This study will test the hypothesis that vorasidenib in combination with lomustine will be safe and tolerable. The overall goal of this study is to identify the optimal vorasidenib dose that can be tested in a subsequent phase 2 study to determine the efficacy of vorasidenib in combination with lomustine in patients with recurrent IDH mutant gliomas.
Age ≥18 years.
Karnofsky performance status score of ≥ 60%.
Be able to understand and willing to sign informed consent or assent as determined by local requirements.
Be willing to comply with scheduled visits, treatment plans, and laboratory tests, including serial peripheral blood sampling and during the study.
Patients who have not recovered to grade 0 or 1 or pre-treatment baseline from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities > grade 1) with the exception of alopecia.
Presence of extracranial metastatic or leptomeningeal disease.
Have had any prior anticancer therapy within 28-days of treatment other than surgery (biopsy, sub-total resection, gross- total resection) for treatment of glioma including systemic chemotherapy, radiotherapy, vaccines, small-molecules, IDH inhibitors, investigational agents, laser ablation, etc.
Early progression prior to 3 months from completion of radiotherapy.
Megan Mantica
Lead sponsor
University of Pittsburgh
Sponsor institution
Institut de Recherches Internationales Servier
Collaborator