Study of Cabozantinib in Combination With Atezolizumab Versus Sorafenib in Participants With Advanced Hepatocellular Carcinoma (HCC) Who Have Not Received Previous Systemic Anticancer Therapy

NCT03755791 | Active Not Recruiting Phase 3 Results DMC FDA Drug

• 2 other identifiers: XL184-3122024-516479-34-00
• Study Type: interventional
• Target: 837
• Locations: 33 countries
• Sites: 240

Brief 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.

Conditions

Hepatocellular Carcinoma

Keywords

liver; cancer; hepatocellular; carcinoma

Outcome Measures

Primary Outcomes (2)

• Progression Free Survival (PFS) for the Experimental Arm Versus the Control Arm in the PFS Intent to Treat (PITT) Population

  PFS was defined as the time from randomization to the earlier of either the date of radiographic progression defined as a 20% increase in the sum of the longest diameters of target lesions, or the unequivocal appearance of new lesions, or progression of non-target disease per Blinded Independent Radiology Committee (BIRC) or the date of death due to any cause per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

  From the date of first participant randomization up to 28 months

• Overall Survival (OS) for the Experimental Arm Versus the Control Arm in the ITT Population

  OS was defined as the time from randomization to death due to any cause.

  From the date of first participant randomization up to 36 months

Secondary Outcomes (1)

• PFS for the Single-Agent Cabozantinib Arm Versus the Control Arm in the ITT Population

  From the date of first participant randomization up to 28 months

Study Arms (3)

Experimental arm

EXPERIMENTAL

Participants with advanced HCC will receive cabozantinib 40 milligrams (mg) oral, once daily (qd) + atezolizumab 1200 mg infusion, once every 3 weeks (q3w)

Drug: Cabozantinib; Drug: Atezolizumab

Control arm

ACTIVE COMPARATOR

Participants with advanced HCC will receive sorafenib 400 mg twice a day (bid)

Drug: Sorafenib

Single-Agent Cabozantinib arm

OTHER

Participants with advanced HCC will receive cabozantinib 60 mg qd

Drug: Cabozantinib

Interventions

Cabozantinib DRUG

Supplied as 20-mg tablets; administered orally daily at 40 mg

Also known as: XL184, Cabometyx®

Experimental arm

Sorafenib DRUG

Supplied as 200-mg tablets; administered orally twice daily at 400 mg

Also known as: Nexavar®

Control arm

Atezolizumab DRUG

Supplied as 1200 mg/20 mL (60 mg/mL) in sing-dose vials; administered as an intravenous (IV) infusion q3w

Also known as: Tecentriq®

Experimental arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histological or cytological diagnosis of HCC or clinical diagnosis of HCC in cirrhotic patients by Computed Tomography (CT) or Computed Tomography (MRI) per the American Association for the Study of Liver Diseases (AASLD) 2018 or European Association for the Study of the Liver (EASL) 2018 guidelines.
• The participant has disease that is not amenable to a curative treatment approach (eg, transplant, surgery, ablation therapy) or locoregional therapy (eg, TACE).
• Measurable disease per Response Evaluation Criteria in Solid Tumors (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.

You may not qualify if:

• 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). Participants 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

Sponsors & Collaborators

• Exelixis: lead

Study Sites (245)

