MedPath

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

Phase 3
Not yet recruiting
Conditions
Metastatic Castration-resistant Prostate Cancer
Interventions
Drug: BMS-986365
Drug: Enzalutamide
Drug: Docetaxel
Drug: Abiraterone
Drug: Predinsone/Prednisolone
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
Inclusion Criteria

Not provided

Read More
Exclusion Criteria

Not provided

Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Part 1: Dose 1BMS-986365-
Part 1: Dose 2BMS-986365-
Part 1: Comparator 1EnzalutamideEnzalutamide or Abiraterone Acetate + Prednisone/Prednisolone
Part 1: Comparator 1AbirateroneEnzalutamide or Abiraterone Acetate + Prednisone/Prednisolone
Part 1: Comparator 1Predinsone/PrednisoloneEnzalutamide or Abiraterone Acetate + Prednisone/Prednisolone
Part 1: Comparator 2Docetaxel-
Part 1: Comparator 2Predinsone/Prednisolone-
Part 2: Dose SelectedBMS-986365-
Part 2: Comparator 1EnzalutamideEnzalutamide or Abiraterone Acetate + Prednisone/Prednisolone
Part 2: Comparator 1AbirateroneEnzalutamide or Abiraterone Acetate + Prednisone/Prednisolone
Part 2: Comparator 1Predinsone/PrednisoloneEnzalutamide or Abiraterone Acetate + Prednisone/Prednisolone
Part 2: Comparator 2Docetaxel-
Part 2: Comparator 2Predinsone/Prednisolone-
Primary Outcome Measures
NameTimeMethod
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) criteriaUp to 4 years
Secondary Outcome Measures
NameTimeMethod
Incidence of laboratory abnormalitiesUp to 4 years
Incidence of AEs leading to discontinuationUp to 4 years
Electrocardiogram (ECG) findingsUp 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 2Up 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) criteriaUp 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 rateUp to 4 years
Change from baseline in Functional Assessment of Cancer Therapy - Prostate Cancer (FACT-P) total scoresUp to 4 years
Change from baseline in Prostate Cancer Subscale (PCS) scoresUp 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) intensityUp 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 modificationsUp to 4 years
Incidence of AEs leading to interruptionsUp 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

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