Checkpoint Inhibition In Pediatric Hepatocellular Carcinoma

Status Recruiting

Clinical Trial Summary

This research study is studying an immunotherapy drug (pembrolizumab or KEYTRUDA) as a possible treatment for pediatric hepatocellular carcinoma or hepatocellular neoplasm not otherwise specified (HCN NOS).

Clinical Trial Description

Patients who fulfill eligibility criteria will be entered into the trial to receive pembrolizumab or KEYTRUDA This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied. In the case of this trial, the investigators are studying whether pembrolizumab can treat pediatric hepatocellular carcinoma. The FDA (the U.S. Food and Drug Administration) has not approved pembrolizumab for your specific disease but it has been approved for other uses in adults. Checkpoint inhibitors are in early-phase study in pediatric patients across diagnoses. In this research study, the investigators plan to investigate whether pediatric patients with hepatocellular carcinoma experience stable disease or response to pembrolizumab. In addition, the investigators would like to explore different biological factors of the tumor and immune system that might help us predict whether pediatric patients with HCC may benefit from treatment with pembrolizumab. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04134559
Study type	Interventional
Source	Dana-Farber Cancer Institute
Contact	DFCI Clinical Trials Hotline
Phone	877-DF-TRIAL
Email	allison_oneill@dfci.harvard.edu
Status	Recruiting
Phase	Phase 2
Start date	November 1, 2020
Completion date	January 1, 2025

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