A Study of Nivolumab or Placebo in Combination With Docetaxel in Men With Advanced Castration-resistant Prostate Cancer

NCT04100018 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: CA209-7DX2019-002030-36
• Study Type: interventional
• Target: 1,030
• Locations: 27 countries
• Sites: 283

Brief Summary

The purpose of this study is to assess the safety and effectiveness of nivolumab with docetaxel in men with advanced castration resistant prostate cancer who have progressed after second-generation hormonal manipulation.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (2)

• Radiographic Progressive Free Survival (rPFS) Assessed by Blinded Independent Central Review (BICR) Per Prostate Cancer Working Group 3 (PCWG3)

  rPFS for randomized participants is the time between randomization and the first date of documented progression or death due to any cause, whichever occurs first. The rPFS was censored at the last radiographic tumor assessment up to the start of subsequent cancer therapy for those without progression or death. It was also censored at the date of last radiographic tumor assessment prior to the missed tumor assessments for participants who had progressive disease (PD) or death immediately after more than one consecutive missed tumor assessments. Radiographic progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). The appearance of one or more new lesions is also considered progression.

  from randomization to the first date of documented progression or death due to any cause, whichever occurs first (up to approximately 31 months)

• Overall Survival (OS)

  OS for all randomized participants is the time between randomization and the date of death from any cause. For participants who are alive, their survival time was censored at the last date that they were known to be alive. OS was censored for participants at the date of randomization if they had no follow-up.

  From randomization to the date of death from any cause (Up to approximately 31 months)

Secondary Outcomes (15)

• Objective Response Rate (ORR) Assessed by Blinded Independent Central Review (BICR) Per Prostate Cancer Working Group (PCWG3)

  From date of randomization to the date of objectively documented progression per PCWG3 or the date of subsequent systemic cancer therapy, whichever occurs first (Up to approximately 52 months)

• Time to Response (TTR) Assessed by Blinded Independent Central Review (BICR) Per Prostate Cancer Working Group (PCWG3)

  From randomization to the date of the first documented CR or PR (Up to approximately 52 months)

• Duration of Response Assessed by Blinded Independent Central Review (BICR) Per Prostate Cancer Working Group (PCWG3)

  From randomization date to the date of first documented radiographic progression or death due to any cause whichever occurs first (Up to approximately 52 months)

• Prostate-specific Antigen (PSA) Response Rate (PSA-RR)

  Up to approximately 52 months

• Time to PSA Progression (TTP-PSA)

  from randomization to the date of PSA Progression (Up to approximately 31 months)

Study Arms (2)

Arm A: Nivolumab + docetaxel + prednisone

EXPERIMENTAL

Biological: Nivolumab; Drug: Prednisone; Drug: Docetaxel

Arm B: Placebo + docetaxel + prednisone

PLACEBO COMPARATOR

Drug: Prednisone; Drug: Docetaxel; Other: Placebo

Interventions

Nivolumab BIOLOGICAL

Specified dose on specified days

Also known as: OPDIVO,, BMS-936558-01

Arm A: Nivolumab + docetaxel + prednisone

Prednisone DRUG

Specified dose on specified days

Arm A: Nivolumab + docetaxel + prednisone; Arm B: Placebo + docetaxel + prednisone

Docetaxel DRUG

Specified dose on specified days

Arm A: Nivolumab + docetaxel + prednisone; Arm B: Placebo + docetaxel + prednisone

Placebo OTHER

Specified dose on specified days

Arm B: Placebo + docetaxel + prednisone

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologic confirmation of adenocarcinoma of the prostate without small cell features
• Current evidence of metastatic disease documented by either bone lesions on radionuclide bone scan and/or soft tissue lesions on computerized tomography/magnetic resonance imaging (CT/MRI)
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Ongoing androgen deprivation therapy (ADT) with a gonadotropin-releasing hormone (GnRH) analogue or bilateral orchiectomy
• Documented prostate cancer progression per Prostate Cancer Working Group (PCWG3) criteria within 6 months prior to screening
• Chemotherapy-naïve for metastatic castration-resistant prostate cancer (mCRPC), with 1 to 2 prior second generation hormonal therapies in the recurrent non-metastatic setting and/or metastatic setting, and no more than 1 second generation hormonal therapy in the mCRPC setting. Must have progressed during or after second generation hormonal therapy or have documented intolerance to second generation hormonal therapy
• Participants must meet one of the following criteria regarding tissue submission: Sufficient tumor samples from a newly obtained ("fresh") biopsy (obtained during screening); or archival tumor tissue in the form of formalin-fixed paraffin-embedded (FFPE) block or unstained tumor tissue slides. For participants with bone-only disease or inaccessible soft tissue lesions or if the biopsy procedure would pose an unacceptable clinical risk for the participant, submission of tumor tissue obtained from a fresh biopsy is not required.
• Men must agree to follow specific methods of contraception, if applicable

