Last updated on September 2018

A Pilot Study of Pembrolizumab in Combination with Decitabine and Hypofractionated Index Lesion Radiation in Pediatric and Young Adult Patients with Relapsed and Refractory Solid Tumors or Lymphoma


Brief description of study

This goal of this study is to demonstrate a safe approach to increasing the activity of PD-1 immunotherapy in younger patients with solid tumors or lymphomas.  Eligible patients between the ages of 1 and 40 may receive repeating cycles of the PD-1 inhibitor, pembrolizumab, coupled with two therapies designed to overcome key hurdles to single agent PD-1 inhibitor success.  Decitabine is a low-dose chemotherapy that is expected to increase the ability of the immune system to recognize cancer cells, and will be given prior to each dose of pembrolizumab.  Furthermore, a short course of radiation will subsequently be administered to one or more tumors to not only control the tumor, but importantly to stimulate the immune system.  In addition to this combination, some patients may have their tumor or tumors surgically removed if it is beneficial to them.  Patients may receive this therapy for up to two years on this trial, as long as the therapy is tolerated and effective.

 

Clinical Study Identifier: TX212753

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