Study of Cabozantinib in Combination With Atezolizumab Versus Sorafenib in Subjects With Advanced HCC Who Have Not Received Previous Systemic Anticancer Therapy (COSMIC-312)

March 20, 2024 updated by: Exelixis

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

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 subjects receive single agent cabozantinib in order to determine its contribution to the overall safety and efficacy of the combination with atezolizumab.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a multicenter, randomized, open-label, controlled Phase 3 trial of cabozantinib in combination with atezolizumab versus sorafenib in adults with advanced HCC who have not received previous systemic anticancer therapy in the advanced HCC setting. The primary objective of this study is to evaluate the effect of cabozantinib in combination with atezolizumab on the duration of progression-free survival (PFS) and duration of overall survival (OS) versus sorafenib. The secondary objective is to evaluate the activity of single-agent cabozantinib compared with sorafenib in this patient population.

Study Type

Interventional

Enrollment (Actual)

837

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
      • City of Buenos Aires, Buenos Aires, Argentina, C1118AAT
        • Exelixis Clinical Site #217
      • City of Buenos Aires, Buenos Aires, Argentina, C1199ABB
        • Exelixis Clinical Site #213
      • City of Buenos Aires, Buenos Aires, Argentina, C1264AAA
        • Exelixis Clinical Site #216
      • Pilar, Buenos Aires, Argentina, B1629ODT
        • Exelixis Clinical Site #219
    • Santa Fe
      • Rosario, Santa Fe, Argentina, 2000
        • Exelixis Clinical Site #220
      • Rosario, Santa Fe, Argentina, S2000CVB
        • Exelixis Clinical Site #201
  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Exelixis Clinical Site #78
      • Darlinghurst, New South Wales, Australia, 2010
        • Exelixis Clinical Site #165
      • Kingswood, New South Wales, Australia, 2747
        • Exelixis Clinical Site #171
      • Kogarah, New South Wales, Australia, 2217
        • Exelixis Clinical Site #126
      • Westmead, New South Wales, Australia, 2145
        • Exelixis Clinical Site #155
    • Queensland
      • Greenslopes, Queensland, Australia, 4120
        • Exelixis Clinical Site #142
    • South Australia
      • Kurralta Park, South Australia, Australia
        • Exelixis Clinical Site #17
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Exelixis Clinical Site #107
      • Heidelberg, Victoria, Australia, 3084
        • Exelixis Clinical Site #166
      • Parkville, Victoria, Australia, 3050
        • Exelixis Clinical Site #72
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Exelixis Clinical Site #190
  • Austria
      • Wien, Austria, 1090
        • Exelixis Clinical Site #174
    • Kärnten
      • Klagenfurt, Kärnten, Austria, 9020
        • Exelixis Clinical Site #150
    • Lower Austria
      • St. Pölten, Lower Austria, Austria, 3100
        • Exelixis Clinical Site #137
    • Oberosterreich
      • Linz, Oberosterreich, Austria, 4010
        • Exelixis Clinical Site #64
    • Steiermark
      • Graz, Steiermark, Austria, 8036
        • Exelixis Clinical Site #198
  • Belgium
      • Brussels, Belgium, 1200
        • Exelixis Clinical Site #65
      • Edegem, Belgium, 2650
        • Exelixis Clinical Site #169
      • Gent, Belgium, 9000
        • Exelixis Clinical Site #148
      • Haine-Saint-Paul, Belgium, 7100
        • Exelixis Clinical Site #57
      • Leuven, Belgium, 3000
        • Exelixis Clinical Site #188
      • Liège, Belgium, 4000
        • Exelixis Clinical Site #102
    • California
      • Brussels, California, Belgium, 1070
        • Exelixis Clinical Site #50
  • Brazil
      • São Paulo, Brazil, 04543-000
        • Exelixis Clinical Site #91
    • BA
      • Salvador, BA, Brazil, 40110-060
        • Exelixis Clinical Site #184
    • MG
      • Belo Horizonte, MG, Brazil, 30110-022
        • Exelixis Clinical Site #89
      • Belo Horizonte, MG, Brazil, 30130-090
        • Exelixis Clinical Site #98
    • PR
      • Curitiba, PR, Brazil, 81520-060
        • Exelixis Clinical Site #113
    • RS
      • Porto Alegre, RS, Brazil, 90050-170
        • Exelixis Clinical Site #203
    • SP
