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

NCT07468136 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2026-04-13

No results posted yet for this study

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

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

Sponsors & Collaborators

Principal Investigators

  • Terence C. Burns, MD, PhD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-24
Primary Completion
2030-10-25
Completion
2030-10-25
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07468136 on ClinicalTrials.gov