Clinical trial evaluates combination therapy for men with metastatic prostate cancer

Human Natural Killer Cell

Colorized scanning electron micrograph of a natural killer cell from a human donor.
Image Credit: National Institutes of Allergy and Infectious Diseases, National Institutes of Health

Men with prostate cancer that has spread to other parts of the body may be eligible to participate in a clinical trial at the NIH Clinical Center.

Ravi A. Madan, M.D., Senior Clinician in the Genitourinary Malignancies Branch, is leading a study of an experimental treatment for men with two types of prostate cancer: one type that responds to hormone therapy and one that doesn’t. Both can spread to other parts of the body, usually to bones. After a series of screening tests, study participants will receive docetaxel, a chemotherapy drug that stops the growth of tumor cells either by killing them or by stopping them from dividing and spreading. Participants will also get M9241, which delivers cytokines (or an immune signal) to dead or dying areas of tumor, helping the immune system become more active and kill cancer cells that have not responded to other treatments. M7824, an immunotherapy drug that blocks two molecular pathways that cancer cells use to evade attack by the immune system, is the third drug in this regimen. In preclinical studies, these drugs were more effective together than separately. Researchers want to find out if this combination is safe and effective in men with prostate cancer.

Clinicaltrials.gov identifier: NCT04633252

NCI Protocol ID: NCI-21-C-0001

Official Title: A Phase I/II Study of Bintrafusp Alfa (M7824) and M9241 in Combination With Docetaxel in Adults With Metastatic Castration Sensitive and Castration Resistant Prostate Cancer

The Center for Cancer Research is NCI’s internal cancer center, a publicly funded organization working to improve the lives of cancer patients by solving important, challenging and neglected problems in cancer research and patient care. Highly trained physician-scientists develop and carry out clinical trials to create the medicines of tomorrow treating patients at the world’s largest dedicated research hospital on the campus of the National Institutes of Health in Bethesda, Maryland.

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Summary Posted: Thu, 03/11/2021