AzTrials
AzTrials

Prostate CancerPhase 3CheckMate 7DXNCT04100018

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

A Phase 3 study testing Nivolumab, Prednisone and Docetaxel in people with Prostate Cancer, run by Bristol-Myers Squibb at 293 sites in 28 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Nivolumab, Prednisone and Docetaxel
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,030 participants
Where
293 sitesin 28 countries
Study dates
6 Feb 2020to 25 Jun 2024
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
  • Other protocol-defined inclusion/exclusion criteria apply

Trial locations and contacts

293 sites in 28 countries.

293 sites in 28 countries

United States45 sites

  • Local Institution - 0300

    Albany, New York, 12208

  • Local Institution - 0180

    Allentown, Pennsylvania, 18103-6218

  • Local Institution - 0012

    Anchorage, Alaska, 99503

  • Local Institution - 0117

    Atlanta, Georgia, 30342

  • Local Institution - 0286

    Austin, Texas, 75251

  • Local Institution - 0074

    Bala-Cynwyd, Pennsylvania, 19004

  • Local Institution - 0150

    Baltimore, Maryland, 21201

  • Local Institution - 0332

    Brandywine, Maryland, 20613

  • Local Institution - 0233

    Charleston, South Carolina, 29414

  • Local Institution - 0333

    Columbus, Ohio, 43210

  • Local Institution - 0303

    Dallas, Texas, 75251

  • Local Institution - 0087

    Denver, Colorado, 80211-5222

  • Local Institution - 0365

    East Brunswick, New Jersey, 08816

  • Local Institution - 0139

    Florham Park, New Jersey, 07932

  • Local Institution - 0183

    Fort Wayne, Indiana, 46804

  • Local Institution - 0149

    Germantown, Tennessee, 38138

  • Local Institution - 0196

    Hollywood, Florida, 33021

  • Local Institution - 0284

    Houston, Texas, 77024-2843

  • Local Institution - 0195

    Houston, Texas, 77030-3721

  • Local Institution - 0397

    Jacksonville, Florida, 32256

  • Local Institution - 0269

    Jonesboro, Arkansas, 72401

  • Local Institution - 0164

    Lakeland, Florida, 33805

  • Local Institution - 0302

    Louisville, Kentucky, 40202

  • Local Institution - 0126

    Marietta, Georgia, 30060

  • Local Institution - 0305

    Mobile, Alabama, 36608-1753

  • Local Institution - 0115

    Myrtle Beach, South Carolina, 29572-4607

  • Local Institution - 0287

    Niles, Illinois, 60714

  • Local Institution - 0299

    Omaha, Nebraska, 68130

  • Local Institution - 0179

    Orange, California, 92868

  • Local Institution - 0181

    Orlando, Florida, 32806

  • Local Institution - 0285

    Pensacola, Florida, 32503

  • Local Institution - 0292

    Pittsburgh, Pennsylvania, 15232

  • Local Institution - 0028

    Port Jefferson Station, New York, 11776

  • Local Institution - 0055

    Rancho Mirage, California, 92270

  • Local Institution - 0260

    Redondo Beach, California, 90277

  • Local Institution - 0011

    San Antonio, Texas, 78229

  • Local Institution - 0081

    Santa Monica, California, 90404

  • Local Institution - 0110

    Seattle, Washington, 98109

  • Local Institution - 0289

    Spokane, Washington, 99208

  • Local Institution - 0382

    Thomasville, Georgia, 31792

  • Local Institution - 0293

    Tucson, Arizona, 85724

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

    Tyler, Texas, 75701

  • Local Institution - 0366

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

  • Local Institution - 0190

    West Haven, Connecticut, 06516-5907

  • Local Institution - 0177

    Weston, Florida, 33331

Other trials in United States

China27 sites

  • Local Institution - 0320

    Baoding Shi, Hebei, 071000

  • Local Institution - 0245

    Beijing, Beijing Municipality, 100020

  • Local Institution - 0140

    Beijing, Beijing Municipality, 100034

