OncoMatch/Clinical Trials/NCT05345002
All-Trans Retinoic Acid (ATRA) Plus PD-1 Inhibition in Recurrent IDH-Mutant Glioma
Is NCT05345002 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Immunotherapy
Other
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
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05345002 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior bevacizumab disqualifies patients from enrollment.
Does this trial require IDH1?
Yes, IDH1 mutation is a required biomarker for enrollment.
Does this trial require IDH2?
Yes, IDH2 mutation is a required biomarker for enrollment.
What disease stage is eligible?
Stage II or III or IV is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages