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)
Sponsor: |
Regeneron Pharmaceuticals |
Enrolling: |
Male Patients Only |
IRB Number: |
AAAS1863 |
U.S. Govt. ID: |
NCT03951831 |
Contact: |
Research Nurse Navigator: 212-342-5162 / cancerclinicaltrials@cumc.columbia.edu |
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
Investigator
Mark Stein, MD
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 |