Single Arm Phase Ib/II Study of Durvalumab and Guadecitabine in Advanced Kidney Cancer: Big Ten Cancer Research Consortium BTCRC-GU16-043
Objective
Primary Objective:
Phase Ib: To estimate the safety and toxicities of durvalumab in combination with guadecitabine in patients with metastatic clear cell renal cell carcinoma
Phase II: To assess the efficacy of durvalumab plus guadecitabine in first-or second-line therapy of patients with advanced RCC patients with no prior anti-PD-1/PD-L1/CTLA4 therapy Cohort.
Secondary Objectives:
To determine the clinical efficacy of patients treated with durvalumab plus guadecitabine in cohort 1 and separately in Cohort 2. To evaluate the safety of guadecitabine in combination with durvalumab in advanced RCC (Cohorts 1 and 2).
