Y-90 Radioembolization + Immunotherapy for Liver Cancer

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: OHSU Knight Cancer Institute

Must not be taking: Anticoagulants, Immunotherapy, mTKI, others

Disqualifiers: Another primary tumor, Brain metastases, Advanced liver disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 18

What You Need to Know Before You Apply

What is the purpose of this trial?

This phase II trial tests how well giving Y-90 radioembolization, durvalumab, tremelimumab and zanzalintinib works for the treatment of hepatocellular carcinoma that cannot be removed by surgery (unresectable) and that has spread to nearby tissue or lymph nodes (locally advanced). Y-90 radioembolization is a therapy that injects radioactive particles directly into an artery that feeds liver tumors to cut off their blood supply. Immunotherapy with monoclonal antibodies, such as durvalumab and tremelimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Zanzalintinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving Y-90 radioembolization, durvalumab, tremelimumab and zanzalintinib may be effective for treating unresectable and locally-advanced hepatocellular carcinoma.

Who Is on the Research Team?

Adel Kardosh

Principal Investigator

OHSU Knight Cancer Institute

Are You a Good Fit for This Trial?

Inclusion Criteria

* Participant must provide written informed consent before any study-specific procedures or interventions are performed

I am 18 years old or older.

My body weight is over 30 kilograms.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Cycle 1 Treatment

Patients receive tremelimumab and durvalumab intravenously, followed by Y-90 radioembolization

7-14 days

2 visits (in-person)

Cycle 2-12 Treatment

Patients receive durvalumab intravenously and zanzalintinib orally daily, with cycles repeating every 28 days

12 cycles of 28 days each

12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

100 days and every 6 months for 1 year

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Durvalumab
• Tremelimumab
• Yttrium-90 Microsphere Radioembolization
• Zanzalintinib

How Is the Trial Designed?

Group I: Treatment (Y-90, tremelimumab, durvalumab, zanzalintinib) Experimental Treatment 10 Interventions

CYCLE 1: Patients receive tremelimumab IV and durvalumab IV, over 60 minutes, on day 1. 7-14 days later patients undergo transarterial radioembolization with Y-90 in the absence of disease progression or unacceptable toxicity. 7 days to 12 weeks later patients proceed to cycle 2. CYCLE 2-12: Patients receive durvalumab IV, over 30-60 minutes, on day 1 and zanzalintinib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo angiogram during screening and undergo SPECT, CT scan or MRI, and blood and urine sample collection throughout the study. Patients optionally undergo tumor biopsy throughout the study.

Who Is Running the Clinical Trial?

OHSU Knight Cancer Institute

Lead Sponsor

Trials

239

Recruited

2,089,000+

Exelixis

Industry Sponsor

Trials

126

Recruited

20,500+

Michael M. Morrissey

Exelixis

Chief Executive Officer since 2010

PhD in Chemistry from Harvard University, BSc in Chemistry from the University of Wisconsin

Vicki L. Goodman

Exelixis

Chief Medical Officer since 2022

MD

Oregon Health and Science University

Collaborator

Trials

1,024

Recruited

7,420,000+