      • Barretos, SP, Brazil, 14784-400
        • Exelixis Clinical Site #175
      • Jaú, SP, Brazil, 17210-120
        • Exelixis Clinical Site #121
      • São Paulo, SP, Brazil, 01246-900
        • Exelixis Clinical Site #186
      • São Paulo, SP, Brazil, 01321-001
        • Exelixis Clinical Site #156
      • São Paulo, SP, Brazil, 01509-010
        • Exelixis Clinical Site #187
      • São Paulo, SP, Brazil, 04538-132
        • Exelixis Clinical Site #181
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Exelixis Clinical Site #71
      • Edmonton, Alberta, Canada, T6G 2B7
        • Exelixis Clinical Site #205
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
        • Exelixis Clinical Site #34
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • Exelixis Clinical Site #222
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
        • Exelixis Clinical Site #194
      • Ottawa, Ontario, Canada, K1H 8L6
        • Exelixis Clinical Site #212
    • Quebec
      • Montréal, Quebec, Canada, H3T 1E2
        • Exelixis Clinical Site #85
  • China
      • Beijing, China, 100034
        • Exelixis Site #239
      • Beijing, China, 100050
        • Exelixis Clinical Site #237
      • Shanghai, China, 200001
        • Exelixis Site #240
      • Shanghai, China, 201305
        • Exelixis Clinical Site #232
    • Anhui
      • Hefei, Anhui, China, 230036
        • Exelixis Clinical Site #233
    • Fujian
      • Fuzhou, Fujian, China, 350014
        • Exelixis Clinical Site #228
      • Xiamen, Fujian, China, 361004
        • Exelixis Clinical Site #225
    • Guangdong
      • Guangzhou, Guangdong, China, 510280
        • Exelixis Clinical Site #242
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150081
        • Exelixis Clinical Site #227
    • Henan
      • Zhengzhou, Henan, China, 450008
        • Exelixis Clinical Site #230
    • Hunan
      • Changsha, Hunan, China, 410008
        • Exelixis Clinical Site #231
      • Changsha, Hunan, China, 410013
        • Exelixis Clinical Site #224
      • Changsha, Hunan, China, 410013
        • Exelixis Site #241
    • Jiangsu
      • Nanjing, Jiangsu, China, 210002
        • Exelixis Clinical Site #185
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Exelixis Clinical Site #221
      • Nanchang, Jiangxi, China, 330006
        • Exelixis Clinical Site #238
    • Jiansu
      • Jiangyin, Jiansu, China, 214400
        • Exelixis Clinical Site #234
    • Jilin
      • Changchun, Jilin, China, 130012
        • Exelixis Clinical Site #246
      • Changchun, Jilin, China, 130021
        • Exelixis Clinical Site #229
    • Liaoning
      • Shenyang, Liaoning, China, 110006
        • Exelixis Clinical Site #236
    • Shandong
      • Linyi, Shandong, China, 276000
        • Exelixis Clinical Site #226
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Exelixis Clinical Site #235
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310016
        • Exelixis Clinical Site #218
      • Hangzhou, Zhejiang, China, 310022
        • Exelixis Clinical Site #223
  • Colombia
    • Cordoba
      • Montería, Cordoba, Colombia, 230002
        • Exelixis Clinical Site #130
  • Czechia
      • Hradec Králové, Czechia, 500 05
        • Exelixis Clinical Site #18
      • Olomouc, Czechia, 779 00
        • Exelixis Clinical Site #37
      • Praha 4, Czechia, 140 59
        • Exelixis Clinical Site #10
      • Praha 5, Czechia, 150 06
        • Exelixis Clinical Site #38
  • France
      • Amiens, France, 80054
        • Exelixis Clinical Site #43
      • Besancon, France, 25030
        • Exelixis Clinical Site #27
      • Bondy Cedex, France, 93140
        • Exelixis Clinical Site #56
      • Caen Cedex 09, France, 14033
        • Exelixis Clinical Site #29
      • Clichy, France, 92110
        • Exelixis Clinical Site #48
      • Grenoble, France, 38043
        • Exelixis Clinical Site #23
      • Lille Cedex, France, 59037
        • Exelixis Clinical Site #55
      • Lyon Cedex 4, France, 69317
        • Exelixis Clinical Site #16
      • Montbeliard, France, 25250
        • Exelixis Clinical Site #31
      • Montpellier, France, 34295
        • Exelixis Clinical Site #49
      • Nantes, France, 44093
        • Exelixis Clinical Site #47
      • Nice, France, 06202
        • Exelixis Clinical Site #51
