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Study of Cabozantinib in Combination With Atezolizumab Versus Sorafenib in Participants With Advanced Hepatocellular Carcinoma (HCC) Who Have Not Received Previous Systemic Anticancer Therapy
Sponsor: Exelixis
Summary
This Phase 3 study evaluates the safety and efficacy of cabozantinib in combination with atezolizumab versus the standard of care sorafenib in adults with advanced hepatocellular carcinoma (HCC) who have not received previous systemic anticancer therapy. A single-agent cabozantinib arm will be enrolled in which participants receive single agent cabozantinib in order to determine its contribution to the overall safety and efficacy of the combination with atezolizumab.
Official title: A Randomized, Controlled Phase 3 Study of Cabozantinib (XL184) in Combination With Atezolizumab Versus Sorafenib in Subjects With Advanced Hepatocellular Carcinoma Who Have Not Received Previous Systemic Anticancer Therapy
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
837
Start Date
2018-06-10
Completion Date
2026-07-31
Last Updated
2025-12-11
Healthy Volunteers
No
Conditions
Interventions
Cabozantinib
Supplied as 20-mg tablets; administered orally daily at 40 mg
Cabozantinib
Supplied as 60-mg tablets; administered orally once daily at 60 mg
Sorafenib
Supplied as 200-mg tablets; administered orally twice daily at 400 mg
Atezolizumab
Supplied as 1200 mg/20 mL (60 mg/mL) in sing-dose vials; administered as an intravenous (IV) infusion q3w
Locations (245)
Exelixis Clinical Site #208
Phoenix, Arizona, United States
Exelixis Clinical Site #159
Tucson, Arizona, United States
Exelixis Clinical Site #44
La Jolla, California, United States
Exelixis Clinical Site #112
Los Angeles, California, United States
Exelixis Clinical Site #200
Orange, California, United States
Exelixis Clinical Site #2
Rialto, California, United States
Exelixis Clinical Site #207
San Diego, California, United States
Exelixis Clinical Site #109
San Francisco, California, United States
Exelixis Clinical Site #54
San Francisco, California, United States
Exelixis Clinical Site #58
Washington D.C., District of Columbia, United States
Exelixis Clinical Site #191
Miami, Florida, United States
Exelixis Clinical Site #4
Atlanta, Georgia, United States
Exelixis Clinical Site #195
Chicago, Illinois, United States
Exelixis Clinical Site #120
Chicago, Illinois, United States
Exelixis Clinical Site #6
Baltimore, Maryland, United States
Exelixis Clinical Site #7
Burlington, Massachusetts, United States
Exelixis Clinical Site #11
Kansas City, Missouri, United States
Exelixis Clinical Site #5
Kansas City, Missouri, United States
Exelixis Clinical Site #8
St Louis, Missouri, United States
Exelixis Clinical Site #1
Las Vegas, Nevada, United States
Exelixis Clinical Site #14
New Brunswick, New Jersey, United States
Exelixis Clinical Site #76
Albuquerque, New Mexico, United States
Exelixis Clinical Site #12
Chapel Hill, North Carolina, United States
Exelixis Clinical Site #39
Toledo, Ohio, United States
Exelixis Clinical Site #176
Portland, Oregon, United States
Exelixis Clinical Site #88
Philadelphia, Pennsylvania, United States
Exelixis Clinical Site #144
Charleston, South Carolina, United States
Exelixis Clinical Site #199
Dallas, Texas, United States
Exelixis Clinical Site #154
Houston, Texas, United States
Exelixis Clinical Site #19
Temple, Texas, United States
Exelixis Clinical Site #13
Seattle, Washington, United States
Exelixis Clinical Site #46
Seattle, Washington, United States
Exelixis Clinical Site #3
Spokane, Washington, United States