You may not qualify if:

• Active brain metastases
• Active, known, or suspected autoimmune disease
• Condition requiring systemic treatment with corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of start of study treatment. Inhaled or topical steroids or adrenal replacement steroid doses are permitted in the absence of active autoimmune disease
• Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
• Prior treatment with docetaxel or other chemotherapy for mCRPC. Prior docetaxel for metastatic castration-sensitive prostate cancer is permitted if at least 12 months have elapsed from last dose of docetaxel

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (293)

Local Institution - 0305

Mobile, Alabama, 36608-1753, United States

Location

Local Institution - 0012

Anchorage, Alaska, 99503, United States

Location

Local Institution - 0293

Tucson, Arizona, 85724, United States

Location

Local Institution - 0269

Jonesboro, Arkansas, 72401, United States

Location

Local Institution - 0179

Orange, California, 92868, United States

Location

Local Institution - 0055

Rancho Mirage, California, 92270, United States

Location

Local Institution - 0260

Redondo Beach, California, 90277, United States

Location

Local Institution - 0081

Santa Monica, California, 90404, United States

Location

Local Institution - 0087

Denver, Colorado, 80211-5222, United States

Location

Local Institution - 0190

West Haven, Connecticut, 06516-5907, United States

Location

Local Institution - 0366

Washington D.C., District of Columbia, 20010-3017, United States

Location

Local Institution - 0196

Hollywood, Florida, 33021, United States

Location

Local Institution - 0397

Jacksonville, Florida, 32256, United States

Location

Local Institution - 0164

Lakeland, Florida, 33805, United States

Location

Local Institution - 0181

Orlando, Florida, 32806, United States

Location

Local Institution - 0285

Pensacola, Florida, 32503, United States

Location

Local Institution - 0177

Weston, Florida, 33331, United States

Location

Local Institution - 0117

Atlanta, Georgia, 30342, United States

Location

Local Institution - 0126

Marietta, Georgia, 30060, United States

Location

Local Institution - 0382

Thomasville, Georgia, 31792, United States

Location

Local Institution - 0287

Niles, Illinois, 60714, United States

Location

Local Institution - 0183

Fort Wayne, Indiana, 46804, United States

Location

Local Institution - 0302

Louisville, Kentucky, 40202, United States

Location

Local Institution - 0150

Baltimore, Maryland, 21201, United States

Location

Local Institution - 0332

Brandywine, Maryland, 20613, United States

Location

Local Institution - 0299

Omaha, Nebraska, 68130, United States

Location

Local Institution - 0365

East Brunswick, New Jersey, 08816, United States

Location

Local Institution - 0139

Florham Park, New Jersey, 07932, United States

Location

Local Institution - 0300

Albany, New York, 12208, United States

Location

Local Institution - 0028

Port Jefferson Station, New York, 11776, United States

Location

Local Institution - 0333

Columbus, Ohio, 43210, United States

Location

Local Institution - 0180

Allentown, Pennsylvania, 18103-6218, United States

Location

Local Institution - 0074

Bala-Cynwyd, Pennsylvania, 19004, United States

Location

Local Institution - 0292

Pittsburgh, Pennsylvania, 15232, United States

Location

Local Institution - 0233

Charleston, South Carolina, 29414, United States

Location

Local Institution - 0115

Myrtle Beach, South Carolina, 29572-4607, United States

Location

Local Institution - 0149

Germantown, Tennessee, 38138, United States

Location

Local Institution - 0286

Austin, Texas, 75251, United States

Location

Local Institution - 0303

Dallas, Texas, 75251, United States

Location

Local Institution - 0284

Houston, Texas, 77024-2843, United States

Location

Local Institution - 0195

Houston, Texas, 77030-3721, United States

Location

Local Institution - 0011

San Antonio, Texas, 78229, United States

Location

The University of Texas Health Science Center at Tyler DBA UT Health East Texas Hope Cancer Center

