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

July 13, 2023 updated by: Exelixis

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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
- Cordoba
  - Córdoba, Cordoba, Argentina, X5004FHP
    - Exelixis Clinical Site #210
- Rio Negro
  - Viedma, Rio Negro, Argentina, R8500ACE
    - Exelixis Clinical Site #152
- Santa Fe
  - Rosario, Santa Fe, Argentina, S2000CVB
    - Exelixis Clinical Site #183
  - Rosario, Santa Fe, 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
- - Wien, Austria, 1080
    - Exelixis Clinical Site #218
- Oberösterreich
  - Linz, Oberösterreich, Austria, 4020
    - Exelixis Site #158
  - Linz, Oberösterreich, Austria, 4020
    - Odensklinikum Linz GmbH Elisabethinen #156
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
  - Gent, 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
- Parana
  - Curitiba, Parana, Brazil, 80520-174
    - Exelixis Clinical Site #204
- Paraná
  - Curitiba, Paraná, Brazil, 80510-130
    - Exelixis Site #163
- RJ
  - Rio De Janeiro, RJ, Brazil, 22793-080
    - Exelixis Clinical Site #171
- Rio Grande Do Sul
  - Porto Alegre, Rio Grande Do Sul, Brazil, 90610-00
    - Exelixis Site #157
- SP
  - Sao Paulo, SP, Brazil, 04538-132
    - Exelixis Site #161
- Santa Catarina
  - Blumenau, Santa Catarina, Brazil, 89010-340
    - Exelixis Clinical Site #132
- Sao Paulo
  - Campinas, Sao Paulo, Brazil, 13083-970
    - Exelixis Clinical Site #191
- São Paulo
  - 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
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
  - Montréal, 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
- Región Metropolitana
  - Santiago, Región Metropolitana, Chile, 7500787
    - Exelixis Clinical #263
- Región Metropolitana De Santiago
  - Santiago de Chile, Región Metropolitana De Santiago, Chile, 7500921
    - Exelixis Clinical Site #139
Czechia
- - Brno, Czechia, 656 91
    - Exelixis Clinical Site #129
  - Olomouc, Czechia, 779 00
    - Exelixis Clinical Site #130
  - Praha, Czechia, 140 59
    - Exelixis Clinical Site #31
  - Praha 2, Czechia, 128 00
    - Exelixis Clinical Site #80
  - Praha 8, Czechia, 180 81
    - Exelixis Clinical Site #47
- Praha
  - Praha 2, Praha, Czechia, 120 00
    - Exelixis Clinical Site #63
France
- - Brest, France, 29229
    - Exelixis Clinical Site #134
  - Clermont-Ferrand, France, 63011
    - Exelixis Clinical Site #77
  - Dijon cedex, France, 21079
    - Exelixis Clinical Site #155
  - Hyères, France, 83400
    - Exelixis Clinical Site #74
  - La Roche-sur-Yon Cedex 9, 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
  - Vandoeuvre les 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
  - Hannover, Germany, 30625
    - Exelixis Clinical Site #273
  - Tübingen, Germany, 72076
    - Exelixis Clinical Site #136
- Baden-Wuerttemberg
  - Nürtingen, Baden-Wuerttemberg, Germany, 72622
    - Exelixis Clinical Site #176
- Nordrhein-Westfalen
  - Gutersloh, Nordrhein-Westfalen, Germany, 33332
    - Exelixis Clinical Site #98
- North Rhine-Westphalia
  - Duisburg, North Rhine-Westphalia, Germany, 47179
    - Exelixis Clinical Site #180
  - 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
  - Maroussi, Attica, Greece, 15123
    - Exelixis Clinical Site #202
  - Maroúsi, Attica, Greece, 15125
    - Exelixis Clinical Site #92
  - Nea Kifisia, Attica, Greece, 14564
    - Exelixis Clinical Site #244
  - Néo Fáliro, Attica, Greece, 18547
    - Exelixis Clinical Site #99
- Crete
  - Heraklion, Crete, Greece, 71110
    - Exelixis Clinical Site #45