Exelixis Clinical Site #217
City of Buenos Aires, Buenos Aires, Argentina
Exelixis Clinical Site #213
City of Buenos Aires, Buenos Aires, Argentina
Exelixis Clinical Site #216
City of Buenos Aires, Buenos Aires, Argentina
Exelixis Clinical Site #219
Pilar, Buenos Aires, Argentina
Exelixis Clinical Site #220
Rosario, Santa Fe Province, Argentina
Exelixis Clinical Site #201
Rosario, Santa Fe Province, Argentina
Exelixis Clinical Site #78
Camperdown, New South Wales, Australia
Exelixis Clinical Site #165
Darlinghurst, New South Wales, Australia
Exelixis Clinical Site #171
Kingswood, New South Wales, Australia
Exelixis Clinical Site #126
Kogarah, New South Wales, Australia
Exelixis Clinical Site #155
Westmead, New South Wales, Australia
Exelixis Clinical Site #142
Greenslopes, Queensland, Australia
Exelixis Clinical Site #17
Kurralta Park, South Australia, Australia
Exelixis Clinical Site #107
Box Hill, Victoria, Australia
Exelixis Clinical Site #166
Heidelberg, Victoria, Australia
Exelixis Clinical Site #72
Parkville, Victoria, Australia
Exelixis Clinical Site #190
Nedlands, Western Australia, Australia
Exelixis Clinical Site #150
Klagenfurt, Carinthia, Austria
Exelixis Clinical Site #137
Sankt Pölten, Lower Austria, Austria
Exelixis Clinical Site #198
Graz, Styria, Austria
Exelixis Clinical Site #64
Linz, Upper Austria, Austria
Exelixis Clinical Site #174
Vienna, Austria
Exelixis Clinical Site #50
Brussels, California, Belgium
Exelixis Clinical Site #65
Brussels, Belgium
Exelixis Clinical Site #169
Edegem, Belgium
Exelixis Clinical Site #148
Ghent, Belgium
Exelixis Clinical Site #57
Haine-Saint-Paul, Belgium
Exelixis Clinical Site #188
Leuven, Belgium
Exelixis Clinical Site #102
Liège, Belgium
Exelixis Clinical Site #184
Salvador, Estado de Bahia, Brazil
Exelixis Clinical Site #89
Belo Horizonte, Minas Gerais, Brazil
Exelixis Clinical Site #98
Belo Horizonte, Minas Gerais, Brazil
Exelixis Clinical Site #113
Curitiba, Paraná, Brazil
Exelixis Clinical Site #203
Porto Alegre, Rio Grande do Sul, Brazil
Exelixis Clinical Site #175
Barretos, São Paulo, Brazil
Exelixis Clinical Site #121
Jaú, São Paulo, Brazil
Exelixis Clinical Site #186
São Paulo, São Paulo, Brazil
Exelixis Clinical Site #156
São Paulo, São Paulo, Brazil
Exelixis Clinical Site #187
São Paulo, São Paulo, Brazil
Exelixis Clinical Site #181
São Paulo, São Paulo, Brazil
Exelixis Clinical Site #91
São Paulo, Brazil
Exelixis Clinical Site #71
Calgary, Alberta, Canada
Exelixis Clinical Site #205
Edmonton, Alberta, Canada
Exelixis Clinical Site #34
Winnipeg, Manitoba, Canada
Exelixis Clinical Site #222
Halifax, Nova Scotia, Canada
Exelixis Clinical Site #194
Hamilton, Ontario, Canada
Exelixis Clinical Site #212
Ottawa, Ontario, Canada
Exelixis Clinical Site #85
Montreal, Quebec, Canada
Exelixis Clinical Site #233
Hefei, Anhui, China
Exelixis Clinical Site #228
Fuzhou, Fujian, China
Exelixis Clinical Site #225
Xiamen, Fujian, China
Exelixis Clinical Site #242
Guangzhou, Guangdong, China
Exelixis Clinical Site #227
Harbin, Heilongjiang, China
Exelixis Clinical Site #230
Zhengzhou, Henan, China
Exelixis Clinical Site #231
Changsha, Hunan, China
Exelixis Clinical Site #224
Changsha, Hunan, China
Exelixis Site #241
Changsha, Hunan, China
Exelixis Clinical Site #185
Nanjing, Jiangsu, China
Exelixis Clinical Site #221
Nanchang, Jiangxi, China
Exelixis Clinical Site #238
Nanchang, Jiangxi, China
Exelixis Clinical Site #234
Jiangyin, Jiansu, China
Exelixis Clinical Site #246
Changchun, Jilin, China
Exelixis Clinical Site #229
Changchun, Jilin, China
Exelixis Clinical Site #236
Shenyang, Liaoning, China
Exelixis Clinical Site #226
