac helps the patient’s own immune system better fight tumor cells targeting the E7 protein, a protein involved in both tumor and human papillomavirus (HPV) proliferation.
In this trial, two-thirds of participants will receive the vaccine every 3 weeks for 3 months, then every 8 weeks for 5 more doses, or until disease recurrence. The remaining one-third of participants will receive a placebo.
Target enrollment is 450 patients, and the trial will run worldwide, with follow-up planned for 3 to 5 years.
All study participants will have completed a course of the standard of care for cervical cancer.
The most common adverse events of axalimogene filolisbac are fever and flu-like symptoms.
Currently, a phase II trial of axalimogene filolisbac in patients with relapsed disease is examining whether the vaccine increases 12-month survival. Preliminary results from this trial indicate that the vaccine does indeed increase survival.
1. Therapeutic vaccine designed to reduce recurrence of cervical cancer under study [press release]. Augusta, GA: medical College of Georgia at Augusta University; April 25, 2017. https://www.eurekalert.org/pub_releases/2017-04/mcog-tvd042517.php. Accessed May 9, 2017.