Study of Cabozantinib in Combination With Atezolizumab Versus Second NHT in Subjects With mCRPC (CONTACT-02)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Metastatic Prostate Cancer; Prostate Adenocarcinoma
• Intervention / Treatment: Drug: Cabozantinib; Drug: Atezolizumab; Drug: Abiraterone Acetate; Drug: Enzalutamide; Drug: Prednisone

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.

• Study Type: Interventional
• Enrollment (Actual): 575
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1426ANZ
    • Exelixis Clinical Site #200
  • Caba, Argentina, C1120AAT
    • Exelixis Clinical Site #256
  • Ciudad Autonoma de Buenos Aire, Argentina, C1012AAR
    • Exelixis Clinical Site #44
  • La Rioja, Argentina, F5300
    • Exelixis Clinical Site #105
  • San Juan, Argentina, 5400
    • Exelixis Clinical Site #124
  • San Salvador de Jujuy, Argentina, Y4600EHA
    • Exelixis Clinical Site #101
  • Buenos Aires
    • Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina, C1280AEB
      • Exelixis Clinical Site #122
    • Mar del Plata, Buenos Aires, Argentina, B7600FZO
      • Exelixis Clinical Site #120
    • Pergamino, Buenos Aires, Argentina, B2700CPM
      • Exelixis Site #170
  • Córdoba Province
    • Córdoba, Córdoba Province, Argentina, X5004FHP
      • Exelixis Clinical Site #210
  • Río Negro Province
    • Viedma, Río Negro Province, Argentina, R8500ACE
      • Exelixis Clinical Site #152
  • Santa Fe Province
    • Rosario, Santa Fe Province, Argentina, S2000CVB
      • Exelixis Clinical Site #183
    • Rosario, Santa Fe Province, Argentina, S2000KZE
      • Exelixis Clinical #261
• Australia
  • Adelaide, Australia, 5000
    • Exelixis Clinical Site #115
  • Box Hill, Australia, 3128
    • Exelixis Clinical Site #149
  • Australian Capital Territory
    • Garran, Australian Capital Territory, Australia, 2605
      • Exelixis Clinical Site #151
  • New South Wales
    • Port Macquarie, New South Wales, Australia, 2444
      • Exelixis Clinical Site #252
    • Saint Leonards, New South Wales, Australia, 2065
      • Exelixis Clinical Site #175
    • Sydney, New South Wales, Australia, 2109
      • Exelixis Clinical Site # 189
    • Wollongong, New South Wales, Australia, 2500
      • Exelixis Site #162
  • Queensland
    • Chermside, Queensland, Australia, 4032
      • Exelixis Clinical Site #253
  • Tasmania
    • Launceston, Tasmania, Australia, 7250
      • Exelixis Clinical Site #103
  • Victoria
    • Ballarat, Victoria, Australia, 3350
      • Exelixis Clinical Site #79
    • Frankston, Victoria, Australia, 3199
      • Exelixis Clinical Site #95
    • Geelong, Victoria, Australia, 3220
      • Exelixis Clinical #262
    • Melbourne, Victoria, Australia, 3000
      • Exelixis Clinical Site #53
    • Saint Albans, Victoria, Australia, 3021
      • Exelixis Clinical Stie #260
• Austria
  • Vienna, Austria, 1080
    • Exelixis Clinical Site #218
  • Upper Austria
    • Linz, Upper Austria, Austria, 4020
      • Exelixis Clinical Site #156
    • Linz, Upper Austria, Austria, 4020
      • Exelixis Site #158
• Belgium
  • Brussels, Belgium, 1000
    • Exelixis Clinical Site #141
  • Roeselare, Belgium, 8800
    • Exelixis Site #165
  • Antwerpen
    • Bonheiden, Antwerpen, Belgium, 2820
      • Exelixis Clinical Site #126
  • Oost-Vlaanderen
    • Ghent, Oost-Vlaanderen, Belgium, 9000
      • Exelixis Clinical Site #39
• Brazil
  • Barretos, Brazil, 14784-400
    • Exelixis Clinical Site #154
  • Fortaleza, Brazil, 60336-232
    • Exelixis Clinical Site #140
  • Porto Alegre, Brazil, 90110-270
    • Exelixis Clinical Site #153
  • Ribeirão Preto, Brazil, 14015-130
    • Exelixis Clinical Site #145