Exelixis Clinical Site #208

Phoenix, Arizona, 85004, United States

Location

Exelixis Clinical Site #159

Tucson, Arizona, 85719, United States

Location

Exelixis Clinical Site #44

La Jolla, California, 92037, United States

Location

Exelixis Clinical Site #112

Los Angeles, California, 90033, United States

Location

Exelixis Clinical Site #200

Orange, California, 92868-3201, United States

Location

Exelixis Clinical Site #2

Rialto, California, 92377, United States

Location

Exelixis Clinical Site #207

San Diego, California, 92093, United States

Location

Exelixis Clinical Site #109

San Francisco, California, 94115, United States

Location

Exelixis Clinical Site #54

San Francisco, California, 94158, United States

Location

Exelixis Clinical Site #58

Washington D.C., District of Columbia, 20007, United States

Location

Exelixis Clinical Site #191

Miami, Florida, 33125, United States

Location

Exelixis Clinical Site #4

Atlanta, Georgia, 30318, United States

Location

Exelixis Clinical Site #195

Chicago, Illinois, 60612, United States

Location

Exelixis Clinical Site #120

Chicago, Illinois, 60637, United States

Location

Exelixis Clinical Site #6

Baltimore, Maryland, 21202, United States

Location

Exelixis Clinical Site #7

Burlington, Massachusetts, 01805, United States

Location

Exelixis Clinical Site #11

Kansas City, Missouri, 64128, United States

Location

Exelixis Clinical Site #5

Kansas City, Missouri, 64131, United States

Location

Exelixis Clinical Site #8

St Louis, Missouri, 63110, United States

Location

Exelixis Clinical Site #1

Las Vegas, Nevada, 89169, United States

Location

Exelixis Clinical Site #14

New Brunswick, New Jersey, 08903, United States

Location

Exelixis Clinical Site #76

Albuquerque, New Mexico, 87131, United States

Location

Exelixis Clinical Site #12

Chapel Hill, North Carolina, 27599-7600, United States

Location

Exelixis Clinical Site #39

Toledo, Ohio, 43614, United States

Location

Exelixis Clinical Site #176

Portland, Oregon, 97213, United States

Location

Exelixis Clinical Site #88

Philadelphia, Pennsylvania, 19107, United States

Location

Exelixis Clinical Site #144

Charleston, South Carolina, 29425, United States

Location

Exelixis Clinical Site #199

Dallas, Texas, 75246, United States

Location

Exelixis Clinical Site #154

Houston, Texas, 77030, United States

Location

Exelixis Clinical Site #19

Temple, Texas, 76508, United States

Location

Exelixis Clinical Site #13

Seattle, Washington, 98101, United States

Location

Exelixis Clinical Site #46

Seattle, Washington, 98109, United States

Location

Exelixis Clinical Site #3

Spokane, Washington, 99208, United States

Location

Exelixis Clinical Site #217

City of Buenos Aires, Buenos Aires, C1118AAT, Argentina

Location

Exelixis Clinical Site #213

City of Buenos Aires, Buenos Aires, C1199ABB, Argentina

Location

Exelixis Clinical Site #216

City of Buenos Aires, Buenos Aires, C1264AAA, Argentina

Location

Exelixis Clinical Site #219

Pilar, Buenos Aires, B1629ODT, Argentina

Location

Exelixis Clinical Site #220

Rosario, Santa Fe Province, 2000, Argentina

Location

Exelixis Clinical Site #201

Rosario, Santa Fe Province, S2000CVB, Argentina

Location

Exelixis Clinical Site #78

Camperdown, New South Wales, 2050, Australia

Location

Exelixis Clinical Site #165

