Phase II, open-label, single-center study evaluating safety and activity of androgen deprivation therapy followed by chemoimmunotherpy (REGN2810, an Anti-PD-1 Antibody, and docetaxel) for newly metastatic hormone-sensitive prostate cancer (mHSPC)
Study of androgen deprivation therapy followed by chemoimmunotherpy for newly metastatic hormone-sensitive prostate cancer (mHSPC)
Sponsor: Regeneron Pharmaceuticals
Enrolling: Male Patients Only
IRB Number: AAAS1863
U.S. Govt. ID: NCT03951831
Contact: Research Nurse Navigator: 212-342-5162 /
Additional Study Information: The purpose of this study is to determine if the addition of immunotherapy to the current standard of care for metastatic prostate cancer, chemotherapy, and hormonal therapy, is safe and improves your response to therapy. People who usually have metastatic prostate cancer to their bones and organs are usually treated with combination of chemotherapy (docetaxel) and hormonal therapy (androgen deprivation therapy or ADT). Chemotherapy is typically given for 18 weeks and hormonal therapy, like degarelix and leuprolide, is usually continued. The immunotherapy used in this trial is using cemiplimab-rwlc, which is a FDA-approved medication for the treatment of squamous cell carcinoma and is proven to be safe and efficacious. Cemiplimab-rwlc is not FDA approved for the use in treatment of prostate cancer. Approximately 20 individuals will be asked to participate in this study.
This study is closed
Mark Stein, MD
Do You Qualify?
Do you have newly diagnosed metastatic hormone sensitive prostate cancer? Yes No
Have you had no androgen deprivation therapy (ADT) in the past 6 months? Yes No
Is your cancerous lesion amenable to biopsy? Yes No
You may be eligible for this study

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