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
- Conditions
- Metastatic Castration-resistant Prostate Cancer
- Interventions
- Registration Number
- NCT06764485
- Lead Sponsor
- Celgene
- Brief Summary
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.
- 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).
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Male
- Target Recruitment
- 960
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 1: Dose 1 BMS-986365 - Part 1: Dose 2 BMS-986365 - Part 1: Comparator 1 Enzalutamide Enzalutamide or Abiraterone Acetate + Prednisone/Prednisolone Part 1: Comparator 1 Abiraterone Enzalutamide or Abiraterone Acetate + Prednisone/Prednisolone Part 1: Comparator 1 Predinsone/Prednisolone Enzalutamide or Abiraterone Acetate + Prednisone/Prednisolone Part 1: Comparator 2 Docetaxel - Part 1: Comparator 2 Predinsone/Prednisolone - Part 2: Dose Selected BMS-986365 - Part 2: Comparator 1 Enzalutamide Enzalutamide or Abiraterone Acetate + Prednisone/Prednisolone Part 2: Comparator 1 Abiraterone Enzalutamide or Abiraterone Acetate + Prednisone/Prednisolone Part 2: Comparator 1 Predinsone/Prednisolone Enzalutamide or Abiraterone Acetate + Prednisone/Prednisolone Part 2: Comparator 2 Docetaxel - Part 2: Comparator 2 Predinsone/Prednisolone -
- Primary Outcome Measures
Name Time Method 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 Up to 4 years
- Secondary Outcome Measures
Name Time Method Incidence of laboratory abnormalities Up to 4 years Incidence of AEs leading to discontinuation Up to 4 years Electrocardiogram (ECG) findings Up to 4 years ECG Findings defined as :
* Number of Postbaseline Abnormal Corrected QT (QTc) Values
* Number of abnormal Beats Per Minute (BPM)Overall Survival (OS) Up to 4 years Recommended dose of BMS-986365 for Part 2 Up to approximately 1.5 years Progression-free survival (PFS) Up to 4 years Confirmed overall response rate (ORR) by BICR assessment in participants with measurable disease using RECIST 1.1 (soft tissue) and PCWG3 (bone) criteria Up to 4 years Time to pain progression (TTPP) Up to 4 years Time to symptomatic progression (TTSP) Up to 4 years Time to initiation of the first subsequent systemic therapy (TFST) Up to 4 years Prostate-specific antigen (PSA) response rate Up to 4 years Change from baseline in Functional Assessment of Cancer Therapy - Prostate Cancer (FACT-P) total scores Up to 4 years Change from baseline in Prostate Cancer Subscale (PCS) scores Up to 4 years Change from baseline in trial outcome index (TOI) Up to 4 years Change from baseline in Brief Pain Inventory - Short Form (BPI-SF) worst pain (item #3) intensity Up to 4 years Incidence of adverse events (AEs) Up to 4 years Incidence of serious adverse events (SAEs) Up to 4 years Incidence of AEs leading to dose modifications Up to 4 years Incidence of AEs leading to interruptions Up to 4 years
Trial Locations
- Locations (230)
Local Institution - 0330
🇺🇸Birmingham, Alabama, United States
Local Institution - 0329
🇺🇸Gilbert, Arizona, United States
Local Institution - 0015
🇺🇸La Jolla, California, United States
Local Institution - 0224
