Phase 2 Study of All-Trans Retinoic Acid ATRA with PD-1 Inhibitor Retifanlimab for Recurrent IDH-Mutant Glioma

What this Trial Is About

Researchers are evaluating the combination of All-Trans Retinoic Acid ATRA and PD-1 inhibitor retifanlimab in patients with recurrent IDH-mutant glioma, a type of brain tumor. This Phase II study aims to assess whether this treatment regimen is safe and can stimulate a strong anti-tumor immune response. The study includes a Safety Run-In phase, a Phase 2 portion, and a Surgical portion to explore different patient groups and treatment settings. During the Safety Run-In, patients receive 28-day treatment cycles with oral ATRA given twice daily on days 1-14 and retifanlimab given intravenously on day 1. Following this, the Phase 2 part enrolls patients in two arms based on their prior chemotherapy history, receiving the same ATRA and retifanlimab schedule. The Surgical portion enrolls patients eligible for tumor removal surgery, randomizing them to either ATRA alone or ATRA plus retifanlimab before surgery, followed by the combination treatment cycles post-surgery. Participants will undergo regular assessments including brain MRIs to measure tumor response using radiographic criteria. Researchers will monitor treatment safety, progression-free survival, and overall survival over months to years. Patients must meet specific health criteria and agree to study procedures, including taking oral medications and attending scheduled visits. The study lasts until disease progression, unacceptable side effects, or up to two years of treatment.

All-Trans Retinoic Acid (ATRA) Plus PD-1 Inhibition in Recurrent IDH-Mutant Glioma