Clinical Studies Search

Protocol Summary


Protocol No.
PSCI-18-008
Prinicipal Investigator
Joshi, Monika
Phase
Phase I/II
Age Group
Adult
Scope
National
Secondary Protocol No.
BTCRC-GU16-043
Title
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).
Applicable Disease Sites
Kidney
Therapies Involved
Chemotherapy multiple agents systemic
Drugs Involved
Durvalumab

Guadecitabine
Status
Open
Participating Institutions
Hershey Medical Center