OncoMatch/Clinical Trials/NCT05345002
All-Trans Retinoic Acid (ATRA) Plus PD-1 Inhibition in Recurrent IDH-Mutant Glioma
Is NCT05345002 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Retifanlimab and All-trans retinoic acid for glioma.
Treatment: Retifanlimab · All-trans retinoic acid — This is a Phase II study of the combination of All-Trans Retinonic Acid (ATRA) and PD-1 inhibition (Retifanlimab) in patient with recurrent IDH-mutant glioma. The Sponsor-Investigator hypothesizes that the proposed regimen will be safe and stimulate a robust anti-tumor immune response.
Check if I qualifyExtracted eligibility criteria
Cancer type
Glioblastoma
Biomarker criteria
Required: IDH1 mutation
Required: IDH2 mutation
Disease stage
Required: Stage II, III, IV (WHO 2021 Classification System)
astrocytoma (grade 2-4) or oligodendroglioma (grade 2-3) according to the World Health Organization (WHO) 2021 Classification System
Prior therapy
Must have received: alkylating agent (temozolomide, lomustine)
progressive or recurrent following at least one prior alkylating chemotherapy regimen (i.e., temozolomide and/or lomustine), +/- radiation therapy
Cannot have received: bevacizumab (bevacizumab)
Patients who have received bevacizumab within the last 3 months are ineligible
Lab requirements
Blood counts
Absolute Neutrophil count ≥1,500/uL; Platelets ≥ 100,000/uL; Hemoglobin ≥ 9 g/dL
Kidney function
Calculated CrCl ≥ 30 ml/min (glomerular filtration rate can also be used in place of CrCl)
Liver function
Total bilirubin <1.5 x ULN (except patients with suspected Gilbert's Syndrome, who are eligible for the study but exempt from the total bilirubin eligibility criterion); ALT and AST ≤ 2.5x ULN
Adequate organ and marrow function: Total bilirubin <1.5 x ULN (except patients with suspected Gilbert's Syndrome, who are eligible for the study but exempt from the total bilirubin eligibility criterion); ALT and AST ≤ 2.5x ULN; Calculated CrCl ≥ 30 ml/min (glomerular filtration rate can also be used in place of CrCl); Absolute Neutrophil count ≥1,500/uL; Platelets ≥ 100,000/uL; Hemoglobin ≥ 9 g/dL
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Pennsylvania · Philadelphia, Pennsylvania
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