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 79 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
Kaiser Permanente Los Angeles Medical Center
Los Angeles California, 90027, United States More Info
Helen Moon, Site 0033
Contact
951-353-3323
Rocky Mountain Cancer Centers - Littleton
Littleton Colorado, 80120, United States More Info
Manojkumar Bupathi, Site 0024
Contact
303-418-7639
Yale School Of Medicine
New Haven Connecticut, 06510, United States More Info
Daniel Petrylak, Site 0082
Contact
718-939-8655
Medical Oncology Hematology Consultants - Newark
Newark Delaware, 19713, United States More Info
Jamal Misleh, Site 0044
Contact
The Winship Cancer Institute of Emory University
Atlanta Georgia, 30322, United States More Info
Bradley Carthon, Site 0047
Contact
404-686-8210
Northwest Georgia Oncology Centers, P.C.
Marietta Georgia, 30060, United States More Info
Steven McCune, Site 0004
Contact
770-281-5162
The University of Chicago Medical Center - Duchossois Center for Advanced Medicine
Chicago Illinois, 60637, United States More Info
Akash Patnaik, Site 0036
Contact
507-358-5327
University Of Iowa Hospitals And Clinics
Iowa City Iowa, 52242, United States More Info
Rohan Garje, Site 0084
Contact
319-356-1770
University of Iowa Hospitals and Clinics
Iowa City Iowa, 52242, United States More Info
Yousef Zakharia, Site 0085
Contact
319-384-8076
The Johns Hopkins Hospital
Baltimore Maryland, 21287, United States More Info
Mark Markowski, Site 0061
Contact
410-614-4459
Washington University School of Medicine in St. Louis
Saint Louis Missouri, 63110, United States More Info
Russell Pachynski, Site 0001
Contact
314-286-2341
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
Duke Cancer Institute
Durham North Carolina, 27710, United States More Info
Michael Harrison, Site 0005
Contact
919-668-4615
Oncology Hematology Care, Inc. - Eastgate
Cincinnati Ohio, 45245, United States More Info
Mark Johns, Site 0058
Contact
Willamette Valley Cancer Institute
Eugene Oregon, 97477, United States More Info
Joseph Fiorillo, Site 0040
Contact
541-683-5001
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, 76104, 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
Texas Oncology - McKinney
McKinney Texas, 75071, United States More Info
Monte Jones, Site 0045
Contact
972-867-3577
Texas Oncology- Tyler
Tyler Texas, 75702, United States More Info
Donald Richards, Site 0038
Contact
903-579-9800
Virginia Oncology Associates - Hampton
Hampton Virginia, 23666, United States More Info
Mark Fleming, Site 0056
Contact
757-873-9833
Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States More Info
Deepak Kilari, Site 0060
Contact
Local Institution - 0070
Pergamino B, B2700, Argentina More Info
Site 0070
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Local Institution - 0055
Buenos Aires C, C1417, Argentina More Info
Site 0055
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Local Institution - 0025
San Miguel De Tocuman T, T4000, Argentina More Info
Site 0025
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Local Institution - 0039
Buenos Aires , 1426, Argentina More Info
Site 0039
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Local Institution - 0046
Buenos Aires , C1426, Argentina More Info
Site 0046
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Local Institution - 0041
MarDel Lata , B7600, Argentina More Info
Site 0041
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Local Institution - 0062
San Juan , 5400, Argentina More Info
Site 0062
Contact
Local Institution - 0019
Darlinghurst New South Wales, 2010, Australia
Local Institution - 0066
Elizabeth Vale South Australia, 5112, Australia
Local Institution - 0078
Heidelberg Victoria, 3084, Australia
Local Institution - 0067
Hamilton Ontario, L8V 5, Canada More Info
Site 0067
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Local Institution - 0083
Ottawa Ontario, K1H 8, Canada More Info
Site 0083
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Local Institution - 0028
Toronto Ontario, M5G 2, Canada More Info
Site 0028
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Local Institution - 0015
Québec Quebec, G1R 3, Canada More Info
Site 0015
Contact
Local Institution - 0086
Angers , 49100, France More Info
Site 0086
Contact
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 More Info
Site 0023
Contact
Local Institution - 0008
Lyon , 69008, France More Info
Site 0008
Contact
Local Institution - 0076
Marseille , 13009, France More Info
Site 0076
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Local Institution - 0012
Nice CEDEX 2 , 06189, France More Info
Site 0012
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Local Institution - 0049
St Quentin , 02321, France More Info
Site 0049
Contact
Local Institution - 0003
Toulouse , 31100, France
Local Institution - 0014
Villejuif Cedex , 94800, France More Info
Site 0014
Contact
Local Institution - 0081
Thessaloniki B, 541 2, Greece More Info
Site 0081
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Local Institution - 0010
Athens I, 115 2, Greece More Info
Site 0010
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Local Institution - 0027
Athina I, 115 2, Greece More Info
Site 0027
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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 - 0077
Athens , 155 6, Greece More Info
Site 0077
Contact
Local Institution - 0069
Thessaloniki , 54645, Greece More Info
Site 0069
Contact
Local Institution - 0037
Milano MI, 20162, Italy More Info
Site 0037
Contact
Local Institution - 0021
Rozzano MI, 20089, Italy More Info
Site 0021
Contact
Local Institution - 0071
Meldola , 47014, Italy More Info
Site 0071
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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
Contact
Local Institution - 0072
Roma , 152, Italy
Local Institution - 0074
Dordrecht ZH, 3318 , Netherlands More Info
Site 0074
Contact
Local Institution - 0002
Rotterdam ZH, 3015 , Netherlands
Local Institution - 0009
Rotterdam , 3045 , Netherlands
Local Institution - 0079
Madrid M, 28040, Spain
Local Institution - 0068
Badajoz , 06006, Spain
Local Institution - 0017
Santander-Cantabria , 39008, Spain
Local Institution - 0075
Brighton BNH, BN2 5, United Kingdom More Info
Site 0075
Contact
Local Institution - 0065
Bristol BST, BS2 8, United Kingdom
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
Contact
Local Institution - 0048
London LND, W6 8R, United Kingdom More Info
Site 0048
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Local Institution - 0053
Guildford SRY, GU2 7, United Kingdom More Info
Site 0053
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Local Institution - 0051
Torquay TOB, TQ2 7, United Kingdom More Info
Site 0051
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Local Institution - 0073
West Midlands WLV, WV10 , United Kingdom More Info
Site 0073
Contact
Local Institution - 0013
Huddersfield , HD3 3, United Kingdom
Local Institution - 0035
Sutton , SM2 5, United Kingdom More Info
Site 0035
Contact
Local Institution - 0063
Truro , TR1 3, United Kingdom More Info
Site 0063
Contact

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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