AzTrials
AzTrials

Metastatic Prostate CancerPhase 3CONTACT-02NCT04446117

Study of Cabozantinib in Combination With Atezolizumab Versus Second NHT in Subjects With mCRPC

A Phase 3 study testing Cabozantinib, Atezolizumab and Abiraterone Acetate in people with Metastatic Prostate Cancer and Prostate Adenocarcinoma, run by Exelixis at 280 sites in 27 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a Phase 3, multi-center, randomized, open-label, controlled study designed to evaluate the safety and efficacy of cabozantinib given in combination with atezolizumab versus a second novel hormonal therapy (NHT) in men with metastatic castration-resistant prostate cancer (mCRPC) who have previously been treated… Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Cabozantinib, Atezolizumab and Abiraterone Acetate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
575 participants
Where
280 sitesin 27 countries
Study dates
19 Oct 2020to 16 Oct 2026
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

  • Men with histologically or cytologically confirmed adenocarcinoma of the prostate
  • Prior treatment with one, and only one, NHT (eg, abiraterone, apalutamide, darolutamide, or enzalutamide) for castration-sensitive locally advanced (T3 or T4) or mCSPC, M0 CRPC, or mCRPC
  • Surgical or medical castration, with serum testosterone ≤ 50 ng/dL (≤ 1.73 nmol/L) at screening
  • Measurable (extrapelvic soft tissue) metastatic disease per Investigator assessment defined by at least one of the following: measurable visceral disease (eg, adrenal, kidney, liver, lung, pancreas, spleen) per RECIST 1.1; OR measurable extrapelvic adenopathy (ie, adenopathy above the aortic bifurcation)
  • Progressive disease at study entry as defined by specific criteria for prostate specific antigen (PSA) progression OR soft tissue disease progression in the opinion of the Investigator (Note: subjects with bone disease progression alone are not eligible)
  • Age ≥ 18 years old or meeting country definition of adult, whichever is older, on the day of consent
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  • ECOG performance status of 0 or 1
  • Recovery to baseline or ≤ Grade 1 per Common Terminology Criteria for Adverse Events (CTCAE) v5 from toxicities related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy in the opinion of the Investigator
  • Adequate organ and marrow function based upon specific laboratory assessments obtained within 21 days prior to randomization
  • Understanding and ability to comply with protocol requirements

Who cannot join

  • Any prior nonhormonal therapy initiated for the treatment of mCRPC
  • Receipt of abiraterone within 1 week; cyproterone within 10 days; or flutamide, nilutamide, bicalutamide, enzalutamide, or other androgen-receptor inhibitors within 2 weeks before randomization
  • Radiation therapy within 4 weeks (2 weeks for bone metastases) prior to randomization (subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible)
  • Known brain metastases or cranial epidural disease unless adequately treated and clinically stable at least 4 weeks prior to randomization
  • Symptomatic or impending spinal cord compression or cauda equina syndrome
  • Concomitant anticoagulation with oral anticoagulants (some specific exceptions apply)
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  • Administration of a live, attenuated vaccine within 30 days prior to randomization
  • Systematic treatment with, or any condition requiring, either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days prior to randomization
  • Uncontrolled, significant intercurrent or recent illness
  • Major surgery within 4 weeks prior to randomization
  • Corrected QT interval calculated by the Fridericia formula (QTcF) > 480 ms per ECG within 21 days before randomization
  • Inability or unwillingness to swallow pills or receive IV administration
  • Previously identified allergy or hypersensitivity to components of the study treatment formulations or history of severe infusion-related reactions to monoclonal antibodies
  • Any other active malignancy at time of randomization or diagnosis of another malignancy within 2 years prior to randomization that requires active treatment (some exceptions apply such as locally curable cancers that have apparently been cured).

Trial locations and contacts

280 sites in 27 countries.

