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Study of Cabozantinib in Combination With Atezolizumab Versus Second NHT in Subjects With mCRPC
Sponsor: Exelixis
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 with one, and only one, NHT for their prostate cancer disease.
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
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
575
Start Date
2020-10-19
Completion Date
2026-10-16
Last Updated
2025-12-18
Healthy Volunteers
No
Interventions
Cabozantinib
Supplied as 20-mg tablets; administered orally daily at 40mg
Atezolizumab
Supplied as 1200 mg/20 mL vials; administered as an IV infusion once every 3 weeks (q3w)
Abiraterone Acetate
Supplied as 500 mg tablets; administered orally daily at 1000mg with prednisone 5 mg orally bid
Enzalutamide
Supplied as 40 mg capsules; administered orally daily at 160mg
Prednisone
Supplied as 5 mg tablets; administered orally bid at 5 mg with abiraterone 1000mg orally daily
Locations (280)
Exelixis Clinical Site #4
Tucson, Arizona, United States
Exelixis Clinical Site #42
Duarte, California, United States
Exelixis Clinical Site #2
Fullerton, California, United States
Exelixis Clinical Site #224
La Jolla, California, United States
Exelixis Clinical Site #3
Marina del Rey, California, United States
Exelixis Clinical Site #114
San Diego, California, United States
Exelixis Clinical Site #125
Santa Monica, California, United States
Exelixis Clinical Site #245
Stanford, California, United States
Exelixis Clinical Site #91
Aurora, Colorado, United States
Exelixis Clinical Site #14
Denver, Colorado, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Yale University, School of Medicine
New Haven, Connecticut, United States
Exelixis Clinical Site #108
Miami, Florida, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States
Exelixis Clinical Site #215
Westwood, Kansas, United States
Exelixis Clinical Site #242
Louisville, Kentucky, United States
Exelixis Clinical Site #6
Baltimore, Maryland, United States
Non-participating Site
Detroit, Michigan, United States
Exelixis Clinical Site #203
Rochester, Minnesota, United States
Exelixis Clinical Site #19
Omaha, Nebraska, United States
Exelixis Clinical Site #144
Las Vegas, Nevada, United States
Exelixis Clinical Site #123
East Brunswick, New Jersey, United States
Non-participating Site
Lawrenceville, New Jersey, United States
Weill Cornell Medical College
New York, New York, United States
Exelixis Clinical Site #198
The Bronx, New York, United States
Exelixis Site #159
Cleveland, Ohio, United States
Exelixis Clinical Site #221
Oklahoma City, Oklahoma, United States
Exelixis Clinical Site #18
Philadelphia, Pennsylvania, United States
Exelixis Clinical Site #201
Pittsburgh, Pennsylvania, United States
Exelixis Clinical Site #1
Nashville, Tennessee, United States
Exelixis Clinical Site #5
Houston, Texas, United States
Exelixis Clinical Site #177
Houston, Texas, United States
Exelixis Clinical Site #259
Houston, Texas, United States
Exelixis Clinical Site #41
Temple, Texas, United States
Exelixis Clinical Site #67