Darlinghurst, New South Wales, 2010, Australia

Location

Exelixis Clinical Site #171

Kingswood, New South Wales, 2747, Australia

Location

Exelixis Clinical Site #126

Kogarah, New South Wales, 2217, Australia

Location

Exelixis Clinical Site #155

Westmead, New South Wales, 2145, Australia

Location

Exelixis Clinical Site #142

Greenslopes, Queensland, 4120, Australia

Location

Exelixis Clinical Site #17

Kurralta Park, South Australia, Australia

Location

Exelixis Clinical Site #107

Box Hill, Victoria, 3128, Australia

Location

Exelixis Clinical Site #166

Heidelberg, Victoria, 3084, Australia

Location

Exelixis Clinical Site #72

Parkville, Victoria, 3050, Australia

Location

Exelixis Clinical Site #190

Nedlands, Western Australia, 6009, Australia

Location

Exelixis Clinical Site #150

Klagenfurt, Carinthia, 9020, Austria

Location

Exelixis Clinical Site #137

Sankt Pölten, Lower Austria, 3100, Austria

Location

Exelixis Clinical Site #198

Graz, Styria, 8036, Austria

Location

Exelixis Clinical Site #64

Linz, Upper Austria, 4010, Austria

Location

Exelixis Clinical Site #174

Vienna, 1090, Austria

Location

Exelixis Clinical Site #50

Brussels, California, 1070, Belgium

Location

Exelixis Clinical Site #65

Brussels, 1200, Belgium

Location

Exelixis Clinical Site #169

Edegem, 2650, Belgium

Location

Exelixis Clinical Site #148

Ghent, 9000, Belgium

Location

Exelixis Clinical Site #57

Haine-Saint-Paul, 7100, Belgium

Location

Exelixis Clinical Site #188

Leuven, 3000, Belgium

Location

Exelixis Clinical Site #102

Liège, 4000, Belgium

Location

Exelixis Clinical Site #184

Salvador, Estado de Bahia, 40110-060, Brazil

Location

Exelixis Clinical Site #89

Belo Horizonte, Minas Gerais, 30110-022, Brazil

Location

Exelixis Clinical Site #98

Belo Horizonte, Minas Gerais, 30130-090, Brazil

Location

Exelixis Clinical Site #113

Curitiba, Paraná, 81520-060, Brazil

Location

Exelixis Clinical Site #203

Porto Alegre, Rio Grande do Sul, 90050-170, Brazil

Location

Exelixis Clinical Site #175

Barretos, São Paulo, 14784-400, Brazil

Location

Exelixis Clinical Site #121

Jaú, São Paulo, 17210-120, Brazil

Location

Exelixis Clinical Site #186

São Paulo, São Paulo, 01246-900, Brazil

Location

Exelixis Clinical Site #156

São Paulo, São Paulo, 01321-001, Brazil

Location

Exelixis Clinical Site #187

São Paulo, São Paulo, 01509-010, Brazil

Location

Exelixis Clinical Site #181

São Paulo, São Paulo, 04538-132, Brazil

Location

Exelixis Clinical Site #91

São Paulo, 04543-000, Brazil

Location

Exelixis Clinical Site #71

Calgary, Alberta, T2N 4N2, Canada

Location

Exelixis Clinical Site #205

Edmonton, Alberta, T6G 2B7, Canada

Location

Exelixis Clinical Site #34

Winnipeg, Manitoba, R3E 0V9, Canada

Location

Exelixis Clinical Site #222

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

Exelixis Clinical Site #194

Hamilton, Ontario, L8V 5C2, Canada

Location

Exelixis Clinical Site #212

Ottawa, Ontario, K1H 8L6, Canada

Location

Exelixis Clinical Site #85

Montreal, Quebec, H3T 1E2, Canada

Location

Exelixis Clinical Site #233

Hefei, Anhui, 230036, China

Location

Exelixis Clinical Site #228

Fuzhou, Fujian, 350014, China

Location

Exelixis Clinical Site #225

Xiamen, Fujian, 361004, China

Location

Exelixis Clinical Site #242

Guangzhou, Guangdong, 510280, China

