Sorafenib + Pembrolizumab for Liver Cancer

Recruiting at1 trial location

Overseen by Renuka Iyer

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Roswell Park Cancer Institute

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This phase Ib/II trial studies how well sorafenib tosylate and pembrolizumab work in treating patients with liver cancer that has spread to other parts of the body. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Giving sorafenib tosylate and pembrolizumab may work better in treating patients with liver cancer.

Research Team

Renuka Iyer

Principal Investigator

Roswell Park Cancer Institute

Eligibility Criteria

This trial is for adults with advanced or metastatic liver cancer who have not had prior treatments with sorafenib or PD1 blockers. They must have good physical function, adequate blood counts, and controlled hepatitis if present. Pregnant women, those with HIV, recent chemotherapy or radiotherapy recipients, and individuals with certain heart conditions cannot participate.

Inclusion Criteria

I have hepatitis B, but it is under control.

Total bilirubin =< 2.0 mg/dL

Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 5 X ULN

Exclusion Criteria

I do not have brain metastases.

I am currently pregnant or breastfeeding.

I've had one treatment for my condition, but not with sorafenib or PD1 blockers.

Treatment Details

Interventions

• Pembrolizumab (Checkpoint Inhibitor)
• Sorafenib Tosylate (Multi-kinase inhibitor)

Trial Overview The study is testing the combination of Sorafenib Tosylate (a drug that blocks tumor growth enzymes) and Pembrolizumab (an antibody that may prevent tumor cells from growing) to see if they are more effective together in treating liver cancer than when used separately.

Participant Groups

Group I: Treatment (sorafenib tosylate, pembrolizumab) Experimental Treatment 3 Interventions

Patients receive sorafenib tosylate PO BID on days -28 to -1 and 1-21. Patients also receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

Who Is Running the Clinical Trial?

Roswell Park Cancer Institute

Lead Sponsor

Trials

427

Recruited

40,500+

Dr. Julia Faller

Roswell Park Cancer Institute

Chief Medical Officer since 2024

DO from an unspecified institution

Dr. Candace S. Johnson

Roswell Park Cancer Institute

Chief Executive Officer since 2015

PhD in Immunology from The Ohio State University

Merck Sharp & Dohme LLC

Industry Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University