280 sites in 27 countries

United States36 sites

  • Winship Cancer Institute of Emory University

    Atlanta, Georgia, 30322

  • Exelixis Clinical Site #91

    Aurora, Colorado, 80045

  • Exelixis Clinical Site #6

    Baltimore, Maryland, 21204

  • Exelixis Site #159

    Cleveland, Ohio, 44195

  • Exelixis Clinical Site #14

    Denver, Colorado, 80211

  • Non-participating Site

    Detroit, Michigan, 48202

  • Exelixis Clinical Site #42

    Duarte, California, 91010

  • Exelixis Clinical Site #123

    East Brunswick, New Jersey, 08816

  • Exelixis Clinical Site #2

    Fullerton, California, 92835

  • Exelixis Clinical Site #5

    Houston, Texas, 77027

  • Exelixis Clinical Site #177

    Houston, Texas, 77030

  • Exelixis Clinical Site #259

    Houston, Texas, 77030

  • Exelixis Clinical Site #224

    La Jolla, California, 92093-0698

  • Exelixis Clinical Site #144

    Las Vegas, Nevada, 89169

  • Non-participating Site

    Lawrenceville, New Jersey, 08648

  • Exelixis Clinical Site #242

    Louisville, Kentucky, 40202

  • Exelixis Clinical Site #3

    Marina del Rey, California, 90292

  • Exelixis Clinical Site #108

    Miami, Florida, 33125

  • Exelixis Clinical Site #1

    Nashville, Tennessee, 37209

  • Yale University School of Medicine

    New Haven, Connecticut, 06520

  • Yale University, School of Medicine

    New Haven, Connecticut, 06520

  • Weill Cornell Medical College

    New York, New York, 10065

  • Exelixis Clinical Site #221

    Oklahoma City, Oklahoma, 73104

  • Exelixis Clinical Site #19

    Omaha, Nebraska, 68130

  • Exelixis Clinical Site #18

    Philadelphia, Pennsylvania, 19111

  • Exelixis Clinical Site #201

    Pittsburgh, Pennsylvania, 15232

  • Exelixis Clinical Site #143

    Roanoke, Virginia, 24014

  • Exelixis Clinical Site #203

    Rochester, Minnesota, 55905

  • Exelixis Clinical Site #67

    Salt Lake City, Utah, 84112

  • Exelixis Clinical Site #114

    San Diego, California, 92161

  • Exelixis Clinical Site #125

    Santa Monica, California, 90404

  • Exelixis Clinical Site #245

    Stanford, California, 94305

  • Exelixis Clinical Site #41

    Temple, Texas, 76504

  • Exelixis Clinical Site #198

    The Bronx, New York, 10461

  • Exelixis Clinical Site #4

    Tucson, Arizona, 85741

  • Exelixis Clinical Site #215

    Westwood, Kansas, 66205

Other trials in United States

Japan24 sites

  • Exelixis Clinical Site #100

    Akita, Akita, 010-8543

  • Exelixis Clinical Site #78

    Chiba, 260-8717

  • Exelixis Clinical Site #88

    Chūōku, Osaka-shi, 541-8567

  • Exelixis Clinical Site #209

    Fukuoka, 815-8588

  • Exelixis Clinical Site #51

    Hidaka, Saitama, 350-1298

  • Exelixis Clinical Site #104

    Hirosaki, Aomori, 036-8563

  • Exelixis Clinical Site #43

    Kashiwa-shi, Chiba, 277-8577

  • Exelixis Clinical Site #84

    Kita-gun, Kagawa-ken, 761-0793

  • Exelixis Clinical Site #70

    Kobe, Hyōgo, 650-0017

  • Exelixis Clinical Site #52

    Kobe, Hyōgo, 650-0047

  • Exelixis Clinical Site #26

    Nagano, 381-8551

  • Exelixis Clinical Site #211

    Natori-shi, Miyagi, 981-1293

  • Exelixis Clinical Site #81

    Ōsaka-sayama, 589-8511

  • Exelixis Clinical Site #68

    Sagamihara, Kanagawa, 252-0375

  • Exelixis Clinical Site #54

    Sakura-shi, Chiba, 285-8741

  • Exelixis Clinical Site #72