🇺🇸Los Alamitos, California, United States
Local Institution - 0370
🇺🇸Los Angeles, California, United States
Local Institution - 0364
🇺🇸Los Angeles, California, United States
Local Institution - 0016
🇺🇸San Francisco, California, United States
Local Institution - 0411
🇺🇸San Francisco, California, United States
Local Institution - 0294
🇺🇸Denver, Colorado, United States
Local Institution - 0077
🇺🇸Athens, Georgia, United States
Local Institution - 0048
🇺🇸Chicago, Illinois, United States
Local Institution - 0331
🇺🇸Westwood, Kansas, United States
Local Institution - 0060
🇺🇸Wichita, Kansas, United States
Local Institution - 0019
🇺🇸Baltimore, Maryland, United States
Local Institution - 0344
🇺🇸Frederick, Maryland, United States
Local Institution - 0054
🇺🇸Towson, Maryland, United States
Local Institution - 0104
🇺🇸Minneapolis, Minnesota, United States
Local Institution - 0049
🇺🇸Las Vegas, Nevada, United States
Local Institution - 0081
🇺🇸Albuquerque, New Mexico, United States
Local Institution - 0334
🇺🇸Albuquerque, New Mexico, United States
Local Institution - 0197
🇺🇸Buffalo, New York, United States
Local Institution - 0069
🇺🇸New York, New York, United States
Local Institution - 0076
🇺🇸New York, New York, United States
Local Institution - 0085
🇺🇸New York, New York, United States
Local Institution - 0071
🇺🇸New York, New York, United States
Local Institution - 0225
🇺🇸Syracuse, New York, United States
Local Institution - 0056
🇺🇸Columbus, Ohio, United States
Local Institution - 0067
🇺🇸Portland, Oregon, United States
Local Institution - 0345
🇺🇸Philadelphia, Pennsylvania, United States
Local Institution - 0349
🇺🇸Philadelphia, Pennsylvania, United States
Local Institution - 0057
🇺🇸Philadelphia, Pennsylvania, United States
Local Institution - 0055
🇺🇸Charleston, South Carolina, United States
Local Institution - 0079
🇺🇸Myrtle Beach, South Carolina, United States
Local Institution - 0335
🇺🇸Nashville, Tennessee, United States
Local Institution - 0114
🇺🇸Austin, Texas, United States
Local Institution - 0018
🇺🇸Austin, Texas, United States
Local Institution - 0042
🇺🇸Houston, Texas, United States
Local Institution - 0220
🇺🇸Houston, Texas, United States
Local Institution - 0109
🇺🇸Murray, Utah, United States
Local Institution - 0050
🇺🇸Charlottesville, Virginia, United States
Local Institution - 0023
🇺🇸Richmond, Virginia, United States
Local Institution - 0078
🇺🇸Seattle, Washington, United States
Local Institution - 0293
🇺🇸Vancouver, Washington, United States
Local Institution - 0112
🇺🇸Milwaukee, Wisconsin, United States
Local Institution - 0125
🇦🇷Caba, Buenos Aires, Argentina
Local Institution - 0124
🇦🇷Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Local Institution - 0128
🇦🇷ABB, Ciudad Autónoma De Buenos Aires, Argentina
Local Institution - 0130
🇦🇷Río Cuarto, Córdoba, Argentina
Local Institution - 0136
🇦🇷Viedma, R, Argentina
Local Institution - 0129
🇦🇷Buenos Aires, Argentina
Local Institution - 0235
🇦🇷Cordoba, Argentina
Local Institution - 0366
🇦🇺Campbelltown, New South Wales, Australia
Local Institution - 0359
🇦🇺Darlinghurst, New South Wales, Australia
Local Institution - 0356
🇦🇺Macquarie University, New South Wales, Australia
Local Institution - 0360
