Study on the Safety and Effectiveness of Pembrolizumab Compared to Placebo for Liver Cancer Patients After Surgery or Local Treatment

Sponsor: Merck Sharp & Dohme LLC

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT03867084

Provider View

This clinical trial is testing whether the drug pembrolizumab is safe and effective in preventing the return of liver cancer after surgery or local treatment. The study compares pembrolizumab to a placebo to see which is better at keeping the cancer from coming back and improving overall survival.

Patient Parameters

Program Overview

The purpose of this study is to find out if pembrolizumab, a medication, is safe and works better than a placebo in preventing the return of liver cancer (hepatocellular carcinoma) after patients have had surgery or local treatment to remove or destroy the cancer. The study will look at how long patients remain free from cancer and their overall survival rates.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with liver cancer (HCC) confirmed by scans or pathology.
  • Recent scan shows no signs of cancer at least 4 weeks after surgery or local treatment, and must join the study within 12 weeks of treatment.
  • No signs of cancer on scans before joining the study.
  • Good overall health with an ECOG performance status of 0 or 1.
  • Liver function score of Child-Pugh class A (5 to 6 points).
  • Alpha fetoprotein (AFP) level below 400 ng/mL.
  • Controlled hepatitis B infection.
  • Fully recovered from any side effects of surgery or local treatment.
  • Women must not be pregnant or breastfeeding and must use effective birth control if of childbearing potential.
  • If surgery was performed, a tumor tissue sample must be provided.
  • Must have good organ function.

Exclusion Criteria

  • Have another active cancer that required treatment in the last 3 years.
  • Have had bleeding from esophageal or gastric varices in the last 6 months.
  • Have noticeable fluid buildup in the abdomen (ascites).
  • Have had liver-related brain issues (hepatic encephalopathy) in the last 6 months.
  • Have had liver treatment other than radiofrequency or microwave ablation.
  • Have a history of lung disease requiring steroids or current lung disease.
  • Have an active infection needing treatment.
  • Have both hepatitis B and C infections.
  • Have HIV infection.
  • Have active tuberculosis.
  • Have had previous treatment with certain immune therapies.
  • Have had previous systemic treatment for liver cancer.
  • Are receiving certain prohibited therapies, including some cancer treatments and investigational drugs.
  • Have received a live vaccine within 30 days before starting the study.
  • Are participating in another clinical trial or have used an investigational device recently.
  • Have an immune deficiency or are on long-term immune-suppressing medication.
  • Have a severe allergy to pembrolizumab or its ingredients.
  • Have an active autoimmune disease needing treatment in the last 2 years.
  • Have a psychiatric or substance abuse issue affecting study participation.
  • Have had a tissue or organ transplant.

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