Cemiplimab +/- Fianlimab for Liver Cancer

(CLeAR Trial)

Overseen By Massey IIT Research Operations

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Virginia Commonwealth University

Must not be taking: Immunosuppressants, Live vaccines

Disqualifiers: Invasive malignancy, Extrahepatic disease, Organ transplant, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 51 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

Randomized, 2-arm, non-comparative, pilot study assessing the efficacy of cemiplimab with or without fianlimab after treatment with yttrium-90 (Y90).

Who Is on the Research Team?

Emily Kinsey, MD

Principal Investigator

Virginia Commonwealth University

Are You a Good Fit for This Trial?

This trial is for adults with hepatocellular carcinoma (HCC), a type of liver cancer. Participants must have an ECOG performance status ≤2, meaning they are able to care for themselves despite the disease. They should not be candidates for immediate surgery or transplant and must meet specific criteria related to liver function and tumor measurability.

Inclusion Criteria

My lung can tolerate a certain radiation dose and I have enough healthy liver volume for treatment.

I am 18 years old or older.

My liver disease can be measured by specific criteria.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Y90 Radioembolization

Patients receive yttrium-90 (Y90) radioembolization treatment

2-8 weeks

Treatment

Patients are randomized to receive cemiplimab or cemiplimab with fianlimab every 3 weeks for up to 17 cycles

51 weeks

Follow-up

Participants are monitored for progression-free survival and overall survival

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

• Cemiplimab
• Fianlimab

Trial Overview

The study is testing the effectiveness of cemiplimab alone or combined with fianlimab in patients who have undergone Y90 radioembolization treatment. It's a randomized pilot study where participants are placed into one of two groups by chance to compare outcomes.

How Is the Trial Designed?

Group I: Arm 2 Treatment with Experimental Treatment 1 Intervention

350 mg cemiplimab intravenous (IV) + 1600 mg fianlimab intravenous (IV) every 3 weeks

Group II: Arm 1 Treatment with cemiplimab Experimental Treatment 1 Intervention

350 mg cemiplimab intravenous (IV) every 3 weeks

Who Is Running the Clinical Trial?

Virginia Commonwealth University

Lead Sponsor

Trials

732

Recruited

22,900,000+

Regeneron Pharmaceuticals

Industry Sponsor

Trials

690

Recruited

948,000+

Founded

1988

Headquarters

Tarrytown, USA

Known For

Precision medicine

Top Products

Dupixent, EYLEA, Libtayo, Praluent

Leonard Schleifer

Regeneron Pharmaceuticals

Chief Executive Officer since 1988

MD and PhD in Medicine

George Yancopoulos

Regeneron Pharmaceuticals

Chief Medical Officer since 1997

MD from Harvard Medical School