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Trial Summary


Protocol No.IUSCC-0574
StatusOPEN TO ACCRUAL
Principal InvestigatorAdra, Nabil
ScopeNational
PhasePhase I/II
Age GroupAdult
TitleA 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
DescriptionThis 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 EligibilityIn order to be eligible to take part in this trial, patients must meet the following criteria:
  • Ability and willingness to comply with the requirements of the study protocol.
  • Greater than or equal to 18-years-old.
  • Must have metastatic renal cell carcinoma.
For a full list of participation criteria, please visit clinicaltrials.gov.
Applicable Disease SitesKidney
Participating InstitutionsIU Health Central Indiana Cancer Centers
    Indiana University (IU)
      Ohio State University
        University at Buffalo
          University of Pennsylvania
            Treatment TypeTreatment
            ContactPhone: (317) 278-5632
            Email: iutrials@iu.edu