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

Status: Recruiting

Location: See location...

Intervention Type: Procedure, Drug, Biological

Study Type: Interventional

Study Phase: Phase 1/Phase 2

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.

Eligibility

Participation Requirements

Sex: All

Minimum Age: 18

Healthy Volunteers: f

View:

• 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)

Locations

United States

Minnesota

Mayo Clinic in Rochester

RECRUITING

Rochester

Contact Information

Primary

Clinical Trials Referral Office

mayocliniccancerstudies@mayo.edu

855-776-0015

Time Frame

Start Date: 2026-06-23

Estimated Completion Date: 2030-10-25

Participants

Target number of participants: 33

Treatments

Experimental: Group A (retifanlimab and DFMO then surgery)

Patients 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.

Experimental: Group B1 (retifanlimab only then surgery)

Patients 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.

Experimental: Group B2 (retifanlimab and DFMO then surgery)

Patients 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.

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