Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:21 AM
Ignite Modification Date:
2025-12-25 @ 12:21 AM
NCT ID:
NCT03445858
Brief 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.
Detailed Description:
Patients will receive pembrolizumab and decitabine every 28 days, and a single 3 day course of fixed-dose hypofractionated index site radiotherapy to one or more index lesions.
One cycle lasts 28 days. Radiation is given in Cycle 1 only. Cycles may repeat for a total of 26 cycles if patient meets criteria to continue protocol therapy.
Study:
NCT03445858
Study Brief:
Protocol Section:
NCT03445858