Study on Using Pembrolizumab (KEYTRUDA) for Treating Liver Cancer in Children

Sponsor: Allison O'Neill, MD

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04134559

Provider View

This clinical trial is testing the immunotherapy drug pembrolizumab (KEYTRUDA) to see if it can help treat liver cancer in children and young adults. The study aims to find out if the drug is safe and effective for this type of cancer.

Patient Parameters

Program Overview

This study is exploring the use of pembrolizumab (KEYTRUDA), an immunotherapy drug, as a potential treatment for children and young adults with liver cancer, specifically hepatocellular carcinoma or hepatocellular neoplasm not otherwise specified (HCN NOS). The trial is in Phase II, which means it is focused on testing the safety and effectiveness of the drug for this specific condition. Pembrolizumab is already approved for other uses in adults, but this study will investigate its potential benefits for pediatric liver cancer. Researchers will also look at biological factors that might predict how well the drug works in these patients.

Description

Participants in this study will receive the drug pembrolizumab (KEYTRUDA) to see if it can help control liver cancer in children and young adults. This is a Phase II clinical trial, which means it is designed to test the safety and effectiveness of the drug for this specific type of cancer. Pembrolizumab is an immunotherapy drug that has been approved for other uses in adults, but it is still being studied for pediatric liver cancer.

The study will investigate whether pembrolizumab can help stabilize or reduce the cancer in pediatric patients. Researchers will also explore different biological factors of the tumor and immune system to see if they can predict which patients might benefit from the treatment. Participants will need to meet certain health criteria and provide a tumor sample for analysis. The study requires approval from each institution's review board, and participants must agree to use contraception during and after the study to prevent pregnancy.

Eligibility Criteria

Inclusion Criteria

  • Must be under 30 years old.
  • Must have a confirmed diagnosis of liver cancer that has returned or not responded to treatment.
  • Must have measurable cancer that can be tracked by scans or exams.
  • Must be in good overall health, with a performance status score of 60% or higher.
  • Must have recovered from any previous cancer treatments.
  • Must not have received certain treatments within a specified time before starting pembrolizumab.
  • Must have normal organ and bone marrow function, as shown by specific blood tests.
  • Must have insurance approval for pembrolizumab.
  • Must be able to understand and sign a consent form, with parental consent for those under 18.
  • Must agree to use contraception during and after the study to prevent pregnancy.
  • Must provide a tumor sample for analysis.

Exclusion Criteria

  • Cannot be taking other experimental drugs.
  • Cannot have received certain immune therapies before.
  • Cannot be on long-term steroid or anti-inflammatory medications.
  • Cannot have autoimmune diseases, except for mild asthma or skin conditions.
  • Cannot have a history of HIV or AIDS.
  • Cannot have severe allergies to pembrolizumab or similar drugs.
  • Cannot have uncontrolled illnesses or conditions that would interfere with the study.
  • Cannot have had a solid organ transplant.

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