  • Santa Cruz do Sul, Brazil, 96810-110
    • Exelixis Clinical Site #116
  • Paraná
    • Curitiba, Paraná, Brazil, 80510-130
      • Exelixis Site #163
    • Curitiba, Paraná, Brazil, 80520-174
      • Exelixis Clinical Site #204
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90610-00
      • Exelixis Site #157
  • Rio de Janeiro
    • Rio de Janeiro, Rio de Janeiro, Brazil, 22793-080
      • Exelixis Clinical Site #171
  • Santa Catarina
    • Blumenau, Santa Catarina, Brazil, 89010-340
      • Exelixis Clinical Site #132
  • São Paulo
    • Campinas, São Paulo, Brazil, 13083-970
      • Exelixis Clinical Site #191
    • Ribeirão Preto, São Paulo, Brazil, 14048-900
      • Exelixis Clinical Site #128
    • São José do Rio Preto, São Paulo, Brazil, 15090-000
      • Exelixis Clinical Site #106
    • São Paulo, São Paulo, Brazil, 04538-132
      • Exelixis Site #161
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Exelixis Clinical Site #69
  • British Columbia
    • Kelowna, British Columbia, Canada, V1Y 5L3
      • Exelixis Clinical Site #112
  • New Brunswick
    • Moncton, New Brunswick, Canada, E1C 6Z8
      • Exelixis Clinical Site #147
  • Ontario
    • Hamilton, Ontario, Canada, L8V 5C2
      • Exelixis Clinical Site #83
    • London, Ontario, Canada, N6A 5W9
      • Exelixis Clinical Site #127
    • Oakville, Ontario, Canada, L6H 3PI
      • Exelixis Clinical Site #7
  • Quebec
    • Granby, Quebec, Canada, J2GIT7
      • Exelixis Clinical Site #178
    • Montreal, Quebec, Canada, H2X 3E4
      • Exelixis Site #160
• Chile
  • Providencia, Chile, 7500713
    • Exelixis Clinical Site #142
  • Recoleta, Chile, 8420383
    • Exelixis Clinical Site #148
  • Santiago, Chile, 7500653
    • Exelixis Clinical Site #90
  • Temuco, Chile, 4810469
    • Exelixis Clinical Site #113
  • Valparaíso, Chile, 2540333
    • Exelixis Clinical Site #119
  • Región de Valparaíso
    • Viña del Mar, Región de Valparaíso, Chile, 2520598
      • Exelixis Clinical Site #247
  • Santiago Metropolitan
    • Santiago, Santiago Metropolitan, Chile, 7500787
      • Exelixis Clinical #263
    • Santiago, Santiago Metropolitan, Chile, 7500921
      • Exelixis Clinical Site #139
• Czechia
  • Brno, Czechia, 656 91
    • Exelixis Clinical Site #129
  • Olomouc, Czechia, 779 00
    • Exelixis Clinical Site #130
  • Prague, Czechia, 128 00
    • Exelixis Clinical Site #80
  • Prague, Czechia, 140 59
    • Exelixis Clinical Site #31
  • Prague, Czechia, 180 81
    • Exelixis Clinical Site #47
  • Prague
    • Prague, Prague, Czechia, 120 00
      • Exelixis Clinical Site #63
• France
  • Brest, France, 29229
    • Exelixis Clinical Site #134
  • Clermont-Ferrand, France, 63011
    • Exelixis Clinical Site #77
  • Dijon, France, 21079
    • Exelixis Clinical Site #155
  • Hyères, France, 83400
    • Exelixis Clinical Site #74
  • La Roche-sur-Yon, France, 85925
    • Exelixis Clinical Site #222
  • Nîmes, France, 30029
    • Exelixis Clinical Site #146
  • Paris, France, 75015
    • Exelixis Clinical Site #38
  • Quimper, France, 29107
    • Exelixis Clinical Site #66
  • Reims, France, 51100
    • Exelixis Clinical Site #214
  • Saint-Grégoire, France, 35760
    • Exelixis Clinical Site #135
  • Strasbourg, France, 67000
    • Exelixis Clinical Site #213
  • Strasbourg, France, 67200
    • Exelixis Clinical Site #36
  • Toulouse, France, 31059
    • Exelixis Clinical Site #73
  • Toulouse, France, 31076
    • Exelixis Clinical Site #85
  • Vandœuvre-lès-Nancy, France, 54511
    • Exelixis Clinical Site #230
• Georgia
  • Tbilisi, Georgia, 0112
    • Exelixis Clinical Site #16
  • Tbilisi, Georgia, 0141
    • Exelixis Clinical Site #9
  • Tbilisi, Georgia, 0144