      • Pessac, France, 33604
        • Exelixis Clinical Site #20
      • Vandœuvre-lès-Nancy, France, 54511
        • Exelixis Clinical Site #32
  • Georgia
      • Batumi, Georgia, 6000
        • Exelixis Clinical Site #69
      • Tbilisi, Georgia, 0112
        • Exelixis Clinical Site #66
      • Tbilisi, Georgia, 0114
        • Exelixis Clinical Site #68
      • Tbilisi, Georgia, 0144
        • Exelixis Clinical Site #67
      • Tbilisi, Georgia, 0186
        • Exelixis Clinical Site #70
  • Germany
      • Berlin, Germany, 13125
        • Exelixis Clinical Site #214
      • Hamburg, Germany, 20246
        • Exelixis Clinical Site #215
    • Hessen
      • Frankfurt, Hessen, Germany, 60590
        • Exelixis Clinical Site #244
      • Kassel, Hessen, Germany, 34125
        • Exelixis Clinical Site #210
  • Hong Kong
      • Hong Kong, Hong Kong
        • Exelixis Clinical Site #146
      • Hong Kong, Hong Kong
        • Exelixis Clinical Site #42
      • Hong Kong, Hong Kong
        • Exelixis Clinical Site #9
  • Hungary
      • Budapest, Hungary, 1083
        • Exelixis Clinical Site #140
      • Debrecen, Hungary, 4032
        • Exelixis Clinical Site #25
      • Szeged, Hungary, 6720
        • Exelixis Clinical Site #26
  • Ireland
      • Dublin, Ireland, 8
        • Exelixis Clinical Site #170
  • Israel
      • Jerusalem, Israel, 9112001
        • Exelixis Clinical Site #30
      • Petah Tikva, Israel, 4941492
        • Exelixis Clinical Site #33
      • Ramat-Gan, Israel, 5262101
        • Exelixis Clinical Site #40
      • Rehovot, Israel, 7661041
        • Exelixis Clinical Site #35
  • Italy
      • Bologna, Italy, 40138
        • Exelixis Clinical Site #158
      • Brescia, Italy, 25124
        • Exelixis Clinical Site #152
      • Milan, Italy, 20122
        • Exelixis Clinical Site #147
      • Napoli, Italy, 80131
        • Exelixis Clinical Site #149
      • Novara, Italy, 28100
        • Exelixis Clinical Site #131
      • Roma, Italy, 00168
        • Exelixis Clinical Site #167
      • Torino, Italy, 10126
        • Exelixis Clinical Site #177
      • Torino, Italy, 10128
        • Exelixis Clinical Site #182
      • Udine, Italy, 33100
        • Exelixis Clinical Site #243
    • Lecce
      • Tricase, Lecce, Italy, 73039
        • Exelixis Clinical Site #163
    • Milano
      • Rozzano, Milano, Italy, 20089
        • Exelixis Clinical Site #53
  • Korea, Republic of
      • Busan, Korea, Republic of, 47392
        • Exelixis Clinical Site #77
      • Busan, Korea, Republic of, 49201
        • Exelixis Clinical Site #86
      • Busan, Korea, Republic of, 49241
        • Exelixis Clinical Site #114
      • Incheon, Korea, Republic of, 22332
        • Exelixis Clinical Site #75
      • Seoul, Korea, Republic of, 03080
        • Exelixis Clinical Site #104
      • Seoul, Korea, Republic of, 03080
        • Exelixis Clinical Site #105
      • Seoul, Korea, Republic of, 05505
        • Exelixis Clinical Site #99
      • Seoul, Korea, Republic of, 06273
        • Exelixis Clinical Site #79
      • Seoul, Korea, Republic of, 06351
        • Exelixis Clinical Site #93
    • Gyeonggi-do
      • Goyang-si, Gyeonggi-do, Korea, Republic of, 10408
        • Exelixis Clinical Site #157
      • Suwon, Gyeonggi-do, Korea, Republic of, 16499
        • Exelixis Clinical Site #127
  • Mexico
      • Ciudad De México, Mexico, 06700
        • Exelixis Clinical Site #133
      • Mexico City, Mexico, 06760
        • Exelixis Clinical Site #160
      • San Luis Potosí, Mexico, 78250
        • Exelixis Clinical Site #134
      • Veracruz, Mexico, 94300
        • Exelixis Clinical Site #153
    • Chiapas
      • Tuxtla Gutiérrez, Chiapas, Mexico, 29038
        • Exelixis Clinical Site #141
    • Guanajuato
      • León, Guanajuato, Mexico, 37000
        • Exelixis Clinical Site #135
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico, 64000
        • Exelixis Clinical Site #132
  • Netherlands
      • Utrecht, Netherlands, 3584 CX
        • Exelixis Clinical Site #36
    • Limburg
      • Maastricht, Limburg, Netherlands, 6229 HX
        • Exelixis Clinical Site #92
    • Noord-Holland
      • Amsterdam, Noord-Holland, Netherlands, 1105 AZ
        • Exelixis Clinical Site #52
    • Zuid-Holland
      • Rotterdam, Zuid-Holland, Netherlands, 3015 GD
