Prostate Cancer Clinical Trial

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A Study of BMS-986218 or BMS-986218 Plus Nivolumab in Combination With Docetaxel in Participants With Metastatic Castration-resistant Prostate Cancer

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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:

204

Study ID:

NCT05169684

Recruitment Status:

Recruiting

Sponsor:

Bristol-Myers Squibb

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There are 80 Locations for this study

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Arizona Oncology - Tucson - Wilmot Road Location
Tucson Arizona, 85711, United States More Info
Aung Bajaj, Site 0043
Contact
Local Institution
Los Angeles California, 90027, United States More Info
Site 0033
Contact
Rocky Mountain Cancer Centers - Littleton
Littleton Colorado, 80120, United States More Info
Manojkumar Bupathi, Site 0024
Contact
303-418-7639
Local Institution
New Haven Connecticut, 06510, United States More Info
Site 0082
Contact
Medical Oncology Hematology Consultants - Newark
Newark Delaware, 19713, United States More Info
Jamal Misleh, Site 0044
Contact
Florida Urology Partners, LLP - Tampa
Tampa Florida, 33609, United States
Local Institution
Atlanta Georgia, 30322, United States More Info
Site 0047
Contact
Northwest Georgia Oncology Centers PC
Marietta Georgia, 30060, United States More Info
Steven McCune, Site 0004
Contact
770-281-5162
Local Institution
Chicago Illinois, 60637, United States More Info
Site 0036
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Local Institution
Baltimore Maryland, 21287, United States More Info
Site 0061
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Maryland Oncology Hematology, P.A.
Columbia Maryland, 21044, United States
Local Institution
Saint Louis Missouri, 63110, United States More Info
Site 0001
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Columbia University Medical Center - Herbert Irving Pavilion Location
New York New York, 10032, United States More Info
Karie Runcie, Site 0006
Contact
212-305-8923
Local Institution
Cary North Carolina, 27518, United States More Info
Site 0005
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Oncology Hematology Care, Inc. - Eastgate
Cincinnati Ohio, 45245, United States More Info
Mark Johns, Site 0058
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Willamette Valley Cancer Institute And Research Center
Eugene Oregon, 97401, United States More Info
Marc Uemura, Site 0040
Contact
541-214-8284
Thomas Jefferson University Hospital
Philadelphia Pennsylvania, 19107, United States More Info
William Kelly, Site 0020
Contact
Texas Oncology-Beaumont Mamie McFaddin Ward Cancer Center
Beaumont Texas, 77702, United States More Info
Scott Mckenney, Site 0026
Contact
409-899-7180
Texas Oncology
Bedford Texas, 76022, United States More Info
Henrik Bo Illum, Site 0022
Contact
817-359-9000
Texas Oncology - Denton North
Denton Texas, 76201, United States More Info
Charles Kurkul, Site 0050
Contact
Texas Oncology
Flower Mound Texas, 75028, United States More Info
Michael Park, Site 0034
Contact
000-000-0000
Texas Oncology - Fort Worth Cancer Center
Fort Worth Texas, 76132, United States More Info
Stephen Richey, Site 0057
Contact
817-413-1500
The University of Texas - MD Anderson Cancer Center - Genitourinary (GU) Cancer Center
Houston Texas, 77030, United States More Info
Sumit Subudhi, Site 0042
Contact
713-563-7213
Local Institution
McKinney Texas, 75071, United States More Info
Site 0045
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Texas Oncology- Tyler
Tyler Texas, 75702, United States More Info
Donald Richards, Site 0038
Contact
903-579-9800
Local Institution
Hampton Virginia, 23666, United States More Info
Site 0056
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Local Institution
Milwaukee Wisconsin, 53226, United States More Info
Site 0060
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Local Institution
Ciudad de Buenos Aires Buenos Aires, C1417, Argentina More Info
Site 0055
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Local Institution
Mar Del Plata Buenos Aires, 7600, Argentina More Info
Site 0041
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Local Institution - 0070
Pergamino Buenos Aires, 2700, Argentina More Info
Site 0070
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Local Institution
Buenos Aires , 1426, Argentina More Info
Site 0039
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Local Institution - 0018
Buenos Aires , C1181, Argentina More Info
Site 0018
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Local Institution
Buenos Aires , C1426, Argentina More Info
Site 0046
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Local Institution - 0025
Tucuman , 4000, Argentina More Info
Site 0025
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Local Institution
Darlinghurst New South Wales, 2010, Australia More Info
Site 0019
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Local Institution - 0066
Elizabeth Vale South Australia, 5112, Australia More Info
Site 0066
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Local Institution
Heidleberg Victoria, 3084, Australia More Info
Site 0078
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Local Institution
Hamilton Ontario, L8V 5, Canada More Info
Site 0067
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Local Institution
