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 · tracked via the Priya Life Science UK tracker

Sponsor

Exelixis

Phase

Phase 3

Started

2018-06-10

Last updated

2025-12-11

Condition(s) studied

Hepatocellular Carcinoma

Investigational drug(s) / intervention(s)

CabozantinibCabozantinibSorafenibAtezolizumab

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

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Key Inclusion Criteria: * 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. Key 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). 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 Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcome measure(s)

Progression Free Survival (PFS) for the Experimental Arm Versus the Control Arm in the PFS Intent to Treat (PITT) Population — From the date of first participant randomization up to 28 months
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.
Overall Survival (OS) for the Experimental Arm Versus the Control Arm in the ITT Population — From the date of first participant randomization up to 36 months
OS was defined as the time from randomization to death due to any cause.

Trial sites (245)

Facility	City	Region
Exelixis Clinical Site #208	Phoenix	Arizona
Exelixis Clinical Site #159	Tucson	Arizona
Exelixis Clinical Site #44	La Jolla	California
Exelixis Clinical Site #112	Los Angeles	California
Exelixis Clinical Site #200	Orange	California
Exelixis Clinical Site #2	Rialto	California
Exelixis Clinical Site #207	San Diego	California
Exelixis Clinical Site #109	San Francisco	California
Exelixis Clinical Site #54	San Francisco	California
Exelixis Clinical Site #58	Washington D.C.	District of Columbia
Exelixis Clinical Site #191	Miami	Florida
Exelixis Clinical Site #4	Atlanta	Georgia
Exelixis Clinical Site #195	Chicago	Illinois
Exelixis Clinical Site #120	Chicago	Illinois
Exelixis Clinical Site #6	Baltimore	Maryland
Exelixis Clinical Site #7	Burlington	Massachusetts
Exelixis Clinical Site #11	Kansas City	Missouri
Exelixis Clinical Site #5	Kansas City	Missouri
Exelixis Clinical Site #8	St Louis	Missouri
Exelixis Clinical Site #1	Las Vegas	Nevada
Exelixis Clinical Site #14	New Brunswick	New Jersey
Exelixis Clinical Site #76	Albuquerque	New Mexico
Exelixis Clinical Site #12	Chapel Hill	North Carolina
Exelixis Clinical Site #39	Toledo	Ohio
Exelixis Clinical Site #176	Portland	Oregon
Exelixis Clinical Site #88	Philadelphia	Pennsylvania
Exelixis Clinical Site #144	Charleston	South Carolina
Exelixis Clinical Site #199	Dallas	Texas
Exelixis Clinical Site #154	Houston	Texas
Exelixis Clinical Site #19	Temple	Texas
Exelixis Clinical Site #13	Seattle	Washington
Exelixis Clinical Site #46	Seattle	Washington
Exelixis Clinical Site #3	Spokane	Washington
Exelixis Clinical Site #217	City of Buenos Aires	Buenos Aires
Exelixis Clinical Site #213	City of Buenos Aires	Buenos Aires
Exelixis Clinical Site #216	City of Buenos Aires	Buenos Aires
Exelixis Clinical Site #219	Pilar	Buenos Aires
Exelixis Clinical Site #220	Rosario	Santa Fe Province
Exelixis Clinical Site #201	Rosario	Santa Fe Province
Exelixis Clinical Site #78	Camperdown	New South Wales

+ 205 more sites — see the full list on the official registry below.

On this site

📄 Cabometyx (cabozantinib) drug profile → 📄 Tecentriq (atezolizumab) drug profile →

More Exelixis trials in the UK

Zanzalintinib Versus Everolimus in Participants With Locally Advanced or Metastatic Neuroendocrine Tumors Recruiting

Study of Cabozantinib in Combination With Nivolumab and Ipilimumab in Patients With Previously Untreated Advanced or Metastatic Renal Cell Carcinoma Active, not recruiting

Study of Cabozantinib in Combination With Atezolizumab Versus Second NHT in Subjects With mCRPC Active, not recruiting

Study of XB010 in Subjects With Solid Tumors Recruiting

Study of Cabozantinib Alone or in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors Active, not recruiting

Other trials for the same condition

The HistoSonics System for Treatment of Primary and Metastatic Liver Tumors Using Histotripsy (#HOPE4LIVER EU/UK) Active, not recruiting

A First-in-human Study to Learn About the Safety of BAY 3547926 and How Well it Works in Participants With Advanced Liver Cancer Recruiting

A Study Evaluating Atezolizumab and Bevacizumab, With or Without Tiragolumab, in Participants With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma (HCC) (IMbrave152) Active, not recruiting

Phase III Study of Rilvegostomig in Combination With Bevacizumab With or Without Tremelimumab as First-line Treatment of Hepatocellular Carcinoma Recruiting

A Study of Nivolumab in Participants With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03755791 on ClinicalTrials.gov ↗ ← All trials in the UK