        • Exelixis Clinical Site #84
  • New Zealand
    • Auckland
      • Grafton, Auckland, New Zealand, 1023
        • Exelixis Clinical Site #60
    • Wellington
      • Newton, Wellington, New Zealand, 6021
        • Exelixis Clinical Site #62
  • Philippines
      • Cebu City, Philippines, 6000
        • Exelixis Clinical Site #118
      • Pasig City, Philippines, 1605
        • Exelixis Clinical Site #117
      • Quezon City, Philippines, 1102
        • Exelixis Clinical Site #136
  • Poland
    • Mazowieckie
      • Warszawa, Mazowieckie, Poland, 02-507
        • Exelixis Clinical Site #41
    • Pomorskie
      • Gdansk, Pomorskie, Poland, 80-952
        • Exelixis Clinical Site #24
    • Slaskie
      • Mysłowice, Slaskie, Poland, 41-400
        • Exelixis Clinical Site #15
  • Romania
      • Bucuresti, Romania, 022328
        • Exelixis Clinical Site #206
      • Iaşi, Romania, 700483
        • Exelixis Clinical Site #209
    • Cluj
      • Cluj-Napoca, Cluj, Romania, 400015
        • Exelixis Clinical Site #204
      • Cluj-Napoca, Cluj, Romania, 400015
        • Exelixis Clinical Site #211
      • Cluj-Napoca, Cluj, Romania, 400641
        • Exelixis Clinical Site #202
  • Russian Federation
      • Kaluga, Russian Federation, 248007
        • Exelixis Clinical Site #81
      • Krasnodar, Russian Federation, 350040
        • Exelixis Clinical Site #95
      • Moscow, Russian Federation, 115478
        • Exelixis Clinical Site #108
      • Murmansk, Russian Federation, 183047
        • Exelixis Clinical Site #101
      • Nizhny Novgorod, Russian Federation, 603137
        • Exelixis Clinical Site #80
      • Saint Petersburg, Russian Federation, 197758
        • Exelixis Clinical Site #111
      • Saint-Petersburg, Russian Federation, 197758
        • Exelixis Clinical Site #90
      • Sochi, Russian Federation, 354057
        • Exelixis Clinical Site #73
    • Kursk Region
      • Kislino, Kursk Region, Russian Federation, 305524
        • Exelixis Clinical Site #74
  • Singapore
      • Singapore, Singapore, 169610
        • Exelixis Clinical Site #106
      • Singapore, Singapore, 217562
        • Exelixis Clinical Site #97
      • Singapore, Singapore, 308433
        • Exelixis Clinical Site #116
  • Spain
      • Barcelona, Spain, 08908
        • Exelixis Clinical Site #103
      • Madrid, Spain, 28007
        • Exelixis Clinical Site #164
      • Madrid, Spain, 28046
        • Exelixis Clinical Site #63
      • Valencia, Spain, 46009
        • Exelixis Clinical Site #168
      • Zaragoza, Spain, 50009
        • Exelixis Clinical Site #45
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Exelixis Clinical Site #28
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Exelixis Clinical Site #21
      • Majadahonda, Madrid, Spain, 28222
        • Exelixis Clinical Site #22
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Exelixis Clinical Site #59
  • Switzerland
      • Basel, Switzerland, 4031
        • Exelixis Clinical Site #115
      • Bern, Switzerland, 3010
        • Exelixis Clinical Site #172
      • Saint Gallen, Switzerland, 9007
        • Exelixis Clinical Site #110
      • Zurich, Switzerland, 8091
        • Exelixis Clinical Site #61
  • Taiwan
      • Changhua, Taiwan, 500
        • Exelixis Clinical Site #119
      • Kaohsiung, Taiwan, 833
        • Exelixis Clinical Site #162
      • Taichung, Taiwan, 407
        • Exelixis Clinical Site #161
      • Tainan, Taiwan, 736
        • Exelixis Clinical Site #145
      • Tainan City, Taiwan, 704
        • Exelixis Clinical Site #197
      • Taipei, Taiwan, 10002
        • Exelixis Clinical Site #82
      • Taipei, Taiwan, 10491
        • Exelixis Clinical Site #128
      • Taipei, Taiwan, 11217
        • Exelixisi Clinical Site #100
      • Taoyuan, Taiwan, 333
        • Exelixis Clinical Site #94
  • Thailand
      • Chiang Mai, Thailand, 50200
        • Exelixis Clinical Site #143
      • Khon Kaen, Thailand, 40002
        • Exelixis Clinical Site #183
    • Bangkok
      • Pathum Wan, Bangkok, Thailand, 10330
        • Exelixis Clinical Site #96
    • Songkla
      • Hat Yai, Songkla, Thailand, 90110
        • Exelixis Clinical Site #139
  • Turkey
      • Ankara, Turkey, 06010
        • Exelixis Clinical Site #193
      • Ankara, Turkey, 06230
