Pembrolizumab for Liver Cancer

Recruiting in Palo Alto (17 mi)

+253 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Merck Sharp & Dohme Corp.

Stay on Your Current Meds

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This study will evaluate the safety and efficacy of pembrolizumab (MK-3475) versus placebo as adjuvant therapy in participants with hepatocellular carcinoma (HCC) and complete radiological response after surgical resection or local ablation. The primary hypotheses of this study are that adjuvant pembrolizumab is superior to placebo with respect to: 1) recurrence-free survival (RFS) as assessed by blinded independent central review (BICR); and 2) overall survival (OS).

Research Team

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Eligibility Criteria

This trial is for people who've had liver cancer (HCC) treated with surgery or local ablation and show no signs of the disease on scans. They must be in good physical condition, not pregnant or breastfeeding, using effective contraception if applicable, have a stable liver function score (Child-Pugh class A), controlled hepatitis B, and no other recent cancers or certain infections like HIV.

Inclusion Criteria

I have recovered from any side effects of my cancer surgery or local treatment.

My scans show no cancer signs 4 weeks after surgery or local treatment.

Has alpha fetoprotein (AFP) concentration lower than 400 ng/mL within 28 days prior to Cycle 1, Day 1

Exclusion Criteria

I have or had lung inflammation that needed steroids.

I have active tuberculosis.

I have had bleeding from varices in my esophagus or stomach in the last 6 months.

Treatment Details

Interventions

• Pembrolizumab (Checkpoint Inhibitor)
• Placebo (Other)

Trial Overview The study tests whether pembrolizumab, an immunotherapy drug, is better than a placebo at preventing cancer from coming back after treatment (recurrence-free survival) and improving overall survival rates in patients whose liver cancer was removed or destroyed.

Participant Groups

Group I: Pembrolizumab Experimental Treatment 1 Intervention

Participants receive intravenous (IV) pembrolizumab at 200 mg on Day 1 of each 21-day cycle for up to 17 cycles.

Group II: Placebo Placebo Group 1 Intervention

Participants receive IV placebo on Day 1 of each 21-day cycle for up to 17 cycles.

Who Is Running the Clinical Trial?

Merck Sharp & Dohme Corp.

Lead Sponsor

Trials

2,287

Recruited

4,582,000+

Chirfi Guindo

Merck Sharp & Dohme Corp.

Chief Medical Officer

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

Robert M. Davis

Merck Sharp & Dohme Corp.

Chief Executive Officer since 2021

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

Merck Sharp & Dohme LLC

Lead 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