- Macedonia
  - Thessaloníki, 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
  - Firenze, Italy, 50134
    - Exelixis Clinical Site #121
  - Milan, Italy, 20132
    - Exelixis Clinical Site #192
  - Milano, 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
  - Trento, Trentino, 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
  - Toyota-shi, Aichi, Japan, 471-8513
    - Exelixis Clinical Site #232
- Akita
  - Akita-Shi, 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
- Hyogo
  - Kobe, Hyogo, Japan, 650-0017
    - Exelixis Clinical Site #70
  - Kobe, Hyogo, Japan, 650-0047
    - Exelixis Clinical Site #52
- Kagawa
  - Kita-gun, Kagawa, Japan, 761-0793
    - Exelixis Clinical Site #84
- Kanagawa
  - Sagamihara, Kanagawa, Japan, 252-0375
    - Exelixis Clinical Site #68
  - Yokohama-shi, Kanagawa, Japan, 232-0024
    - Exelixis Clinical Site #22
- Miyagi
  - Natori-shi, Miyagi, Japan, 981-1293
    - Exelixis Clinical Site #211
- Osaka-shi
  - Chuo-Ku, Osaka-shi, Japan, 541-8567
    - Exelixis Clinical Site #88
- Saitama
  - Hidaka, Saitama, Japan, 350-1298
    - Exelixis Clinical Site #51
- Shizuoka
  - Shizuoka City, 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
Korea, Republic of
- - Busan, Korea, Republic of, 47392
    - Exelixis Clinical Site #58
  - Busan, Korea, Republic of, 49241
    - Exelixis Clinical Site #24
  - Daegu, Korea, Republic of, 41404
    - Exelixis Clinical Site #94
  - Daegu, Korea, Republic of, 42601
    - Exelixis Clinical Site #21
  - Gwangju, Korea, Republic of, 61469
    - Exelixis Clinical Site #40
  - Seoul, Korea, Republic of, 03080
    - Exelixis Clinical Site #59
  - Seoul, Korea, Republic of, 03722
    - Exelixis Clinical Site #46
  - Seoul, Korea, Republic of, 06273
    - Exelixis Clinical Site #25
  - Seoul, Korea, Republic of, 06351
    - Exelixis Clinical Site #48
- Daejeon
  - Junggu, Daejeon, Korea, Republic of, 35015
    - Exelixis Clinical Site #20
- Gyeonggi-Do
  - Seongnam-si, Gyeonggi-Do, Korea, Republic of, 13620
    - Exelixis Clinical Site #60
- Gyeonggi-do
  - Goyang-si, Gyeonggi-do, Korea, Republic of, 10408
    - Exelixis Clinical Site #49
- Jeollanam-do
  - Hwasun, Jeollanam-do, Korea, Republic of, 58128
    - Exelixis Clinical Site #34
Mexico
- - Mexico City, Mexico, 01120
    - Exelixis Clinical Site #174
  - Puebla, Mexico, 72530
    - Exelixis Clinical Site #272
- Chiapas
  - Tuxtla Gutiérrez, Chiapas, Mexico, 29038
    - Exelixis Clinical Site #206
- Distrito Federal
  - Mexico City, Distrito Federal, Mexico, 06760
    - Exelixis Clinical Site #187
- Guanajuato
  - Leon, 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
- Nuevo Leon
  - Monterrey, Nuevo Leon, Mexico, 64710
    - Exelixis Clinical Site #257
- Queretaro
  - Querétaro, Queretaro, Mexico, 76070
    - Exelixis Clinical Site #172
  - Querétaro, Queretaro, Mexico, 76230
    - Exelixis Clinical Site #182
- San Luis Potosi
  - San Luis Potosí, San Luis Potosi, Mexico, 78200
    - Exelixis Clinical Site #250
  - San Luis Potosí, San Luis Potosi, 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
  - Poznań, Poland, 60-569
    - Exelixis Clinical Site #89
  - Łódź, Poland, 93-513
    - Exelixis Clinical #268
- Mazowieckie
  - Otwock, Mazowieckie, Poland, 05-400
    - Exelixis Clinical Site #243
Portugal
- - Braga, Portugal, 4710-243
    - Exelixis Clinical Site #110
  - Guimarães, Portugal, 4835-044
    - Exelixis Clinical Site #188
  - Lisboa, Portugal, 1400-038
    - Exelixis Site #164
  - Lisboa, 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
Russian Federation
