Actively Recruiting
Atezolizumab in Combination With a Multi-Kinase Inhibitor for the Treatment of Unresectable, Locally Advanced, or Metastatic Liver Cancer
Led by Academic and Community Cancer Research United · Updated on 2025-09-16
122
Participants Needed
16
Research Sites
239 weeks
Total Duration
On this page
Sponsors
A
Academic and Community Cancer Research United
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Atezolizumab in Combination With a Multi-Kinase Inhibitor for the Treatment of Unresectable, Locally Advanced, or Metastatic Liver Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent within 28 days before randomization
- Willing to return to the enrolling institution for follow-up during active monitoring
- Age 18 years or older
- Confirmed hepatocellular carcinoma by biopsy or clinical criteria
- Locally advanced, metastatic, or unresectable liver cancer not suitable for curative treatment
- Previous progression on atezolizumab combined with bevacizumab as first-line therapy
- ECOG performance status of 0 or 1
- Child Pugh liver function class A
- Documented hepatitis B or C status with controlled viral levels if active
- At least one measurable untreated tumor lesion per RECIST v1.1
- Consent to use of archival tumor tissue if available
- Willingness to provide blood samples for research
- Willingness to provide tissue samples for research for first 10 patients per arm at Mayo Clinic sites
- Adequate blood counts and liver/kidney function within 28 days before randomization
- Negative pregnancy test for women of childbearing potential within 14 days before randomization
- Resolution of prior treatment toxicities to mild or less, except for certain conditions
- Use of two forms of contraception during and for 5 months after treatment if of childbearing potential or partner is
- Ability to take oral medications
You will not qualify if you...
- Diagnosis of fibrolamellar carcinoma, sarcomatoid carcinoma, or mixed hepatocellular cholangiocarcinoma
- Prior multi-kinase inhibitor treatment for advanced disease
- Major surgery within 4 weeks or minor surgery within 7 days before randomization with complications
- Anti-cancer treatment within 2 weeks before randomization
- Radiation therapy within 4 weeks or radionuclide treatment within 6 weeks before randomization
- Investigational therapy within 28 days before randomization
- Known brain or leptomeningeal metastases
- Co-infection with hepatitis B and C
- Active or history of autoimmune or immune deficiency diseases with some exceptions
- History or evidence of lung inflammation or pneumonitis
- Any other condition that contraindicates investigational drug use or increases risk
- Live vaccine within 4 weeks before or 5 months after atezolizumab treatment
- Severe allergic reactions to antibodies or atezolizumab components
- Untreated or high-risk esophageal/gastric varices for bleeding
- Recent or planned use of systemic immunostimulatory or immunosuppressive agents with exceptions
- Prior treatment with certain immune therapies except atezolizumab
- Use of strong CYP3A4 inducers or inhibitors within 14 days before randomization for cabozantinib
- Active tuberculosis
- Significant uncontrolled illnesses including serious heart conditions, infections, HIV, recent thromboembolic events, or cancer within 5 years except certain skin and localized cancers
- Pregnancy, breastfeeding, or intention to become pregnant during or within 5 months after treatment
- Uncontrolled hepatic encephalopathy within 6 weeks before randomization except mild cases
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 16 locations
1
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
Actively Recruiting
2
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224-9980
Withdrawn
3
Cleveland Clinic Weston Florida
Weston, Florida, United States, 33331
Withdrawn
4
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637
Not Yet Recruiting
5
Carle Cancer Center NCI Community Oncology Research Program
Urbana, Illinois, United States, 61801
Actively Recruiting
6
University Medical Center New Orleans
New Orleans, Louisiana, United States, 70112
Actively Recruiting
7
Michigan Cancer Research Consortium NCORP
Ann Arbor, Michigan, United States, 48106
Actively Recruiting
8
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109
Not Yet Recruiting
9
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
10
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Actively Recruiting
11
Duke University Medical Center
Durham, North Carolina, United States, 27710
Completed
12
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Withdrawn
13
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
Actively Recruiting
14
Rapid City Regional Hospital
Rapid City, South Dakota, United States, 57701
Actively Recruiting
15
Froedtert and the Medical College of Wisconsin LAPS
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
16
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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