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Anti-metabolites

Pembrolizumab + Decitabine + Radiation for Cancer

Phase < 1

Waitlist Available

Led By Brian Turpin, DO

Research Sponsored by Children's Hospital Medical Center, Cincinnati

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age: greater than or equal to 12 months and less than or equal to 40 years

Patients must have had histologic verification of malignancy at original diagnosis or relapse. Eligible diagnoses include relapsed or refractory solid tumors (excluding primary CNS tumors) and lymphoma in second or greater relapse or with refractory disease

Must not have

Patients with an uncontrolled infection

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 cycles (56 days)

Awards & highlights

No Placebo-Only Group

Summary

This trial is assessing the safety and preliminary effectiveness of a combination of pembrolizumab, decitabine, and radiation therapy in children and young adults with relapsed, refractory, or progressive non-CNS solid tumors and lymphomas.

Who is the study for?

This trial is for pediatric and young adult patients (12 months to 40 years old) with relapsed, refractory or progressive non-CNS solid tumors and lymphomas. They must have a history of cancer verified by tests, adequate organ function, no severe cardiac disease, not pregnant or breastfeeding, and not on other investigational drugs. Patients who've had certain treatments like stem cell infusions need to wait specific periods before joining.

What is being tested?

The study is testing the safety and potential effectiveness of combining pembrolizumab (an immune therapy drug), decitabine (a chemotherapy drug), and targeted radiation therapy in children and young adults with tough-to-treat cancers. The goal is to see if this combo can help control the cancer better than current methods.

What are the potential side effects?

Possible side effects include reactions related to the immune system that may affect organs, fatigue from treatment, changes in blood counts leading to increased infection risk or bleeding problems. Specific side effects will depend on how each patient's body reacts to the combination of therapies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 1 year and 40 years old.

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My cancer was confirmed by a lab test and has come back or didn’t respond to treatment.

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I have a cancer lesion that can be targeted with radiation.

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I can do most activities but need help with some.

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I have recovered from side effects of my previous cancer treatments.

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My current condition has no cure or treatments that would extend my life with good quality.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any infections that aren't responding to treatment.

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I have had an organ or bone marrow transplant, or I show signs of graft-versus-host disease.

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I have ongoing lung inflammation or scarring.

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I have a brain tumor, brainstem metastases, or carcinomatous meningitis.

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I have been diagnosed with hepatitis B or C.

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I have a history of serious heart problems.

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I am not currently taking any experimental drugs or cancer treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 cycles (56 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 cycles (56 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 cycles (56 days) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Feasibility of administering Pembrolizumab in combination with Decitabine and hypofractionated index radiation

Secondary study objectives

Define anti-tumor efficacy of treatment combination of pembrolizumab, decitabine, and hypofractionated index radiation (per irRECIST criteria)

Identification of treatment related toxicities and tolerability

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Pembrolizumab, Decitabine, RadiationExperimental Treatment3 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~2810

Decitabine

2004

Completed Phase 3

~1680