Tyler, Texas, 75701, United States

Location

Local Institution - 0110

Seattle, Washington, 98109, United States

Location

Local Institution - 0289

Spokane, Washington, 99208, United States

Location

Local Institution - 0129

Mar del Plata, Buenos Aires, B7602CBM, Argentina

Location

Local Institution - 0061

Pergamino, Buenos Aires, B2700, Argentina

Location

Local Institution - 0153

Parana, Córdoba Province, 5000, Argentina

Location

Local Institution - 0393

Río Cuarto, Córdoba Province, 5800, Argentina

Location

Local Institution - 0083

Viedma, Río Negro Province, 8500, Argentina

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Local Institution - 0077

Buenos Aires, 1280, Argentina

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Local Institution - 0178

Buenos Aires, 1426, Argentina

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Local Institution - 0185

Buenos Aires, C1012, Argentina

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Local Institution - 0369

La Rioja, F5300COE, Argentina

Location

Local Institution - 0394

San Juan, J5402DIL, Argentina

Location

Local Institution - 0152

Gosford, New South Wales, 2250, Australia

Location

Local Institution - 0091

Lismore, New South Wales, 2480, Australia

Location

Local Institution - 0132

Wahroonga, New South Wales, 2076, Australia

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Local Institution - 0127

Westmead, New South Wales, 2145, Australia

Location

Local Institution - 0006

South Brisbane, Queensland, 4101, Australia

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Local Institution - 0084

Woolloongabba, Queensland, 4102, Australia

Location

Local Institution - 0010

North Adelaide, South Australia, 5006, Australia

Location

Local Institution - 0379

Ballarat, Victoria, 3350, Australia

Location

Local Institution - 0040

Frankston, Victoria, 3199, Australia

Location

Local Institution - 0032

Malvern, Victoria, 3144, Australia

Location

Local Institution - 0118

Linz, Upper Austria, 4020, Austria

Location

Local Institution - 0038

Salzburg, 5020, Austria

Location

Local Institution - 0157

Vienna, 1020, Austria

Location

Local Institution - 0131

Vienna, 1090, Austria

Location

Local Institution - 0122

Anderlecht, Brussels Capital, 1070, Belgium

Location

Local Institution - 0121

Bruges, 8000, Belgium

Location

Local Institution - 0114

Ghent, 9000, Belgium

Location

Local Institution - 0162

Ghent, 9000, Belgium

Location

Local Institution - 0137

Turnhout, 2300, Belgium

Location

Local Institution - 0029

Wilrijk, 2610, Belgium

Location

Local Institution - 0097

Belo Horizonte, Minas Gerais, 30110022, Brazil

Location

Local Institution - 0022

Belo Horizonte, Minas Gerais, 30130090, Brazil

Location

Local Institution - 0100

Curitiba, Paraná, 80530-010, Brazil

Location

Local Institution - 0082

Curitiba, Paraná, 80810050, Brazil

Location

Local Institution - 0321

Natal, Rio Grande do Norte, 59075-740, Brazil

Location

Local Institution - 0058

Ijuí, Rio Grande do Sul, 98700-000, Brazil

Location

Local Institution - 0063

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

Location

Local Institution - 0056

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

Local Institution - 0057

Porto Alegre, Rio Grande do Sul, 90110-270, Brazil

Location

Local Institution - 0086

Campinas, São Paulo, 13083 970, Brazil

Location

Local Institution - 0059

Santo André, São Paulo, 09060-650, Brazil

Location

Local Institution - 0096

São José do Rio Preto, São Paulo, 15090-000, Brazil

Location

Local Institution - 0189