🇦🇺Port Macquarie, New South Wales, Australia
Local Institution - 0355
🇦🇺Wahroonga, New South Wales, Australia
Local Institution - 0347
🇦🇺Brisbane, Queensland, Australia
Local Institution - 0351
🇦🇺Southport, Queensland, Australia
Local Institution - 0362
🇦🇺Adelaide, South Australia, Australia
Local Institution - 0358
🇦🇺Elizabeth Vale, South Australia, Australia
Local Institution - 0352
🇦🇺Kurralta Park, South Australia, Australia
Local Institution - 0354
🇦🇺Hobart, Tasmania, Australia
Local Institution - 0363
🇦🇺Heidelberg, Victoria, Australia
Local Institution - 0353
🇦🇺Malvern, Victoria, Australia
Local Institution - 0348
🇦🇺Melbourne, Victoria, Australia
Local Institution - 0361
🇦🇺Melbourne, Victoria, Australia
Local Institution - 0357
🇦🇺Murdoch, Western Australia, Australia
Local Institution - 0369
🇦🇹Krems, Niederösterreich, Austria
Local Institution - 0373
🇦🇹Linz, Oberösterreich, Austria
Local Institution - 0367
🇦🇹Salzburg, Austria
Local Institution - 0368
🇦🇹Wien, Austria
Local Institution - 0039
🇧🇷Vitória, Espírito Santo, Brazil
Local Institution - 0025
🇧🇷Belo Horizonte, Minas Gerais, Brazil
Local Institution - 0035
🇧🇷Natal, Rio Grande Do Norte, Brazil
Local Institution - 0026
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
Local Institution - 0395
🇧🇷Sao Paulo, São Paulo, Brazil
Local Institution - 0031
🇧🇷Sao Paulo, São Paulo, Brazil
Local Institution - 0304
🇨🇦Kelowna, British Columbia, Canada
Local Institution - 0152
🇨🇦Vancouver, British Columbia, Canada
Local Institution - 0151
🇨🇦Halifax, Nova Scotia, Canada
Local Institution - 0193
🇨🇦Toronto, Ontario, Canada
Local Institution - 0093
🇨🇦Chicoutimi, Quebec, Canada
Local Institution - 0305
🇨🇦Montréal, Quebec, Canada
Local Institution - 0150
🇨🇦Québec, Quebec, Canada
Local Institution - 0164
🇨🇦Rimouski, Quebec, Canada
Local Institution - 0135
🇨🇱Santiago, Región Metropolitana De Santiago, Chile
Local Institution - 0132
🇨🇱Santiago, Región Metropolitana De Santiago, Chile
Local Institution - 0127
🇨🇱Viña del Mar, Valparaíso, Chile
Local Institution - 0232
🇨🇳Hefei, Anhui, China
Local Institution - 0168
🇨🇳Beijing, Beijing, China
Local Institution - 0192
🇨🇳Beijing, Beijing, China
Local Institution - 0176
🇨🇳Beijing, Beijing, China
Local Institution - 0237
🇨🇳Chongqing, Chongqing, China
Local Institution - 0249
🇨🇳Fuzhou, Fujian, China
Local Institution - 0213
🇨🇳Xiamen, Fujian, China
Local Institution - 0226
🇨🇳Guangzhou, Guangdong, China
Local Institution - 0180
🇨🇳Guangzhou, Guangdong, China
Local Institution - 0222
🇨🇳Harbin, Heilongjiang, China
Local Institution - 0211
🇨🇳Zhengzhou, Henan, China
Local Institution - 0279
🇨🇳Zhengzhou, Henan, China
Local Institution - 0284
🇨🇳Wuhan, Hubei, China
Local Institution - 0216
🇨🇳Changsha, Hunan, China
Local Institution - 0217
🇨🇳Changsha, Hunan, China
Local Institution - 0233
🇨🇳Nanjing, Jiangsu, China
Local Institution - 0228
🇨🇳Nanjing, Jiangsu, China
Local Institution - 0229
🇨🇳Nanjing, Jiangsu, China
Local Institution - 0219
🇨🇳Nanchang, Jiangxi, China
Local Institution - 0198
🇨🇳Xi'an, Shaanxi, China
Local Institution - 0191
🇨🇳Jinan, Shandong, China
Local Institution - 0221
🇨🇳Yantai, Shandong, China
Local Institution - 0300