        • Exelixis Clinical Site #178
      • Edirne, Turkey, 22030
        • Exelixis Clinical Site #173
      • Istanbul, Turkey, 34214
        • Exelixis Clinical Site #179
      • Malatya, Turkey, 44280
        • Exelixis Clinical Site #180
    • Instanbul
      • Istanbul, Instanbul, Turkey, 34098
        • Exelixis Clinical Site #189
  • Ukraine
      • Chernivtsi, Ukraine, 58013
        • Exelixis Clinical Site #125
      • Dnipro, Ukraine, 49102
        • Exelixis Clinical Site #122
      • Kharkiv, Ukraine, 61070
        • Exelixis Clinical Site #123
      • Odesa, Ukraine, 65055
        • Exelixis Clinical Site #124
      • Uzhhorod, Ukraine, 88000
        • Exelixis Clinical Site #138
  • United Kingdom
    • England
      • Bristol, England, United Kingdom, BS2 8ED
        • Exelixis Clinical Site #83
      • Cambridge, England, United Kingdom, CB2 0QQ
        • Exelixis Clinical Site #87
      • London, England, United Kingdom, NW3 2QG
        • Exelixis Clinical Site #151
      • London, England, United Kingdom, W12 0HS
        • Exelixis Clinical Site #129
      • Manchester, England, United Kingdom, M20 4BX
        • Exelixis Clinical Site #192
    • Northern Ireland
      • Belfast, Northern Ireland, United Kingdom, BT9 7AB
        • Exelixis Clinical Site #196
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85004
        • Exelixis Clinical Site #208
      • Tucson, Arizona, United States, 85719
        • Exelixis Clinical Site #159
    • California
      • La Jolla, California, United States, 92037
        • Exelixis Clinical Site #44
      • Los Angeles, California, United States, 90033
        • Exelixis Clinical Site #112
      • Orange, California, United States, 92868-3201
        • Exelixis Clinical Site #200
      • Rialto, California, United States, 92377
        • Exelixis Clinical Site #2
      • San Diego, California, United States, 92093
        • Exelixis Clinical Site #207
      • San Francisco, California, United States, 94115
        • Exelixis Clinical Site #109
      • San Francisco, California, United States, 94158
        • Exelixis Clinical Site #54
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Exelixis Clinical Site #58
    • Florida
      • Miami, Florida, United States, 33125
        • Exelixis Clinical Site #191
    • Georgia
      • Atlanta, Georgia, United States, 30318
        • Exelixis Clinical Site #4
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Exelixis Clinical Site #195
      • Chicago, Illinois, United States, 60637
        • Exelixis Clinical Site #120
    • Maryland
      • Baltimore, Maryland, United States, 21202
        • Exelixis Clinical Site #6
    • Massachusetts
      • Burlington, Massachusetts, United States, 01805
        • Exelixis Clinical Site #7
    • Missouri
      • Kansas City, Missouri, United States, 64128
        • Exelixis Clinical Site #11
      • Kansas City, Missouri, United States, 64131
        • Exelixis Clinical Site #5
      • Saint Louis, Missouri, United States, 63110
        • Exelixis Clinical Site #8
    • Nevada
      • Las Vegas, Nevada, United States, 89169
        • Exelixis Clinical Site #1
    • New Jersey
      • New Brunswick, New Jersey, United States, 08903
        • Exelixis Clinical Site #14
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • Exelixis Clinical Site #76
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7600
        • Exelixis Clinical Site #12
    • Ohio
      • Toledo, Ohio, United States, 43614
        • Exelixis Clinical Site #39
    • Oregon
      • Portland, Oregon, United States, 97213
        • Exelixis Clinical Site #176
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Exelixis Clinical Site #88
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Exelixis Clinical Site #144
    • Texas
      • Dallas, Texas, United States, 75246
        • Exelixis Clinical Site #199
      • Houston, Texas, United States, 77030
        • Exelixis Clinical Site #154
      • Temple, Texas, United States, 76508
        • Exelixis Clinical Site #19
    • Washington
      • Seattle, Washington, United States, 98101
        • Exelixis Clinical Site #13
      • Seattle, Washington, United States, 98109
        • Exelixis Clinical Site #46
      • Spokane, Washington, United States, 99208
        • Exelixis Clinical Site #3

