A Study to Compare the Efficacy and Safety of BMS-986365 Versus the Investigator's Choice of Therapy in Participants With Metastatic Castration-resistant Prostate Cancer (rechARge)

September 4, 2026 updated by: Celgene

A Phase 3, Two-part, Randomized, Open-label, Adaptive Study Comparing BMS-986365 Versus Investigator's Choice of Therapy Comprising Either Docetaxel or Second Androgen Receptor Pathway Inhibitor (ARPI), in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) - rechARge

The purpose of this study is to compare the efficacy and safety of BMS-986365 versus the investigator's choice of therapy in participants with Metastatic Castration-resistant Prostate Cancer.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The primary objective of this clinical trial is to assess the radiographic progression free survival (rPFS) of BMS-986365 versus investigator's choice comprising Docetaxel + Prednisone/Prednisolone or Abiraterone + Prednisone/Prednisolone or Enzalutamide.

In Part 1, participants will be randomized 1:1:1 to one of the two BMS-986365 dose levels, or to the active comparator arm (investigator's choice). In Part 2 of the study, participants will be randomized 1:1 between BMS-986365 selected dose, or to the active comparator arm (investigator's choice).

Study Type

Interventional

Enrollment (Estimated)

960

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1419AHN
        • Local Institution - 0129
      • Córdoba, Argentina, 5016
        • Local Institution - 0430
    • Buenos Aires
      • CABA, Buenos Aires, Argentina, CP1280AEB
        • Local Institution - 0125
      • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1426ANZ
        • Local Institution - 0124
    • Buenos Aires F.D.
      • ABB, Buenos Aires F.D., Argentina, C1199ABB
        • Local Institution - 0128
    • Córdoba Province
      • Córdoba, Córdoba Province, Argentina, X5004BAL
        • Local Institution - 0235
      • Río Cuarto, Córdoba Province, Argentina, X5800AEV
        • Local Institution - 0130
    • R
      • Viedma, R, Argentina, R8500ACE
        • Local Institution - 0136
  • Australia
    • New South Wales
      • Campbelltown, New South Wales, Australia, 2560
        • Local Institution - 0366
      • Darlinghurst, New South Wales, Australia, 2010
        • Local Institution - 0359
      • Macquarie University, New South Wales, Australia, 2109
        • Local Institution - 0356
      • Port Macquarie, New South Wales, Australia, 2444
        • Local Institution - 0360
      • Wahroonga, New South Wales, Australia, 2076
        • Local Institution - 0355
    • Queensland
      • Greenslopes, Queensland, Australia, 4120
        • Local Institution - 0347
      • Southport, Queensland, Australia, 4215
        • Local Institution - 0351
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Local Institution - 0362
      • Elizabeth Vale, South Australia, Australia, 5112
        • Local Institution - 0358
      • Kurralta Park, South Australia, Australia, 5037
        • Local Institution - 0352
    • Tasmania
      • Hobart, Tasmania, Australia, 7000
        • Local Institution - 0354
    • Victoria
      • Heidelberg, Victoria, Australia, 3084
        • Local Institution - 0363
      • Malvern, Victoria, Australia, 3144
        • Local Institution - 0353
      • Melbourne, Victoria, Australia, 3000
        • Local Institution - 0348
      • Melbourne, Victoria, Australia, 3004
        • Local Institution - 0361
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Local Institution - 0357
  • Austria
      • Salzburg, Austria, 5020
        • Local Institution - 0367
      • Vienna, Austria, 1090
        • Local Institution - 0368
    • Lower Austria
      • Krems, Lower Austria, Austria, 3500
        • Local Institution - 0369
    • Upper Austria
      • Linz, Upper Austria, Austria, 4020
        • Local Institution - 0373
  • Brazil
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30110-022
        • Local Institution - 0025
    • Rio Grande do Norte
