A Phase 2 Open-label, Randomized Controlled Trial of BMS-986218 or BMS-986218 plus Nivolumab in combination with Docetaxel in Participants with metastatic Castration-Resistant Prostate Cancer
Study of BMS-986218 Alone or in Combination with Nivolumab for Male Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Sponsor: BMS
Enrolling: Male Patients Only
IRB Number: AAAT8973
U.S. Govt. ID: NCT05169684
Contact: Research Nurse Navigator: 212-342-5162 / cancerclinicaltrials@cumc.columbia.edu
Additional Study Information: The purpose of this study is to assess the effectiveness and safety of combining an investigational drug called BMS-986218 (also known as Anti-CTLA4-NF monoclonal antibody), or BMS-986218 plus nivolumab, with standard of care docetaxel (chemotherapy), in men who have metastatic castration-resistant prostate cancer (mCRPC) that progressed after a second-generation hormonal manipulation, also known as novel antiandrogen therapy (NAT), and have not received chemotherapy for mCRPC.This study will investigate how participants with mCRPC tolerate these drugs and identify the most suitable dose of BMS-986218 in combination with docetaxel and BMS-986218 in combination with docetaxel and nivolumab. BMS-986218 is an investigational drug that is not approved for a particular use by a local health authority, such as the Food and Drug Administration. Nivolumab and docetaxel have been administered to and are approved for human use in multiple tumor types.
This study is closed
Investigator
Karie D. Runcie, MD
Do You Qualify?
Are you a male who is 18 years of age or older? Yes No
Have you been diagnosed metastatic castration-resistant prostate cancer (mCRPC)? Yes No
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For more information, please contact:
Research Nurse Navigator
cancerclinicaltrials@cumc.columbia.edu
212-342-5162