Rio de Janeiro, 22250-905, Brazil

Location

Local Institution - 0060

Rio de Janeiro, 22793-080, Brazil

Location

Local Institution - 0080

São Paulo, 01321-001, Brazil

Location

Local Institution - 0273

São Paulo, 01327-0001, Brazil

Location

Local Institution - 0328

São Paulo, 05652- 900, Brazil

Location

Local Institution - 0151

Brampton, Ontario, L6R 3J7, Canada

Location

Local Institution - 0191

Toronto, Ontario, M2K 1E1, Canada

Location

Local Institution - 0143

Montreal, Quebec, H2X 0A9, Canada

Location

Local Institution - 0027

Viña del Mar, Región de Valparaíso, 2520598, Chile

Location

Local Institution - 0026

Santiago, RM, 7630372, Chile

Location

Local Institution - 0378

Providencia, Santiago Metropolitan, 1234, Chile

Location

Local Institution - 0025

Santiago, Santiago Metropolitan, 0, Chile

Location

Local Institution - 0377

Santiago, Santiago Metropolitan, 7500653, Chile

Location

Local Institution - 0245

Beijing, Beijing Municipality, 100020, China

Location

Local Institution - 0140

Beijing, Beijing Municipality, 100034, China

Location

Local Institution - 0254

Beijing, Beijing Municipality, 100036, China

Location

Local Institution - 0337

Beijing, Beijing Municipality, 100050, China

Location

Local Institution - 0345

Beijing, Beijing Municipality, 100730, China

Location

Local Institution - 0312

Beijing, Bei, 100071, China

Location

Local Institution - 0256

Fuzhou, Fujian, 350001, China

Location

Local Institution - 0319

Guangzhou, Guangdong, 510000, China

Location

Local Institution - 0320

Baoding Shi, Hebei, 071000, China

Location

Local Institution - 0224

Harbin, Heilongjiang, 150081, China

Location

Local Institution - 0314

Henan Sheng, Henan, 450003, China

Location

Local Institution - 0275

Zhengzhou, Henan, 450003, China

Location

Local Institution - 0313

Wuhan, Hubei, 430000, China

Location

Local Institution - 0168

Changsha, Hunan, 410031, China

Location

Local Institution - 0165

Nanjing, Jiangsu, 210000, China

Location

Local Institution - 0317

Nanjing, Jiangsu, 210009, China

Location

Local Institution - 0325

Nanjing, Jiangsu, 210009, China

Location

Local Institution - 0347

Nanchang, Jiangxi, 330006, China

Location

Local Institution - 0330

Nanchang, Jiangxi, 330029, China

Location

Local Institution - 0161

Shenyang, Liaoning, 110042, China

Location

Local Institution - 0326

Jinan, Shandong, 250012, China

Location

Local Institution - 0155

Shanghai, Shanghai Municipality, 200032, China

Location

Local Institution - 0353

Xi'an, Shannxi, 710061, China

Location

Local Institution - 0253

Chengdu, Sichuan, 610041, China

Location

Local Institution - 0310

Ürümqi, Xinjiang, 830011, China

Location

Local Institution - 0316

Hangzhou, Zhejiang, 310003, China

Location

Local Institution - 0344

Hangzhou, Zhejiang, 310014, China

Location

Local Institution - 0108

Brno, 656 53, Czechia

Location

Local Institution - 0093

Brno, 656 91, Czechia

Location

Local Institution - 0049

Olomouc, 779 00, Czechia

Location

Local Institution - 0088

Ostrava, 70852, Czechia

Location

Local Institution - 0050

Prague, 140 59, Czechia

Location

Local Institution - 0361

Prague, 180 81, Czechia

Location

Local Institution - 0105

Strasbourg, Alsace, 67200, France

Location

Local Institution - 0079

Lille, Nord, 59020, France

Location

Local Institution - 0167

Le Mans, Sarthe, 72000, France

Location

Local Institution - 0107

Angers, 49055, France

Location

Local Institution - 0202

Brest, 29200, France

Location

Local Institution - 0398

Dijon, 21079, France

