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Anaplastic OligodendrogliomaPhase 1/2NCT07468136

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

A Phase 1/2 study testing Biospecimen Collection, Eflornithine and Lumbar Puncture in people with Anaplastic Oligodendroglioma and Astrocytoma, IDH-Mutant, Grade 3, run by Mayo Clinic at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Biospecimen Collection, Eflornithine and Lumbar Puncture
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
1 siteUnited States
Study dates
23 Jun 2026to 25 Oct 2030
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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)

Who cannot join

  • 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
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  • 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
  • EXCEPTIONS:
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Clinical Trials Referral Office contact

855-776-0015

mayocliniccancerstudies@mayo.edu

United States1 site, 1 recruiting

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

    Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu

    Terence C. Burns, MD, PhD

    Recruiting

Other trials in United States

About this study

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

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.

Being tested
Biospecimen Collection, Eflornithine, Lumbar Puncture, Magnetic Resonance Imaging, Retifanlimab
Medical subject headings
Oligodendroglioma, Astrocytoma, Lymphoma, Follicular, Glioblastoma, Glioma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo blood and CSF collection

  • EflornithineDrug

    Also called Alpha-Difluoromethylornithine, DFMO, Difluoromethylornithine, Difluromethylornithine

    Given PO

  • Lumbar PunctureProcedure or surgery

    Also called LP, Spinal Tap

    Undergo lumbar puncture

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan

    Undergo MRI

  • RetifanlimabBiological

    Also called INCMGA 0012, INCMGA-0012, INCMGA00012, INCMGA0012

    Given IV

  • Tumor ResectionProcedure or surgery

    Undergo resection surgery

Study groups in NCT07468136
Study groupRoleWhat they receive
Group A (retifanlimab and DFMO then surgery)ExperimentalPatients receive retifanlimab IV, over 30 minutes on day 1 of cycle 1 and DFMO PO Q8H on days 1-14 of cycle 1 in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care resection surgery. Patients then receive retifanlimab IV, over 30 minutes, on day 1 of each cycle and DFMO PO Q8H on days 1-14 of each cycle. Cycles repeat every 28 days for 16 additional cycles in the absence of disease progression or unacceptable toxicity. Patients undergo MRI and blood sample collection throughout the study and may optionally undergo CSF fluid collection with or without lumbar puncture.
Receives: Procedure: Biospecimen Collection; Procedure: Lumbar Puncture; Procedure: Magnetic Resonance Imaging; Biological: Retifanlimab; Procedure: Tumor Resection
Group B1 (retifanlimab only then surgery)ExperimentalPatients receive retifanlimab IV, over 30 minutes, on day 1 of cycle 1. Patients then undergo standard of care resection surgery. Patients then receive retifanlimab IV, over 30 minutes, on day 1 of each cycle and DFMO PO Q8H on days 1-14 of each cycle. Cycles repeat every 28 days for 16 additional cycles in the absence of disease progression or unacceptable toxicity. Patients undergo MRI and blood sample collection throughout the study and may optionally undergo cerebrospinal fluid collection with or without lumbar puncture.
Receives: Procedure: Biospecimen Collection; Drug: Eflornithine; Procedure: Lumbar Puncture; Procedure: Magnetic Resonance Imaging; Procedure: Tumor Resection
Group B2 (retifanlimab and DFMO then surgery)ExperimentalPatients receive retifanlimab IV, over 30 minutes on day 1 of cycle 1 and DFMO PO Q8H on days 1-14 of cycle 1, in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care resection surgery. Patients then receive retifanlimab IV, over 30 minutes, on day 1 of each cycle and DFMO PO Q8H on days 1-14 of each cycle. Cycles repeat every 28 days for 16 additional cycles in the absence of disease progression or unacceptable toxicity. Patients undergo MRI and blood sample collection throughout the study and may optionally undergo cerebrospinal fluid collection with or without lumbar puncture.
Receives: Procedure: Biospecimen Collection; Drug: Eflornithine; Procedure: Lumbar Puncture; Procedure: Magnetic Resonance Imaging; Biological: Retifanlimab; Procedure: Tumor Resection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Best tolerable dose level of Difluoromethylornithine (DFMO, or eflornithine) (phase I)

    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.

    Measured: Up to 5 years

  2. Change in T cell/myeloid cell ratio (phase IIa)

    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.

    Measured: From baseline up to 5 years

Secondary outcomes (5)

  1. T cell/myeloid cell ratio

    Will use a two-sample t-test or the nonparametric Wilcoxon rank sum test to evaluate whether the combination of eflornithine (DFMO) and retifanlimab increases the average increase in the T cell/myeloid cell ratio versus with retifanlimab alone.

    Measured: From baseline up to 5 years

  2. Myeloid cell abundance

    Will use a two-sample t-test or the nonparametric Wilcoxon rank sum test to evaluate if the combination of DFMO and retifanlimab increases the average increase in the T cell/myeloid cell ratio versus with retifanlimab alone.

    Measured: Up to 5 years

  3. Extracellular cytokines/ chemokines

    Will evaluate concentrations of pro-inflammatory cytokines/chemokines, CSCL9 and CCL5 in tissue and in cerebrospinal fluid (CSF), and how these correspond or correlate to each other.

    Measured: Up to 5 years

  4. Incidence of adverse events (AE)

    Assessed according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The number, type, and grade of adverse events will be summarized for each treatment arm.

    Measured: Up to 5 years

  5. Progression free survival (PFS)

    Defined as the time from randomization to the time of documented progression and/or death due to any cause. Will be evaluated based on the Response Assessment in Neuro-Oncology criteria.

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2026
  2. Study start23 Jun 2026
  3. Primary completion25 Oct 2030 (estimated)
  4. Study completion25 Oct 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Model description
Patients are assigned to group A or B. Patients in group B are randomized to 1 of 2 arms (group B1 or B2)
Masking
None (open label)
Enrolment
33 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07468136
Sponsor's protocol ID
MC230718
Other IDs
NCI-2026-01392, 24-000432, MC230718
Status last verified
Jun 2026
First submitted
9 Mar 2026
Last updated
24 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Biospecimen Collection, Eflornithine and Lumbar Puncture in people with Anaplastic Oligodendroglioma and Astrocytoma, IDH-Mutant, Grade 3, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Clinical Trials Referral Office (855-776-0015, mayocliniccancerstudies@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Best tolerable dose level of Difluoromethylornithine (DFMO, or eflornithine) (phase I) (time frame: Up to 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07468136.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.

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