      • Natal, Rio Grande do Norte, Brazil, 59075-740
        • Local Institution - 0035
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035-001
        • Local Institution - 0026
    • São Paulo
      • São Paulo, São Paulo, Brazil, 01308-060
        • Local Institution - 0395
      • São Paulo, São Paulo, Brazil, 01509-010
        • Local Institution - 0031
  • Canada
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 5L3
        • Local Institution - 0304
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • Local Institution - 0152
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • Local Institution - 0151
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Local Institution - 0193
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 5H6
        • Local Institution - 0093
      • Montreal, Quebec, Canada, H3T 1E2
        • Local Institution - 0149
      • Montreal, Quebec, Canada, H4A 3J1
        • Local Institution - 0305
      • Québec, Quebec, Canada, G1J 1Z4
        • Local Institution - 0150
      • Rimouski, Quebec, Canada, G5L 5T1
        • Local Institution - 0164
  • Chile
    • Los Ríos Region
      • Valdivia, Los Ríos Region, Chile, 5112129
        • Local Institution - 0236
    • Santiago Metropolitan
      • Santiago, Santiago Metropolitan, Chile, 7500921
        • Local Institution - 0135
      • Santiago, Santiago Metropolitan, Chile, 8420383
        • Local Institution - 0132
    • Valparaiso
      • Viña del Mar, Valparaiso, Chile, 2520598
        • Local Institution - 0127
  • China
    • Anhui
      • Hefei, Anhui, China, 230000
        • Local Institution - 0232
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100034
        • Local Institution - 0192
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Local Institution - 0249
      • Xiamen, Fujian, China, 361003
        • Local Institution - 0213
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Local Institution - 0226
      • Guangzhou, Guangdong, China, 510180
        • Local Institution - 0180
      • Huizhou, Guangdong, China, 516001
        • Local Institution - 0415
    • Jiangsu
      • Changzhou, Jiangsu, China, 213003
        • Local Institution - 0417
      • Nanjing, Jiangsu, China, 210000
        • Local Institution - 0233
      • Nanjing, Jiangsu, China, 210009
        • Local Institution - 0229
    • Jiangxi
      • Nanchang, Jiangxi, China, 330209
        • Local Institution - 0219
    • Shandong
      • Jinan, Shandong, China, 250117
        • Local Institution - 0191
      • Yantai, Shandong, China, 264099
        • Local Institution - 0221
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200032
        • Local Institution - 0214
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Local Institution - 0240
      • Chengdu, Sichuan, China, 610072
        • Local Institution - 0283
      • Chengdu, Sichuan, China, 610041
        • Local Institution - 0278
    • Xinjiang
      • Ürümqi, Xinjiang, China, 830000
        • Local Institution - 0218
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310014
        • Local Institution - 0196
      • Linhai, Zhejiang, China, 317000
        • Local Institution - 0281
  • Czechia
      • Prague, Czechia, 128 08
        • Local Institution - 0006
    • Brno-město
      • Brno, Brno-město, Czechia, 656 53
        • Local Institution - 0008
    • Hradec Králové
      • Hradec Králové, Hradec Králové, Czechia, 500 05
        • Local Institution - 0005
    • Olomouc Region
      • Olomouc, Olomouc Region, Czechia, 779 00
        • Local Institution - 0010
    • Praha 2
      • Prague, Praha 2, Czechia, 120 00
        • Local Institution - 0009
    • Praha 5
      • Prague, Praha 5, Czechia, 150 06
        • Local Institution - 0004
  • Denmark
    • Capital Region
      • Copenhagen, Capital Region, Denmark, 2730
        • Local Institution - 0243
      • Copenhagen, Capital Region, Denmark, DK-2100
        • Local Institution - 0098
    • Central Jutland
      • Aarhus, Central Jutland, Denmark, 8200
