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

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Investigational drug late phase More information Active drug More information Moderate burden on patient More information

Trial Details

Sponsor: Celgene (industry)

Phase: 3

Start date: March 13, 2025

Planned enrollment: 960

Trial ID: NCT06764485
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More trial details at ClinicalTrials.gov More info

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chevron Show for: BMS-986365 (Gridegalutamide)

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Goal: Evaluate whether BMS-986365 improves radiographic progression-free survival versus investigator’s choice of standard therapy in metastatic castration-resistant prostate cancer and characterize its safety.

Patients: Adults with histologically or cytologically confirmed prostatic adenocarcinoma (no small cell/neuroendocrine features), evidence of metastatic disease on bone scan and/or CT/MRI, asymptomatic or mildly symptomatic disease (BPI-SF worst pain <4), and prior treatment with at least one androgen receptor pathway inhibitor (abiraterone, enzalutamide, apalutamide, or darolutamide). Key exclusions include clinically significant cardiac disease or impaired cardiac function, brain or liver metastases, and superscan on Tc-99m bone scan.

Design: Global, two-part, randomized, open-label, adaptive phase 3 trial. Part 1 randomizes participants 1:1:1 to two BMS-986365 dose levels or investigator’s choice comparator to select the dose. Part 2 randomizes 1:1 to the selected BMS-986365 dose versus investigator’s choice. Approximately 960 participants; primary endpoint assessed by blinded independent central review.

Treatments: Experimental: BMS-986365 (gridegalutamide/CC-94676), an oral androgen receptor ligand-directed degrader that recruits cereblon E3 ligase to induce proteasomal degradation of AR and also acts as a competitive AR antagonist. In phase 1, heavily pretreated mCRPC showed PSA50 responses around 32% overall with higher activity at the top dose and median rPFS of approximately 6–8 months in higher-dose cohorts, with manageable safety; common adverse events included asymptomatic QTc prolongation and bradycardia. The agent targets AR signaling, including certain AR mutations, aiming to overcome resistance to prior ARPIs. Comparator: investigator’s choice of docetaxel plus prednisone/prednisolone or a switch ARPI (abiraterone plus prednisone/prednisolone or enzalutamide), both standard options after prior ARPI.

Outcomes: Primary: radiographic progression-free survival by BICR per RECIST 1.1 (soft tissue) and PCWG3 (bone). Key secondary endpoints include overall survival, determination of recommended dose for Part 2, PFS, confirmed ORR by BICR, PSA response rate, time to pain progression, time to symptomatic progression, time to first subsequent systemic therapy, patient-reported outcomes (FACT-P total, PCS, TOI, BPI-SF worst pain), and safety (AEs, SAEs, dose modifications/interruptions/discontinuations, ECG parameters including QTc and heart rate, and laboratory abnormalities).

Burden on patient: Moderate. As a phase 3 study, imaging and laboratory monitoring are similar to standard of care for mCRPC, likely with periodic CT/MRI and bone scans and routine labs. The investigational agent is oral, limiting infusion visits compared with docetaxel; however, added safety surveillance is expected, particularly ECG monitoring and repeat assessments for QTc and bradycardia signals noted in phase 1. Patient-reported outcome questionnaires and scheduled visits for central imaging review contribute to visit frequency but are typical for pivotal trials. No protocol-mandated biopsies or intensive pharmacokinetic blood draws are indicated, reducing procedural burden compared with early-phase studies.

Last updated: Oct 2025

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Denver, Colorado, 80218, United States

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Status: Recruiting

Lakeland Regional Cancer Center

Lakeland, Florida, 33805, United States

No email / 412-573-9554

Status: Recruiting

University Cancer & Blood Center, LLC

Athens, Georgia, 30607, United States

No email / 706-353-2990

Status: Recruiting

The University of Kansas Cancer Center - Westwood

Westwood, Kansas, 66205, United States

No email / 913-588-6029

Status: Recruiting

Wichita Urology Group

Wichita, Kansas, 67226, United States

No email / 316-636-6141

Status: Recruiting

Chesapeake Urology

Baltimore, Maryland, 21204, United States

No email / 443-471-5741

Status: Recruiting

James M Stockman Cancer Institute

Frederick, Maryland, 21702, United States

No email / 301-662-8477

Status: Recruiting

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

No email / 617-820-3433

Status: Recruiting

Thomas Jefferson University, Kennedy Health Alliance

Sewell, New Jersey, 08080, United States

No email / 215-481-2400

Status: Recruiting

New Mexico Oncology Hematology Consultants Ltd.