    Sapporo, Hokkaido, 060-8543

  • Exelixis Clinical Site #37

    Sapporo, Hokkaido, 060-8648

  • Exelixis Clinical Site #65

    Shinjuku-Ku, Tokyo, 160-8582

  • Exelixis Clinical Site #216

    Shizuoka, Shizuoka, 420-8527

  • Exelixis Clinical Site #75

    Tokyo, 135-8550

  • Exelixis Clinical Site #232

    Toyota-shi, Aichi-ken, 471-8513

  • Exelixis Clinical Site #61

    Ube, Yamaguchi, 755-8505

  • Exelixis Clinical Site #32

    Wakayama, 641-8510

  • Exelixis Clinical Site #22

    Yokohama, Kanagawa, 232-0024

Other trials in Japan

Spain21 sites

  • Exelixis Clinical Site #17

    Alcorcón, Madrid, 28922

  • Exelixis Clinical Site #274

    Badalona, 08916

  • Exelixis Clinical Site #228

    Barcelona, 08003

  • Exelixis Clinical Site #23

    Barcelona, 08035

  • Exelixis Clinical Site #255

    Barcelona, 08036

  • Exelixis Clinical Site #190

    Barcelona, 08041

  • Exelixis Clinical Site #226

    Cadiz, 11407

  • Exelixis Clinical Site #33

    Córdoba, 14004

  • Exelixis Clinical Site #229

    Elche, Alicante, 03203

  • Exelixis Clinical Site #28

    Lugo, 27003

  • Exelixis Clinical Site #131

    Madrid, 28033

  • Exelixis Clinical Site #248

    Madrid, 28040

  • Exelixis Clinical Site #236

    Madrid, 28041

  • Exelixis Clinical Site #251

    Madrid, 28046

  • Exelixis Clinical Site #13

    Madrid, 28050

  • Exelixis Clinical #270

    Málaga, 29010

  • Exelixis Clinical Site #12

    Manresa, Barcelona, 08243

  • Exelixis Clinical Site #225

    Oviedo, Principality of Asturias, 33011

  • Exelixis Clinical Site #220

    Palma de Mallorca, Balearic Islands, 07120

  • Exelixis Clinical Site #233

    Santiago de Compostela, La Coruna, 15706

  • Exelixis Clinical Site #29

    Seville, 41009

Other trials in Spain

France15 sites

  • Exelixis Clinical Site #134

    Brest, 29229

  • Exelixis Clinical Site #77

    Clermont-Ferrand, 63011

  • Exelixis Clinical Site #155

    Dijon, 21079

  • Exelixis Clinical Site #74

    Hyères, 83400

  • Exelixis Clinical Site #222

    La Roche-sur-Yon, 85925

  • Exelixis Clinical Site #146

    Nîmes, 30029

  • Exelixis Clinical Site #38

    Paris, 75015

  • Exelixis Clinical Site #66

    Quimper, 29107

  • Exelixis Clinical Site #214

    Reims, 51100

  • Exelixis Clinical Site #135

    Saint-Grégoire, 35760

  • Exelixis Clinical Site #213

    Strasbourg, 67000

  • Exelixis Clinical Site #36

    Strasbourg, 67200

  • Exelixis Clinical Site #73

    Toulouse, 31059

  • Exelixis Clinical Site #85

    Toulouse, 31076

  • Exelixis Clinical Site #230

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Italy15 sites

  • Exelixis Clinical Site #217

    Ancona, 60126

  • Exelixis Clinical Site #121

    Florence, 50134

  • Exelixis Site #168

    Meldola, FC, 47014

  • Exelixis Clinical Site #192

    Milan, 20132

  • Exelixis Clinical Site #258

    Milan, 20133

  • Exelixis Clinical #267

    Parma, 43126

  • Exelixis Clinical Site #237

    Pavia, 27100

  • Exelixis Clinical Site #107

    Perugia, 06132

  • Exelixis Clinical #269

    Pisa, 56126

  • Exelixis Clinical Site #62

    Roma, 00144

  • Exelixis Clinical Site #234

    Roma, 00168

  • Exelixis Clinical Site #246

    Rozzano, Milano, 20089

  • Exelixis Site #156

    Sondrio, SO, 23100

  • Exelixis Clinical Site #96

    Terni, 05100