- - Moscow, Russian Federation, 115478
    - Exelixis Site #166
  - Saint Petersburg, Russian Federation, 197022
    - Exelixis Clinical Site #137
  - Saint Petersburg, Russian Federation, 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
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
  - Sevilla, Spain, 41009
    - Exelixis Clinical Site #29
- Alicante
  - Elche, Alicante, Spain, 03203
    - Exelixis Clinical Site #229
- Asturias
  - Oviedo, Asturias, Spain, 33011
    - Exelixis Clinical Site #225
- Barcelona
  - Manresa, Barcelona, Spain, 08243
    - Exelixis Clinical Site #12
- Islas Baleares
  - Palma De Mallorca, Islas Baleares, Spain, 07120
    - Exelixis Clinical Site #220
- La Coruna
  - Santiago de Compostela, La Coruna, Spain, 15706
    - Exelixis Clinical Site #233
- Madrid
  - Alcorcón, Madrid, Spain, 28922
    - Exelixis Clinical Site #17
Taiwan
- - Kaohsiung, Taiwan, 81362
    - Exelixis Clinical #266
  - Kaohsiung, Taiwan, 833
    - Exelixis Clinical Site #138
  - Taichung, Taiwan, 407
    - Exelixis Clinical Site #133
  - Taichung City, Taiwan, 404
    - Exelixis Clinical Site #86
  - Tainan, Taiwan, 704
    - Exelixis Clinical Site #111
  - Tainan City, Taiwan, 710
    - Exelixis Clinical Site #271
  - Taipei city, Taiwan, 11217
    - Exelixis Clinical #264
  - Taoyuan, 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
  - Luts'k, Ukraine, 43018
    - Exelixis Clinical Site #71
United Kingdom
- England
  - London, England, United Kingdom, SE1 9RT
    - Exelixis Clinical Site #205
  - Somerset, England, United Kingdom, TA1 5DA
    - Exelixis Clinical Site #241
  - Surrey Quays, England, United Kingdom, SM2 5PT
    - Exelixis Clinical Site #235
- 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
  - 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
- Florida
  - Miami, Florida, United States, 33125
    - Exelixis Clinical Site #108
- 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
- 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
- New York
  - 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Number of Arms

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 per Response Evaluable Criteria in Solid Tumors version 1.1 (RECIST 1.1) Time Frame: Approximately 21 months after the first subject is randomized.	Defined as time from randomization to the earlier of progressive disease (PD) per RECIST 1.1 as determined by the Blinded Independent Radiology Committee (BIRC) or death from any cause	Approximately 21 months after the first subject is randomized.
Duration of Overall Survival (OS) Time Frame: Approximately 37 months after the first subject is randomized	Defined as time from randomization to date of death from any cause	Approximately 37 months after the first subject is randomized

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Exelixis

Collaborators

Takeda

Roche-Genentech

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2020

Primary Completion (Actual)

June 30, 2023

Study Completion (Estimated)

August 31, 2024

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 (Actual)

July 17, 2023

Last Update Submitted That Met QC Criteria

July 13, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

XL184-315

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Publications and helpful links

General Publications

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Actual)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on Metastatic Prostate Cancer

Clinical Trials on Cabozantinib

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