🇨🇳Shanghai, Shanghai, China
Local Institution - 0212
🇨🇳Shanghai, Shanghai, China
Local Institution - 0214
🇨🇳Shanghai, Shanghai, China
Local Institution - 0215
🇨🇳Shanghai, Shanghai, China
Local Institution - 0308
🇨🇳Shanghai, Shanghai, China
Local Institution - 0205
🇨🇳Taiyuan, Shanxi, China
Local Institution - 0278
🇨🇳Cheng Du, Sichuan, China
Local Institution - 0240
🇨🇳Chengdu, Sichuan, China
Local Institution - 0283
🇨🇳Chengdu, Sichuan, China
Local Institution - 0218
🇨🇳Urumqi, Xinjiang, China
Local Institution - 0181
🇨🇳Hangzhou, Zhejiang, China
Local Institution - 0196
🇨🇳Hangzhou, Zhejiang, China
Local Institution - 0280
🇨🇳Hangzhou, Zhejiang, China
Local Institution - 0281
🇨🇳Linhai, Zhejiang, China
Local Institution - 0223
🇨🇳Wenzhou, Zhejiang, China
Local Institution - 0011
🇨🇿Horovice, Beroun, Czechia
Local Institution - 0008
🇨🇿Brno, Brno-město, Czechia
Local Institution - 0005
🇨🇿Hradec Kralove, Hradec Králové, Czechia
Local Institution - 0010
🇨🇿Olomouc, Olomoucký Kraj, Czechia
Local Institution - 0009
🇨🇿Prague, Praha 2, Czechia
Local Institution - 0004
🇨🇿Praha, Praha 5, Czechia
Local Institution - 0006
🇨🇿Praha 2, Czechia
Local Institution - 0243
🇩🇰Copenhagen, Hovedstaden, Denmark
Local Institution - 0098
🇩🇰Copenhagen, Hovedstaden, Denmark
Local Institution - 0396
🇩🇰Aarhus, Midtjylland, Denmark
Local Institution - 0100
🇩🇰Aalborg, Nordjylland, Denmark
Local Institution - 0167
🇫🇷Nice, Alpes-Maritimes, France
Local Institution - 0169
🇫🇷Strasbourg, Alsace, France
Local Institution - 0177
🇫🇷Vandoeuvre-lès-Nancy, Lorraine, France
Local Institution - 0166
🇫🇷Pierre-Bénite, Rhône, France
Local Institution - 0231
🇫🇷Le Mans, Sarthe, France
Local Institution - 0179
🇫🇷Villejuif, Val-de-Marne, France
Local Institution - 0165
🇫🇷Clermont-Ferrand, France
Local Institution - 0178
🇫🇷Paris, France
Local Institution - 0374
🇩🇪München, Bayern, Germany
Local Institution - 0371
🇩🇪Lübeck, Schleswig-Holstein, Germany
Local Institution - 0380
🇩🇪Jena, Thüringen, Germany
Local Institution - 0382
🇩🇪Bonn, Germany
Local Institution - 0375
🇩🇪Essen, Germany
Local Institution - 0378
🇩🇪Hamburg, Germany
Local Institution - 0379
🇩🇪Heidelberg, Germany
Local Institution - 0377
🇩🇪Herne, Germany
Local Institution - 0376
🇩🇪Tübingen, Germany
Local Institution - 0372
🇩🇪Wuerzburg, Germany
Local Institution - 0271
🇮🇪Cork, Ireland
Local Institution - 0272
🇮🇪Dublin, Ireland
Local Institution - 0273
🇮🇪Dublin, Ireland
Local Institution - 0157
🇮🇹Milan, Lombardia, Italy
Local Institution - 0234
🇮🇹Orbassano, Piemonte, Italy
Local Institution - 0155
🇮🇹Rome, Roma, Italy
Local Institution - 0153
🇮🇹Padova, Veneto, Italy
Local Institution - 0156
🇮🇹Arezzo, Italy
Local Institution - 0409
🇮🇹Foggia, Italy
Local Institution - 0160
🇮🇹Napoli, Italy
Local Institution - 0159
🇮🇹Terni, Italy
Local Institution - 0158
🇮🇹Trento, Italy
Local Institution - 0389
🇰🇷Goyang-si, Kyǒnggi-do, Korea, Republic of
Local Institution - 0386
🇰🇷Seongnam, Kyǒnggi-do, Korea, Republic of
Local Institution - 0385
🇰🇷Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Local Institution - 0387
🇰🇷Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Local Institution - 0388
