drugset / Trial / NCT03501381
High Dose IL 2 and Entinostat in RCC
Phase 2
Active not recruiting
46 enrolled
Roberto Pili
Clinigen, Inc. · collabIndiana University · collabSyndax Pharmaceuticals · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2018-05-24
- Primary completion
- 2023-01-20
- Completion
- 2024-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Entinostat | Small molecule | 5 mg | Oral |
| Background | aldesleukin | Protein / enzyme biologic | 600000 iu/kg | Intravenous |