Location

Local Institution - 0030

Hyères, 83400, France

Location

Local Institution - 0395

Montpellier, 34070, France

Location

Local Institution - 0109

Montpellier, 34295, France

Location

Local Institution - 0384

Nice, 06189, France

Location

Local Institution - 0068

Nîmes, 30029, France

Location

Local Institution - 0381

Paris, 75013, France

Location

Local Institution - 0106

Paris, 75014, France

Location

Local Institution - 0071

Paris, 75015, France

Location

Local Institution - 0133

Pierre-Bénite, 69310, France

Location

Local Institution - 0399

Reims, 51100, France

Location

Local Institution - 0380

Rennes, 35042 Rennes, France

Location

Local Institution - 0387

Strasbourg, 67000, France

Location

Local Institution - 0271

Villejuif, 94805, France

Location

Local Institution - 0023

Nürtingen, Baden-Wurttemberg, 72622, Germany

Location

Local Institution - 0014

Koblenz, Rheinland Pfa, 56068, Germany

Location

Local Institution - 0090

Dresden, Saxony, 01307, Germany

Location

Local Institution - 0089

Bonn, 53127, Germany

Location

Local Institution - 0376

Düsseldorf, 40225, Germany

Location

Local Institution - 0172

Emmendingen, 79312, Germany

Location

Local Institution - 0142

Erlangen, 91054, Germany

Location

Local Institution - 0018

Frankfurt am Main, 60590, Germany

Location

Local Institution - 0064

Hamburg, 20246, Germany

Location

Local Institution - 0069

Hamburg, 22763, Germany

Location

Local Institution - 0389

Heidelberg, 69120, Germany

Location

Local Institution - 0004

Magdeburg, 39120, Germany

Location

Local Institution - 0372

Marburg, 35043, Germany

Location

Local Institution - 0204

München, 81675, Germany

Location

Local Institution - 0036

Münster, 48149, Germany

Location

Local Institution - 0169

Tübingen, 72076, Germany

Location

Local Institution - 0145

Hong Kong, 852, Hong Kong

Location

Local Institution - 0045

Hong Kong, NT, Hong Kong

Location

Local Institution - 0146

Hong Kong, Hong Kong

Location

Local Institution - 0072

Haifa, 3109601, Israel

Location

Local Institution - 0388

Jerusalem, 9112001, Israel

Location

Local Institution - 0368

Kfar Saba, 4428164, Israel

Location

Local Institution - 0128

Petah Tikva, 4941492, Israel

Location

Local Institution - 0135

Ramat Gan, 5265601, Israel

Location

Local Institution - 0138

Tel Aviv, 6423906, Israel

Location

Local Institution - 0099

Benevento, 82100, Italy

Location

Local Institution - 0001

Bergamo, 24127, Italy

Location

Local Institution - 0111

Bologna, 40138, Italy

Location

Local Institution - 0039

Brescia, 25123, Italy

Location

Local Institution - 0053

Cremona, 26100, Italy

Location

Local Institution - 0066

Milan, 20141, Italy

Location

Local Institution - 0120

Napoli, 80131, Italy

Location

Local Institution - 0070

Orbassano, 10043, Italy

Location

Local Institution - 0037

Parma, 43126, Italy

Location

Local Institution - 0199

Pisa, 56126, Italy

Location

Local Institution - 0046

Rome, 00128, Italy

Location

Local Institution - 0385

Rome, 00152, Italy

Location

Local Institution - 0067

Trento, 38122, Italy

Location

Local Institution - 0362

Nagoya, Aichi-ken, 4678602, Japan

Location

Local Institution - 0340

Akita, Akita, 010-8543, Japan

Location

Local Institution - 0358

Hirosaki-shi, Aomori, 036-8563, Japan

Location

Local Institution - 0346

Chiba, Chiba, 260-8717, Japan

Location

Local Institution - 0339

Sakura-Shi, Chiba, 285-8741, Japan

Location

Local Institution - 0307

Matsuyama, Ehime, 791-0280, Japan

Location

Local Institution - 0280