Location

Exelixis Clinical Site #227

Harbin, Heilongjiang, 150081, China

Location

Exelixis Clinical Site #230

Zhengzhou, Henan, 450008, China

Location

Exelixis Clinical Site #231

Changsha, Hunan, 410008, China

Location

Exelixis Clinical Site #224

Changsha, Hunan, 410013, China

Location

Exelixis Site #241

Changsha, Hunan, 410013, China

Location

Exelixis Clinical Site #185

Nanjing, Jiangsu, 210002, China

Location

Exelixis Clinical Site #221

Nanchang, Jiangxi, 330006, China

Location

Exelixis Clinical Site #238

Nanchang, Jiangxi, 330006, China

Location

Exelixis Clinical Site #234

Jiangyin, Jiansu, 214400, China

Location

Exelixis Clinical Site #246

Changchun, Jilin, 130012, China

Location

Exelixis Clinical Site #229

Changchun, Jilin, 130021, China

Location

Exelixis Clinical Site #236

Shenyang, Liaoning, 110006, China

Location

Exelixis Clinical Site #226

Linyi, Shandong, 276000, China

Location

Exelixis Clinical Site #235

Chengdu, Sichuan, 610041, China

Location

Exelixis Clinical Site #218

Hangzhou, Zhejiang, 310016, China

Location

Exelixis Clinical Site #223

Hangzhou, Zhejiang, 310022, China

Location

Exelixis Site #239

Beijing, 100034, China

Location

Exelixis Clinical Site #237

Beijing, 100050, China

Location

Exelixis Site #240

Shanghai, 200001, China

Location

Exelixis Clinical Site #232

Shanghai, 201305, China

Location

Exelixis Clinical Site #130

Montería, Departamento de Córdoba, 230002, Colombia

Location

Exelixis Clinical Site #18

Hradec Králové, 500 05, Czechia

Location

Exelixis Clinical Site #37

Olomouc, 779 00, Czechia

Location

Exelixis Clinical Site #10

Prague, 140 59, Czechia

Location

Exelixis Clinical Site #38

Prague, 150 06, Czechia

Location

Exelixis Clinical Site #43

Amiens, 80054, France

Location

Exelixis Clinical Site #27

Besançon, 25030, France

Location

Exelixis Clinical Site #56

Bondy, 93140, France

Location

Exelixis Clinical Site #29

Caen, 14033, France

Location

Exelixis Clinical Site #48

Clichy, 92110, France

Location

Exelixis Clinical Site #23

Grenoble, 38043, France

Location

Exelixis Clinical Site #55

Lille, 59037, France

Location

Exelixis Clinical Site #16

Lyon, 69317, France

Location

Exelixis Clinical Site #31

Montbéliard, 25250, France

Location

Exelixis Clinical Site #49

Montpellier, 34295, France

Location

Exelixis Clinical Site #47

Nantes, 44093, France

Location

Exelixis Clinical Site #51

Nice, 06202, France

Location

Exelixis Clinical Site #20

Pessac, 33604, France

Location

Exelixis Clinical Site #32

Vandœuvre-lès-Nancy, 54511, France

Location

Exelixis Clinical Site #69

Batumi, 6000, Georgia

Location

Exelixis Clinical Site #66

Tbilisi, 0112, Georgia

Location

Exelixis Clinical Site #68

Tbilisi, 0114, Georgia

Location

Exelixis Clinical Site #67

Tbilisi, 0144, Georgia

Location

Exelixis Clinical Site #70

Tbilisi, 0186, Georgia

Location

Exelixis Clinical Site #244

Frankfurt am Main, Hesse, 60590, Germany

Location

Exelixis Clinical Site #210

Kassel, Hesse, 34125, Germany

Location

Exelixis Clinical Site #214

Berlin, 13125, Germany

Location

Exelixis Clinical Site #215

Hamburg, 20246, Germany

Location

Exelixis Clinical Site #146

Hong Kong, Hong Kong

Location

Exelixis Clinical Site #42

Hong Kong, Hong Kong

Location

Exelixis Clinical Site #9

Hong Kong, Hong Kong

