Pembrolizumab in Combination With Decitabine and Hypofractionated Index Lesion Radiation in Pediatrics and Young Adults
Status:
Recruiting
Trial end date:
2025-01-12
Target enrollment:
Participant gender:
Summary
This pilot study is designed to assess the safety, tolerability, and preliminary anti-tumor
activity of the combination of pembrolizumab, decitabine and fixed-dose hypofractionated
index site radiotherapy in pediatric and young adult patients with relapsed, refractory or
progressive non-primary CNS solid tumors and lymphomas.
Primary Objectives
- To determine the feasibility of administering pembrolizumab in combination with
decitabine and hypofractionated index lesion radiation
- To identify the treatment related toxicity and tolerability of the combination of
decitabine and pembrolizumab with hypofractionated index lesion radiation
Secondary Objective
To preliminarily define the anti-tumor efficacy of the combination of pembrolizumab,
decitabine and hypofractionated index lesion radiation in patients with relapsed, refractory,
or progressive non-CNS solid tumors and lymphomas using overall response rate (CR + PR) by
irRECIST after 2 cycles of therapy.
Exploratory Objectives
To profile the kinetics of the immune response and to correlate with promotor methylation
changes, nuclear imaging, stool microbiota diversity, and tumor associated antigen immune
responses.