Fukuoka, Fukuoka, 8128582, Japan

Location

Local Institution - 0281

Sapporo, Hokkaido, 0608543, Japan

Location

Local Institution - 0296

Sapporo, Hokkaido, 608648, Japan

Location

Local Institution - 0283

Yokohama, Kanagawa, 2320024, Japan

Location

Local Institution - 0324

Kumamoto, Kumamoto, 860-0008, Japan

Location

Local Institution - 0342

Kamigyō-ku, Kyoto, 602-8566, Japan

Location

Local Institution - 0355

Kashihara-shi, Nara, 6348522, Japan

Location

Local Institution - 0343

Osaka, Osaka, 5418567, Japan

Location

Local Institution - 0323

Ōsaka-sayama, Osaka, 5898511, Japan

Location

Local Institution - 0309

Hamamatsu, Shizuoka, 431-3192, Japan

Location

Local Institution - 0279

Toyama, Toyama, 9300194, Japan

Location

Local Institution - 0282

Ube Shi, Yamaguchi, 7550046, Japan

Location

Local Institution - 0341

Nagasaki, 8528501, Japan

Location

Local Institution - 0327

Niigata, 951-8520, Japan

Location

Local Institution - 0354

Okayama, 7000914, Japan

Location

Local Institution - 0338

Osaka, 565-0871, Japan

Location

Local Institution - 0308

Tokyo, 1608582, Japan

Location

Local Institution - 0278

Wakayama, 641-8510, Japan

Location

Local Institution - 0017

Mexico City, D.F., 3100, Mexico

Location

Local Institution - 0015

Zapopan, Jalisco, 45030, Mexico

Location

Local Institution - 0016

Zapopan, Jalisco, 45070, Mexico

Location

Local Institution - 0062

Morelia, Michoacán, 58260, Mexico

Location

Local Institution - 0184

Palmerston North, Manawatu-Wanganui, 4414, New Zealand

Location

Local Institution - 0101

Hamilton, 3204, New Zealand

Location

Local Institution - 0102

Tauranga, 3112, New Zealand

Location

Local Institution - 0383

Bydgoszcz, 85-796, Poland

Location

Local Institution - 0136

Koszalin, 75-581, Poland

Location

Local Institution - 0009

Lodz, 93-513, Poland

Location

Local Institution - 0013

Lublin, 20-090, Poland

Location

Local Institution - 0065

Poznan, 60-848, Poland

Location

Local Institution

Warsaw, 02 797, Poland

Location

Local Institution - 0095

Warsaw, 04-073, Poland

Location

Local Institution - 0329

Rio Piedras, 00935, Puerto Rico

Location

Local Institution - 0359

San Juan, 00927, Puerto Rico

Location

Local Institution - 0041

Cluj-Napoca, Cluj-Napoca, 400015, Romania

Location

Local Institution - 0042

Bucharest, 022328, Romania

Location

Local Institution - 0043

Cluj-Napoca, 400015, Romania

Location

Local Institution - 0020

Constanța, 900591, Romania

Location

Local Institution - 0052

Craiova, 200347, Romania

Location

Local Institution - 0035

Timișoara, 300425, Romania

Location

SBHI Arkhangelsk Region - Arkhangelsk Clinical Oncological Dispensary

Arkhangelsk, 163045, Russia

Location

SAHI Republican Clinical Oncology Dispensary of MoH of RT

Kazan', 163045, Russia

Location

Clinical Hospital MEDSI in Otradnoye

Krasnogorsk Moscow Region, 143442, Russia

Location

Federal State Budgetary Institution N.N. Blokhin National Medical Research Center of Oncology of the

Moscow, 115478, Russia

Location

Sechenov University

Moscow, 119435, Russia

Location

P.A. Herzen Moscow Oncology Research Institute

Moscow, 125284, Russia

Location

FSBI National Medical Research Radiology Center NMRRC - A. Tsyb Medical Radiological Research Centre

Obninsk, 249036, Russia

Location

Budgetary Healthcare Institution of Omsk Region &quot,Clinical Oncological Dispensary&quot,

Omsk, 644013, Russia

Location

Andros Clinic LLC

Saint Petersburg, 197136, Russia

Location

Russian Scientific Centre of Radiology and Surgical Technologies n.a. acad. M.A.

