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
Description
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 subjects receive single agent cabozantinib in
order to determine its contribution to the overall safety and efficacy of the combination
with atezolizumab.
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.
Phase
N/AInclusion and Exclusion 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.
- 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
Sites
Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.
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