RecruitingPhase 1Phase 2NCT07468136

Retifanlimab With or Without Difluoromethylornithine for the Treatment of Progressive High Grade Gliomas

Phase I/IIa Trial of Retifanlimab and Difluoromethylornithine (DFMO) in Patients With Progressive High-Grade Glioma


Sponsor

Mayo Clinic

Enrollment

33 participants

Start Date

Jun 23, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This phase I/II trial tests the safety, side effects best dose and effect of retifanlimab with or without difluoromethylornithine (DFMO) for the treatment of high grade gliomas that are growing, spreading, or getting worse (progressive). Immunotherapy with monoclonal antibodies, such as retifanlimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. DFMO is in a class of medications called ornithine decarboxylase (ODC) inhibitors. It works by blocking the action of a substance that signals tumor cells to multiply. This helps stop or slow the spread of tumor cells. Giving retifanlimab with or without DFMO mat be safe, tolerable and/or effective in treating patients with progressive high grade glioma.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Biospecimen Collection, a drug called Eflornithine, and others for people with anaplastic oligodendroglioma, astrocytoma, idh-mutant, grade 3, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiospecimen Collection

Undergo blood and CSF collection

DRUGEflornithine

Given PO

PROCEDURELumbar Puncture

Undergo lumbar puncture

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

BIOLOGICALRetifanlimab

Given IV

PROCEDURETumor Resection

Undergo resection surgery


Locations(1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

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NCT07468136


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