Albuquerque, New Mexico, 87109, United States

No email / 505-842-8171

Status: Recruiting

University of New Mexico Comprehensive Cancer Center

Albuquerque, New Mexico, 87106, United States

No email / 941-941-9281

Status: Recruiting

Associated Medical Professionals - Urology

Syracuse, New York, 13210, United States

No email / 315-478-4185

Status: Recruiting

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

No email / 212-604-6010

Status: Recruiting

Laura and Isaac Perlmutter Cancer Center

New York, New York, 10016, United States

No email / 347-724-5409

Status: Recruiting

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

No email / 646-422-4379

Status: Recruiting

Perlmutter Cancer Center at NYU Langone Hospital - Long Island

Mineola, New York, 11501, United States

No email / 347-724-5409

Status: Recruiting

Providence Portland Medical Center

Portland, Oregon, 97213, United States

No email / 503-215-5696

Status: Recruiting

Providence St. Vincent Medical Center

Portland, Oregon, 97225, United States

No email / 503-215-5696

Status: Recruiting

Asplundh Cancer Pavilion

Willow Grove, Pennsylvania, 19090, United States

No email / 215-481-2400

Status: Recruiting

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

No email / 215-728-3889

Status: Recruiting

Philadelphia Veterans Affairs Medical Center

Philadelphia, Pennsylvania, 19104, United States

No email / (215)823-5800x206895

Status: Recruiting

Thomas Jefferson University - Clinical Research Institute

Philadelphia, Pennsylvania, 19107, United States

No email / 215-481-2400

Status: Recruiting

Carolina Urologic Research Center, LLC

Myrtle Beach, South Carolina, 29572, United States

No email / 843-449-1010

Status: Recruiting

Tennessee Oncology

Nashville, Tennessee, 37203, United States

No email / 877-836-6662

Status: Recruiting

Texas Oncology - Central/South Texas

Austin, Texas, 78705, United States

No email / 512-427-9400

Status: Recruiting

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

No email / 713-792-5543

Status: Recruiting

Urology Austin, PLLC

Austin, Texas, 78681, United States

No email / 336-512-0813

Status: Recruiting

Intermountain Medical Center

Murray, Utah, 84107, United States

No email / 913-568-7449

Status: Recruiting

University of Virginia Cancer Center

Charlottesville, Virginia, 22903, United States

No email / 434-981-5585

Status: Recruiting

Northwest Cancer Specialists, P.C.