Linyi, Shandong, China
Exelixis Clinical Site #235
Chengdu, Sichuan, China
Exelixis Clinical Site #218
Hangzhou, Zhejiang, China
Exelixis Clinical Site #223
Hangzhou, Zhejiang, China
Exelixis Site #239
Beijing, China
Exelixis Clinical Site #237
Beijing, China
Exelixis Site #240
Shanghai, China
Exelixis Clinical Site #232
Shanghai, China
Exelixis Clinical Site #130
Montería, Departamento de Córdoba, Colombia
Exelixis Clinical Site #18
Hradec Králové, Czechia
Exelixis Clinical Site #37
Olomouc, Czechia
Exelixis Clinical Site #10
Prague, Czechia
Exelixis Clinical Site #38
Prague, Czechia
Exelixis Clinical Site #43
Amiens, France
Exelixis Clinical Site #27
Besançon, France
Exelixis Clinical Site #56
Bondy, France
Exelixis Clinical Site #29
Caen, France
Exelixis Clinical Site #48
Clichy, France
Exelixis Clinical Site #23
Grenoble, France
Exelixis Clinical Site #55
Lille, France
Exelixis Clinical Site #16
Lyon, France
Exelixis Clinical Site #31
Montbéliard, France
Exelixis Clinical Site #49
Montpellier, France
Exelixis Clinical Site #47
Nantes, France
Exelixis Clinical Site #51
Nice, France
Exelixis Clinical Site #20
Pessac, France
Exelixis Clinical Site #32
Vandœuvre-lès-Nancy, France
Exelixis Clinical Site #69
Batumi, Georgia
Exelixis Clinical Site #66
Tbilisi, Georgia
Exelixis Clinical Site #68
Tbilisi, Georgia
Exelixis Clinical Site #67
Tbilisi, Georgia
Exelixis Clinical Site #70
Tbilisi, Georgia
Exelixis Clinical Site #244
Frankfurt am Main, Hesse, Germany
Exelixis Clinical Site #210
Kassel, Hesse, Germany
Exelixis Clinical Site #214
Berlin, Germany
Exelixis Clinical Site #215
Hamburg, Germany
Exelixis Clinical Site #146
Hong Kong, Hong Kong
Exelixis Clinical Site #42
Hong Kong, Hong Kong
Exelixis Clinical Site #9
Hong Kong, Hong Kong
Exelixis Clinical Site #140
Budapest, Hungary
Exelixis Clinical Site #25
Debrecen, Hungary
Exelixis Clinical Site #26
Szeged, Hungary
Exelixis Clinical Site #170
Dublin, Ireland
Exelixis Clinical Site #30
Jerusalem, Israel
Exelixis Clinical Site #33
Petah Tikva, Israel
Exelixis Clinical Site #40
Ramat Gan, Israel
Exelixis Clinical Site #35
Rehovot, Israel
Exelixis Clinical Site #163
Tricase, Lecce, Italy
Exelixis Clinical Site #53
Rozzano, Milano, Italy
Exelixis Clinical Site #158
Bologna, Italy
Exelixis Clinical Site #152
Brescia, Italy
Exelixis Clinical Site #147
Milan, Italy
Exelixis Clinical Site #149
Naples, Italy
Exelixis Clinical Site #131
Novara, Italy
Exelixis Clinical Site #167
Roma, Italy
Exelixis Clinical Site #177
Torino, Italy
Exelixis Clinical Site #182
Torino, Italy
Exelixis Clinical Site #243
Udine, Italy
Exelixis Clinical Site #141
Tuxtla Gutiérrez, Chiapas, Mexico
Exelixis Clinical Site #135
León, Guanajuato, Mexico
Exelixis Clinical Site #132
Monterrey, Nuevo León, Mexico
Exelixis Clinical Site #133
Mexico City, Mexico
Exelixis Clinical Site #160
Mexico City, Mexico
Exelixis Clinical Site #134
San Luis Potosí City, Mexico
Exelixis Clinical Site #153
Veracruz, Mexico
Exelixis Clinical Site #92
Maastricht, Limburg, Netherlands
Exelixis Clinical Site #52
Amsterdam, North Holland, Netherlands
Exelixis Clinical Site #84
Rotterdam, South Holland, Netherlands
Exelixis Clinical Site #36
Utrecht, Netherlands
Exelixis Clinical Site #60
Grafton, Auckland, New Zealand
Exelixis Clinical Site #62
Newton, Wellington Region, New Zealand
Exelixis Clinical Site #118
Cebu City, Philippines
Exelixis Clinical Site #117
Pasig, Philippines
Exelixis Clinical Site #136
Quezon City, Philippines
Exelixis Clinical Site #41
Warsaw, Masovian Voivodeship, Poland
Exelixis Clinical Site #24
Gdansk, Pomeranian Voivodeship, Poland
