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NOT YET RECRUITING
NCT07468136
PHASE1/PHASE2

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

Sponsor: Mayo Clinic

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

33

Start Date

2026-04-24

Completion Date

2030-10-25

Last Updated

2026-03-12

Healthy Volunteers

No

Interventions

PROCEDURE

Biospecimen Collection

Undergo blood and CSF collection

DRUG

Eflornithine

Given PO

PROCEDURE

Lumbar Puncture

Undergo lumbar puncture

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

BIOLOGICAL

Retifanlimab

Given IV

PROCEDURE

Tumor Resection

Undergo resection surgery

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States