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:

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
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Local Institution
Los Angeles California, 90027, United States More Info
Site 0033
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Rocky Mountain Cancer Centers (Littleton) - USOR
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 PA, Helen F Graham Cancer Center
Newark Delaware, 19713, United States More Info
Jamal Misleh, Site 0044
Contact
000-000-0000
Florida Urology Partners, LLP - Tampa
Tampa Florida, 33609, United States
Local Institution
Atlanta Georgia, 30322, United States More Info
Site 0047
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Northwest Georgia Oncology Centers PC
Marietta Georgia, 30060, United States More Info
Steven McCune, Site 0004
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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
New York New York, 10032, United States More Info
Matthew Dallos, Site 0006
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212-851-4893
Local Institution
Cary North Carolina, 27518, United States More Info
Site 0005
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Oncology Hematology Care Incorporated
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
Texas Oncology-Beaumont
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
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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
University of Texas MD Anderson 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
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903-579-9800
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Hampton Virginia, 23666, United States More Info
Site 0056
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Milwaukee Wisconsin, 53226, United States More Info
Site 0060
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Ciudad de Buenos Aires Buenos Aires, C1417, Argentina More Info
Site 0055
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Mar Del Plata Buenos Aires, 7600, Argentina More Info
Site 0041
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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
Local Institution
Buenos Aires , C1426, Argentina More Info
Site 0046
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Local Institution
Tucuman , 4000, Argentina More Info
Site 0025
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Darlinghurst New South Wales, 2010, Australia More Info
Site 0019
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Elizabeth Vale South Australia, 5112, Australia More Info
Site 0066
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Heidleberg Victoria, 3084, Australia More Info
Site 0078
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Hamilton Ontario, L8V 5, Canada More Info
Site 0067
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Toronto Ontario, M5G 2, Canada More Info
Site 0028
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Quebec , G1R 2, Canada More Info
Site 0015
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Nice Paca, 06189, France More Info
Site 0012
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Besançon , 25030, France More Info
Site 0011
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Bordeaux , 33076, France More Info
Site 0080
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Brest , 29609, France More Info
Site 0031
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Clermont-Ferrand , 63003, France More Info
Site 0023
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Lyon , 69008, France More Info
Site 0008
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Marseille , 13273, France More Info
Site 0076
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Saint-Quentin , 02321, France More Info
Site 0049
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Toulouse , 31100, France More Info
Site 0003
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Villejuif Cedex , 94800, France More Info
Site 0014
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Local Institution
Athens , 11528, Greece More Info
Site 0007
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Local Institution
Athens , 11528, Greece More Info
Site 0010
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Local Institution
Athens , 14564, Greece More Info
Site 0032
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Local Institution
Athens , 155 6, Greece More Info
Site 0077
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Marousi , 15125, Greece More Info
Site 0054
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Pylaia-Chortiatis , 57001, Greece More Info
Site 0027
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Thessaloniki , 54645, Greece More Info
Site 0069
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Thessaloniki , 56403, Greece More Info
Site 0081
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Meldola , 47014, Italy More Info
Site 0071
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Milano , 20162, Italy More Info
Site 0037
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Modena , 41124, Italy More Info
Site 0016
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Pozzuoli , 80078, Italy More Info
Site 0029
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Roma , 00152, Italy More Info
Site 0072
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Rozzano , 20089, Italy More Info
Site 0021
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Dordrecht , 3318 , Netherlands More Info
Site 0074
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Rotterdam , 3015 , Netherlands More Info
Site 0002
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Rotterdam , 3045 , Netherlands More Info
Site 0009
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Badajoz , 06006, Spain More Info
Site 0068
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Madrid , 28040, Spain More Info
Site 0079
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Santander , 39008, Spain More Info
Site 0017
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Blackburn , BB2 3, United Kingdom More Info
Site 0064
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Brighton , BN2 5, United Kingdom More Info
Site 0075
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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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Huddersfield , HD3 3, United Kingdom More Info
Site 0013
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London , SM2 5, United Kingdom More Info
Site 0035
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London , W6 8R, United Kingdom More Info
Site 0048
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Preston , PR2 9, United Kingdom More Info
Site 0030
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Torquay , TQ2 7, United Kingdom More Info
Site 0051
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Local Institution
Truro , TR1 3, United Kingdom More Info
Site 0063
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Local Institution
Wolverhampton , WV10 , United Kingdom More Info
Site 0073
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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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