  • Exelixis Clinical Site #199

    Trento, Trentino-Alto Adige, 38122

Other trials in Italy

Australia14 sites

  • Exelixis Clinical Site #115

    Adelaide, 5000

  • Exelixis Clinical Site #79

    Ballarat, Victoria, 3350

  • Exelixis Clinical Site #149

    Box Hill, 3128

  • Exelixis Clinical Site #253

    Chermside, Queensland, 4032

  • Exelixis Clinical Site #95

    Frankston, Victoria, 3199

  • Exelixis Clinical Site #151

    Garran, Australian Capital Territory, 2605

  • Exelixis Clinical #262

    Geelong, Victoria, 3220

  • Exelixis Clinical Site #103

    Launceston, Tasmania, 7250

  • Exelixis Clinical Site #53

    Melbourne, Victoria, 3000

  • Exelixis Clinical Site #252

    Port Macquarie, New South Wales, 2444

  • Exelixis Clinical Stie #260

    Saint Albans, Victoria, 3021

  • Exelixis Clinical Site #175

    Saint Leonards, New South Wales, 2065

  • Exelixis Clinical Site # 189

    Sydney, New South Wales, 2109

  • Exelixis Site #162

    Wollongong, New South Wales, 2500

Other trials in Australia

Brazil14 sites

  • Exelixis Clinical Site #154

    Barretos, 14784-400

  • Exelixis Clinical Site #132

    Blumenau, Santa Catarina, 89010-340

  • Exelixis Clinical Site #191

    Campinas, São Paulo, 13083-970

  • Exelixis Site #163

    Curitiba, Paraná, 80510-130

  • Exelixis Clinical Site #204

    Curitiba, Paraná, 80520-174

  • Exelixis Clinical Site #140

    Fortaleza, 60336-232

  • Exelixis Site #157

    Porto Alegre, Rio Grande do Sul, 90610-00

  • Exelixis Clinical Site #153

    Porto Alegre, 90110-270

  • Exelixis Clinical Site #128

    Ribeirão Preto, São Paulo, 14048-900

  • Exelixis Clinical Site #145

    Ribeirão Preto, 14015-130

  • Exelixis Clinical Site #171

    Rio de Janeiro, Rio de Janeiro, 22793-080

  • Exelixis Clinical Site #116

    Santa Cruz do Sul, 96810-110

  • Exelixis Clinical Site #106

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

  • Exelixis Site #161

    São Paulo, São Paulo, 04538-132

Other trials in Brazil

Mexico14 sites

  • Exelixis Clinical Site #208

    Culiacán, Sinaloa, C.P. 80020

  • Exelixis Clinical Site #212

    Guadalajara, Jalisco, 44500

  • Exelixis Clinical Site #173

    Guadalajara, Jalisco, 44600

  • Exelixis Clinical Site #254

    León, Guanajuato, 37178

  • Exelixis Clinical Site #187

    Mexico City, Mexico City, 06760

  • Exelixis Clinical Site #174

    Mexico City, 01120

  • Exelixis Clinical Site #257

    Monterrey, Nuevo León, 64710

  • Exelixis Clinical Site #272

    Puebla City, 72530

  • Exelixis Clinical Site #172

    Querétaro City, Querétaro, 76070

  • Exelixis Clinical Site #182

    Querétaro City, Querétaro, 76230

  • Exelixis Clinical Site #250

    San Luis Potosí City, San Luis Potosí, 78200

  • Exelixis Clinical Site #184

    San Luis Potosí City, San Luis Potosí, 78209

  • Exelixis Clinical Site #206

    Tuxtla Gutiérrez, Chiapas, 29038

  • Exelixis Clinical Site #219

    Zapopan, Jalisco, 45040

Other trials in Mexico

Argentina13 sites

  • Exelixis Clinical Site #200

    Buenos Aires, C1426ANZ

  • Exelixis Clinical Site #256

    Caba, C1120AAT

  • Exelixis Clinical Site #122

    Ciudad Autonoma de Buenos Aire, Buenos Aires, C1280AEB

  • Exelixis Clinical Site #44

    Ciudad Autonoma de Buenos Aire, C1012AAR

  • Exelixis Clinical Site #210

    Córdoba, Córdoba Province, X5004FHP