Location

Exelixis Clinical Site #140

Budapest, 1083, Hungary

Location

Exelixis Clinical Site #25

Debrecen, 4032, Hungary

Location

Exelixis Clinical Site #26

Szeged, 6720, Hungary

Location

Exelixis Clinical Site #170

Dublin, 8, Ireland

Location

Exelixis Clinical Site #30

Jerusalem, 9112001, Israel

Location

Exelixis Clinical Site #33

Petah Tikva, 4941492, Israel

Location

Exelixis Clinical Site #40

Ramat Gan, 5262101, Israel

Location

Exelixis Clinical Site #35

Rehovot, 7661041, Israel

Location

Exelixis Clinical Site #163

Tricase, Lecce, 73039, Italy

Location

Exelixis Clinical Site #53

Rozzano, Milano, 20089, Italy

Location

Exelixis Clinical Site #158

Bologna, 40138, Italy

Location

Exelixis Clinical Site #152

Brescia, 25124, Italy

Location

Exelixis Clinical Site #147

Milan, 20122, Italy

Location

Exelixis Clinical Site #149

Naples, 80131, Italy

Location

Exelixis Clinical Site #131

Novara, 28100, Italy

Location

Exelixis Clinical Site #167

Roma, 00168, Italy

Location

Exelixis Clinical Site #177

Torino, 10126, Italy

Location

Exelixis Clinical Site #182

Torino, 10128, Italy

Location

Exelixis Clinical Site #243

Udine, 33100, Italy

Location

Exelixis Clinical Site #141

Tuxtla Gutiérrez, Chiapas, 29038, Mexico

Location

Exelixis Clinical Site #135

León, Guanajuato, 37000, Mexico

Location

Exelixis Clinical Site #132

Monterrey, Nuevo León, 64000, Mexico

Location

Exelixis Clinical Site #133

Mexico City, 06700, Mexico

Location

Exelixis Clinical Site #160

Mexico City, 06760, Mexico

Location

Exelixis Clinical Site #134

San Luis Potosí City, 78250, Mexico

Location

Exelixis Clinical Site #153

Veracruz, 94300, Mexico

Location

Exelixis Clinical Site #92

Maastricht, Limburg, 6229 HX, Netherlands

Location

Exelixis Clinical Site #52

Amsterdam, North Holland, 1105 AZ, Netherlands

Location

Exelixis Clinical Site #84

Rotterdam, South Holland, 3015 GD, Netherlands

Location

Exelixis Clinical Site #36

Utrecht, 3584 CX, Netherlands

Location

Exelixis Clinical Site #60

Grafton, Auckland, 1023, New Zealand

Location

Exelixis Clinical Site #62

Newton, Wellington Region, 6021, New Zealand

Location

Exelixis Clinical Site #118

Cebu City, 6000, Philippines

Location

Exelixis Clinical Site #117

Pasig, 1605, Philippines

Location

Exelixis Clinical Site #136

Quezon City, 1102, Philippines

Location

Exelixis Clinical Site #41

Warsaw, Masovian Voivodeship, 02-507, Poland

Location

Exelixis Clinical Site #24

Gdansk, Pomeranian Voivodeship, 80-952, Poland

Location

Exelixis Clinical Site #15

Mysłowice, Silesian Voivodeship, 41-400, Poland

Location

Exelixis Clinical Site #204

Cluj-Napoca, Cluj, 400015, Romania

Location

Exelixis Clinical Site #211

Cluj-Napoca, Cluj, 400015, Romania

Location

Exelixis Clinical Site #202

Cluj-Napoca, Cluj, 400641, Romania

Location

Exelixis Clinical Site #206

Bucharest, 022328, Romania

Location

Exelixis Clinical Site #209

Iași, 700483, Romania

Location

Exelixis Clinical Site #74

Kislino, Kursk Oblast, 305524, Russia

Location

Exelixis Clinical Site #81

Kaluga, 248007, Russia

Location

Exelixis Clinical Site #95

Krasnodar, 350040, Russia

Location

Exelixis Clinical Site #108

Moscow, 115478, Russia

Location

Exelixis Clinical Site #101

Murmansk, 183047, Russia

Location

Exelixis Clinical Site #80