        • Local Institution - 0396
    • North Denmark
      • Aalborg, North Denmark, Denmark, 9000
        • Local Institution - 0100
  • France
      • Clermont-Ferrand, France, 63011
        • Local Institution - 0165
      • Strasbourg, France, 67098
        • Local Institution - 0169
    • Alpes-Maritimes
      • Nice, Alpes-Maritimes, France, 06189
        • Local Institution - 0167
    • Côte-d'Or
      • Dijon, Côte-d'Or, France, 21079
        • Local Institution - 0432
    • Haute-Garonne
      • Toulouse, Haute-Garonne, France, 31059
        • Local Institution - 0307
    • Lorraine
      • Vandœuvre-lès-Nancy, Lorraine, France, 54519
        • Local Institution - 0177
    • Rhône
      • Pierre-Bénite, Rhône, France, 69310
        • Local Institution - 0166
    • Sarthe
      • Le Mans, Sarthe, France, 72000
        • Local Institution - 0231
    • Val-de-Marne
      • Villejuif, Val-de-Marne, France, 94800
        • Local Institution - 0179
  • Germany
      • Bonn, Germany, 53127
        • Local Institution - 0382
      • Essen, Germany, 45122
        • Local Institution - 0375
      • Hamburg, Germany, 20246
        • Local Institution - 0378
      • Heidelberg, Germany, D-69120
        • Local Institution - 0379
      • Herne, Germany, 44625
        • Local Institution - 0377
      • Tübingen, Germany, 72076
        • Local Institution - 0376
      • Würzburg, Germany, 97080
        • Local Institution - 0372
    • Baden-Wurttemberg
      • Nürtingen, Baden-Wurttemberg, Germany, 72622
        • Local Institution - 0421
    • Bavaria
      • München, Bavaria, Germany, 81675
        • Local Institution - 0374
    • Schleswig-Holstein
      • Lübeck, Schleswig-Holstein, Germany, 23538
        • Local Institution - 0371
    • Thuringia
      • Jena, Thuringia, Germany, 07747
        • Local Institution - 0380
  • Ireland
      • Cork, Ireland, T12 DC4A
        • Local Institution - 0271
      • Dublin, Ireland, D24 NR0A
        • Local Institution - 0272
      • Dublin, Ireland, D9
        • Local Institution - 0273
  • Italy
      • Arezzo, Italy, 52100
        • Local Institution - 0156
      • Foggia, Italy, 71100
        • Local Institution - 0409
      • Naples, Italy, 80131
        • Local Institution - 0160
      • Terni, Italy, 05100
        • Local Institution - 0159
      • Trento, Italy, 38122
        • Local Institution - 0158
    • Lombardy
      • Milan, Lombardy, Italy, 20133
        • Local Institution - 0157
    • Piedmont
      • Orbassano, Piedmont, Italy, 10043
        • Local Institution - 0234
    • Roma
      • Rome, Roma, Italy, 00144
        • Local Institution - 0155
    • Veneto
      • Padova, Veneto, Italy, 35128
        • Local Institution - 0153
  • Poland
      • Bydgoszcz, Poland, 85796
        • Local Institution - 0189
      • Katowice, Poland, 40-519
        • Local Institution - 0336
    • Greater Poland Voivodeship
      • Poznan, Greater Poland Voivodeship, Poland, 60-192
        • Local Institution - 0365
    • Lower Silesian Voivodeship
      • Wroclaw, Lower Silesian Voivodeship, Poland, 53-329
        • Local Institution - 0346
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 02-507
        • Local Institution - 0187
    • Opole Voivodeship
      • Opole, Opole Voivodeship, Poland, 45-061
        • Local Institution - 0190
    • Pomeranian Voivodeship
      • Gdansk, Pomeranian Voivodeship, Poland, 80-219
        • Local Institution - 0186
    • Silesian Voivodeship
      • Bytom, Silesian Voivodeship, Poland, 41-902
        • Local Institution - 0185
  • Puerto Rico
      • Yauco, Puerto Rico, 00698
        • Local Institution - 0117
  • Romania
      • Cluj-Napoca, Romania, 400015
        • Local Institution - 0144
      • Cluj-Napoca, Romania, 400015
        • Local Institution - 0145
      • Iași, Romania, 700483
        • Local Institution - 0141
      • Ploieşti, Romania, 100337
        • Local Institution - 0142
    • Dolj
      • Craiova, Dolj, Romania, 200542
        • Local Institution - 0139