  • Exelixis Clinical Site #105

    La Rioja, F5300

  • Exelixis Clinical Site #120

    Mar del Plata, Buenos Aires, B7600FZO

  • Exelixis Site #170

    Pergamino, Buenos Aires, B2700CPM

  • Exelixis Clinical Site #183

    Rosario, Santa Fe Province, S2000CVB

  • Exelixis Clinical #261

    Rosario, Santa Fe Province, S2000KZE

  • Exelixis Clinical Site #124

    San Juan, 5400

  • Exelixis Clinical Site #101

    San Salvador de Jujuy, Y4600EHA

  • Exelixis Clinical Site #152

    Viedma, Río Negro Province, R8500ACE

Other trials in Argentina

South Korea13 sites

  • Exelixis Clinical Site #58

    Busan, 47392

  • Exelixis Clinical Site #24

    Busan, 49241

  • Exelixis Clinical Site #94

    Daegu, 41404

  • Exelixis Clinical Site #21

    Daegu, 42601

  • Exelixis Clinical Site #49

    Goyang-si, Gyeonggi-do, 10408

  • Exelixis Clinical Site #40

    Gwangju, 61469

  • Exelixis Clinical Site #34

    Hwasun, Jeollanam-do, 58128

  • Exelixis Clinical Site #20

    Junggu, Daejeon, 35015

  • Exelixis Clinical Site #60

    Seongnam-si, Gyeonggi-do, 13620

  • Exelixis Clinical Site #59

    Seoul, 03080

  • Exelixis Clinical Site #46

    Seoul, 03722

  • Exelixis Clinical Site #25

    Seoul, 06273

  • Exelixis Clinical Site #48

    Seoul, 06351

Other trials in South Korea

Germany9 sites

  • Exelixis Clinical Site #227

    Berlin, 10117

  • Exelixis Clinical Site #180

    Duisburg, North Rhine-Westphalia, 47179

  • Exelixis Clinical Site #98

    Gütersloh, North Rhine-Westphalia, 33332

  • Exelixis Clinical Site #239

    Hamburg, 20246

  • Exelixis Clinical Site #273

    Hanover, 30625

  • Exelixis Clinical Site #185

    Lübeck, Schleswig-Holstein, 23538

  • Exelixis Clinical Site #179

    Münster, North Rhine-Westphalia, 48149

  • Exelixis Clinical Site #176

    Nürtingen, Baden-Wurttemberg, 72622

  • Exelixis Clinical Site #136

    Tübingen, 72076

Other trials in Germany

Greece9 sites

  • Exelixis Clinical Site #238

    Athens, Attica, 11526

  • Exelixis Clinical Site #93

    Cholargós, Attica, 15562

  • Exelixis Clinical Site #45

    Heraklion, Crete, 71110

  • Exelixis Clinical Site #97

    Larissa, Thessaly, 41110

  • Exelixis Clinical Site #202

    Marousi, Attica, 15123

  • Exelixis Clinical Site #92

    Marousi, Attica, 15125

  • Exelixis Clinical Site #244

    Nea Kifissia, Attica, 14564

  • Exelixis Clinical Site #99

    Neo Faliro, Attica, 18547

  • Exelixis Clinical Site #64

    Thessaloniki, Macedonia, 54007

Other trials in Greece

Canada8 sites

  • Exelixis Clinical Site #69

    Edmonton, Alberta, T6G 1Z2

  • Exelixis Clinical Site #178

    Granby, Quebec, J2GIT7

  • Exelixis Clinical Site #83

    Hamilton, Ontario, L8V 5C2

  • Exelixis Clinical Site #112

    Kelowna, British Columbia, V1Y 5L3

  • Exelixis Clinical Site #127

    London, Ontario, N6A 5W9

  • Exelixis Clinical Site #147

    Moncton, New Brunswick, E1C 6Z8

  • Exelixis Site #160

    Montreal, Quebec, H2X 3E4

  • Exelixis Clinical Site #7

    Oakville, Ontario, L6H 3PI

Other trials in Canada

Chile8 sites

  • Exelixis Clinical Site #142

    Providencia, 7500713

  • Exelixis Clinical Site #148

    Recoleta, 8420383

  • Exelixis Clinical #263

    Santiago, Santiago Metropolitan, 7500787

  • Exelixis Clinical Site #139

    Santiago, Santiago Metropolitan, 7500921