Nizhny Novgorod, 603137, Russia

Location

Exelixis Clinical Site #111

Saint Petersburg, 197758, Russia

Location

Exelixis Clinical Site #90

Saint Petersburg, 197758, Russia

Location

Exelixis Clinical Site #73

Sochi, 354057, Russia

Location

Exelixis Clinical Site #106

Singapore, 169610, Singapore

Location

Exelixis Clinical Site #97

Singapore, 217562, Singapore

Location

Exelixis Clinical Site #116

Singapore, 308433, Singapore

Location

Exelixis Clinical Site #157

Goyang-si, Gyeonggi-do, 10408, South Korea

Location

Exelixis Clinical Site #127

Suwon, Gyeonggi-do, 16499, South Korea

Location

Exelixis Clinical Site #77

Busan, 47392, South Korea

Location

Exelixis Clinical Site #86

Busan, 49201, South Korea

Location

Exelixis Clinical Site #114

Busan, 49241, South Korea

Location

Exelixis Clinical Site #75

Incheon, 22332, South Korea

Location

Exelixis Clinical Site #104

Seoul, 03080, South Korea

Location

Exelixis Clinical Site #105

Seoul, 03080, South Korea

Location

Exelixis Clinical Site #99

Seoul, 05505, South Korea

Location

Exelixis Clinical Site #79

Seoul, 06273, South Korea

Location

Exelixis Clinical Site #93

Seoul, 06351, South Korea

Location

Exelixis Clinical Site #28

Santander, Cantabria, 39008, Spain

Location

Exelixis Clinical Site #21

Majadahonda, Madrid, 28222, Spain

Location

Exelixis Clinical Site #22

Majadahonda, Madrid, 28222, Spain

Location

Exelixis Clinical Site #59

Pamplona, Navarre, 31008, Spain

Location

Exelixis Clinical Site #103

Barcelona, 08908, Spain

Location

Exelixis Clinical Site #164

Madrid, 28007, Spain

Location

Exelixis Clinical Site #63

Madrid, 28046, Spain

Location

Exelixis Clinical Site #168

Valencia, 46009, Spain

Location

Exelixis Clinical Site #45

Zaragoza, 50009, Spain

Location

Exelixis Clinical Site #115

Basel, 4031, Switzerland

Location

Exelixis Clinical Site #172

Bern, 3010, Switzerland

Location

Exelixis Clinical Site #110

Sankt Gallen, 9007, Switzerland

Location

Exelixis Clinical Site #61

Zurich, 8091, Switzerland

Location

Exelixis Clinical Site #119

Changhua, 500, Taiwan

Location

Exelixis Clinical Site #162

Kaohsiung City, 833, Taiwan

Location

Exelixis Clinical Site #161

Taichung, 407, Taiwan

Location

Exelixis Clinical Site #197

Tainan, 704, Taiwan

Location

Exelixis Clinical Site #145

Tainan, 736, Taiwan

Location

Exelixis Clinical Site #82

Taipei, 10002, Taiwan

Location

Exelixis Clinical Site #128

Taipei, 10491, Taiwan

Location

Exelixisi Clinical Site #100

Taipei, 11217, Taiwan

Location

Exelixis Clinical Site #94

Taoyuan District, 333, Taiwan

Location

Exelixis Clinical Site #96

Pathum Wan, Bangkok, 10330, Thailand

Location

Exelixis Clinical Site #139

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

Exelixis Clinical Site #143

Chiang Mai, 50200, Thailand

Location

Exelixis Clinical Site #183

Khon Kaen, 40002, Thailand

Location

Exelixis Clinical Site #189

Istanbul, Instanbul, 34098, Turkey (Türkiye)

Location

Exelixis Clinical Site #193

Ankara, 06010, Turkey (Türkiye)

Location

Exelixis Clinical Site #178

Ankara, 06230, Turkey (Türkiye)

Location

Exelixis Clinical Site #173

Edirne, 22030, Turkey (Türkiye)

Location

Exelixis Clinical Site #179

Istanbul, 34214, Turkey (Türkiye)

Location

Exelixis Clinical Site #180

Malatya, 44280, Turkey (Türkiye)