  • Slovakia
    • Presov
      • Prešov, Presov, Slovakia, 080 01
        • Local Institution - 0381
  • South Korea
    • Kyǒnggi-do
      • Goyang-si, Kyǒnggi-do, South Korea, 10408
        • Local Institution - 0389
      • Seongnam, Kyǒnggi-do, South Korea, 13620
        • Local Institution - 0386
    • Seoul-teukbyeolsi [Seoul]
      • Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 03080
        • Local Institution - 0385
      • Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 03722
        • Local Institution - 0387
      • Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 05505
        • Local Institution - 0388
      • Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 06351
        • Local Institution - 0384
  • Spain
      • Badajoz, Spain, 06006
        • Local Institution - 0320
      • Burgos, Spain, 09006
        • Local Institution - 0328
      • Granada, Spain, 18008
        • Local Institution - 0318
      • Madrid, Spain, 28040
        • Local Institution - 0309
      • Málaga, Spain, 29016
        • Local Institution - 0327
      • Seville, Spain, 41009
        • Local Institution - 0322
      • Seville, Spain, 41013
        • Local Institution - 0313
      • Valencia, Spain, 46026
        • Local Institution - 0324
    • Andalusia
      • Córdoba, Andalusia, Spain, 14004
        • Local Institution - 0312
    • Barcelona [Barcelona]
      • Barcelona, Barcelona [Barcelona], Spain, 08035
        • Local Institution - 0310
      • Sabadell, Barcelona [Barcelona], Spain, 08208
        • Local Institution - 0311
    • Bizkaia
      • Barakaldo, Bizkaia, Spain, 48903
        • Local Institution - 0325
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Local Institution - 0314
    • Catalunya [Cataluña]
      • Barcelona, Catalunya [Cataluña], Spain, 08041
        • Local Institution - 0315
    • Lugo [Lugo]
      • Lugo, Lugo [Lugo], Spain, 27003
        • Local Institution - 0319
    • Madrid, Comunidad de
      • Madrid, Madrid, Comunidad de, Spain, 28009
        • Local Institution - 0321
      • Madrid, Madrid, Comunidad de, Spain, 28034
        • Local Institution - 0316
      • Madrid, Madrid, Comunidad de, Spain, 28041
        • Local Institution - 0317
      • Madrid, Madrid, Comunidad de, Spain, 28046
        • Local Institution - 0323
      • Majadahonda, Madrid, Comunidad de, Spain, 28222
        • Local Institution - 0326
    • Navarre
      • Pamplona, Navarre, Spain, 31009
        • Local Institution - 0406
    • Ourense [Orense]
      • Ourense, Ourense [Orense], Spain, 32005
        • Local Institution - 0407
  • Sweden
    • Skåne Län [se-12]
      • Lund, Skåne Län [se-12], Sweden, 22185
        • Local Institution - 0099
    • Stockholms Län [se-01]
      • Solna, Stockholms Län [se-01], Sweden, 171 64
        • Local Institution - 0408
    • Uppsala Län [se-03]
      • Uppsala, Uppsala Län [se-03], Sweden, 751 85
        • Local Institution - 0097
    • Västra Götalands Län [se-14]
      • Gothenburg, Västra Götalands Län [se-14], Sweden, 413 45
        • Local Institution - 0095
  • Taiwan
      • Taichung, Taiwan, 404332
        • Local Institution - 0398
      • Taipei, Taiwan, 10002
        • Local Institution - 0399
      • Taipei, Taiwan, 11217
        • Local Institution - 0397
      • Taoyuan, Taiwan, 333
        • Local Institution - 0420
  • United Kingdom
      • Manchester, United Kingdom, M20 4BX
        • Local Institution - 0248
    • Glasgow City
      • Glasgow, Glasgow City, United Kingdom, G12 0YN
        • Local Institution - 0393
    • Hillingdon
      • Northwood, Hillingdon, United Kingdom, HA6 2RN
        • Local Institution - 0383
    • London, City of
      • London, London, City of, United Kingdom, EC1A 7BE
        • Local Institution - 0266
    • Sutton
      • London, Sutton, United Kingdom, SM2 5PT
        • Local Institution - 0391
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Local Institution - 0330
    • Arizona
      • Gilbert, Arizona, United States, 85234
