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NCT03755791 · ClinicalTrials.gov record · last posted 2025-12-11

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

Study acronym: COSMIC-312
StatusActive, Not Recruiting
PhasePhase 3
SponsorExelixis
Started2018-06-10
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from the ClinicalTrials.gov record
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.

Amendment record 45 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 45 times since 2018-11-26; most recent amendment 2025-11-25. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

2023-07-07
Status change Recruiting→Active, Not Recruitingv42
2018-12-04
Status change Not Yet Recruiting→Recruitingv1
Trial Details
NCT Number NCT03755791
Lead Sponsor Exelixis
Conditions Hepatocellular Carcinoma
Enrollment 837 participants
Start Date 2018-06-10
Primary Completion 2021-11-30 (estimated)
Study Completion 2026-07-31 (estimated)
Updated on ClinicalTrials.gov 2025-12-11