MedTrace Logo

Pembrolizumab in Combination With Decitabine and Hypofractionated Index Lesion Radiation in Pediatrics and Young Adults

NCT03445858 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2026-02-18

No results posted yet for this study

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.

Conditions

  • Childhood Solid Tumor
  • Childhood Lymphoma
  • Relapsed Cancer
  • Refractory Cancer
  • Adult Solid Tumor
  • Adult Lymphoma

Interventions

DRUG

Pembrolizumab

Patients will receive pembrolizumab every 28 days.One cycle lasts 28 days. Cycles may repeat for a total of 26 cycles if patient meets criteria to continue protocol therapy.

DRUG

Decitabine

Patients will receive decitabine every 28 days.One cycle lasts 28 days. Cycles may repeat for a total of 26 cycles if patient meets criteria to continue protocol therapy.

RADIATION

Hypofractionated Index Site Radiation

Patients will receive a single 3 day course of fixed-dose hypofractionated radiotherapy to one or more index lesions during the first cycle only.

Sponsors & Collaborators

  • Children's Hospital Medical Center, Cincinnati

    lead OTHER

Principal Investigators

  • Brian Turpin, DO · Children's Hospital Medical Center, Cincinnati

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Months
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-12
Primary Completion
2023-11-07
Completion
2023-11-07
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03445858 on ClinicalTrials.gov