    • Exelixis Clinical Site #10
  • Tbilisi, Georgia, 0159
    • Exelixis Clinical Site #11
  • Tbilisi, Georgia, 0167
    • Exelixis Clinical Site #15
  • Tbilisi, Georgia, 0186
    • Exelixis Clinical Site #8
• Germany
  • Berlin, Germany, 10117
    • Exelixis Clinical Site #227
  • Hamburg, Germany, 20246
    • Exelixis Clinical Site #239
  • Hanover, Germany, 30625
    • Exelixis Clinical Site #273
  • Tübingen, Germany, 72076
    • Exelixis Clinical Site #136
  • Baden-Wurttemberg
    • Nürtingen, Baden-Wurttemberg, Germany, 72622
      • Exelixis Clinical Site #176
  • North Rhine-Westphalia
    • Duisburg, North Rhine-Westphalia, Germany, 47179
      • Exelixis Clinical Site #180
    • Gütersloh, North Rhine-Westphalia, Germany, 33332
      • Exelixis Clinical Site #98
    • Münster, North Rhine-Westphalia, Germany, 48149
      • Exelixis Clinical Site #179
  • Schleswig-Holstein
    • Lübeck, Schleswig-Holstein, Germany, 23538
      • Exelixis Clinical Site #185
• Greece
  • Attica
    • Athens, Attica, Greece, 11526
      • Exelixis Clinical Site #238
    • Cholargós, Attica, Greece, 15562
      • Exelixis Clinical Site #93
    • Marousi, Attica, Greece, 15123
      • Exelixis Clinical Site #202
    • Marousi, Attica, Greece, 15125
      • Exelixis Clinical Site #92
    • Nea Kifissia, Attica, Greece, 14564
      • Exelixis Clinical Site #244
    • Neo Faliro, Attica, Greece, 18547
      • Exelixis Clinical Site #99
  • Crete
    • Heraklion, Crete, Greece, 71110
      • Exelixis Clinical Site #45
  • Macedonia
    • Thessaloniki, Macedonia, Greece, 54007
      • Exelixis Clinical Site #64
  • Thessaly
    • Larissa, Thessaly, Greece, 41110
      • Exelixis Clinical Site #97
• Hungary
  • Budapest, Hungary, 1062
    • Exelixis Clinical Site #118
  • Budapest, Hungary, 1082
    • Exelixis Clinical Site #207
  • Budapest, Hungary, 1122
    • Exelixis Clinical Site #57
  • Budapest, Hungary, 1145
    • Exelixis Clinical Site #109
  • Debrecen, Hungary, 4032
    • Exelixis Clinical Site #240
  • Gyula, Hungary, 5700
    • Exelixis site #167
• Israel
  • Haifa, Israel, 3109601
    • Exelixis Clinical Site #55
  • Jerusalem, Israel, 9112001
    • Exelixis Clinical Site #27
  • Petah Tikva, Israel, 4941492
    • Exelixis Clinical Site #150
  • Ramat Gan, Israel, 5265601
    • Exelixis Clinical Site #117
  • Safed, Israel, 1311001
    • Exelixis Clinical Site #30
  • Tel Aviv, Israel, 6423906
    • Exelixis Clinical Site #35
• Italy
  • Ancona, Italy, 60126
    • Exelixis Clinical Site #217
  • Florence, Italy, 50134
    • Exelixis Clinical Site #121
  • Milan, Italy, 20132
    • Exelixis Clinical Site #192
  • Milan, Italy, 20133
    • Exelixis Clinical Site #258
  • Parma, Italy, 43126
    • Exelixis Clinical #267
  • Pavia, Italy, 27100
    • Exelixis Clinical Site #237
  • Perugia, Italy, 06132
    • Exelixis Clinical Site #107
  • Pisa, Italy, 56126
    • Exelixis Clinical #269
  • Roma, Italy, 00144
    • Exelixis Clinical Site #62
  • Roma, Italy, 00168
    • Exelixis Clinical Site #234
  • Terni, Italy, 05100
    • Exelixis Clinical Site #96
  • FC
    • Meldola, FC, Italy, 47014
      • Exelixis Site #168
  • Milano
    • Rozzano, Milano, Italy, 20089
      • Exelixis Clinical Site #246
  • SO
    • Sondrio, SO, Italy, 23100
      • Exelixis Site #156
  • Trentino-Alto Adige
    • Trento, Trentino-Alto Adige, Italy, 38122
      • Exelixis Clinical Site #199
• Japan
  • Chiba, Japan, 260-8717
    • Exelixis Clinical Site #78
  • Fukuoka, Japan, 815-8588
    • Exelixis Clinical Site #209
  • Nagano, Japan, 381-8551
    • Exelixis Clinical Site #26
  • Tokyo, Japan, 135-8550
    • Exelixis Clinical Site #75
