Retifanlimab With or Without Difluoromethylornithine for the Treatment of Progressive High Grade … (NCT07468136) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
Retifanlimab With or Without Difluoromethylornithine for the Treatment of Progressive High Grade Gliomas
United States33 participantsStarted 2026-04-24
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 s…
What they're measuring
1
Best tolerable dose level of Difluoromethylornithine (DFMO, or eflornithine) (phase I)