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MEKPEM: A Phase I/II trial of MK-3475 (pembrolizumab) in children’s solid tumors and lymphomas

About this study

This study will enroll participants who have melanoma or other solid tumors or lymphoma that is growing or has come back after receiving standard therapy. People with these conditions are usually treated with surgeries and/or chemotherapy using drugs approved by the U.S. Food and Drug Administration (FDA) because there is no standard therapy for this type of cancer. The drug in this study is called pembrolizumab.

Before enrolling, prospective participants will be screened. This process will include certain exams, tests, or procedures to make sure this study is a good option for them.

Purpose of this clinical trial

The main goal of the study is to see how safe and effective pembrolizumab is in treating children with these conditions. Researchers also want to learn the good and bad side effects of this medicine.

Eligibility overview

  • Between 6 months and 18 years old with diagnosis of MSI-H solid tumor OR
  • Between 3 and 18 years old with relapsed or refractory classical Hodgkin lymphoma OR
  • Between 12 and 18 years old with diagnosis of melanoma OR
  • Between 12 and 18 years old with a diagnosis of Stage IIB, IIC, III, or IV melanoma, who had prior surgery to remove the tumor, but no other treatment (including radiation), no metastatic disease, and who have completely recovered
  • Negative pregnancy test 72 hours prior to medication administration in participants of child-bearing potential
  • Appropriate liver and kidney functions

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.

Overview

Full title:

A Phase I/II Study of Pembrolizumab (MK-3475) in Children With Advanced Melanoma or a PD-L1 Positive Advanced, Relapsed or Refractory Solid Tumor or Lymphoma (KEYNOTE-051)

Study goal:

The main goal of the study is to see how safe and effective pembrolizumab is in treating children with these conditions. Researchers also want to learn the good and bad side effects of this medicine.

Diagnosis:

Advanced melanoma or PD-L1 positive advanced relapsed or refractory solid tumor or lymphoma or high-grade glioma

Age:

6 months to 18 years old

For physicians and researchers

Patients accepted to St. Jude must be referred by a physician or other qualified medical professional. Learn how St. Jude can partner with you to care for your patient.

 

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