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 79 Locations for this study
Tucson Arizona, 85711, United States More Info
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Newark Delaware, 19713, United States More Info
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Chicago Illinois, 60637, United States More Info
Saint Louis Missouri, 63110, United States More Info
New York New York, 10032, United States More Info
Cincinnati Ohio, 45245, United States More Info
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Beaumont Texas, 77702, United States More Info
Denton Texas, 76201, United States More Info
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Houston Texas, 77030, United States More Info
Milwaukee Wisconsin, 53226, United States More Info
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Darlinghurst New South Wales, 2010, Australia
Elizabeth Vale South Australia, 5112, Australia
Heidelberg Victoria, 3084, Australia
Besancon , 25000, France
Bordeaux , 33076, France
Brest , 29609, France
Toulouse , 31100, France
Roma , 152, Italy
Rotterdam ZH, 3015 , Netherlands
Rotterdam , 3045 , Netherlands
Madrid M, 28040, Spain
Badajoz , 06006, Spain
Santander-Cantabria , 39008, Spain
Bristol BST, BS2 8, United Kingdom
Huddersfield , HD3 3, United Kingdom
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