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

Completed · Early Phase 1

Conditions studied: Childhood Solid Tumor, Childhood Lymphoma, Relapsed Cancer, Refractory Cancer, Adult Solid Tumor, Adult Lymphoma

In brief

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.

Key facts

Study ID

NCT03445858

Run by

Children's Hospital Medical Center, Cincinnati

People needed

22

Starts

2018-02-12

Expected to finish

2023-11-07

Last updated by the study team

2026-02-18

Who can join

Age: 1 and older, up to 40. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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.
• 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.

Where it is running

• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.