  • Exelixis Clinical Site #90

    Santiago, 7500653

  • Exelixis Clinical Site #113

    Temuco, 4810469

  • Exelixis Clinical Site #119

    Valparaíso, 2540333

  • Exelixis Clinical Site #247

    Viña del Mar, Valparaiso, 2520598

Other trials in Chile

Portugal8 sites

  • Exelixis Clinical Site #110

    Braga, 4710-243

  • Exelixis Clinical Site #188

    Guimarães, 4835-044

  • Exelixis Site #164

    Lisbon, 1400-038

  • Exelixis Clinical Site #197

    Lisbon, 1500-650

  • Exelixis Clinical Site #196

    Loures, 2674-514

  • Exelixis Clinical Site #56

    Porto, 4099-001

  • Exelixis Clinical Site #223

    Porto, 4200-072

  • Exelixis Clinical Site #193

    Vila Real, 5000-508

Other trials in Portugal

Taiwan8 sites

  • Exelixis Clinical #266

    Kaohsiung City, 81362

  • Exelixis Clinical Site #138

    Kaohsiung City, 833

  • Exelixis Clinical Site #86

    Taichung, 404

  • Exelixis Clinical Site #133

    Taichung, 407

  • Exelixis Clinical Site #111

    Tainan, 704

  • Exelixis Clinical Site #271

    Tainan, 710

  • Exelixis Clinical #264

    Taipei, 11217

  • Exelixis Clinical #265

    Taoyuan, 333

Other trials in Taiwan

Czechia6 sites

  • Exelixis Clinical Site #129

    Brno, 656 91

  • Exelixis Clinical Site #130

    Olomouc, 779 00

  • Exelixis Clinical Site #63

    Prague, Prague, 120 00

  • Exelixis Clinical Site #80

    Prague, 128 00

  • Exelixis Clinical Site #31

    Prague, 140 59

  • Exelixis Clinical Site #47

    Prague, 180 81

Other trials in Czechia

Georgia6 sites

  • Exelixis Clinical Site #16

    Tbilisi, 0112

  • Exelixis Clinical Site #9

    Tbilisi, 0141

  • Exelixis Clinical Site #10

    Tbilisi, 0144

  • Exelixis Clinical Site #11

    Tbilisi, 0159

  • Exelixis Clinical Site #15

    Tbilisi, 0167

  • Exelixis Clinical Site #8

    Tbilisi, 0186

Other trials in Georgia

Hungary6 sites

  • Exelixis Clinical Site #118

    Budapest, 1062

  • Exelixis Clinical Site #207

    Budapest, 1082

  • Exelixis Clinical Site #57

    Budapest, 1122

  • Exelixis Clinical Site #109

    Budapest, 1145

  • Exelixis Clinical Site #240

    Debrecen, 4032

  • Exelixis site #167

    Gyula, 5700

Other trials in Hungary

Israel6 sites

  • Exelixis Clinical Site #55

    Haifa, 3109601

  • Exelixis Clinical Site #27

    Jerusalem, 9112001

  • Exelixis Clinical Site #150

    Petah Tikva, 4941492

  • Exelixis Clinical Site #117

    Ramat Gan, 5265601

  • Exelixis Clinical Site #30

    Safed, 1311001

  • Exelixis Clinical Site #35

    Tel Aviv, 6423906

Other trials in Israel

United Kingdom6 sites

  • Exelixis Clinical Site #249

    Blackburn, Lancashire, BB2 3HH

  • Exelixis Clinical Site #205

    London, England, SE1 9RT

  • Exelixis Clinical Site #231

    Northwood, Middlesex, HA6 2RN

  • Exelixis Clinical Site #235

    Surrey Quays, England, SM2 5PT

  • Exelixis Clinical Site #194

    Swansea, Wales, SA2 Q8A

  • Exelixis Clinical Site #241

    Taunton, England, TA1 5DA

Other trials in United Kingdom

Belgium4 sites

  • Exelixis Clinical Site #126

    Bonheiden, Antwerpen, 2820

  • Exelixis Clinical Site #141

    Brussels, 1000

  • Exelixis Clinical Site #39

    Ghent, Oost-Vlaanderen, 9000

  • Exelixis Site #165

    Roeselare, 8800

Other trials in Belgium

Poland4 sites

  • Exelixis Clinical Site #82

    Bydgoszcz, 85-796