Salt Lake City, Utah, United States
Exelixis Clinical Site #143
Roanoke, Virginia, United States
Exelixis Clinical Site #122
Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina
Exelixis Clinical Site #120
Mar del Plata, Buenos Aires, Argentina
Exelixis Site #170
Pergamino, Buenos Aires, Argentina
Exelixis Clinical Site #210
Córdoba, Córdoba Province, Argentina
Exelixis Clinical Site #152
Viedma, Río Negro Province, Argentina
Exelixis Clinical Site #183
Rosario, Santa Fe Province, Argentina
Exelixis Clinical #261
Rosario, Santa Fe Province, Argentina
Exelixis Clinical Site #200
Buenos Aires, Argentina
Exelixis Clinical Site #256
Caba, Argentina
Exelixis Clinical Site #44
Ciudad Autonoma de Buenos Aire, Argentina
Exelixis Clinical Site #105
La Rioja, Argentina
Exelixis Clinical Site #124
San Juan, Argentina
Exelixis Clinical Site #101
San Salvador de Jujuy, Argentina
Exelixis Clinical Site #151
Garran, Australian Capital Territory, Australia
Exelixis Clinical Site #252
Port Macquarie, New South Wales, Australia
Exelixis Clinical Site #175
Saint Leonards, New South Wales, Australia
Exelixis Clinical Site # 189
Sydney, New South Wales, Australia
Exelixis Site #162
Wollongong, New South Wales, Australia
Exelixis Clinical Site #253
Chermside, Queensland, Australia
Exelixis Clinical Site #103
Launceston, Tasmania, Australia
Exelixis Clinical Site #79
Ballarat, Victoria, Australia
Exelixis Clinical Site #95
Frankston, Victoria, Australia
Exelixis Clinical #262
Geelong, Victoria, Australia
Exelixis Clinical Site #53
Melbourne, Victoria, Australia
Exelixis Clinical Stie #260
Saint Albans, Victoria, Australia
Exelixis Clinical Site #115
Adelaide, Australia
Exelixis Clinical Site #149
Box Hill, Australia
Exelixis Clinical Site #156
Linz, Upper Austria, Austria
Exelixis Site #158
Linz, Upper Austria, Austria
Exelixis Clinical Site #218
Vienna, Austria
Exelixis Clinical Site #126
Bonheiden, Antwerpen, Belgium
Exelixis Clinical Site #39
Ghent, Oost-Vlaanderen, Belgium
Exelixis Clinical Site #141
Brussels, Belgium
Exelixis Site #165
Roeselare, Belgium
Exelixis Site #163
Curitiba, Paraná, Brazil
Exelixis Clinical Site #204
Curitiba, Paraná, Brazil
Exelixis Clinical Site #171
Rio de Janeiro, Rio de Janeiro, Brazil
Exelixis Site #157
Porto Alegre, Rio Grande do Sul, Brazil
Exelixis Clinical Site #132
Blumenau, Santa Catarina, Brazil
Exelixis Clinical Site #191
Campinas, São Paulo, Brazil
Exelixis Clinical Site #128
Ribeirão Preto, São Paulo, Brazil
Exelixis Clinical Site #106
São José do Rio Preto, São Paulo, Brazil
Exelixis Site #161
São Paulo, São Paulo, Brazil
Exelixis Clinical Site #154
Barretos, Brazil
Exelixis Clinical Site #140
Fortaleza, Brazil
Exelixis Clinical Site #153
Porto Alegre, Brazil
Exelixis Clinical Site #145
Ribeirão Preto, Brazil
Exelixis Clinical Site #116
Santa Cruz do Sul, Brazil
Exelixis Clinical Site #69
Edmonton, Alberta, Canada
Exelixis Clinical Site #112
Kelowna, British Columbia, Canada
Exelixis Clinical Site #147
Moncton, New Brunswick, Canada
Exelixis Clinical Site #83
Hamilton, Ontario, Canada
Exelixis Clinical Site #127
London, Ontario, Canada
