Childhood Solid TumorEarly Phase 1NCT03445858

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

A Early Phase 1 study testing Pembrolizumab, Decitabine and Hypofractionated Index Site Radiation in people with Childhood Solid Tumor and Childhood Lymphoma, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 12 months to 40 years
Conditions the study is for: Childhood Solid Tumor, Childhood Lymphoma, Relapsed Cancer
What is being tested?: Pembrolizumab, Decitabine and Hypofractionated Index Site Radiation
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 22 participants
Where: 1 siteUnited States
Study dates: 12 Feb 2018to 7 Nov 2023
Phase: Early Phase 1

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 months to 40 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

None listed.

Who cannot join

Patients with primary CNS tumors, brainstem metastases, and/or carcinomatous meningitis are not eligible.
Pregnant or breast-feeding women will not be entered on this study.
Corticosteroids and other immunosuppressive therapy: Patients requiring systemic corticosteroids or other immunosuppressive medication within 7 days prior to enrollment are not eligible with the exception of physiologic replacement doses of corticosteroids.
Patients who are currently receiving another investigational drug are not eligible.
Patients who are currently receiving other anti-cancer agents are not eligible.
Patients with a history of a non-thyroiditis autoimmune disorder are not eligible. Asymptomatic laboratory abnormalities (e.g. ANA, rheumatoid factor) will not render a patient ineligible in the absence of a diagnosis of an autoimmune disorder. Autoimmune thyroiditis will not render a patient ineligible.

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Patients with known hepatitis B (HBsAg reactive) or C (HCV RNA -qualitative is detected) are excluded.
Patients with HIV are excluded if they have detectable viral loads or CD4 count is below 400 or they are not compliant with antiretroviral agents.
Patients who have an uncontrolled infection are not eligible.
Patients with immunodeficiency syndromes are not eligible.
Patients with a history of clinically significant cardiac disease are not eligible.
Patients with ongoing interstitial lung disease or pneumonitis are not eligible.
Patients with any clinically significant unrelated systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction).
Patients who have received a live vaccine less than or equal to 30 days prior to enrollment are ineligible.
Patients who have received a prior solid organ transplant at any time, or allogeneic bone marrow transplantation within the past 5 years (or have signs or symptoms of GVHD) are not eligible.
Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible.

Trial locations and contacts

1 site in 1 country.

United States1 site

Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229

Other trials in United States

About this study

Official title: 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

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.

Read the 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.

Conditions: Childhood Solid Tumor, Childhood Lymphoma, Relapsed Cancer, Refractory Cancer, Adult Solid Tumor, Adult Lymphoma
Being tested: Pembrolizumab, Decitabine, Hypofractionated Index Site Radiation
Keywords: Pediatric, Immunotherapy, Radiation, Radiotherapy, PD-1, Decitabine, DNMT, Epigenetic, Solid Tumor, Saroma, Lymphoma, Checkpoint, Abscopal, Cancer, Immune, SBRT
Medical subject headings: Recurrence, Neoplasms, Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PembrolizumabDrug
Also called Keytruda
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.
DecitabineDrug
Also called Dacogen
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.
Hypofractionated Index Site RadiationRadiation
Patients will receive a single 3 day course of fixed-dose hypofractionated radiotherapy to one or more index lesions during the first cycle only.

Study groups in NCT03445858
Study group	Role	What they receive
Pembrolizumab, Decitabine, Radiation	Experimental	Patients will receive pembrolizumab and decitabine every 28 days, and a single 3 day course of fixed-dose hypofractionated radiotherapy to one or more index lesions. Receives: Drug: Pembrolizumab; Drug: Decitabine; Radiation: Hypofractionated Index Site Radiation

What is being measured

The primary outcome is the main question the study is designed to answer.

Feasibility of administering Pembrolizumab in combination with Decitabine and hypofractionated index radiation
Incidence of number of patients who experience a DLT
Measured: Days 1 thru 57

Secondary outcomes (2)

Identification of treatment related toxicities and tolerability
Incidence of adverse events (toxicities) according to NCI CTCAE version 5.0
Measured: Days 1 thru 57
Define anti-tumor efficacy of treatment combination of pembrolizumab, decitabine, and hypofractionated index radiation (per irRECIST criteria)
Incidence of patients who experience an overall complete response or partial response to study treatment
Measured: 2 cycles (56 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Feb 20187 Nov 2023

First posted26 Feb 2018
Study start12 Feb 2018
Primary completion7 Nov 2023
Study completion7 Nov 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Childhood Solid TumorStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Early Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03445858
Sponsor's protocol ID: Pembro_BT_1603
Status last verified: Feb 2026
First submitted: 14 Feb 2018
Last updated: 18 Feb 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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