  • Wakayama, Japan, 641-8510
    • Exelixis Clinical Site #32
  • Ōsaka-sayama, Japan, 589-8511
    • Exelixis Clinical Site #81
  • Aichi-ken
    • Toyota-shi, Aichi-ken, Japan, 471-8513
      • Exelixis Clinical Site #232
  • Akita
    • Akita, Akita, Japan, 010-8543
      • Exelixis Clinical Site #100
  • Aomori
    • Hirosaki, Aomori, Japan, 036-8563
      • Exelixis Clinical Site #104
  • Chiba
    • Kashiwa-shi, Chiba, Japan, 277-8577
      • Exelixis Clinical Site #43
    • Sakura-shi, Chiba, Japan, 285-8741
      • Exelixis Clinical Site #54
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 060-8543
      • Exelixis Clinical Site #72
    • Sapporo, Hokkaido, Japan, 060-8648
      • Exelixis Clinical Site #37
  • Hyōgo
    • Kobe, Hyōgo, Japan, 650-0017
      • Exelixis Clinical Site #70
    • Kobe, Hyōgo, Japan, 650-0047
      • Exelixis Clinical Site #52
  • Kagawa-ken
    • Kita-gun, Kagawa-ken, Japan, 761-0793
      • Exelixis Clinical Site #84
  • Kanagawa
    • Sagamihara, Kanagawa, Japan, 252-0375
      • Exelixis Clinical Site #68
    • Yokohama, Kanagawa, Japan, 232-0024
      • Exelixis Clinical Site #22
  • Miyagi
    • Natori-shi, Miyagi, Japan, 981-1293
      • Exelixis Clinical Site #211
  • Osaka-shi
    • Chūōku, Osaka-shi, Japan, 541-8567
      • Exelixis Clinical Site #88
  • Saitama
    • Hidaka, Saitama, Japan, 350-1298
      • Exelixis Clinical Site #51
  • Shizuoka
    • Shizuoka, Shizuoka, Japan, 420-8527
      • Exelixis Clinical Site #216
  • Tokyo
    • Shinjuku-Ku, Tokyo, Japan, 160-8582
      • Exelixis Clinical Site #65
  • Yamaguchi
    • Ube, Yamaguchi, Japan, 755-8505
      • Exelixis Clinical Site #61
• Mexico
  • Mexico City, Mexico, 01120
    • Exelixis Clinical Site #174
  • Puebla City, Mexico, 72530
    • Exelixis Clinical Site #272
  • Chiapas
    • Tuxtla Gutiérrez, Chiapas, Mexico, 29038
      • Exelixis Clinical Site #206
  • Guanajuato
    • León, Guanajuato, Mexico, 37178
      • Exelixis Clinical Site #254
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44500
      • Exelixis Clinical Site #212
    • Guadalajara, Jalisco, Mexico, 44600
      • Exelixis Clinical Site #173
    • Zapopan, Jalisco, Mexico, 45040
      • Exelixis Clinical Site #219
  • Mexico City
    • Mexico City, Mexico City, Mexico, 06760
      • Exelixis Clinical Site #187
  • Nuevo León
    • Monterrey, Nuevo León, Mexico, 64710
      • Exelixis Clinical Site #257
  • Querétaro
    • Querétaro City, Querétaro, Mexico, 76070
      • Exelixis Clinical Site #172
    • Querétaro City, Querétaro, Mexico, 76230
      • Exelixis Clinical Site #182
  • San Luis Potosí
    • San Luis Potosí City, San Luis Potosí, Mexico, 78200
      • Exelixis Clinical Site #250
    • San Luis Potosí City, San Luis Potosí, Mexico, 78209
      • Exelixis Clinical Site #184
  • Sinaloa
    • Culiacán, Sinaloa, Mexico, C.P. 80020
      • Exelixis Clinical Site #208
• Poland
  • Bydgoszcz, Poland, 85-796
    • Exelixis Clinical Site #82
  • Lodz, Poland, 93-513
    • Exelixis Clinical #268
  • Poznan, Poland, 60-569
    • Exelixis Clinical Site #89
  • Masovian Voivodeship
    • Otwock, Masovian Voivodeship, Poland, 05-400
      • Exelixis Clinical Site #243
• Portugal
  • Braga, Portugal, 4710-243
    • Exelixis Clinical Site #110
  • Guimarães, Portugal, 4835-044
    • Exelixis Clinical Site #188
  • Lisbon, Portugal, 1400-038
    • Exelixis Site #164
  • Lisbon, Portugal, 1500-650
    • Exelixis Clinical Site #197
  • Loures, Portugal, 2674-514
    • Exelixis Clinical Site #196
  • Porto, Portugal, 4099-001
    • Exelixis Clinical Site #56
  • Porto, Portugal, 4200-072
    • Exelixis Clinical Site #223
  • Vila Real, Portugal, 5000-508
    • Exelixis Clinical Site #193
• Russia
  • Moscow, Russia, 115478
    • Exelixis Site #166
  • Saint Petersburg, Russia, 197022
    • Exelixis Clinical Site #137
  • Saint Petersburg, Russia, 197758
    • Exelixis Clinical Site #195
• Singapore
  • Singapore, Singapore, 169610
    • Exelixis Clinical Site #50
  • Singapore, Singapore, 258499
    • Exelixis Clinical Site #87
  • Singapore, Singapore, 329563
    • Exelixis Clinical Site #181
• South Korea
  • Busan, South Korea, 47392
    • Exelixis Clinical Site #58
  • Busan, South Korea, 49241
    • Exelixis Clinical Site #24
  • Daegu, South Korea, 41404
    • Exelixis Clinical Site #94
  • Daegu, South Korea, 42601
    • Exelixis Clinical Site #21
  • Gwangju, South Korea, 61469
    • Exelixis Clinical Site #40
  • Seoul, South Korea, 03080
    • Exelixis Clinical Site #59
  • Seoul, South Korea, 03722
    • Exelixis Clinical Site #46
  • Seoul, South Korea, 06273
    • Exelixis Clinical Site #25
  • Seoul, South Korea, 06351
    • Exelixis Clinical Site #48
  • Daejeon
    • Junggu, Daejeon, South Korea, 35015
      • Exelixis Clinical Site #20
  • Gyeonggi-do
    • Goyang-si, Gyeonggi-do, South Korea, 10408
      • Exelixis Clinical Site #49
    • Seongnam-si, Gyeonggi-do, South Korea, 13620
      • Exelixis Clinical Site #60
  • Jeollanam-do
    • Hwasun, Jeollanam-do, South Korea, 58128
      • Exelixis Clinical Site #34
• Spain
  • Badalona, Spain, 08916
    • Exelixis Clinical Site #274
  • Barcelona, Spain, 08003
    • Exelixis Clinical Site #228
  • Barcelona, Spain, 08035
    • Exelixis Clinical Site #23
  • Barcelona, Spain, 08036
    • Exelixis Clinical Site #255
  • Barcelona, Spain, 08041
    • Exelixis Clinical Site #190
  • Cadiz, Spain, 11407
    • Exelixis Clinical Site #226
  • Córdoba, Spain, 14004
    • Exelixis Clinical Site #33
  • Lugo, Spain, 27003
    • Exelixis Clinical Site #28
  • Madrid, Spain, 28033
    • Exelixis Clinical Site #131
  • Madrid, Spain, 28040
    • Exelixis Clinical Site #248
  • Madrid, Spain, 28041
    • Exelixis Clinical Site #236
  • Madrid, Spain, 28046
    • Exelixis Clinical Site #251
  • Madrid, Spain, 28050
    • Exelixis Clinical Site #13
  • Málaga, Spain, 29010
    • Exelixis Clinical #270
  • Seville, Spain, 41009
    • Exelixis Clinical Site #29
  • Alicante
    • Elche, Alicante, Spain, 03203
      • Exelixis Clinical Site #229
  • Balearic Islands
    • Palma de Mallorca, Balearic Islands, Spain, 07120
      • Exelixis Clinical Site #220
  • Barcelona
    • Manresa, Barcelona, Spain, 08243
      • Exelixis Clinical Site #12
  • La Coruna
    • Santiago de Compostela, La Coruna, Spain, 15706
      • Exelixis Clinical Site #233
  • Madrid
    • Alcorcón, Madrid, Spain, 28922
      • Exelixis Clinical Site #17
  • Principality of Asturias
    • Oviedo, Principality of Asturias, Spain, 33011
      • Exelixis Clinical Site #225
• Taiwan
  • Kaohsiung City, Taiwan, 81362
    • Exelixis Clinical #266
  • Kaohsiung City, Taiwan, 833
    • Exelixis Clinical Site #138
  • Taichung, Taiwan, 407
    • Exelixis Clinical Site #133
  • Taichung, Taiwan, 404
    • Exelixis Clinical Site #86
  • Tainan, Taiwan, 704
    • Exelixis Clinical Site #111
  • Tainan, Taiwan, 710
    • Exelixis Clinical Site #271
  • Taipei, Taiwan, 11217
    • Exelixis Clinical #264
  • Taoyuan District, Taiwan, 333
    • Exelixis Clinical #265
• Ukraine
  • Dnipro, Ukraine, 49005
    • Exelixis Clinical Site #102
  • Dnipro, Ukraine, 49102
    • Exelixis Clinical Site #186
  • Kyiv, Ukraine, 02125
    • Exelixis Clinical Site #76
  • Lutsk, Ukraine, 43018
    • Exelixis Clinical Site #71
• United Kingdom
  • England
    • London, England, United Kingdom, SE1 9RT
