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NCT03755791 · ClinicalTrials.gov registry record · Phase 3
Study of Cabozantinib in Combination With Atezolizumab Versus Sorafenib in Participants With Advanced Hepatocellular Carcinoma (HCC) Who Have Not Received Previous Systemic Anticancer Therapy
A Phase 3 study of Hepatocellular Carcinoma, sponsored by Exelixis.
- Active
- Registry status
- Phase 3
- Development phase
- 837
- Enrollment target
- 20
- Study locations
NCT03755791: Active Phase 3 study of Hepatocellular Carcinoma, sponsored by Exelixis.
NCT03755791 is a Phase 3 study of Hepatocellular Carcinoma that is active but no longer recruiting, run by Exelixis. The registered enrollment target is 837 participants, above the 252-participant average among 145 other Hepatocellular Carcinoma trials with a reported enrollment target (232% higher). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03755791, a Phase 3 study of Hepatocellular Carcinoma, is active but no longer recruiting, sponsored by Exelixis.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 837 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Atezolizumab
- DRUG Cabozantinib
- DRUG Sorafenib
Study Locations (20)
California
- Exelixis Clinical Site #44 - La Jolla
- Exelixis Clinical Site #112 - Los Angeles
- Exelixis Clinical Site #200 - Orange
- Exelixis Clinical Site #2 - Rialto
- Exelixis Clinical Site #207 - San Diego
- Exelixis Clinical Site #109 - San Francisco
- Exelixis Clinical Site #54 - San Francisco
Missouri
- Exelixis Clinical Site #11 - Kansas City
- Exelixis Clinical Site #5 - Kansas City
- Exelixis Clinical Site #8 - St Louis
Arizona
- Exelixis Clinical Site #208 - Phoenix
- Exelixis Clinical Site #159 - Tucson
Illinois
- Exelixis Clinical Site #195 - Chicago
- Exelixis Clinical Site #120 - Chicago
District of Columbia
- Exelixis Clinical Site #58 - Washington D.C.
Florida
- Exelixis Clinical Site #191 - Miami
Georgia
- Exelixis Clinical Site #4 - Atlanta
Maryland
- Exelixis Clinical Site #6 - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 837 participants |
| Start Date | 2018-06-10 |
| Est. Completion | 2026-07-31 |
| Phase | Phase 3 |
What the registry record for NCT03755791 still lists
NCT03755791 is an interventional study that assigns participants to a tested intervention. The registered 837 participants enrollment target is mid-sized for trials with a published cap, above the 252-participant average among 145 other Hepatocellular Carcinoma trials with a reported enrollment target (232% higher).
The record links to 1 condition, with Hepatocellular Carcinoma appearing as the primary indexed condition, and to 3 interventions - of which Atezolizumab is the first listed.
NCT03755791 names 20 study sites across 10 states, led by California, Missouri, Arizona.
Frequently Asked Questions
What is clinical trial NCT03755791 about?
NCT03755791 is a clinical study titled "Study of Cabozantinib in Combination With Atezolizumab Versus Sorafenib in Participants With Advanced Hepatocellular Carcinoma (HCC) Who Have Not Received Previous Systemic Anticancer Therapy". 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 enrol...
What is the current status of trial NCT03755791?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 837 participants. The study started on 2018-06-10. Estimated completion is 2026-07-31.
What conditions does trial NCT03755791 study?
This clinical trial studies the following conditions: Hepatocellular Carcinoma.
What interventions are being tested in trial NCT03755791?
The interventions under investigation include: Atezolizumab (DRUG), Cabozantinib (DRUG), Sorafenib (DRUG).
Who is sponsoring clinical trial NCT03755791?
This trial is sponsored by Exelixis, which has 48 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03755791 being conducted?
This trial has 20 study locations across Arizona, California, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hepatocellular Carcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03755791's enrollment target sits among peer trials
837 12th of 145 higher than 134 of 145 other Hepatocellular Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hepatocellular Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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