        • Local Institution - 0329
    • California
      • Anaheim, California, United States, 92801
        • Local Institution - 0370
      • La Jolla, California, United States, 92093
        • Local Institution - 0015
      • Los Alamitos, California, United States, 90720
        • Local Institution - 0224
      • San Francisco, California, United States, 94115
        • Local Institution - 0016
      • San Francisco, California, United States, 94121
        • Local Institution - 0411
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Local Institution - 0238
      • Denver, Colorado, United States, 80218
        • Local Institution - 0294
      • Lakewood, Colorado, United States, 80228
        • Local Institution - 0419
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20016
        • Local Institution - 0413
    • Florida
      • Lakeland, Florida, United States, 33805
        • Local Institution - 0426
    • Georgia
      • Athens, Georgia, United States, 30607
        • Local Institution - 0077
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Local Institution - 0048
    • Kansas
      • Westwood, Kansas, United States, 66205
        • Local Institution - 0331
      • Wichita, Kansas, United States, 67226
        • Local Institution - 0060
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Local Institution - 0019
      • Baltimore, Maryland, United States, 21204
        • Local Institution - 0054
      • Frederick, Maryland, United States, 21702
        • Local Institution - 0344
    • New Jersey
      • Sewell, New Jersey, United States, 08080
        • Local Institution - 0429
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • Local Institution - 0081
      • Albuquerque, New Mexico, United States, 87109
        • Local Institution - 0334
    • New York
      • Buffalo, New York, United States, 14263
        • Local Institution - 0197
      • Mineola, New York, United States, 11501
        • Local Institution - 0412
      • New York, New York, United States, 10016
        • Local Institution - 0069
      • New York, New York, United States, 10029
        • Local Institution - 0076
      • New York, New York, United States, 10032
        • Local Institution - 0085
      • New York, New York, United States, 10065
        • Local Institution - 0071
      • Syracuse, New York, United States, 13210
        • Local Institution - 0225
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Local Institution - 0056
    • Oregon
      • Portland, Oregon, United States, 97213
        • Local Institution - 0067
      • Portland, Oregon, United States, 97225
        • Local Institution - 0416
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Local Institution - 0345
      • Philadelphia, Pennsylvania, United States, 19111
        • Local Institution - 0057
      • Philadelphia, Pennsylvania, United States, 19107
        • Local Institution - 0414
      • Willow Grove, Pennsylvania, United States, 19090
        • Local Institution - 0349
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Local Institution - 0055
      • Myrtle Beach, South Carolina, United States, 29572
        • Local Institution - 0079
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Local Institution - 0335
    • Texas
      • Austin, Texas, United States, 78705
        • Local Institution - 0018
      • Austin, Texas, United States, 78745
        • Local Institution - 0114
      • Houston, Texas, United States, 77030
        • Local Institution - 0042
      • Houston, Texas, United States, 77030
        • Local Institution - 0220
    • Utah
      • Murray, Utah, United States, 84107
        • Local Institution - 0109
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • Local Institution - 0050
    • Washington
      • Seattle, Washington, United States, 98109
        • Local Institution - 0078
      • Vancouver, Washington, United States, 98684
        • Local Institution - 0293
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Local Institution - 0112