  • Exelixis Clinical #268

    Lodz, 93-513

  • Exelixis Clinical Site #243

    Otwock, Masovian Voivodeship, 05-400

  • Exelixis Clinical Site #89

    Poznan, 60-569

Other trials in Poland

Ukraine4 sites

  • Exelixis Clinical Site #102

    Dnipro, 49005

  • Exelixis Clinical Site #186

    Dnipro, 49102

  • Exelixis Clinical Site #76

    Kyiv, 02125

  • Exelixis Clinical Site #71

    Lutsk, 43018

Other trials in Ukraine

Austria3 sites

  • Exelixis Clinical Site #156

    Linz, Upper Austria, 4020

  • Exelixis Site #158

    Linz, Upper Austria, 4020

  • Exelixis Clinical Site #218

    Vienna, 1080

Other trials in Austria

Russia3 sites

  • Exelixis Site #166

    Moscow, 115478

  • Exelixis Clinical Site #137

    Saint Petersburg, 197022

  • Exelixis Clinical Site #195

    Saint Petersburg, 197758

Other trials in Russia

Singapore3 sites

  • Exelixis Clinical Site #50

    Singapore, 169610

  • Exelixis Clinical Site #87

    Singapore, 258499

  • Exelixis Clinical Site #181

    Singapore, 329563

Other trials in Singapore

About this study

Official title: A Phase 3, Randomized, Open-Label, Controlled Study of Cabozantinib (XL184) in Combination With Atezolizumab vs Second Novel Hormonal Therapy (NHT) in Subjects With Metastatic Castration-Resistant Prostate Cancer

This is a Phase 3, multi-center, randomized, open-label, controlled study designed to evaluate the safety and efficacy of cabozantinib given in combination with atezolizumab versus a second novel hormonal therapy (NHT) in men with metastatic castration-resistant prostate cancer (mCRPC) who have previously been treated with one, and only one, NHT for their prostate cancer disease.

Read the detailed description

The primary objective of this study is to evaluate the efficacy of cabozantinib (XL184) in combination with atezolizumab versus a second NHT (abiraterone or enzalutamide) in subjects with mCRPC who have previously been treated with one, and only one, NHT (e.g. abiraterone, apalutamide, darolutamide, or enzalutamide) to treat metastatic castration-sensitive prostate cancer (mCSPC), non-metastatic CRPC (M0 CRPC), or mCRPC, and who have measurable extrapelvic disease. The multiple primary efficacy endpoints comparing the experimental arm and control arm are Duration of Progression Free Survival (PFS) per RECIST 1.1 by Blinded Independent Radiology Committee (BIRC) and Duration of Overall Survival (OS). The secondary efficacy endpoint is Objective Response Rate (ORR) per RECIST 1.1 per BIRC.

Being tested
Cabozantinib, Atezolizumab, Abiraterone Acetate, Enzalutamide, Prednisone
Keywords
prostate cancer, castration-resistant prostate cancer
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • CabozantinibDrug

    Also called XL184, Cabometyx®

    Supplied as 20-mg tablets; administered orally daily at 40mg

  • AtezolizumabDrug

    Also called Tecentriq®

    Supplied as 1200 mg/20 mL vials; administered as an IV infusion once every 3 weeks (q3w)

  • Abiraterone AcetateDrug

    Also called Abiraterone, Zytiga

    Supplied as 500 mg tablets; administered orally daily at 1000mg with prednisone 5 mg orally bid

  • EnzalutamideDrug

    Also called Xtandi

    Supplied as 40 mg capsules; administered orally daily at 160mg

  • PrednisoneDrug

    Supplied as 5 mg tablets; administered orally bid at 5 mg with abiraterone 1000mg orally daily

