Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Fibrolamellar Carcinoma
  • Hepatocellular Carcinoma, Childhood
  • Liver Cancer
  • Liver Cancer, Pediatric
Type
Interventional
Phase
Phase 2
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Younger than 30 years
Gender
Both males and females

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...

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.

Tracking Information

NCT #
NCT04134559
Collaborators
Not Provided
Investigators
Principal Investigator: Allison O'Neill, MD Dana-Farber Cancer Institute