🇰🇷Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Local Institution - 0384
🇰🇷Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Local Institution - 0346
🇵🇱Wroclaw, Dolnośląskie, Poland
Local Institution - 0187
🇵🇱Warszawa, Mazowieckie, Poland
Local Institution - 0190
🇵🇱Opole, Opolskie, Poland
Local Institution - 0186
🇵🇱Gdansk, Pomorskie, Poland
Local Institution - 0365
🇵🇱Skorzewo, Wielkopolskie, Poland
Local Institution - 0189
🇵🇱Bydgoszcz, Poland
Local Institution - 0336
🇵🇱Katowice, Poland
Local Institution - 0185
🇵🇱Bytom, Śląskie, Poland
Local Institution - 0117
🇵🇷Mayaguez, Puerto Rico
Local Institution - 0139
🇷🇴Craiova, Dolj, Romania
Local Institution - 0142
🇷🇴Ploiești, Prahova, Romania
Local Institution - 0144
🇷🇴Cluj, Romania
Local Institution - 0145
🇷🇴Cluj, Romania
Local Institution - 0141
🇷🇴Iași, Romania
Local Institution - 0275
🇸🇰Banska Bystrica, Banskobystrický Kraj, Slovakia
Local Institution - 0381
🇸🇰Prešov, Prešovský Kraj, Slovakia
Local Institution - 0201
🇸🇰Bratislava, Slovakia
Local Institution - 0200
🇸🇰Martin, Žilinský Kraj, Slovakia
Local Institution - 0312
🇪🇸Cordoba, Andalucía, Spain
Local Institution - 0310
🇪🇸Barcelona, Barcelona [Barcelona], Spain
Local Institution - 0311
🇪🇸Sabadell, Barcelona [Barcelona], Spain
Local Institution - 0325
🇪🇸Barakaldo, Bizkaia, Spain
Local Institution - 0314
🇪🇸Santander, Cantabria, Spain
Local Institution - 0315
🇪🇸Barcelona, Catalunya [Cataluña], Spain
Local Institution - 0319
🇪🇸Lugo, Lugo [Lugo], Spain
Local Institution - 0321
🇪🇸Madrid, Madrid, Comunidad De, Spain
Local Institution - 0316
🇪🇸Madrid, Madrid, Comunidad De, Spain
Local Institution - 0317
🇪🇸Madrid, Madrid, Comunidad De, Spain
Local Institution - 0323
🇪🇸Madrid, Madrid, Comunidad De, Spain
Local Institution - 0326
🇪🇸Majadahonda, Madrid, Comunidad De, Spain
Local Institution - 0406
🇪🇸Pamplona, Navarra, Spain
Local Institution - 0407
🇪🇸Ourense, Ourense [Orense], Spain
Local Institution - 0320
🇪🇸Badajoz, Spain
Local Institution - 0328
🇪🇸Burgos, Spain
Local Institution - 0318
🇪🇸Granada, Spain
Local Institution - 0309
🇪🇸Madrid, Spain
Local Institution - 0327
🇪🇸Málaga, Spain
Local Institution - 0322
🇪🇸Sevilla, Spain
Local Institution - 0313
🇪🇸Sevilla, Spain
Local Institution - 0324
🇪🇸València, Spain
Local Institution - 0099
🇸🇪Lund, Skåne Län [se-12], Sweden
Local Institution - 0408
🇸🇪Solna, Stockholms Län [se-01], Sweden
Local Institution - 0097
🇸🇪Uppsala, Uppsala Län [se-03], Sweden
Local Institution - 0095
🇸🇪Gothenburg, Västra Götalands Län [se-14], Sweden
Local Institution - 0398
🇨🇳Taichung, Taiwan
Local Institution - 0399
🇨🇳Taipei, Taiwan
Local Institution - 0397
🇨🇳Taipei, Taiwan
Local Institution - 0340
🇹🇷Adana, Turkey
Local Institution - 0339
🇹🇷Ankara, Turkey
Local Institution - 0341
🇹🇷Ankara, Turkey
Local Institution - 0338
🇹🇷Ankara, Turkey
Local Institution - 0337
🇹🇷Istanbul, Turkey
Local Institution - 0342
🇹🇷Istanbul, Turkey
Local Institution - 0393
🇬🇧Glasgow, Glasgow City, United Kingdom
Local Institution - 0383
🇬🇧Northwood, Hillingdon, United Kingdom
Local Institution - 0266
🇬🇧London, London, City Of, United Kingdom
Local Institution - 0391
🇬🇧London, Sutton, United Kingdom
Local Institution - 0248
🇬🇧Manchester, United Kingdom