RecruitingPhase 2NCT05168163

Atezolizumab in Combination With a Multi-Kinase Inhibitor for the Treatment of Unresectable, Locally Advanced, or Metastatic Liver Cancer

A Phase II Randomized Study of Atezolizumab Plus Multi-Kinase Inhibitor Versus Multi-Kinase Inhibitor Alone in Subjects With Unresectable, Advanced Hepatocellular Carcinoma Who Previously Received Atezolizumab Plus Bevacizumab


Sponsor

Academic and Community Cancer Research United

Enrollment

122 participants

Start Date

May 27, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II trial tests whether atezolizumab in combination with a multi-kinase inhibitor (cabozantinib or lenvatinib) compared to multi-kinase inhibitor alone in treating patients with liver cancer that cannot be removed by surgery (unresectable), has spread to has spread to nearby tissue or lymph nodes (locally advanced), or has spread to other places in the body (metastatic), for which the patient has received treatment in the past (previously treated). Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cabozantinib and lenvatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving atezolizumab with cabozantinib or lenvatinib may kill more tumor cells in patients with liver cancer.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of atezolizumab (an immunotherapy drug) and a multi-kinase inhibitor (a targeted drug that blocks cancer growth signals) in people with advanced liver cancer (hepatocellular carcinoma) whose disease progressed after a prior combination immunotherapy treatment. **You may be eligible if...** - You are 18 years of age or older - You have confirmed hepatocellular carcinoma (liver cancer) that cannot be surgically removed or has spread - Your disease progressed after first-line treatment with atezolizumab plus bevacizumab - You are in reasonably good health (ECOG 0 or 1) with well-functioning liver (Child-Pugh class A) - You have at least one measurable tumor lesion on scans **You may NOT be eligible if...** - Your cancer has not previously been treated with first-line immunotherapy - You have severely impaired liver or kidney function - You have active, uncontrolled hepatitis B or C - You have serious heart or blood clotting problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALAtezolizumab

Given IV

DRUGCabozantinib

Given PO

DRUGLenvatinib

Given PO


Locations(16)

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Mayo Clinic in Florida

Jacksonville, Florida, United States

Cleveland Clinic Weston Florida

Weston, Florida, United States

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, United States

Carle Cancer Center NCI Community Oncology Research Program

Urbana, Illinois, United States

University Medical Center New Orleans

New Orleans, Louisiana, United States

Michigan Cancer Research Consortium NCORP

Ann Arbor, Michigan, United States

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

Rapid City Regional Hospital

Rapid City, South Dakota, United States

Froedtert and the Medical College of Wisconsin LAPS

Milwaukee, Wisconsin, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT05168163


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