Study groups in NCT04446117
Study groupRoleWhat they receive
Experimental ArmExperimentalSubjects with mCRPC will receive cabozantinib 40mg oral, qd + atezolizumab 1200mg infusion, q3w
Receives: Drug: Cabozantinib; Drug: Atezolizumab
Control ArmActive comparatorSubjects with mCRPC will receive active comparator of EITHER abiraterone 1000mg oral, qd + prednisone 5 mg oral, bid; OR enzalutamide 160mg oral, qd as designated by the Investigator prior to randomization
Receives: Drug: Abiraterone Acetate; Drug: Enzalutamide; Drug: Prednisone

What is being measured

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

  1. Duration of Progression Free Survival (PFS) Per Response Evaluable Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Blinded Independent Radiology Committee (BIRC)

    Duration of PFS was defined as the time from randomization to the earlier of either the date of radiographic progression (defined as progressive disease [PD] per RECIST 1.1) per BIRC or the date of death due to any cause. PD was defined as at least a 20% increase in the sum of diameters of target lesions, with an absolute increase of ≥ 5 mm, unequivocal progression of non-target lesions and/or the appearance of new lesions.

    Measured: Up to a maximum of approximately 30 months (Median duration of follow-up was 14.31 months)

  2. Duration of Overall Survival (OS)

    Duration of OS was defined as the time from randomization to death due to any cause. For participants, who were not known to have died at the time of data cutoff and were permanently lost to follow-up, duration of OS was censored at the earlier of the following dates: date the participant was last known to be alive or date of full withdrawal of consent (including survival follow-up), or date of data cutoff.

    OS was calculated as earlier of date of death or censoring - date of randomization + 1)/30.4375

    Measured: Up to a maximum of approximately 45 months (Median duration of follow-up was 24.05 months)

Timeline

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

  1. First posted24 Jun 2020
  2. Study start19 Oct 2020
  3. Primary completion19 Apr 2024
  4. Study completion16 Oct 2026 (estimated)

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
Model description
Approximately 580 eligible subjects will be randomized in a 1:1 fashion to the experimental arm receiving cabozantinib and atezolizumab in combination (290) or to the control arm receiving a second NHT (290).
Masking
None (open label)
Enrolment
575 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04446117
Sponsor's protocol ID
XL184-315
Acronym
CONTACT-02
Status last verified
Dec 2025
First submitted
22 Jun 2020
Last updated
18 Dec 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Agarwal N, Azad AA, Carles J, Matsubara N, Oudard S, Saad F, Merseburger AS, Soares A, McGregor BA, Zurawski B, Tsiatas M, North S, Bondarenko I, Alfie M, Bournakis E, Antonuzzo L, Evilevitch L, Simmons A, Wang F, Ferraldeschi R, Nandoskar P, Pal SK. Cabozantinib plus atezolizumab in metastatic prostate cancer (CONTACT-02): final analyses from a phase 3, open-label, randomised trial. Lancet Oncol. 2025 Jul;26(7):860-876. doi: 10.1016/S1470-2045(25)00209-8. Epub 2025 Jun 13.

    PubMed 40523369

  • Agarwal N, Azad A, Carles J, Chowdhury S, McGregor B, Merseburger AS, Oudard S, Saad F, Soares A, Benzaghou F, Kerloeguen Y, Kimura A, Mohamed N, Panneerselvam A, Wang F, Pal S. A phase III, randomized, open-label study (CONTACT-02) of cabozantinib plus atezolizumab versus second novel hormone therapy in patients with metastatic castration-resistant prostate cancer. Future Oncol. 2022 Mar;18(10):1185-1198. doi: 10.2217/fon-2021-1096. Epub 2022 Jan 17.

    PubMed 35034502

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cabozantinib, Atezolizumab and Abiraterone Acetate in people with Metastatic Prostate Cancer and Prostate Adenocarcinoma, run by Exelixis at 280 sites in 27 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 10 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 280 sites in United States, Japan, Spain, France, Italy and 22 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. 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 18 Dec 2025). 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?

Duration of Progression Free Survival (PFS) Per Response Evaluable Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Blinded Independent Radiology Committee (BIRC) (time frame: Up to a maximum of approximately 30 months (Median duration of follow-up was 14.31 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 NCT04446117, which also lists 2 linked publications.

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 18 Dec 2025.

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