Pembrolizumab + Decitabine + Radiation for Cancer

Recruiting in Palo Alto (17 mi)

Overseen ByBrian Turpin, DO

Age: < 65

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: Children's Hospital Medical Center, Cincinnati

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

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.

Inclusion Criteria

I am between 1 year and 40 years old.

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

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

I can do most activities but need help with some.

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

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

Exclusion Criteria

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

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

I have ongoing lung inflammation or scarring.

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

I have been diagnosed with hepatitis B or C.

I have a history of serious heart problems.

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

Participant Groups

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.

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.

Decitabine is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Dacogen for: