Clinical Trials Directory

Trials / Recruiting

RecruitingNCT04134559

Checkpoint Inhibition In Pediatric Hepatocellular Carcinoma

The Role of Checkpoint Inhibition in Relapsed/Refractory Pediatric Hepatocellular Carcinoma: Clinical Efficacy and Biologic Correlates - A Phase II Study

Status
Recruiting
Phase
Phase 2
Study type
Interventional
Enrollment
18 (estimated)
Sponsor
Allison O'Neill, MD · Academic / Other
Sex
All
Age
0 Years – 30 Years
Healthy volunteers
Not accepted

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).

Detailed 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.

Conditions

Interventions

TypeNameDescription
DRUGPembrolizumabPembrolizumab will be administered every 3 weeks, at predetermined dose with 21 consecutive days defined as a treatment cycle.

Timeline

Start date
2020-11-01
Primary completion
2027-01-01
Completion
2028-01-01
First posted
2019-10-22
Last updated
2026-02-24

Locations

5 sites across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT04134559. Inclusion in this directory is not an endorsement.