Saint Petersburg, 197758, Russia

Location

Local Institution - 0116

Singapore, 169610, Singapore

Location

Local Institution - 0005

Singapore, 258499, Singapore

Location

Local Institution - 0170

Singapore, 308430, Singapore

Location

Local Institution - 0297

Jung-gu, Daejeon, 35015, South Korea

Location

Local Institution - 0186

Songnam-si, Gyeonggi-do, 13620, South Korea

Location

Local Institution - 0391

Daegu, 42601, South Korea

Location

Local Institution - 0298

Incheon, 405-760, South Korea

Location

Local Institution - 0375

Jeollanam-do, 58128, South Korea

Location

Local Institution - 0374

Seodaemun-Gu, 3722, South Korea

Location

Local Institution - 0370

Seoul, 02841, South Korea

Location

Local Institution - 0171

Seoul, 03080, South Korea

Location

Local Institution - 0193

Seoul, 05505, South Korea

Location

Local Institution - 0187

Seoul, 06351, South Korea

Location

Local Institution - 0373

Seoul, 6591, South Korea

Location

Local Institution - 0158

Yangsan, 50612, South Korea

Location

Local Institution - 0141

Manresa, Barcelona, 8243, Spain

Location

Local Institution - 0073

Barcelona, 08916, Spain

Location

Local Institution - 0123

Barcelona, 8908, Spain

Location

Local Institution - 0360

Córdoba, 14004, Spain

Location

Local Institution - 0044

Girona, 17007, Spain

Location

Local Institution - 0034

Lugo, 27003, Spain

Location

Local Institution - 0076

Madrid, 28006, Spain

Location

Local Institution - 0024

Madrid, 28033, Spain

Location

Local Institution - 0003

Madrid, 28034, Spain

Location

Local Institution - 0031

Madrid, 28041, Spain

Location

Local Institution - 0364

Madrid, 28222, Spain

Location

Local Institution - 0124

Sabadell (Barcelona), 08208, Spain

Location

Local Institution - 0363

Seville, 41013, Spain

Location

Local Institution - 0192

Niaosng, Kaohsiung, 833, Taiwan

Location

Local Institution - 0194

Taichung, 404, Taiwan

Location

Local Institution - 0371

Taichung, 40705, Taiwan

Location

Local Institution - 0386

Tainan, 704, Taiwan

Location

Local Institution - 0175

Taipei, 10002, Taiwan

Location

Local Institution - 0188

Taipei, 111217, Taiwan

Location

Local Institution - 0094

Adana, 01330, Turkey (Türkiye)

Location

Local Institution - 0119

Ankara, 06620, Turkey (Türkiye)

Location

Local Institution - 0130

Ankara, 6100, Turkey (Türkiye)

Location

Local Institution - 0113

Istanbul, 34098, Turkey (Türkiye)

Location

Local Institution - 0104

Izmir, 35575, Turkey (Türkiye)

Location

Local Institution - 0112

Malatya, 44280, Turkey (Türkiye)

Location

Local Institution - 0173

London, Greater London, SW3 6JJ, United Kingdom

Location

Local Institution - 0098

Manchester, Lancashire, M20 4BX, United Kingdom

Location

Local Institution - 0008

Northwood, Middlesex, HA6 2RN, United Kingdom

Location

Local Institution - 0051

Nottingham, Nottinghamshire, NG5 1PB, United Kingdom

Location

Local Institution - 0265

Oxford, Oxfordshire, OX4 6LB, United Kingdom

Location

Local Institution - 0048

Guildford, Surrey, GU2 7XX, United Kingdom

Location

Local Institution - 0154

London, NW1 2PG, United Kingdom

Location

Related Publications (1)

• Fizazi K, Saad F, Alonso-Gordoa T, Zurawski B, Barthelemy P, Voog E, Cutuli HJ, Buchler T, Ye D, Castellano D, Kwiatkowski M, Arslan C, Richardet M, Alifrangis C, Goh JC, Vianna K, Han W, Hatano K, Todenhofer T, Retz M, Srivastava A, Jin C, Gupta S, Trandafirescu G, Campos A, Lee CW, van Kooten Losio M, Subudhi SK. Nivolumab plus docetaxel versus placebo plus docetaxel for androgen receptor pathway inhibitor-pretreated and chemotherapy-naive metastatic castration-resistant prostate cancer (CheckMate 7DX): a double-blind, randomised, phase 3 trial. Lancet Oncol. 2026 Jan;27(1):68-78. doi: 10.1016/S1470-2045(25)00566-2.

  PMID: 41449150 DERIVED

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Nivolumab; Prednisone; Docetaxel

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Please email

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-Blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2019
• First Posted: September 23, 2019
• Study Start: February 6, 2020
• Primary Completion: June 1, 2023
• Study Completion: June 25, 2024
• Last Updated: June 12, 2025
• Results First Posted: July 22, 2024

Record last verified: 2025-05

Locations

KR (12); TW (6); TU (6); BR (17); CN (27); RO (6); AU (4); HK (3); RU (10); GB (7); AR (10); NZ (3); FR (19); CA (3); BE (6); US (45); IT (13); PR (2); SG (3); ES (13); PL (7); IL (6); DE (16); CZ (6); JP (24); ME (4); CL (5)