  • Local Institution - 0254

    Beijing, Beijing Municipality, 100036

  • Local Institution - 0337

    Beijing, Beijing Municipality, 100050

  • Local Institution - 0345

    Beijing, Beijing Municipality, 100730

  • Local Institution - 0312

    Beijing, Bei, 100071

  • Local Institution - 0168

    Changsha, Hunan, 410031

  • Local Institution - 0253

    Chengdu, Sichuan, 610041

  • Local Institution - 0256

    Fuzhou, Fujian, 350001

  • Local Institution - 0319

    Guangzhou, Guangdong, 510000

  • Local Institution - 0316

    Hangzhou, Zhejiang, 310003

  • Local Institution - 0344

    Hangzhou, Zhejiang, 310014

  • Local Institution - 0224

    Harbin, Heilongjiang, 150081

  • Local Institution - 0314

    Henan Sheng, Henan, 450003

  • Local Institution - 0326

    Jinan, Shandong, 250012

  • Local Institution - 0347

    Nanchang, Jiangxi, 330006

  • Local Institution - 0330

    Nanchang, Jiangxi, 330029

  • Local Institution - 0165

    Nanjing, Jiangsu, 210000

  • Local Institution - 0317

    Nanjing, Jiangsu, 210009

  • Local Institution - 0325

    Nanjing, Jiangsu, 210009

  • Local Institution - 0155

    Shanghai, Shanghai Municipality, 200032

  • Local Institution - 0161

    Shenyang, Liaoning, 110042

  • Local Institution - 0310

    Ürümqi, Xinjiang, 830011

  • Local Institution - 0313

    Wuhan, Hubei, 430000

  • Local Institution - 0353

    Xi'an, Shannxi, 710061

  • Local Institution - 0275

    Zhengzhou, Henan, 450003

Other trials in China

Japan24 sites

  • Local Institution - 0340

    Akita, Akita, 010-8543

  • Local Institution - 0346

    Chiba, Chiba, 260-8717

  • Local Institution - 0280

    Fukuoka, Fukuoka, 8128582

  • Local Institution - 0309

    Hamamatsu, Shizuoka, 431-3192

  • Local Institution - 0358

    Hirosaki-shi, Aomori, 036-8563

  • Local Institution - 0342

    Kamigyō-ku, Kyoto, 602-8566

  • Local Institution - 0355

    Kashihara-shi, Nara, 6348522

  • Local Institution - 0324

    Kumamoto, Kumamoto, 860-0008

  • Local Institution - 0307

    Matsuyama, Ehime, 791-0280

  • Local Institution - 0341

    Nagasaki, 8528501

  • Local Institution - 0362

    Nagoya, Aichi-ken, 4678602

  • Local Institution - 0327

    Niigata, 951-8520

  • Local Institution - 0354

    Okayama, 7000914

  • Local Institution - 0343

    Osaka, Osaka, 5418567

  • Local Institution - 0338

    Osaka, 565-0871

  • Local Institution - 0323

    Ōsaka-sayama, Osaka, 5898511

  • Local Institution - 0339

    Sakura-Shi, Chiba, 285-8741

  • Local Institution - 0281

    Sapporo, Hokkaido, 0608543

  • Local Institution - 0296

    Sapporo, Hokkaido, 608648

  • Local Institution - 0308

    Tokyo, 1608582

  • Local Institution - 0279

    Toyama, Toyama, 9300194

  • Local Institution - 0282

    Ube Shi, Yamaguchi, 7550046

  • Local Institution - 0278

    Wakayama, 641-8510

  • Local Institution - 0283

    Yokohama, Kanagawa, 2320024

Other trials in Japan

France19 sites

  • Local Institution - 0107

    Angers, 49055

  • Local Institution - 0202

    Brest, 29200

  • Local Institution - 0398

    Dijon, 21079

  • Local Institution - 0030

    Hyères, 83400

  • Local Institution - 0167

    Le Mans, Sarthe, 72000

  • Local Institution - 0079

    Lille, Nord, 59020

  • Local Institution - 0395

    Montpellier, 34070

  • Local Institution - 0109

    Montpellier, 34295

  • Local Institution - 0384

    Nice, 06189

  • Local Institution - 0068

    Nîmes, 30029

  • Local Institution - 0381

    Paris, 75013

  • Local Institution - 0106

    Paris, 75014

  • Local Institution - 0071

    Paris, 75015

  • Local Institution - 0133

    Pierre-Bénite, 69310

  • Local Institution - 0399

    Reims, 51100

  • Local Institution - 0380

    Rennes, 35042 Rennes

  • Local Institution - 0105