Vancouver, Washington, 98684, United States

No email / 503-885-5411

Status: Recruiting

Local Institution - 0430

Córdoba, X5016, Argentina

No email / No phone

Status: Not yet recruiting

Local Institution - 0130

Río Cuarto, Córdoba Province, X5800AEV, Argentina

No email / No phone

Status: Not yet recruiting

Local Institution - 0039

Vitória, Espírito Santo, 29055450, Brazil

No email / No phone

Status: Not yet recruiting

Local Institution - 0026

Porto Alegre, Rio Grande do Sul, 90035-001, Brazil

No email / No phone

Status: Not yet recruiting

Local Institution - 0395

São Paulo, São Paulo, 01308-060, Brazil

No email / No phone

Status: Not yet recruiting

Local Institution - 0151

Halifax, Nova Scotia, B3H 2Y9, Canada

No email / No phone

Status: Not yet recruiting

Local Institution - 0168

Beijing, Beijing Municipality, 100005, China

No email / No phone

Status: Not yet recruiting

Local Institution - 0176

Beijing, Beijing Municipality, 100142, China

No email / No phone

Status: Not yet recruiting

Local Institution - 0192

Beijing, Beijing Municipality, 100034, China

No email / No phone

Status: Not yet recruiting

Local Institution - 0237

Chongqing, Chongqing Municipality, 400030, China

No email / No phone

Status: Not yet recruiting

Local Institution - 0415

Huizhou, Guangdong, 516001, China

No email / No phone

Status: Not yet recruiting

Local Institution - 0222

Harbin, Heilongjiang, 150081, China

No email / No phone

Status: Not yet recruiting

Local Institution - 0211

Zhengzhou, Henan, 450003, China

No email / No phone

Status: Not yet recruiting

Local Institution - 0279

Zhengzhou, Henan, 450008, China

No email / No phone

Status: Not yet recruiting

Local Institution - 0284

Wuhan, Hubei, 430030, China

No email / No phone

Status: Not yet recruiting

Local Institution - 0216

Changsha, Hunan, 410008, China

No email / No phone

Status: Not yet recruiting

Local Institution - 0217

Changsha, Hunan, 410013, China

No email / No phone

Status: Not yet recruiting

Local Institution - 0228

Nanjing, Jiangsu, 210009, China

No email / No phone

Status: Not yet recruiting

Local Institution - 0198

Xi'an, Shaanxi, 710061, China

No email / No phone

Status: Not yet recruiting

Local Institution - 0212

Shanghai, Shanghai Municipality, 200032, China

No email / No phone

Status: Not yet recruiting

Local Institution - 0308

Shanghai, Shanghai Municipality, 200080, China

No email / No phone

Status: Not yet recruiting

Local Institution - 0205

Taiyuan, Shanxi, 030001, China

No email / No phone

Status: Not yet recruiting

Local Institution - 0181

Hangzhou, Zhejiang, 310003, China

No email / No phone

Status: Not yet recruiting

Local Institution - 0223

Wenzhou, Zhejiang, 325000, China

No email / No phone

Status: Not yet recruiting

Local Institution - 0280

Hangzhou, Zhejiang, 310022, China

No email / No phone

Status: Not yet recruiting

Local Institution - 0418

Prague, Praha 4, 14059, Czechia

No email / No phone

Status: Not yet recruiting

Local Institution - 0432

Dijon, Côte-d'Or, 21079, France

No email / No phone

Status: Not yet recruiting

Local Institution - 0431

Saint-Grégoire, Ille-et-Vilaine, 35760, France

No email / No phone

Status: Not yet recruiting

Local Institution - 0179

Villejuif, Val-de-Marne, 94800, France

No email / No phone

Status: Not yet recruiting

Local Institution - 0421

Nürtingen, Baden-Wurttemberg, 72622, Germany

No email / No phone

Status: Not yet recruiting

Local Institution - 0404

Thiruvananthapuram, Kerala, 695011, India

No email / No phone

Status: Not yet recruiting

Local Institution - 0401

Navi Mumbai, Maharashtra, 410210, India

No email / No phone

Status: Not yet recruiting

Local Institution - 0400

New Delhi, National Capital Territory of Delhi, 110085, India

No email / No phone

Status: Not yet recruiting

Local Institution - 0402

New Delhi, National Capital Territory of Delhi, 110029, India

No email / No phone

Status: Not yet recruiting

Local Institution - 0405

Kolkata, West Bengal, 700156, India

No email / No phone

Status: Not yet recruiting

Local Institution - 0424

Catania, 95126, Italy

No email / No phone

Status: Not yet recruiting

Local Institution - 0425

Milan, 20132, Italy

No email / No phone

Status: Not yet recruiting

Local Institution - 0434

Kashiwa, 277-8577, Japan

No email / No phone

Status: Not yet recruiting

Local Institution - 0201

Bratislava, 83101, Slovakia

No email / No phone

Status: Not yet recruiting

Local Institution - 0275

Banská Bystrica, 97517, Slovakia

No email / No phone

Status: Not yet recruiting

Local Institution - 0381

Prešov, Presov, 080 01, Slovakia

No email / No phone

Status: Not yet recruiting

Local Institution - 0200

Martin, Žilina Region, 036 01, Slovakia

No email / No phone

Status: Not yet recruiting

Local Institution - 0327

Málaga, 29016, Spain

No email / No phone

Status: Not yet recruiting

Local Institution - 0314

Santander, Cantabria, 39008, Spain

No email / No phone

Status: Not yet recruiting

Local Institution - 0420

Taoyuan District, 333, Taiwan

No email / No phone

Status: Not yet recruiting

Local Institution - 0337

Istanbul, 34295, Turkey (Türkiye)

No email / No phone

Status: Not yet recruiting

Local Institution - 0338

Ankara, 06620, Turkey (Türkiye)

No email / No phone

Status: Not yet recruiting

Local Institution - 0339

Ankara, 06010, Turkey (Türkiye)

No email / No phone

Status: Not yet recruiting

Local Institution - 0340

Adana, 01370, Turkey (Türkiye)

No email / No phone

Status: Not yet recruiting

Local Institution - 0341

Ankara, 06800, Turkey (Türkiye)

No email / No phone

Status: Not yet recruiting

Local Institution - 0342

Istanbul, 34722, Turkey (Türkiye)

No email / No phone

Status: Not yet recruiting

Local Institution - 0238

Aurora, Colorado, 80045, United States

No email / No phone

Status: Not yet recruiting

Local Institution - 0048

Chicago, Illinois, 60611, United States

No email / No phone

Status: Not yet recruiting

Local Institution - 0104

Minneapolis, Minnesota, 55455, United States

No email / No phone

Status: Not yet recruiting

Local Institution - 0085

New York, New York, 10032, United States

No email / No phone

Status: Not yet recruiting

Local Institution - 0197

Buffalo, New York, 14263, United States

No email / No phone

Status: Not yet recruiting

Local Institution - 0056

Columbus, Ohio, 43210, United States

No email / No phone

Status: Not yet recruiting

Local Institution - 0055

Charleston, South Carolina, 29425, United States

No email / No phone

Status: Not yet recruiting

Local Institution - 0220

Houston, Texas, 77030, United States

No email / No phone

Status: Not yet recruiting

Local Institution - 0078

Seattle, Washington, 98109, United States

No email / No phone

Status: Not yet recruiting

Local Institution - 0112

Milwaukee, Wisconsin, 53226, United States

No email / No phone

Status: Not yet recruiting

Local Institution - 0215

Shanghai, Shanghai Municipality, 200041, China

No email / No phone

Status: Withdrawn

Local Institution - 0300

Shanghai, Shanghai Municipality, 0, China

No email / No phone

Status: Withdrawn

Local Institution - 0011

Hořovice, Beroun, 268 31, Czechia

No email / No phone

Status: Withdrawn

Local Institution - 0178

Paris, 75014, France

No email / No phone

Status: Withdrawn

Local Institution - 0364

Los Angeles, California, 90048, United States

No email / No phone

Status: Withdrawn

Local Institution - 0049

Las Vegas, Nevada, 89148, United States

No email / No phone

Status: Withdrawn

Local Institution - 0433

Allentown, Pennsylvania, 18103, United States

No email / No phone

Status: Withdrawn

Local Institution - 0023

Richmond, Virginia, 23219, United States

No email / No phone

Status: Withdrawn

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