      • Exelixis Clinical Site #205
    • Surrey Quays, England, United Kingdom, SM2 5PT
      • Exelixis Clinical Site #235
    • Taunton, England, United Kingdom, TA1 5DA
      • Exelixis Clinical Site #241
  • Lancashire
    • Blackburn, Lancashire, United Kingdom, BB2 3HH
      • Exelixis Clinical Site #249
  • Middlesex
    • Northwood, Middlesex, United Kingdom, HA6 2RN
      • Exelixis Clinical Site #231
  • Wales
    • Swansea, Wales, United Kingdom, SA2 Q8A
      • Exelixis Clinical Site #194
• United States
  • Arizona
    • Tucson, Arizona, United States, 85741
      • Exelixis Clinical Site #4
  • California
    • Duarte, California, United States, 91010
      • Exelixis Clinical Site #42
    • Fullerton, California, United States, 92835
      • Exelixis Clinical Site #2
    • La Jolla, California, United States, 92093-0698
      • Exelixis Clinical Site #224
    • Marina del Rey, California, United States, 90292
      • Exelixis Clinical Site #3
    • San Diego, California, United States, 92161
      • Exelixis Clinical Site #114
    • Santa Monica, California, United States, 90404
      • Exelixis Clinical Site #125
    • Stanford, California, United States, 94305
      • Exelixis Clinical Site #245
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Exelixis Clinical Site #91
    • Denver, Colorado, United States, 80211
      • Exelixis Clinical Site #14
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale University School of Medicine
    • New Haven, Connecticut, United States, 06520
      • Yale University, School of Medicine
  • Florida
    • Miami, Florida, United States, 33125
      • Exelixis Clinical Site #108
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Winship Cancer Institute of Emory University
  • Kansas
    • Westwood, Kansas, United States, 66205
      • Exelixis Clinical Site #215
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Exelixis Clinical Site #242
  • Maryland
    • Baltimore, Maryland, United States, 21204
      • Exelixis Clinical Site #6
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Non-participating Site
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Exelixis Clinical Site #203
  • Nebraska
    • Omaha, Nebraska, United States, 68130
      • Exelixis Clinical Site #19
  • Nevada
    • Las Vegas, Nevada, United States, 89169
      • Exelixis Clinical Site #144
  • New Jersey
    • East Brunswick, New Jersey, United States, 08816
      • Exelixis Clinical Site #123
    • Lawrenceville, New Jersey, United States, 08648
      • Non-participating Site
  • New York
    • New York, New York, United States, 10065
      • Weill Cornell Medical College
    • The Bronx, New York, United States, 10461
      • Exelixis Clinical Site #198
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Exelixis Site #159
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Exelixis Clinical Site #221
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19111
      • Exelixis Clinical Site #18
    • Pittsburgh, Pennsylvania, United States, 15232
      • Exelixis Clinical Site #201
  • Tennessee
    • Nashville, Tennessee, United States, 37209
      • Exelixis Clinical Site #1
  • Texas
    • Houston, Texas, United States, 77027
      • Exelixis Clinical Site #5
    • Houston, Texas, United States, 77030
      • Exelixis Clinical Site #177
    • Houston, Texas, United States, 77030
      • Exelixis Clinical Site #259
    • Temple, Texas, United States, 76504
      • Exelixis Clinical Site #41
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Exelixis Clinical Site #67
  • Virginia
    • Roanoke, Virginia, United States, 24014
      • Exelixis Clinical Site #143