    Strasbourg, Alsace, 67200

  • Local Institution - 0387

    Strasbourg, 67000

  • Local Institution - 0271

    Villejuif, 94805

Other trials in France

Brazil17 sites

  • Local Institution - 0097

    Belo Horizonte, Minas Gerais, 30110022

  • Local Institution - 0022

    Belo Horizonte, Minas Gerais, 30130090

  • Local Institution - 0086

    Campinas, São Paulo, 13083 970

  • Local Institution - 0100

    Curitiba, Paraná, 80530-010

  • Local Institution - 0082

    Curitiba, Paraná, 80810050

  • Local Institution - 0058

    Ijuí, Rio Grande do Sul, 98700-000

  • Local Institution - 0321

    Natal, Rio Grande do Norte, 59075-740

  • Local Institution - 0063

    Porto Alegre, Rio Grande do Sul, 90035-001

  • Local Institution - 0056

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Local Institution - 0057

    Porto Alegre, Rio Grande do Sul, 90110-270

  • Local Institution - 0189

    Rio de Janeiro, 22250-905

  • Local Institution - 0060

    Rio de Janeiro, 22793-080

  • Local Institution - 0059

    Santo André, São Paulo, 09060-650

  • Local Institution - 0096

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

  • Local Institution - 0080

    São Paulo, 01321-001

  • Local Institution - 0273

    São Paulo, 01327-0001

  • Local Institution - 0328

    São Paulo, 05652- 900

Other trials in Brazil

Germany16 sites

  • Local Institution - 0089

    Bonn, 53127

  • Local Institution - 0090

    Dresden, Saxony, 01307

  • Local Institution - 0376

    Düsseldorf, 40225

  • Local Institution - 0172

    Emmendingen, 79312

  • Local Institution - 0142

    Erlangen, 91054

  • Local Institution - 0018

    Frankfurt am Main, 60590

  • Local Institution - 0064

    Hamburg, 20246

  • Local Institution - 0069

    Hamburg, 22763

  • Local Institution - 0389

    Heidelberg, 69120

  • Local Institution - 0014

    Koblenz, Rheinland Pfa, 56068

  • Local Institution - 0004

    Magdeburg, 39120

  • Local Institution - 0372

    Marburg, 35043

  • Local Institution - 0204

    München, 81675

  • Local Institution - 0036

    Münster, 48149

  • Local Institution - 0023

    Nürtingen, Baden-Wurttemberg, 72622

  • Local Institution - 0169

    Tübingen, 72076

Other trials in Germany

Italy13 sites

  • Local Institution - 0099

    Benevento, 82100

  • Local Institution - 0001

    Bergamo, 24127

  • Local Institution - 0111

    Bologna, 40138

  • Local Institution - 0039

    Brescia, 25123

  • Local Institution - 0053

    Cremona, 26100

  • Local Institution - 0066

    Milan, 20141

  • Local Institution - 0120

    Naples, 80131

  • Local Institution - 0070

    Orbassano, 10043

  • Local Institution - 0037

    Parma, 43126

  • Local Institution - 0199

    Pisa, 56126

  • Local Institution - 0046

    Rome, 00128

  • Local Institution - 0385

    Rome, 00152

  • Local Institution - 0067

    Trento, 38122

Other trials in Italy

Spain13 sites

  • Local Institution - 0073

    Barcelona, 08916

  • Local Institution - 0123

    Barcelona, 8908

  • Local Institution - 0360

    Córdoba, 14004

  • Local Institution - 0044

    Girona, 17007

  • Local Institution - 0034

    Lugo, 27003

  • Local Institution - 0076

    Madrid, 28006

  • Local Institution - 0024

    Madrid, 28033

  • Local Institution - 0003

    Madrid, 28034

  • Local Institution - 0031

    Madrid, 28041

  • Local Institution - 0364

    Madrid, 28222

  • Local Institution - 0141

    Manresa, Barcelona, 8243

  • Local Institution - 0124

    Sabadell (Barcelona), 08208

  • Local Institution - 0363

    Seville, 41013

Other trials in Spain

South Korea12 sites

  • Local Institution - 0391

    Daegu, 42601

  • Local Institution - 0298

    Incheon, 405-760

  • Local Institution - 0375

    Jeollanam-do, 58128

  • Local Institution - 0297

