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.

View Eligibility Criteria

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

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

10

Study ID:

NCT05169684

Recruitment Status:

Completed

Sponsor:

Bristol-Myers Squibb

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There are 68 Locations for this study

See Locations Near You

Arizona Oncology - Tucson - Wilmot Road Location
Tucson Arizona, 85711, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles California, 90027, United States
Rocky Mountain Cancer Centers - Littleton
Littleton Colorado, 80120, United States
Yale School Of Medicine
New Haven Connecticut, 06510, United States
Medical Oncology Hematology Consultants - Newark
Newark Delaware, 19713, United States
The Winship Cancer Institute of Emory University
Atlanta Georgia, 30322, United States
Northwest Georgia Oncology Centers, P.C.
Marietta Georgia, 30060, United States
The University of Chicago Medical Center - Duchossois Center for Advanced Medicine
Chicago Illinois, 60637, United States
University Of Iowa Hospitals And Clinics
Iowa City Iowa, 52242, United States
The Johns Hopkins Hospital
Baltimore Maryland, 21287, United States
Washington University School of Medicine in St. Louis
Saint Louis Missouri, 63110, United States
Columbia University Medical Center - Herbert Irving Pavilion Location
New York New York, 10032, United States
Duke Cancer Institute
Durham North Carolina, 27710, United States
Oncology Hematology Care, Inc. - Eastgate
Cincinnati Ohio, 45245, United States
Willamette Valley Cancer Institute
Eugene Oregon, 97477, United States
Texas Oncology-Beaumont Mamie McFaddin Ward Cancer Center
Beaumont Texas, 77702, United States
Texas Oncology
Bedford Texas, 76022, United States
Texas Oncology - Denton North
Denton Texas, 76201, United States
Texas Oncology
Flower Mound Texas, 75028, United States
Texas Oncology - Fort Worth Cancer Center
Fort Worth Texas, 76104, United States
The University of Texas - MD Anderson Cancer Center - Genitourinary (GU) Cancer Center
Houston Texas, 77030, United States
Texas Oncology - McKinney
McKinney Texas, 75071, United States
Texas Oncology- Tyler
Tyler Texas, 75702, United States
Virginia Oncology Associates - Hampton
Hampton Virginia, 23666, United States
Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States
Local Institution - 0070
Pergamino B, B2700, Argentina
Local Institution - 0055
Buenos Aires C, C1417, Argentina
Local Institution - 0025
San Miguel De Tocuman T, T4000, Argentina
Local Institution - 0039
Buenos Aires , 1426, Argentina
Local Institution - 0046
Buenos Aires , C1426, Argentina
Local Institution - 0041
MarDel Lata , B7600, Argentina
Local Institution - 0062
San Juan , 5400, Argentina
Local Institution - 0067
Hamilton Ontario, L8V 5, Canada
Local Institution - 0083
Ottawa Ontario, K1H 8, Canada
Local Institution - 0028
Toronto Ontario, M5G 2, Canada
Local Institution - 0015
Québec Quebec, G1R 3, Canada
Local Institution - 0086
Angers , 49100, France
Local Institution - 0011
Besancon , 25000, France
Local Institution - 0080
Bordeaux , 33076, France
Local Institution - 0031
Brest , 29609, France
Local Institution - 0023
Clermont-Ferrand CEDEX 01 , 63011, France
Local Institution - 0008
Lyon , 69008, France
Local Institution - 0076
Marseille , 13009, France
Local Institution - 0012
Nice CEDEX 2 , 06189, France
Local Institution - 0049
St Quentin , 02321, France
Local Institution - 0003
Toulouse , 31100, France
Local Institution - 0014
Villejuif Cedex , 94800, France
Local Institution - 0081
Thessaloniki B, 541 2, Greece
Local Institution - 0010
Athens I, 115 2, Greece
Local Institution - 0027
Athina I, 115 2, Greece
Local Institution - 0007
Athina I, 115 2, Greece
Local Institution - 0054
Marousi I, 151 2, Greece
Local Institution - 0032
Peiraias I, 185 4, Greece
Local Institution - 0077
Athens , 155 6, Greece
Local Institution - 0069
Thessaloniki , 54645, Greece
Local Institution - 0037
Milano MI, 20162, Italy
Local Institution - 0021
Rozzano MI, 20089, Italy
Local Institution - 0071
Meldola , 47014, Italy
Local Institution - 0016
Modena , 41124, Italy
Local Institution - 0029
Pozzuoli , 80078, Italy
Local Institution - 0074
Dordrecht ZH, 3318 , Netherlands
Local Institution - 0075
Brighton BNH, BN2 5, United Kingdom
Local Institution - 0064
Blackburn LAN, BB2 3, United Kingdom
Local Institution - 0030
Preston LAN, PR2 9, United Kingdom
Local Institution - 0048
London LND, W6 8R, United Kingdom
Local Institution - 0053
Guildford SRY, GU2 7, United Kingdom
Local Institution - 0051
Torquay TOB, TQ2 7, United Kingdom
Local Institution - 0073
West Midlands WLV, WV10 , United Kingdom
Local Institution - 0035
Sutton , SM2 5, United Kingdom
Local Institution - 0063
Truro , TR1 3, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

10

Study ID:

NCT05169684

Recruitment Status:

Completed

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

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