Bintrafusp Alfa (M7824) and M9241 in Combination With Docetaxel in Adults With Metastatic Castration Sensitive and Castration Resistant Prostate Cancer

• Status: Recruiting
• Trial end date: 2023-07-31

Summary

Background:

Metastatic castration sensitive and castration resistant prostate cancer (mCSPC and mCRPC) are prostate cancers that have spread to other parts of the body. Use of the drug docetaxel with androgen deprivation therapy can improve survival for men with mCSPC. Researchers want to see if combining this treatment with other drugs can help delay the time it takes for mCSPC and mCRPC to get worse.

Objective:

To learn if giving docetaxel with M7824 and M9241 is safe and effective for men with prostate cancer.

Eligibility:

Men age 18 and older with mCSPC or mCRPC.

Design:

Participants will be screened with a medical history and physical exam. Their diagnosis will be confirmed. Their symptoms and how well they do their normal activities will be reviewed. They will have blood and urine tests. Their heart will be evaluated. They will have imaging scans of the chest, abdomen, and pelvis. They will have bone scans with intravenous (IV) injections of Tc99 to check for tumor spread in the bones.

Some screening tests will be repeated during the study.

Participants may have tumor biopsies.

Participants will get treatment in cycles. Each cycle will last 21 days. They will get docetaxel and M7824 through IV infusion. They will get M9241 as an injection under the skin.

Participants with mCSPC will have up to 6 cycles. Those with mCRPC will be treated until they cannot tolerate the side effects or their disease gets worse.

Participants will have a follow-up visit 30 days after treatment ends. Those with mCSPC will then have follow-up visits at the clinic every 3 months....

• Phase: Phase 1/Phase 2

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Docetaxel; Prednisone