Location

Exelixis Clinical Site #125

Chernivtsi, 58013, Ukraine

Location

Exelixis Clinical Site #122

Dnipro, 49102, Ukraine

Location

Exelixis Clinical Site #123

Kharkiv, 61070, Ukraine

Location

Exelixis Clinical Site #124

Odesa, 65055, Ukraine

Location

Exelixis Clinical Site #138

Uzhhorod, 88000, Ukraine

Location

Exelixis Clinical Site #83

Bristol, England, BS2 8ED, United Kingdom

Location

Exelixis Clinical Site #87

Cambridge, England, CB2 0QQ, United Kingdom

Location

Exelixis Clinical Site #151

London, England, NW3 2QG, United Kingdom

Location

Exelixis Clinical Site #129

London, England, W12 0HS, United Kingdom

Location

Exelixis Clinical Site #192

Manchester, England, M20 4BX, United Kingdom

Location

Exelixis Clinical Site #196

Belfast, Northern Ireland, BT9 7AB, United Kingdom

Location

Related Publications (3)

• Yau T, Kaseb A, Cheng AL, Qin S, Zhu AX, Chan SL, Melkadze T, Sukeepaisarnjaroen W, Breder V, Verset G, Gane E, Borbath I, Rangel JDG, Ryoo BY, Makharadze T, Merle P, Benzaghou F, Milwee S, Wang Z, Curran D, Kelley RK, Rimassa L. Cabozantinib plus atezolizumab versus sorafenib for advanced hepatocellular carcinoma (COSMIC-312): final results of a randomised phase 3 study. Lancet Gastroenterol Hepatol. 2024 Apr;9(4):310-322. doi: 10.1016/S2468-1253(23)00454-5. Epub 2024 Feb 13.

  PMID: 38364832 DERIVED

• Kelley RK, Rimassa L, Cheng AL, Kaseb A, Qin S, Zhu AX, Chan SL, Melkadze T, Sukeepaisarnjaroen W, Breder V, Verset G, Gane E, Borbath I, Rangel JDG, Ryoo BY, Makharadze T, Merle P, Benzaghou F, Banerjee K, Hazra S, Fawcett J, Yau T. Cabozantinib plus atezolizumab versus sorafenib for advanced hepatocellular carcinoma (COSMIC-312): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2022 Aug;23(8):995-1008. doi: 10.1016/S1470-2045(22)00326-6. Epub 2022 Jul 4.

  PMID: 35798016 DERIVED

• Kelley RK, W Oliver J, Hazra S, Benzaghou F, Yau T, Cheng AL, Rimassa L. Cabozantinib in combination with atezolizumab versus sorafenib in treatment-naive advanced hepatocellular carcinoma: COSMIC-312 Phase III study design. Future Oncol. 2020 Jul;16(21):1525-1536. doi: 10.2217/fon-2020-0283. Epub 2020 Jun 3.

  PMID: 32491932 DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Neoplasms; Carcinoma

Interventions

cabozantinib; Sorafenib; atezolizumab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Exelixis Medical Information
• Organization: Exelixis, Inc.

druginfo@exelixis.com

855-292-3935

Study Officials

• Medical Director

  Exelixis

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: At least 740 eligible participants with advanced HCC will be randomized in a 2:1:1 ratio. Experimental arm (at least 370 participants) will receive cabozantinib plus atezolizumab. Control arm (at least 185 participants) will receive sorafenib. Single-agent cabozantinib arm (at least185 participants) will receive single-agent cabozantinib

Study Record Dates

• First Submitted: November 26, 2018
• First Posted: November 28, 2018
• Study Start: June 10, 2018
• Primary Completion: November 30, 2021
• Study Completion (Estimated): July 31, 2026
• Last Updated: December 11, 2025
• Results First Posted: December 11, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

HU (3); UA (5); CN (24); AR (6); CO (1); CZ (4); KR (11); US (33); TU (6); GB (6); RO (5); IL (4); SG (3); IT (11); RU (9); PH (3); NL (4); IE (1); TW (9); PL (3); TH (4); ME (7); AU (11); FR (14); BR (12); HK (3); BE (7); CA (7); ES (9); NZ (2); CH (4); GE (5); DE (4)