Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03755791 | Study of Cabozantinib in Combination With Atezolizumab Versus Sorafenib in Participants With Advanced Hepatocellular Carcinoma (HCC) Who Have Not Received Previous Systemic Anticancer Therapy | PHASE3 | ACTIVE NOT_RECRUITING | 837 | — | — | Jun 10, 2018 | Jul 31, 2026 | Dec 11, 2025 | 245 | United States, Argentina +32 |
| NCT01908426 | Study of Cabozantinib (XL184) vs Placebo in Subjects With Hepatocellular Carcinoma Who Have Received Prior Sorafenib | PHASE3 | COMPLETED | 707 | — | — | Sep 26, 2013 | Jan 12, 2021 | May 6, 2021 | 104 | United States, Australia +17 |
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.
OS was defined as the time from randomization to death due to any cause.
The primary analysis of OS is defined as the time from randomization to death from any cause. The analysis was based on a second planned interim analysis prespecified to be performed at approximately the 75% information fraction (ie, at approximately 466 deaths). The data cutoff date for this event-driven analysis in the Intent to Treat (ITT) population was 01 June 2017. Median OS was calculated using the Kaplan-Meier estimates.
| Arm | Type | Description |
|---|---|---|
| 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) |
| Control arm | ACTIVE_COMPARATOR | Participants with advanced HCC will receive sorafenib 400 mg twice a day (bid) |
| Single-Agent Cabozantinib arm | OTHER | Participants with advanced HCC will receive cabozantinib 60 mg qd |
| Cabozantinib (XL184) | EXPERIMENTAL | Cabozantinib (XL184) 60 mg tablet once daily |
| Placebo | PLACEBO_COMPARATOR | Oral cabozantinib-matched placebo tablet once daily |
| Name | Type | Description |
|---|---|---|
| Cabozantinib | DRUG | Supplied as 20-mg tablets; administered orally daily at 40 mg |
| Sorafenib | DRUG | Supplied as 200-mg tablets; administered orally twice daily at 400 mg |
| Atezolizumab | DRUG | Supplied as 1200 mg/20 mL (60 mg/mL) in sing-dose vials; administered as an intravenous (IV) infusion q3w |
| Cabozantinib tablets | DRUG | - |
| Placebo tablets | DRUG | - |
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 L...