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  • Participants must have histologic or cytologic confirmation of adenocarcinoma of the prostate without small cell or neuro-endocrine features.
  • Participants must have current evidence of metastatic disease documented by either bone lesions on radionuclide bone scan and/or soft tissue lesions on computed tomography/magnetic resonance imaging (CT/MRI).
  • Participants must be asymptomatic or mildly symptomatic from prostate cancer with score on Brief Pain Inventory - Short Form (BPI-SF) that must be < 4.
  • Participants must have had previous treatment with an androgen receptor pathway inhibitor (abiraterone, enzalutamide, apalutamide, or darolutamide).

Exclusion Criteria

  • Participants must not have impaired cardiac function or clinically significant cardiac disease.
  • Participants must not have any brain metastasis.
  • Participants must not have any liver metastasis.
  • Participants with superscan on technetium-99m (Tc-99m) radionuclide bone scans.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part 1: Dose 1
Drug: BMS-986365
Specified dose on specified days
Experimental: Part 1: Dose 2
Drug: BMS-986365
Specified dose on specified days
Active Comparator: Part 1: Comparator 1
Enzalutamide or Abiraterone Acetate + Prednisone/Prednisolone
Drug: Enzalutamide
Specified dose on specified days
Drug: Abiraterone
Specified dose on specified days
Drug: Predinsone/Prednisolone
Specified dose on specified days
Active Comparator: Part 1: Comparator 2
Drug: Docetaxel
Specified dose on specified days
Drug: Predinsone/Prednisolone
Specified dose on specified days
Experimental: Part 2: Dose Selected
Drug: BMS-986365
Specified dose on specified days
Active Comparator: Part 2: Comparator 1
Enzalutamide or Abiraterone Acetate + Prednisone/Prednisolone
Drug: Enzalutamide
Specified dose on specified days
Drug: Abiraterone
Specified dose on specified days
Drug: Predinsone/Prednisolone
Specified dose on specified days
Active Comparator: Part 2: Comparator 2
Drug: Docetaxel
Specified dose on specified days
Drug: Predinsone/Prednisolone
Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Radiographic progression-free survival (rPFS) by blinded independent central review (BICR) using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (soft tissue) and Prostate Cancer Clinical Trials Working Group 3 (PCWG3) (bone) criteria
Time Frame: Up to 4 years
Up to 4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS)
Time Frame: Up to 4 years
Up to 4 years
Overall Survival (OS)
Time Frame: Up to 4 years
Up to 4 years
Incidence of adverse events (AEs)
Time Frame: Up to 4 years
Up to 4 years
Incidence of serious adverse events (SAEs)
Time Frame: Up to 4 years
Up to 4 years
Incidence of AEs leading to discontinuation
Time Frame: Up to 4 years
Up to 4 years
Recommended dose of BMS-986365 for Part 2
Time Frame: Up to approximately 1.5 years
Up to approximately 1.5 years
Confirmed overall response rate (ORR) by BICR assessment in participants with measurable disease using RECIST 1.1 (soft tissue) and PCWG3 (bone) criteria
Time Frame: Up to 4 years
Up to 4 years
Time to pain progression (TTPP)
Time Frame: Up to 4 years
Up to 4 years
Time to symptomatic progression (TTSP)
Time Frame: Up to 4 years
Up to 4 years
Time to initiation of the first subsequent systemic therapy (TFST)
Time Frame: Up to 4 years
Up to 4 years
Prostate-specific antigen (PSA) response rate
Time Frame: Up to 4 years
Up to 4 years
Change from baseline in Functional Assessment of Cancer Therapy - Prostate Cancer (FACT-P) total scores
Time Frame: Up to 4 years
Up to 4 years
Change from baseline in Prostate Cancer Subscale (PCS) scores
Time Frame: Up to 4 years
Up to 4 years
Change from baseline in trial outcome index (TOI)
Time Frame: Up to 4 years
Up to 4 years
Change from baseline in Brief Pain Inventory - Short Form (BPI-SF) worst pain (item #3) intensity
Time Frame: Up to 4 years
Up to 4 years
Incidence of AEs leading to dose modifications
Time Frame: Up to 4 years
Up to 4 years
Incidence of AEs leading to interruptions
Time Frame: Up to 4 years
Up to 4 years
Electrocardiogram (ECG) findings
Time Frame: Up to 4 years

ECG Findings defined as :

  • Number of Postbaseline Abnormal Corrected QT (QTc) Values
  • Number of abnormal Beats Per Minute (BPM)
Up to 4 years
Incidence of laboratory abnormalities
Time Frame: Up to 4 years
Up to 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celgene

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 13, 2025

Primary Completion (Estimated)

September 12, 2027

Study Completion (Estimated)

January 19, 2029

Study Registration Dates

First Submitted

December 17, 2024

First Submitted That Met QC Criteria

January 2, 2025

First Posted (Actual)

January 8, 2025

Study Record Updates

Last Update Posted (Actual)

September 8, 2026

Last Update Submitted That Met QC Criteria

September 4, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA071-1000
  • 2024-517422-25 (Other Identifier: EU CTR)
  • U1111-1311-0532 (Other Identifier: WHO)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

IPD Sharing Time Frame

See Plan Description

IPD Sharing Access Criteria

See Plan Description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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