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Retifanlimab with or without Difluoromethylornithine for Progressive High-Grade Gliomas

This study is testing a new treatment for high-grade gliomas (a type of brain tumor) that are growing or getting worse. It combines retifanlimab, an immunotherapy that helps your body's immune system fight cancer, with or without difluoromethylornithine (DFMO). DFMO is a medication that may slow down the growth of tumor cells. The study aims to find the safest and most effective dose of DFMO and see how well this combination works. You may be able to join if you are 18 or older and have a high-grade glioma, including certain types of glioblastoma or astrocytoma. The study will look at how well the treatment changes the ratio of certain immune cells (T cells and myeloid cells) in your body. The current recruitment status is unclear.

Study design
This is a Phase I/II interventional study planning to enroll 33 participants. It is testing the safety, side effects, best dose, and effect of the treatments.
What's involved
You would undergo blood and CSF (cerebrospinal fluid) collection, lumbar punctures, and MRI scans. You would also receive retifanlimab intravenously (IV) and/or eflornithine by mouth (PO).
Compensation
Not stated in the trial record.
Follow-up
The study will measure outcomes for up to 5 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07468136

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Mayo Clinic
~33 participants
Updated 2026-06-24 on ClinicalTrials.gov
What's tested:Biospecimen CollectionEflornithineLumbar PunctureMagnetic Resonance ImagingRetifanlimabTumor Resection

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Best tolerable dose level of Difluoromethylornithine (DFMO, or eflornithine) (phase I)
Measured over Up to 5 years
+1 more outcome measured

Conditions

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

Explore related trials

AstrocytomaGlioblastomaMalignant GliomaOligodendrogliomaIDH1 wt Allele

Where it's being run

1 sites across 1 states
Minnesota1

Study leadership

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

Who to contact

Clinical Trials Referral Office
[email protected]
855-776-0015
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age ≥ 18 years
Diagnosis of high-grade glioma, including any of the following:
Glioblastoma, IDH-wild type (WT)
Grade 3 or 4 IDH1/2 mutant astrocytoma or
Grade 3 oligodendroglioma
Any prior grade 2 astrocytoma or oligodendroglioma that is suspected to have recurred at a higher grade
Other high-grade glioma
Plan for surgical resection as part of routine clinical care
Radiographic disease progression, with or without tissue confirmation
Measurable disease
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2 and Karnofsky Performance Status (KPS) ≥ 60
NOTE: PS must be assessed (again) within 7 days prior to first dose of study drug
Hemoglobin ≥ 9.0 g/dL (obtained ≤ 15 days prior to registration)
Absolute neutrophil count (ANC) ≥ 1500/mm\^3 (obtained ≤ 15 days prior to registration)
Platelet count ≥ 100,000/mm\^3 (obtained ≤ 15 days prior to registration)
Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (obtained ≤ 15 days prior to registration)
Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 3 x ULN (≤ 5 x ULN for patients with liver involvement) (obtained ≤ 15 days prior to registration)
Calculated creatinine clearance ≥ 45 ml/min using the Cockcroft-Gault formula (obtained ≤ 15 days prior to registration)
Negative pregnancy test done ≤ 7 days prior to registration, for persons of childbearing potential only
Provide written informed consent for the current study
Willing to provide consent for the Neuro-oncology biorepository (IRB 12-003458) for archiving of tissue, cerebrospinal fluid (CSF), and/or blood samples
Ability to complete forms by themselves or with assistance
Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)

Exclusion

Any of the following because this study involves an investigational agent, the genotoxic, mutagenic, and teratogenic effects of which on the developing fetus and newborn are unknown:
Pregnant persons
Nursing persons
Persons of childbearing potential or able to father a child who are unwilling to employ adequate contraception
Uncontrolled intercurrent illness that by the judgement of the investigator would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the regimens including, but not limited to:
ongoing or active infection (e.g., pneumonia, sepsis, etc.) requiring systemic therapy
current diagnosis or previous history of immune-related (non-infectious) pneumonitis or interstitial lung disease that requires or required steroids
active autoimmune disease that required systemic treatment other than replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroids) ≤ 2 years prior to registration
symptomatic congestive heart failure
unstable angina pectoris
psychiatric illness/social situations that would limit compliance with study requirements (e.g., drug addiction)
concurrent active Hepatitis B (defined as hepatitis B surface antigen \[HBsAg\] positive and/or detectable hepatitis B virus \[HBV\] deoxyribonucleic acid \[DNA\]) and Hepatitis C virus (defined as anti-hepatitis C virus \[HCV\] antibody \[Ab\] positive and detectable HCV ribonucleic acid \[RNA\]) infection
Patients with evidence of hepatitis B virus (HBV) infection (HBsAg positive) must have completed at least 4 weeks of HBV antiviral therapy, and the HBV viral load must be undetectable at the time of registration
Patients with a history of hepatitis C virus (HCV) are eligible if they have an undetectable HCV viral load. Patients must have completed curative anti-viral treatment ≥ 4 weeks prior to registration.
NOTE: Patients without symptoms or prior history do not require testing prior to registration
Co-morbid systemic illnesses or other severe concurrent disease that would make the patient inappropriate for entry into the study or interfere with proper assessment of safety and toxicity
History of myocardial infarction ≤ 6 months prior to registration or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
Active autoimmune disease that has required systemic treatment (other than replacement therapy) ≤ 1 year prior to registration
History of allogeneic stem cell transplant
Receiving any other investigational agent with therapeutic intent
Participants who are unable to swallow the DFMO solution or who are at risk for impaired absorption of oral medication.
NOTE: This restriction includes, but is not limited to, refractory vomiting, gastric resection/bypass, and duodenal/jejunal resection
Patients with known hypersensitivity or allergy to DFMO or retifanlimab
Contraindication to MRI or administration of gadolinium

What this trial measures

  • Best tolerable dose level of Difluoromethylornithine (DFMO, or eflornithine) (phase I)Up to 5 years

    Will use a modified Bayesian Optimal Interval phase I/II (BOIN12) trial design to identify a dose level that is tolerable and has sufficient/optimal pharmacodynamic effects \[e.g., maximum tolerated dose (MTD)\]. Will evaluate toxicity up front to determine dose levels that have acceptable tolerability. Both dose limiting toxicity and pharmacodynamic activity will be used to identify the best dose to bring forward for the phase IIa portion.

  • Change in T cell/myeloid cell ratio (phase IIa)From baseline up to 5 years

    Will use a log2 transformation of this percentage measure. Will summarize this within each of the treatment arms, and will compare these measures between arms using a two-sample t-test or a nonparametric Wilcoxon rank sum test if not sufficiently normally distributed.