Status:
ACTIVE_NOT_RECRUITING
Study of Cabozantinib in Combination With Atezolizumab Versus Sorafenib in Participants With Advanced Hepatocellular Carcinoma (HCC) Who Have Not Received Previous Systemic Anticancer Therapy
Lead Sponsor:
Exelixis
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 h...
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 sys...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
June 10 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2026
Estimated Enrollment :
837 Patients enrolled
Trial Details
Trial ID
NCT03755791
Start Date
June 10 2018
End Date
July 31 2026
Last Update
December 11 2025
Active Locations (245)
Enter a location and click search to find clinical trials sorted by distance.
1
Exelixis Clinical Site #208
Phoenix, Arizona, United States, 85004
2
Exelixis Clinical Site #159
Tucson, Arizona, United States, 85719
3
Exelixis Clinical Site #44
La Jolla, California, United States, 92037
4
Exelixis Clinical Site #112
Los Angeles, California, United States, 90033