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Trial Summary
| Protocol No. | IUSCC-0574 | ||
|---|---|---|---|
| Status | OPEN TO ACCRUAL | ||
| Principal Investigator | Adra, Nabil | ||
| Scope | National | ||
| Phase | Phase I/II | ||
| Age Group | Adult | ||
| Title | A PHASE I/II STUDY TO EVALUATE THE SAFETY, PHARMACODYNAMICS AND EFFICACY OF ATEZOLIZUMAB IN COMBINATION WITH ENTINOSTAT AND BEVACIZUMAB IN PATIENTS WITH ADVANCED RENAL CELL CARCINOMA | ||
| Description | This study will assess the immunomodulatory activity of entinostat in patients with advanced renal cell carcinoma receiving the PD-L1 inhibitor atezolizumab. The overall hypothesis is that entinostat will increase the immune response and anti-tumor effect induced by the PD-L1 inhibition by suppressing Treg function. We have chosen renal cell carcinoma that has been reported to respond to PD1/PD-L 1 inhibition. The schedule of entinostat is based on our previous experience with this agent. Based on our working hypothesis that low dose HDAC inhibitors will have a suppressive function on Tregs but not on T effector cells, the starting dose of entinostat will be 1 mg and will be escalated up to 5 mg rather than the 10 mg dose. The combination also with bevacizumab will provide an effective VEGF inhibition that may potentiate the immune response and anti-tumor effect induced by atezolizumab. The proposed dose and schedule for atezolizumab and bevacizumab has been shown to be well tolerated in prior Phase/I/II studies and is currently tested in a Phase III randomized study in patients with renal cell carcinoma with sunitinib as a control arm. The highest proposed dose level for entinostat (5 mg) represents 50% of the recommended Phase II dose for this compound as a single agent. | ||
| Key Eligibility | In order to be eligible to take part in this trial, patients must meet the following criteria:
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| Applicable Disease Sites | Kidney | ||
| Participating Institutions | IU Health Central Indiana Cancer Centers | ||
| Treatment Type | Treatment | ||
| Contact | Phone: (317) 278-5632 Email: iutrials@iu.edu | ||