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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

About this trial

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 criteria

Qualifiers

Age ≥ 18 years

Glioblastoma, IDH-wild type (WT)

Grade 3 or 4 IDH1/2 mutant astrocytoma or

Grade 3 oligodendroglioma

Disqualifiers

Pregnant persons

Nursing persons

Persons of childbearing potential or able to father a child who are unwilling to employ adequate contraception

ongoing or active infection (e.g., pneumonia, sepsis, etc.) requiring systemic therapy

Trial design

Treatments tested in this trial

  • Biospecimen Collection
  • Eflornithine
  • Lumbar Puncture
  • Magnetic Resonance Imaging
  • Retifanlimab
  • Tumor Resection

Treatment groups

33 Participants
are divided into 3 treatment groups

Sponsors and collaborators