Exelixis Clinical Site #7
Oakville, Ontario, Canada
Exelixis Clinical Site #178
Granby, Quebec, Canada
Exelixis Site #160
Montreal, Quebec, Canada
Exelixis Clinical Site #247
Viña del Mar, Región de Valparaíso, Chile
Exelixis Clinical #263
Santiago, Santiago Metropolitan, Chile
Exelixis Clinical Site #139
Santiago, Santiago Metropolitan, Chile
Exelixis Clinical Site #142
Providencia, Chile
Exelixis Clinical Site #148
Recoleta, Chile
Exelixis Clinical Site #90
Santiago, Chile
Exelixis Clinical Site #113
Temuco, Chile
Exelixis Clinical Site #119
Valparaíso, Chile
Exelixis Clinical Site #63
Prague, Prague, Czechia
Exelixis Clinical Site #129
Brno, Czechia
Exelixis Clinical Site #130
Olomouc, Czechia
Exelixis Clinical Site #80
Prague, Czechia
Exelixis Clinical Site #31
Prague, Czechia
Exelixis Clinical Site #47
Prague, Czechia
Exelixis Clinical Site #134
Brest, France
Exelixis Clinical Site #77
Clermont-Ferrand, France
Exelixis Clinical Site #155
Dijon, France
Exelixis Clinical Site #74
Hyères, France
Exelixis Clinical Site #222
La Roche-sur-Yon, France
Exelixis Clinical Site #146
Nîmes, France
Exelixis Clinical Site #38
Paris, France
Exelixis Clinical Site #66
Quimper, France
Exelixis Clinical Site #214
Reims, France
Exelixis Clinical Site #135
Saint-Grégoire, France
Exelixis Clinical Site #213
Strasbourg, France
Exelixis Clinical Site #36
Strasbourg, France
Exelixis Clinical Site #73
Toulouse, France
Exelixis Clinical Site #85
Toulouse, France
Exelixis Clinical Site #230
Vandœuvre-lès-Nancy, France
Exelixis Clinical Site #16
Tbilisi, Georgia
Exelixis Clinical Site #9
Tbilisi, Georgia
Exelixis Clinical Site #10
Tbilisi, Georgia
Exelixis Clinical Site #11
Tbilisi, Georgia
Exelixis Clinical Site #15
Tbilisi, Georgia
Exelixis Clinical Site #8
Tbilisi, Georgia
Exelixis Clinical Site #176
Nürtingen, Baden-Wurttemberg, Germany
Exelixis Clinical Site #180
Duisburg, North Rhine-Westphalia, Germany
Exelixis Clinical Site #98
Gütersloh, North Rhine-Westphalia, Germany
Exelixis Clinical Site #179
Münster, North Rhine-Westphalia, Germany
Exelixis Clinical Site #185
Lübeck, Schleswig-Holstein, Germany
Exelixis Clinical Site #227
Berlin, Germany
Exelixis Clinical Site #239
Hamburg, Germany
Exelixis Clinical Site #273
Hanover, Germany
Exelixis Clinical Site #136
Tübingen, Germany
Exelixis Clinical Site #238
Athens, Attica, Greece
Exelixis Clinical Site #93
Cholargós, Attica, Greece
Exelixis Clinical Site #202
Marousi, Attica, Greece
Exelixis Clinical Site #92
Marousi, Attica, Greece
Exelixis Clinical Site #244
Nea Kifissia, Attica, Greece
Exelixis Clinical Site #99
Neo Faliro, Attica, Greece
Exelixis Clinical Site #45
Heraklion, Crete, Greece
Exelixis Clinical Site #64
Thessaloniki, Macedonia, Greece
Exelixis Clinical Site #97
Larissa, Thessaly, Greece
Exelixis Clinical Site #118
Budapest, Hungary
Exelixis Clinical Site #207
Budapest, Hungary
Exelixis Clinical Site #57
Budapest, Hungary
Exelixis Clinical Site #109
Budapest, Hungary
Exelixis Clinical Site #240
Debrecen, Hungary
Exelixis site #167
Gyula, Hungary
Exelixis Clinical Site #55
Haifa, Israel
Exelixis Clinical Site #27
