NCT07468136

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

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 33 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anaplastic Oligodendroglioma
• Astrocytoma, IDH-Mutant, Grade 3
• Astrocytoma, IDH-Mutant, Grade 4
• Diffuse Astrocytoma
• Glioblastoma, IDH-Wildtype
• Malignant Glioma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2026-04-24
• Primary completion: 2030-10-25
• Completion: 2030-10-25
• First posted: 2026-03-12
• Last updated: 2026-04-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study