    Jung-gu, Daejeon, 35015

  • Local Institution - 0374

    Seodaemun-Gu, 3722

  • Local Institution - 0370

    Seoul, 02841

  • Local Institution - 0171

    Seoul, 03080

  • Local Institution - 0193

    Seoul, 05505

  • Local Institution - 0187

    Seoul, 06351

  • Local Institution - 0373

    Seoul, 6591

  • Local Institution - 0186

    Songnam-si, Gyeonggi-do, 13620

  • Local Institution - 0158

    Yangsan, 50612

Other trials in South Korea

Argentina10 sites

  • Local Institution - 0077

    Buenos Aires, 1280

  • Local Institution - 0178

    Buenos Aires, 1426

  • Local Institution - 0185

    Buenos Aires, C1012

  • Local Institution - 0369

    La Rioja, F5300COE

  • Local Institution - 0129

    Mar del Plata, Buenos Aires, B7602CBM

  • Local Institution - 0153

    Parana, Córdoba Province, 5000

  • Local Institution - 0061

    Pergamino, Buenos Aires, B2700

  • Local Institution - 0393

    Río Cuarto, Córdoba Province, 5800

  • Local Institution - 0394

    San Juan, J5402DIL

  • Local Institution - 0083

    Viedma, Río Negro Province, 8500

Other trials in Argentina

Australia10 sites

  • Local Institution - 0379

    Ballarat, Victoria, 3350

  • Local Institution - 0040

    Frankston, Victoria, 3199

  • Local Institution - 0152

    Gosford, New South Wales, 2250

  • Local Institution - 0091

    Lismore, New South Wales, 2480

  • Local Institution - 0032

    Malvern, Victoria, 3144

  • Local Institution - 0010

    North Adelaide, South Australia, 5006

  • Local Institution - 0006

    South Brisbane, Queensland, 4101

  • Local Institution - 0132

    Wahroonga, New South Wales, 2076

  • Local Institution - 0127

    Westmead, New South Wales, 2145

  • Local Institution - 0084

    Woolloongabba, Queensland, 4102

Other trials in Australia

Russia10 sites

  • SBHI Arkhangelsk Region - Arkhangelsk Clinical Oncological Dispensary

    Arkhangelsk, 163045

  • SAHI Republican Clinical Oncology Dispensary of MoH of RT

    Kazan', 163045

  • Clinical Hospital MEDSI in Otradnoye

    Krasnogorsk Moscow Region, 143442

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

    Moscow, 115478

  • Sechenov University

    Moscow, 119435

  • P.A. Herzen Moscow Oncology Research Institute

    Moscow, 125284

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

    Obninsk, 249036

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

    Omsk, 644013

  • Andros Clinic LLC

    Saint Petersburg, 197136

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

    Saint Petersburg, 197758

Other trials in Russia

Poland7 sites

  • Local Institution - 0383

    Bydgoszcz, 85-796

  • Local Institution - 0136

    Koszalin, 75-581

  • Local Institution - 0009

    Lodz, 93-513

  • Local Institution - 0013

    Lublin, 20-090

  • Local Institution - 0065

    Poznan, 60-848

  • Local Institution

    Warsaw, 02 797

  • Local Institution - 0095

    Warsaw, 04-073

Other trials in Poland

United Kingdom7 sites

  • Local Institution - 0048

    Guildford, Surrey, GU2 7XX

  • Local Institution - 0173

    London, Greater London, SW3 6JJ

  • Local Institution - 0154

    London, NW1 2PG

  • Local Institution - 0098

    Manchester, Lancashire, M20 4BX

  • Local Institution - 0008

    Northwood, Middlesex, HA6 2RN

  • Local Institution - 0051

    Nottingham, Nottinghamshire, NG5 1PB

  • Local Institution - 0265

    Oxford, Oxfordshire, OX4 6LB

Other trials in United Kingdom

Belgium6 sites

  • Local Institution - 0122

    Anderlecht, Brussels Capital, 1070

  • Local Institution - 0121

    Bruges, 8000

  • Local Institution - 0114

    Ghent, 9000

  • Local Institution - 0162

    Ghent, 9000

  • Local Institution - 0137

    Turnhout, 2300

  • Local Institution - 0029

    Wilrijk, 2610

Other trials in Belgium

Czechia6 sites

