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
Are there results?: None posted in the registry

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.
More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
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

Recruiting
An Exploratory Study to Evaluate Immune Determinants of the Response to Adoptive Cell Therapy (ACT) in Solid and Hematologic Tumors
Solid Tumor, Adult, Solid Tumor, Childhood
RecruitingObservational study
NCI Childhood Cancer Data Initiative (CCDI) Led Pediatric, Adolescent, and Young Adult Rare Cancer Registry for Very Rare Solid Tumors
Very Rare Tumors, Very Rare Cancers
RecruitingPhase 1
Metarrestin (ML-246) in Subjects With Metastatic Solid Tumors
Advanced Solid Tumors, Metastatic Pancreatic Cancer
RecruitingPhase 3
An Imaging Agent (Pafolacianine) for Identifying Lesions in Pediatric Patients With Primary or Metastatic Solid Tumors
Childhood Malignant Solid Neoplasm, Childhood Malignant Thoracic Neoplasm
Active, not recruiting
The Effect of Exercise and Nicotinamide Riboside Muscle Health and Insulin Resistance in Survivors of Childhood Cancer
Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm

All Childhood Solid Tumor trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03445858
Acronym / sponsor ID: Pembro_BT_1603
Conditions: Childhood Solid Tumor, Childhood Lymphoma, Relapsed Cancer, Refractory Cancer, Adult Solid Tumor, Adult Lymphoma
Keywords: Pediatric, Immunotherapy, Radiation, Radiotherapy, PD-1, Decitabine, DNMT, Epigenetic
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
Study start: 12 Feb 2018 (actual)
Primary completion: 7 Nov 2023 (actual)
Study completion: 7 Nov 2023 (actual)
First posted: 26 Feb 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

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 design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Pembrolizumab, Decitabine, Radiation	Experimental	Drug: Pembrolizumab, Drug: Decitabine, Radiation: Hypofractionated Index Site RadiationPatients 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.

Who may qualify

Ages: 12 months to 40 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (0 listed)

Key exclusion criteria (16 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PembrolizumabAlso: KeytrudaPatients 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	Pembrolizumab, Decitabine, Radiation
DecitabineAlso: DacogenPatients 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.	Drug	Pembrolizumab, Decitabine, Radiation
Hypofractionated Index Site RadiationPatients will receive a single 3 day course of fixed-dose hypofractionated radiotherapy to one or more index lesions during the first cycle only.	Radiation	Pembrolizumab, Decitabine, Radiation

Primary outcome

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

2 secondary outcomes

Identification of treatment related toxicities and tolerability
Time frame: Days 1 thru 57
Define anti-tumor efficacy of treatment combination of pembrolizumab, decitabine, and hypofractionated index radiation (per irRECIST criteria)
Time frame: 2 cycles (56 days)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.

Related trials for Childhood Solid Tumor

Recruiting
An Exploratory Study to Evaluate Immune Determinants of the Response to Adoptive Cell Therapy (ACT) in Solid and Hematologic Tumors
Solid Tumor, Adult, Solid Tumor, Childhood
RecruitingObservational study
NCI Childhood Cancer Data Initiative (CCDI) Led Pediatric, Adolescent, and Young Adult Rare Cancer Registry for Very Rare Solid Tumors
Very Rare Tumors, Very Rare Cancers
RecruitingPhase 1
Metarrestin (ML-246) in Subjects With Metastatic Solid Tumors
Advanced Solid Tumors, Metastatic Pancreatic Cancer
RecruitingPhase 3
An Imaging Agent (Pafolacianine) for Identifying Lesions in Pediatric Patients With Primary or Metastatic Solid Tumors
Childhood Malignant Solid Neoplasm, Childhood Malignant Thoracic Neoplasm
Active, not recruiting
The Effect of Exercise and Nicotinamide Riboside Muscle Health and Insulin Resistance in Survivors of Childhood Cancer
Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Brian Turpin, DO principal investigator

Children's Hospital Medical Center, Cincinnati

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of administering Pembrolizumab in combination with Decitabine and hypofractionated index radiation (time frame: Days 1 thru 57). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03445858.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.