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

No

Description

Inclusion Criteria:

  • Histological or cytological diagnosis of HCC or clinical diagnosis of HCC in cirrhotic patients by CT or MRI per the AASLD 2018 or EASL 2018 guidelines.
  • The subject has disease that is not amenable to a curative treatment approach (eg, transplant, surgery, ablation therapy) or locoregional therapy (eg, TACE).
  • Measurable disease per RECIST 1.1 as determined by the Investigator.
  • Barcelona Clinic Liver Cancer (BCLC) stage Category B or C.
  • Child-Pugh Score of A.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Exclusion Criteria:

  • Known fibrolamellar carcinoma, sarcomatoid HCC or mixed hepatocellular cholangiocarcinoma.
  • Prior systemic anticancer therapy for advanced HCC including but not limited to chemotherapy, small molecule kinase inhibitors, and immune checkpoint inhibitors (ICIs). Subjects who have received local intratumoral or arterial chemotherapy are eligible; local anticancer therapy within ≥ 28 days before randomization
  • Radiation therapy for bone metastasis within 2 weeks, any other radiation therapy within 8 weeks prior to randomization.
  • Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 8 weeks prior to randomization.
  • Concomitant anticoagulation with oral anticoagulants

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)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental arm
Subjects with advanced HCC will receive cabozantinib 40 mg oral, qd + atezolizumab 1200 mg infusion, q3w
Drug: Cabozantinib
Supplied as 20-mg tablets; administered orally daily at 40 mg
Other Names:
  • XL184
  • Cabometyx®
Drug: Cabozantinib
Supplied as 60-mg tablets; administered orally once daily at 60 mg
Other Names:
  • XL184
  • Cabometyx®
Drug: Atezolizumab
Supplied as 1200 mg/20 mL (60 mg/mL) in sing-dose vials; administered as an IV infusion once every 3 weeks (q3w).
Other Names:
  • Tecentriq®
Active Comparator: Control arm
Subjects with advanced HCC will receive sorafenib 400 mg bid (twice a day)
Drug: Sorafenib
Supplied as 200-mg tablets; administered orally twice daily at 400 mg
Other Names:
  • Nexavar®
Other: Single-Agent Cabozantinib arm
Subjects with advanced HCC will receive cabozantinib 60 mg qd
Drug: Cabozantinib
Supplied as 20-mg tablets; administered orally daily at 40 mg
Other Names:
  • XL184
  • Cabometyx®
Drug: Cabozantinib
Supplied as 60-mg tablets; administered orally once daily at 60 mg
Other Names:
  • XL184
  • Cabometyx®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of Progression Free Survival (PFS) for the experimental arm vs. the control arm
Time Frame: Up to 27 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.
Duration of PFS per Response Evaluable Criteria in Solid Tumors version 1.1 (RECIST 1.1)
Up to 27 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.
Duration of Overall Survival (OS) for the experimental arm vs. the control arm
Time Frame: Up to 36 months after the first subject is randomized. Defined as time from randomization to date of death from any cause.
Up to 36 months after the first subject is randomized. Defined as time from randomization to date of death from any cause.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of Progression Free Survival (PFS) for the single-agent arm vs. the control arm
Time Frame: Up to 20 months after the first subject is randomized.
Duration of PFS per RECIST 1.1 by BIRC
Up to 20 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

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

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 10, 2018

Primary Completion (Actual)

March 8, 2021

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

November 26, 2018

First Submitted That Met QC Criteria

November 26, 2018

First Posted (Actual)

November 28, 2018

Study Record Updates

Last Update Posted (Actual)

March 22, 2024

Last Update Submitted That Met QC Criteria

March 20, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XL184-312

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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