Jerusalem, Israel
Exelixis Clinical Site #150
Petah Tikva, Israel
Exelixis Clinical Site #117
Ramat Gan, Israel
Exelixis Clinical Site #30
Safed, Israel
Exelixis Clinical Site #35
Tel Aviv, Israel
Exelixis Site #168
Meldola, FC, Italy
Exelixis Clinical Site #246
Rozzano, Milano, Italy
Exelixis Site #156
Sondrio, SO, Italy
Exelixis Clinical Site #199
Trento, Trentino-Alto Adige, Italy
Exelixis Clinical Site #217
Ancona, Italy
Exelixis Clinical Site #121
Florence, Italy
Exelixis Clinical Site #192
Milan, Italy
Exelixis Clinical Site #258
Milan, Italy
Exelixis Clinical #267
Parma, Italy
Exelixis Clinical Site #237
Pavia, Italy
Exelixis Clinical Site #107
Perugia, Italy
Exelixis Clinical #269
Pisa, Italy
Exelixis Clinical Site #62
Roma, Italy
Exelixis Clinical Site #234
Roma, Italy
Exelixis Clinical Site #96
Terni, Italy
Exelixis Clinical Site #232
Toyota-shi, Aichi-ken, Japan
Exelixis Clinical Site #100
Akita, Akita, Japan
Exelixis Clinical Site #104
Hirosaki, Aomori, Japan
Exelixis Clinical Site #43
Kashiwa-shi, Chiba, Japan
Exelixis Clinical Site #54
Sakura-shi, Chiba, Japan
Exelixis Clinical Site #72
Sapporo, Hokkaido, Japan
Exelixis Clinical Site #37
Sapporo, Hokkaido, Japan
Exelixis Clinical Site #70
Kobe, Hyōgo, Japan
Exelixis Clinical Site #52
Kobe, Hyōgo, Japan
Exelixis Clinical Site #84
Kita-gun, Kagawa-ken, Japan
Exelixis Clinical Site #68
Sagamihara, Kanagawa, Japan
Exelixis Clinical Site #22
Yokohama, Kanagawa, Japan
Exelixis Clinical Site #211
Natori-shi, Miyagi, Japan
Exelixis Clinical Site #88
Chūōku, Osaka-shi, Japan
Exelixis Clinical Site #51
Hidaka, Saitama, Japan
Exelixis Clinical Site #216
Shizuoka, Shizuoka, Japan
Exelixis Clinical Site #65
Shinjuku-Ku, Tokyo, Japan
Exelixis Clinical Site #61
Ube, Yamaguchi, Japan
Exelixis Clinical Site #78
Chiba, Japan
Exelixis Clinical Site #209
Fukuoka, Japan
Exelixis Clinical Site #26
Nagano, Japan
Exelixis Clinical Site #81
Ōsaka-sayama, Japan
Exelixis Clinical Site #75
Tokyo, Japan
Exelixis Clinical Site #32
Wakayama, Japan
Exelixis Clinical Site #206
Tuxtla Gutiérrez, Chiapas, Mexico
Exelixis Clinical Site #254
León, Guanajuato, Mexico
Exelixis Clinical Site #212
Guadalajara, Jalisco, Mexico
Exelixis Clinical Site #173
Guadalajara, Jalisco, Mexico
Exelixis Clinical Site #219
Zapopan, Jalisco, Mexico
Exelixis Clinical Site #187
Mexico City, Mexico City, Mexico
Exelixis Clinical Site #257
Monterrey, Nuevo León, Mexico
Exelixis Clinical Site #172
Querétaro City, Querétaro, Mexico
Exelixis Clinical Site #182
Querétaro City, Querétaro, Mexico
Exelixis Clinical Site #250
San Luis Potosí City, San Luis Potosí, Mexico
Exelixis Clinical Site #184
San Luis Potosí City, San Luis Potosí, Mexico
Exelixis Clinical Site #208
Culiacán, Sinaloa, Mexico
Exelixis Clinical Site #174
Mexico City, Mexico
Exelixis Clinical Site #272
Puebla City, Mexico
Exelixis Clinical Site #243
Otwock, Masovian Voivodeship, Poland
Exelixis Clinical Site #82
Bydgoszcz, Poland
Exelixis Clinical #268
Lodz, Poland
Exelixis Clinical Site #89
Poznan, Poland
Exelixis Clinical Site #110
Braga, Portugal
Exelixis Clinical Site #188
Guimarães, Portugal