Exelixis Clinical Site #15
Mysłowice, Silesian Voivodeship, Poland
Exelixis Clinical Site #204
Cluj-Napoca, Cluj, Romania
Exelixis Clinical Site #211
Cluj-Napoca, Cluj, Romania
Exelixis Clinical Site #202
Cluj-Napoca, Cluj, Romania
Exelixis Clinical Site #206
Bucharest, Romania
Exelixis Clinical Site #209
Iași, Romania
Exelixis Clinical Site #74
Kislino, Kursk Oblast, Russia
Exelixis Clinical Site #81
Kaluga, Russia
Exelixis Clinical Site #95
Krasnodar, Russia
Exelixis Clinical Site #108
Moscow, Russia
Exelixis Clinical Site #101
Murmansk, Russia
Exelixis Clinical Site #80
Nizhny Novgorod, Russia
Exelixis Clinical Site #111
Saint Petersburg, Russia
Exelixis Clinical Site #90
Saint Petersburg, Russia
Exelixis Clinical Site #73
Sochi, Russia
Exelixis Clinical Site #106
Singapore, Singapore
Exelixis Clinical Site #97
Singapore, Singapore
Exelixis Clinical Site #116
Singapore, Singapore
Exelixis Clinical Site #157
Goyang-si, Gyeonggi-do, South Korea
Exelixis Clinical Site #127
Suwon, Gyeonggi-do, South Korea
Exelixis Clinical Site #77
Busan, South Korea
Exelixis Clinical Site #86
Busan, South Korea
Exelixis Clinical Site #114
Busan, South Korea
Exelixis Clinical Site #75
Incheon, South Korea
Exelixis Clinical Site #104
Seoul, South Korea
Exelixis Clinical Site #105
Seoul, South Korea
Exelixis Clinical Site #99
Seoul, South Korea
Exelixis Clinical Site #79
Seoul, South Korea
Exelixis Clinical Site #93
Seoul, South Korea
Exelixis Clinical Site #28
Santander, Cantabria, Spain
Exelixis Clinical Site #21
Majadahonda, Madrid, Spain
Exelixis Clinical Site #22
Majadahonda, Madrid, Spain
Exelixis Clinical Site #59
Pamplona, Navarre, Spain
Exelixis Clinical Site #103
Barcelona, Spain
Exelixis Clinical Site #164
Madrid, Spain
Exelixis Clinical Site #63
Madrid, Spain
Exelixis Clinical Site #168
Valencia, Spain
Exelixis Clinical Site #45
Zaragoza, Spain
Exelixis Clinical Site #115
Basel, Switzerland
Exelixis Clinical Site #172
Bern, Switzerland
Exelixis Clinical Site #110
Sankt Gallen, Switzerland
Exelixis Clinical Site #61
Zurich, Switzerland
Exelixis Clinical Site #119
Changhua, Taiwan
Exelixis Clinical Site #162
Kaohsiung City, Taiwan
Exelixis Clinical Site #161
Taichung, Taiwan
Exelixis Clinical Site #197
Tainan, Taiwan
Exelixis Clinical Site #145
Tainan, Taiwan
Exelixis Clinical Site #82
Taipei, Taiwan
Exelixis Clinical Site #128
Taipei, Taiwan
Exelixisi Clinical Site #100
Taipei, Taiwan
Exelixis Clinical Site #94
Taoyuan District, Taiwan
Exelixis Clinical Site #96
Pathum Wan, Bangkok, Thailand
Exelixis Clinical Site #139
Hat Yai, Changwat Songkhla, Thailand
Exelixis Clinical Site #143
Chiang Mai, Thailand
Exelixis Clinical Site #183
Khon Kaen, Thailand
Exelixis Clinical Site #189
Istanbul, Instanbul, Turkey (Türkiye)
Exelixis Clinical Site #193
Ankara, Turkey (Türkiye)
Exelixis Clinical Site #178
Ankara, Turkey (Türkiye)
Exelixis Clinical Site #173
Edirne, Turkey (Türkiye)
Exelixis Clinical Site #179
Istanbul, Turkey (Türkiye)
Exelixis Clinical Site #180
Malatya, Turkey (Türkiye)
Exelixis Clinical Site #125
Chernivtsi, Ukraine
Exelixis Clinical Site #122
Dnipro, Ukraine
Exelixis Clinical Site #123
Kharkiv, Ukraine
Exelixis Clinical Site #124
Odesa, Ukraine
Exelixis Clinical Site #138
Uzhhorod, Ukraine
Exelixis Clinical Site #83
Bristol, England, United Kingdom
Exelixis Clinical Site #87
Cambridge, England, United Kingdom
Exelixis Clinical Site #151
London, England, United Kingdom
Exelixis Clinical Site #129
London, England, United Kingdom
Exelixis Clinical Site #192
Manchester, England, United Kingdom
Exelixis Clinical Site #196
Belfast, Northern Ireland, United Kingdom