Toronto Ontario, M5G 2, Canada More Info
Site 0028
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Local Institution
Quebec , G1R 2, Canada More Info
Site 0015
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Local Institution
Nice Paca, 06189, France More Info
Site 0012
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Local Institution
Besançon , 25030, France More Info
Site 0011
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Local Institution
Bordeaux , 33076, France More Info
Site 0080
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Local Institution
Brest , 29609, France More Info
Site 0031
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Local Institution
Clermont-Ferrand , 63003, France More Info
Site 0023
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Local Institution - 0008
Lyon , 69008, France More Info
Site 0008
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Local Institution - 0076
Marseille , 13009, France More Info
Site 0076
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Local Institution
Saint-Quentin , 02321, France More Info
Site 0049
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Local Institution
Toulouse , 31100, France More Info
Site 0003
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Local Institution - 0014
Villejuif Cedex , 94800, France More Info
Site 0014
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Local Institution - 0010
Athens I, 115 2, Greece More Info
Site 0010
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Local Institution - 0007
Athina I, 115 2, Greece More Info
Site 0007
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Local Institution - 0054
Marousi I, 151 2, Greece More Info
Site 0054
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Local Institution - 0032
Peiraias I, 185 4, Greece More Info
Site 0032
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Local Institution
Athens , 155 6, Greece More Info
Site 0077
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Local Institution
Pylaia-Chortiatis , 57001, Greece More Info
Site 0027
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Local Institution - 0069
Thessaloniki , 54645, Greece More Info
Site 0069
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Local Institution
Thessaloniki , 56403, Greece More Info
Site 0081
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Local Institution - 0021
Rozzano MI, 20089, Italy More Info
Site 0021
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Local Institution
Meldola , 47014, Italy More Info
Site 0071
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Local Institution - 0037
Milano , 20162, Italy More Info
Site 0037
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Local Institution - 0016
Modena , 41124, Italy More Info
Site 0016
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Local Institution - 0029
Pozzuoli , 80078, Italy More Info
Site 0029
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Local Institution
Roma , 00152, Italy More Info
Site 0072
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Local Institution - 0074
Dordrecht ZH, 3318 , Netherlands More Info
Site 0074
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Local Institution
Rotterdam , 3015 , Netherlands More Info
Site 0002
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Local Institution
Rotterdam , 3045 , Netherlands More Info
Site 0009
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Local Institution
Badajoz , 06006, Spain More Info
Site 0068
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Local Institution
Madrid , 28040, Spain More Info
Site 0079
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Local Institution
Santander , 39008, Spain More Info
Site 0017
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Local Institution - 0075
Brighton BNH, BN2 5, United Kingdom More Info
Site 0075
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Local Institution - 0064
Blackburn LAN, BB2 3, United Kingdom More Info
Site 0064
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Local Institution - 0030
Preston LAN, PR2 9, United Kingdom More Info
Site 0030
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Local Institution - 0073
West Midlands WLV, WV10 , United Kingdom More Info
Site 0073
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Local Institution - 0065
Bristol , BS2 8, United Kingdom
Local Institution
Guildford , GU2 7, United Kingdom More Info
Site 0053
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Local Institution
Huddersfield , HD3 3, United Kingdom More Info
Site 0013
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Local Institution
London , SM2 5, United Kingdom More Info
Site 0035
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Local Institution
London , W6 8R, United Kingdom More Info
Site 0048
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Local Institution
Torquay , TQ2 7, United Kingdom More Info
Site 0051
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Local Institution - 0063
Truro , TR1 3, United Kingdom More Info
Site 0063
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How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

204

Study ID:

NCT05169684

Recruitment Status:

Recruiting

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

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