Exelixis Site #164
Lisbon, Portugal
Exelixis Clinical Site #197
Lisbon, Portugal
Exelixis Clinical Site #196
Loures, Portugal
Exelixis Clinical Site #56
Porto, Portugal
Exelixis Clinical Site #223
Porto, Portugal
Exelixis Clinical Site #193
Vila Real, Portugal
Exelixis Site #166
Moscow, Russia
Exelixis Clinical Site #137
Saint Petersburg, Russia
Exelixis Clinical Site #195
Saint Petersburg, Russia
Exelixis Clinical Site #50
Singapore, Singapore
Exelixis Clinical Site #87
Singapore, Singapore
Exelixis Clinical Site #181
Singapore, Singapore
Exelixis Clinical Site #20
Junggu, Daejeon, South Korea
Exelixis Clinical Site #49
Goyang-si, Gyeonggi-do, South Korea
Exelixis Clinical Site #60
Seongnam-si, Gyeonggi-do, South Korea
Exelixis Clinical Site #34
Hwasun, Jeollanam-do, South Korea
Exelixis Clinical Site #58
Busan, South Korea
Exelixis Clinical Site #24
Busan, South Korea
Exelixis Clinical Site #94
Daegu, South Korea
Exelixis Clinical Site #21
Daegu, South Korea
Exelixis Clinical Site #40
Gwangju, South Korea
Exelixis Clinical Site #59
Seoul, South Korea
Exelixis Clinical Site #46
Seoul, South Korea
Exelixis Clinical Site #25
Seoul, South Korea
Exelixis Clinical Site #48
Seoul, South Korea
Exelixis Clinical Site #229
Elche, Alicante, Spain
Exelixis Clinical Site #220
Palma de Mallorca, Balearic Islands, Spain
Exelixis Clinical Site #12
Manresa, Barcelona, Spain
Exelixis Clinical Site #233
Santiago de Compostela, La Coruna, Spain
Exelixis Clinical Site #17
Alcorcón, Madrid, Spain
Exelixis Clinical Site #225
Oviedo, Principality of Asturias, Spain
Exelixis Clinical Site #274
Badalona, Spain
Exelixis Clinical Site #228
Barcelona, Spain
Exelixis Clinical Site #23
Barcelona, Spain
Exelixis Clinical Site #255
Barcelona, Spain
Exelixis Clinical Site #190
Barcelona, Spain
Exelixis Clinical Site #226
Cadiz, Spain
Exelixis Clinical Site #33
Córdoba, Spain
Exelixis Clinical Site #28
Lugo, Spain
Exelixis Clinical Site #131
Madrid, Spain
Exelixis Clinical Site #248
Madrid, Spain
Exelixis Clinical Site #236
Madrid, Spain
Exelixis Clinical Site #251
Madrid, Spain
Exelixis Clinical Site #13
Madrid, Spain
Exelixis Clinical #270
Málaga, Spain
Exelixis Clinical Site #29
Seville, Spain
Exelixis Clinical #266
Kaohsiung City, Taiwan
Exelixis Clinical Site #138
Kaohsiung City, Taiwan
Exelixis Clinical Site #86
Taichung, Taiwan
Exelixis Clinical Site #133
Taichung, Taiwan
Exelixis Clinical Site #111
Tainan, Taiwan
Exelixis Clinical Site #271
Tainan, Taiwan
Exelixis Clinical #264
Taipei, Taiwan
Exelixis Clinical #265
Taoyuan District, Taiwan
Exelixis Clinical Site #102
Dnipro, Ukraine
Exelixis Clinical Site #186
Dnipro, Ukraine
Exelixis Clinical Site #76
Kyiv, Ukraine
Exelixis Clinical Site #71
Lutsk, Ukraine
Exelixis Clinical Site #205
London, England, United Kingdom
Exelixis Clinical Site #235
Surrey Quays, England, United Kingdom
Exelixis Clinical Site #241
Taunton, England, United Kingdom
Exelixis Clinical Site #249
Blackburn, Lancashire, United Kingdom
Exelixis Clinical Site #231
Northwood, Middlesex, United Kingdom
Exelixis Clinical Site #194
Swansea, Wales, United Kingdom