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ACTIVE NOT RECRUITING
NCT04580771
PHASE2

A Vaccine (PDS0101) and Chemoradiation for the Treatment of Stage IB3-IVA Cervical Cancer, the IMMUNOCERV Trial

Sponsor: M.D. Anderson Cancer Center

View on ClinicalTrials.gov

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.

Official title: IMMUNOCERV: Evaluating the Safety of Chemoradiation Combined With PDS0101 Immunotherapy in Treating Locally Advanced Cervical Cancer

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

22

Start Date

2020-10-14

Completion Date

2027-03-08

Last Updated

2025-10-10

Healthy Volunteers

No

Interventions

DRUG

Cisplatin

Given IV

BIOLOGICAL

Liposomal HPV-16 E6/E7 Multipeptide Vaccine PDS0101

Given SC

RADIATION

Radiation Therapy

Undergo radiation therapy

Locations (1)

M D Anderson Cancer Center

Houston, Texas, United States