  • Local Institution - 0108

    Brno, 656 53

  • Local Institution - 0093

    Brno, 656 91

  • Local Institution - 0049

    Olomouc, 779 00

  • Local Institution - 0088

    Ostrava, 70852

  • Local Institution - 0050

    Prague, 140 59

  • Local Institution - 0361

    Prague, 180 81

Other trials in Czechia

Israel6 sites

  • Local Institution - 0072

    Haifa, 3109601

  • Local Institution - 0388

    Jerusalem, 9112001

  • Local Institution - 0368

    Kfar Saba, 4428164

  • Local Institution - 0128

    Petah Tikva, 4941492

  • Local Institution - 0135

    Ramat Gan, 5265601

  • Local Institution - 0138

    Tel Aviv, 6423906

Other trials in Israel

Romania6 sites

  • Local Institution - 0042

    Bucharest, 022328

  • Local Institution - 0041

    Cluj-Napoca, Cluj-Napoca, 400015

  • Local Institution - 0043

    Cluj-Napoca, 400015

  • Local Institution - 0020

    Constanța, 900591

  • Local Institution - 0052

    Craiova, 200347

  • Local Institution - 0035

    Timișoara, 300425

Other trials in Romania

Taiwan6 sites

  • Local Institution - 0192

    Niaosng, Kaohsiung, 833

  • Local Institution - 0194

    Taichung, 404

  • Local Institution - 0371

    Taichung, 40705

  • Local Institution - 0386

    Tainan, 704

  • Local Institution - 0175

    Taipei, 10002

  • Local Institution - 0188

    Taipei, 111217

Other trials in Taiwan

Turkey (Türkiye)6 sites

  • Local Institution - 0094

    Adana, 01330

  • Local Institution - 0119

    Ankara, 06620

  • Local Institution - 0130

    Ankara, 6100

  • Local Institution - 0113

    Istanbul, 34098

  • Local Institution - 0104

    Izmir, 35575

  • Local Institution - 0112

    Malatya, 44280

Other trials in Turkey (Türkiye)

Chile5 sites

  • Local Institution - 0378

    Providencia, Santiago Metropolitan, 1234

  • Local Institution - 0026

    Santiago, RM, 7630372

  • Local Institution - 0025

    Santiago, Santiago Metropolitan, 0

  • Local Institution - 0377

    Santiago, Santiago Metropolitan, 7500653

  • Local Institution - 0027

    Viña del Mar, Valparaiso, 2520598

Other trials in Chile

Austria4 sites

  • Local Institution - 0118

    Linz, Upper Austria, 4020

  • Local Institution - 0038

    Salzburg, 5020

  • Local Institution - 0157

    Vienna, 1020

  • Local Institution - 0131

    Vienna, 1090

Other trials in Austria

Mexico4 sites

  • Local Institution - 0017

    Mexico City, D.F., 3100

  • Local Institution - 0062

    Morelia, Michoacán, 58260

  • Local Institution - 0015

    Zapopan, Jalisco, 45030

  • Local Institution - 0016

    Zapopan, Jalisco, 45070

Other trials in Mexico

Canada3 sites

  • Local Institution - 0151

    Brampton, Ontario, L6R 3J7

  • Local Institution - 0143

    Montreal, Quebec, H2X 0A9

  • Local Institution - 0191

    Toronto, Ontario, M2K 1E1

Other trials in Canada

Hong Kong3 sites

  • Local Institution - 0145

    Hong Kong, 852

  • Local Institution - 0045

    Hong Kong, NT

  • Local Institution - 0146

    Hong Kong

Other trials in Hong Kong

New Zealand3 sites

  • Local Institution - 0101

    Hamilton, 3204

  • Local Institution - 0184

    Palmerston North, Manawatu-Wanganui, 4414

  • Local Institution - 0102

    Tauranga, 3112

Other trials in New Zealand

Singapore3 sites

  • Local Institution - 0116

    Singapore, 169610

  • Local Institution - 0005

    Singapore, 258499

  • Local Institution - 0170

    Singapore, 308430

Other trials in Singapore

Puerto Rico2 sites

  • Local Institution - 0329

    Rio Piedras, 00935

  • Local Institution - 0359

    San Juan, 00927

Other trials in Puerto Rico

About this study

Official title: A Phase 3, Randomized, Double-Blind Study of Nivolumab or Placebo in Combination With Docetaxel, in Men With Metastatic Castration-resistant Prostate Cancer

