A Vaccine (PDS0101) and Chemoradiation for the Treatment of Stage IB3-IVA Cervical Cancer, the IMMUNOCERV Trial
Status:
Recruiting
Trial end date:
2024-03-08
Target enrollment:
Participant gender:
Summary
This phase IIA trial studies the effect of a vaccine (PDS0101) when given together with
chemotherapy and radiation therapy (chemoradiation) in treating patients with stage IB3-IVA
cervical cancer. Chemotherapy drugs, such as cisplatin, work in different ways to stop the
growth of tumor cells, either by killing the cells, by stopping them from dividing, or by
stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells
and shrink tumors. PDS0101 is a type of vaccine that is intended to help the immune system
respond to human papillomavirus (HPV16)-infected cervical tumor cells. PDS0101 contains two
active components: the first is called R-DOTAP (Versamune) and is included in the vaccine to
boost the immune system's response against the HPV viral proteins and the second group of
active components are selected small pieces of proteins (called peptides) taken from the HPV
virus. Giving PDS0101 in combination with chemoradiation may work help to control cervical
cancer.