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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
• 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

Exclusion Criteria:

• 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)
• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Arm; Subjects with mCRPC will receive cabozantinib 40mg oral, qd + atezolizumab 1200mg infusion, q3w	Drug: Cabozantinib; Supplied as 20-mg tablets; administered orally daily at 40mg; Other Names: XL184; Cabometyx®; Drug: Atezolizumab; Supplied as 1200 mg/20 mL vials; administered as an IV infusion once every 3 weeks (q3w); Other Names: Tecentriq®
Active Comparator: Control Arm; Subjects 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	Drug: Abiraterone Acetate; Supplied as 500 mg tablets; administered orally daily at 1000mg with prednisone 5 mg orally bid; Other Names: Zytiga; Abiraterone; Drug: Enzalutamide; Supplied as 40 mg capsules; administered orally daily at 160mg; Other Names: Xtandi; Drug: Prednisone; Supplied as 5 mg tablets; administered orally bid at 5 mg with abiraterone 1000mg orally daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to a maximum of approximately 30 months (Median duration of follow-up was 14.31 months)
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	Up to a maximum of approximately 45 months (Median duration of follow-up was 24.05 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate (ORR)	ORR per RECIST 1.1 by BIRC	Approximately 37 months after the first subject is randomized

Collaborators and Investigators

• Sponsor: Exelixis
• Collaborators: Takeda; Roche-Genentech

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2020
• Primary Completion (Actual): April 19, 2024
• Study Completion (Estimated): October 16, 2026

Study Registration Dates

• First Submitted: June 22, 2020
• First Submitted That Met QC Criteria: June 22, 2020
• First Posted (Actual): June 24, 2020

Study Record Updates

• Last Update Posted (Estimated): December 18, 2025
• Last Update Submitted That Met QC Criteria: December 17, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: prostate cancer; castration-resistant prostate cancer
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms; Polycyclic Compounds; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Pregnadienediols; Androstenes; Androstanes; Abiraterone Acetate; Prednisone; abiraterone; enzalutamide; atezolizumab; cabozantinib
• Other Study ID Numbers: XL184-315

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No