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
Being tested
Nivolumab, Prednisone, Docetaxel, Placebo
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NivolumabBiological

    Also called OPDIVO,, BMS-936558-01

    Specified dose on specified days

  • PrednisoneDrug

    Specified dose on specified days

  • DocetaxelDrug

    Specified dose on specified days

  • PlaceboOther

    Specified dose on specified days

Study groups in NCT04100018
Study groupRoleWhat they receive
Arm A: Nivolumab + docetaxel + prednisoneExperimentalNot described
Receives: Biological: Nivolumab; Drug: Prednisone; Drug: Docetaxel
Arm B: Placebo + docetaxel + prednisonePlacebo comparatorNot described
Receives: Drug: Prednisone; Drug: Docetaxel; Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

Secondary outcomes (15)

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

    Objective Response Rate per PCWG3 (ORR-PCWG3) is the percentage of participants who have a confirmed complete or partial best overall response (BOR) per PCWG3 among randomized participants who have measurable disease at baseline. Complete Response (CR) is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. Partial Response (PR) is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Baseline was defined as evaluations or events that occur before the date and time of the first dose of study treatment or evaluations on the same date and time of the first dose of study treatment were also considered as baseline evaluations.

    Measured: 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)

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

    Time to Response per PCWG3 (TTR-PCWG3) is the time from randomization to the date of the first documented CR or PR per PCWG3, as determined by BICR. Complete Response (CR) is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. Partial Response (PR) is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

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

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

    Duration of Response per PCWG3 (DOR-PCWG3) is time between the date of first response (CR/PR per PCWG3) to the date of first documented radiographic progression per PCWG3,as determined by BICR, or death due to any cause whichever occurs first. Complete Response (CR) is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. Partial Response (PR) is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Radiographic progression was 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.

    Measured: 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)

  4. Prostate-specific Antigen (PSA) Response Rate (PSA-RR)

    PSA Response Rate (PSA-RR) is the percentage of randomized participants with a 50% or greater decrease in PSA from baseline to the lowest post-baseline PSA result. A second consecutive value obtained 3 or more weeks later is required to confirm the PSA response. Baseline was defined as valuations or events that occur before the date and time of the first dose of study treatment or evaluations on the same date and time of the first dose of study treatment were also considered as baseline evaluations.

    Measured: Up to approximately 52 months

  5. Time to PSA Progression (TTP-PSA)

    Time to PSA Progression (TTP-PSA) is the time between randomization to the date of PSA progression per PCWG3 in randomized participants. PSA Progression: For participants with an initial PSA decline from baseline, the date of PSA progression is the date that an increase of 25% or more and an absolute increase of 2 ng/mL or more from the nadir are documented and confirmed by a second consecutive PSA value at least 3 weeks later. For participants with no PSA decline from baseline, the date of PSA progression is date that an increase of 25% or more and an absolute increase of 2 ng/mL or more from baseline are documented at or beyond Week 13. Baseline was defined as valuations or events that occur before the date and time of the first dose of study treatment or evaluations on the same date and time of the first dose of study treatment were also considered as baseline evaluations. Censored at date of last PSA evaluation on/prior to start of subsequent cancer therapy.

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

  6. Number of Participants With Adverse Events

    An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.

    Measured: From first dose and 30 days after last dose of study therapy (Up to approximately 25 months)

  7. Number of Participants With Serious Adverse Events

    Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death or Is life-threatening or requires inpatient hospitalization or causes prolongation of existing hospitalization or results in persistent or significant disability/incapacity or is a congenital anomaly/birth defect.

    Measured: From first dose and 30 days after last dose of study therapy (Up to approximately 25 months)

  8. Number of Participants With Adverse Events Leading to Discontinuation

    An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.

