Prostate Cancer Clinical Trial
A Study of BMS-986218 or BMS-986218 Plus Nivolumab in Combination With Docetaxel in Participants With Metastatic Castration-resistant Prostate Cancer
Summary
The purpose of this study is to assess the safety, efficacy, tolerability, and toxicity of docetaxel alone, in combination with BMS-986218, or in combination with nivolumab plus BMS-986218 in men who have metastatic castration-resistant prostate cancer (mCRPC) that progressed after novel antiandrogen therapy and have not received chemotherapy for mCRPC.
Eligibility Criteria
Inclusion Criteria:
Histologic confirmation of carcinoma of the prostate without small cell features
Documented prostate cancer progression by Prostate Cancer Working Group 3 (PCWG3) criteria while castrate
Evidence of metastatic disease documented by either bone lesions on radionuclide bone scan and/or soft tissue lesions on computed tomography (CT)/magnetic resonance imaging (MRI)
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
Ongoing androgen deprivation therapy (ADT) with a gonadotropin-releasing hormone (GnRH) agonist/antagonist or bilateral orchiectomy (i.e., surgical or medical castration) confirmed by testosterone level ≤ 1.73 nmol/L (50 ng/dL) at the screening visit
Chemotherapy-naive for metastatic castration-resistant prostate cancer (mCRPC) and have received at least one novel antiandrogen therapy (NAT)
Exclusion Criteria:
Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to treatment assignment in Part 1 or randomization in Part 2
Untreated central nervous system (CNS) metastases
Leptomeningeal metastases
Active, known or suspected autoimmune disease
Other protocol-defined inclusion/exclusion criteria apply
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There are 68 Locations for this study
Tucson Arizona, 85711, United States
Los Angeles California, 90027, United States
Littleton Colorado, 80120, United States
New Haven Connecticut, 06510, United States
Newark Delaware, 19713, United States
Atlanta Georgia, 30322, United States
Marietta Georgia, 30060, United States
Chicago Illinois, 60637, United States
Iowa City Iowa, 52242, United States
Baltimore Maryland, 21287, United States
Saint Louis Missouri, 63110, United States
New York New York, 10032, United States
Durham North Carolina, 27710, United States
Cincinnati Ohio, 45245, United States
Eugene Oregon, 97477, United States
Beaumont Texas, 77702, United States
Bedford Texas, 76022, United States
Denton Texas, 76201, United States
Flower Mound Texas, 75028, United States
Fort Worth Texas, 76104, United States
Houston Texas, 77030, United States
McKinney Texas, 75071, United States
Tyler Texas, 75702, United States
Hampton Virginia, 23666, United States
Milwaukee Wisconsin, 53226, United States
Pergamino B, B2700, Argentina
Buenos Aires C, C1417, Argentina
San Miguel De Tocuman T, T4000, Argentina
Buenos Aires , 1426, Argentina
Buenos Aires , C1426, Argentina
MarDel Lata , B7600, Argentina
San Juan , 5400, Argentina
Hamilton Ontario, L8V 5, Canada
Ottawa Ontario, K1H 8, Canada
Toronto Ontario, M5G 2, Canada
Québec Quebec, G1R 3, Canada
Angers , 49100, France
Besancon , 25000, France
Bordeaux , 33076, France
Brest , 29609, France
Clermont-Ferrand CEDEX 01 , 63011, France
Lyon , 69008, France
Marseille , 13009, France
Nice CEDEX 2 , 06189, France
St Quentin , 02321, France
Toulouse , 31100, France
Villejuif Cedex , 94800, France
Thessaloniki B, 541 2, Greece
Athens I, 115 2, Greece
Athina I, 115 2, Greece
Athina I, 115 2, Greece
Marousi I, 151 2, Greece
Peiraias I, 185 4, Greece
Athens , 155 6, Greece
Thessaloniki , 54645, Greece
Milano MI, 20162, Italy
Rozzano MI, 20089, Italy
Meldola , 47014, Italy
Modena , 41124, Italy
Pozzuoli , 80078, Italy
Dordrecht ZH, 3318 , Netherlands
Brighton BNH, BN2 5, United Kingdom
Blackburn LAN, BB2 3, United Kingdom
Preston LAN, PR2 9, United Kingdom
London LND, W6 8R, United Kingdom
Guildford SRY, GU2 7, United Kingdom
Torquay TOB, TQ2 7, United Kingdom
West Midlands WLV, WV10 , United Kingdom
Sutton , SM2 5, United Kingdom
Truro , TR1 3, United Kingdom
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