This is a multicenter, randomized, open label study of high dose interleukin 2 vs high dose
interleukin 2 plus entinostat in clear cell RCC patients who are candidate for high dose
interleukin 2. Patients will be randomized to ARM 1 (high dose interleukin 2 plus entinostat)
or ARM 2 (high dose interleukin 2). Subjects will receive up to 3 courses of high dose
interleukin 600,000 units/kg administered IV every 8 hrs on Days 1-5 and Days 15-19 (maximum
28 doses) +/- entinostat 5 mg orally given every 2 weeks starting on Day-14, continuously.
Tumor response assessment will be performed between HD IL-2 courses.
Phase:
Phase 2
Details
Lead Sponsor:
Roberto Pili
Collaborators:
Clinigen, Inc. Indiana University Melvin and Bren Simon Cancer Center Prometheus Laboratories Syndax Pharmaceuticals