    Measured: From first dose and 30 days after last dose of study therapy (Up to approximately 25 months)

  9. Number of Participants With Endocrine Immune-Mediated Adverse Events

    Immune-mediated adverse events are AEs consistent with an immune-mediated mechanism or immune-mediated component for which non-inflammatory etiologies (eg, infection or tumor progression) have been ruled out. IMAEs can include events with an alternate etiology which were exacerbated by the induction of autoimmunity. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.

    Measured: From first dose and 100 days after last dose of study therapy (Up to approximately 13 months)

  10. Number of Participants With Non-Endocrine Immune-Mediated Adverse Events

    Immune-mediated adverse events are AEs consistent with an immune-mediated mechanism or immune-mediated component for which non-inflammatory etiologies (eg, infection or tumor progression) have been ruled out. IMAEs can include events with an alternate etiology which were exacerbated by the induction of autoimmunity. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.

    Measured: From first dose and 100 days after last dose of study therapy (Up to approximately 13 months)

  11. Number of Participants With Select Adverse Events

    An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.

    Measured: From first dose and 30 days after last dose of study therapy (Up to approximately 25 months)

  12. Number of Participants Who Died

    Measured: Up to approximately 52 months

  13. Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline

    The severity of laboratory test results were graded based upon the participants symptoms according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0); Hematology parameters were evaluated for severity according to the following scale: Grade 0 is defined as absence of an AE or within normal limits; Grade 1 = Mild - transient or mild discomfort; no medical intervention required; Grade 2 = Moderate - mild to moderate limitation in activity; Grade 3 = Severe; Grade 4 = Life threatening. Number of participants with worst grade change results to Grade 3 or Grade 4 laboratory test results is presented. E.g., the row title HEMOGLOBIN Grade 0 to Grade 3, Grade 0 is baseline and Grade 3 is post baseline.

    Measured: From first dose and 30 days after last dose of study therapy (Up to approximately 25 months)

  14. Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests

    Blood samples were collected for conducting specific thyroid test. Baseline is defined as evaluations or events that occur before the date and time of the first dose of study treatment. Baseline was defined as evaluations or events that occur before the date and time of the first dose of study treatment or evaluations on the same date and time of the first dose of study treatment were also considered as baseline evaluations.

    Measured: From first dose and 30 days after last dose of study therapy (Up to approximately 11 months)

  15. Time to Pain Progression as Assessed by Brief Pain Inventory-Short Form (BPI-SF)

    The BPI-SF is an instrument to assess pain and includes severity and interference scores. BPI-SF is an 11-item self-report questionnaire designed to assess severity and impact of pain on daily function. Participants rate severity of pain at its "worst," "least," and "average" in last 24 hours using an 11-point numerical rating scale with anchors of "no pain" and "pain as bad. The participant's assessment of pain with BPI-SF Item number 3 (pain symptoms at their worst over the last 24 hours) form basis for analysis. Time to pain progression is time between date of randomization and date of first increase in worst pain intensity. Pain progression occurred if an increase in worst pain intensity of >= 2 points is observed from baseline and maintained over 2 consecutive time periods. Baseline was evaluations or events that occur before date and time of first dose of study treatment or evaluations on same date and time of first dose of study treatment were also considered as baseline.

    Measured: From randomization to 1st pain symptoms at their worst over the last 24 hours (Up to approximately 31 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2019
  2. Study start6 Feb 2020
  3. Primary completion1 Jun 2023
  4. Study completion25 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,030 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04100018
Sponsor's protocol ID
CA209-7DX
Other IDs
2019-002030-36, 2019
Acronym
CheckMate 7DX
Status last verified
May 2025
First submitted
20 Sep 2019
Last updated
12 Jun 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Fizazi K, Saad F, Alonso-Gordoa T, Zurawski B, Barthelemy P, Voog E, Javier Cutuli H, 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.

    PubMed 41449150

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nivolumab, Prednisone and Docetaxel in people with Prostate Cancer, run by Bristol-Myers Squibb at 293 sites in 28 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 293 sites in United States, China, Japan, France, Brazil and 23 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Radiographic Progressive Free Survival (rPFS) Assessed by Blinded Independent Central Review (BICR) Per Prostate Cancer Working Group 3 (PCWG3) (time frame: from randomization to the first date of documented progression or death due to any cause, whichever occurs first (up to approximately 31 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04100018, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025.

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