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Brief Title: Phase 1b/2 Trial of Ipilimumab, Nivolumab, and Ciforadenant (Adenosine A2a Receptor Antagonist) in First-line Advanced Renal Cell Carcinoma.
Official Title: Phase 1b/2 Trial of Ipilimumab, Nivolumab, and Ciforadenant (Adenosine A2a Receptor Antagonist) in First-line Advanced Renal Cell Carcinoma.
Study ID: NCT05501054
Brief Summary: To learn if the combination of ciforadenant, ipilimumab, and nivolumab can help to control advanced renal cell carcinoma
Detailed Description: Primary Objectives: * To determine the safety and tolerability of ipilimumab, nivolumab, and ciforadenant in patients with untreated advanced renal cell carcinoma (RCC). * To assess the depth of responsein patients with untreated advanced renal cell carcinoma treated with ipilimumab, nivolumab, and ciforadenant. Secondary Objectives: • To estimate the objective response rate (ORR), duration of response (DOR) progression free survival (PFS), progressive disease (PD) rate, and irAE rate of ipilimumab, niovlumab, and Ciforadenant combination in untreated advanced RCC. Exploratory Objectives: • To assess association of gene expression signatures and pharmacodynamic parameters with outcome.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Duke Cancer Institute, Durham, North Carolina, United States
Abramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania, United States
M D Anderson Cancer Center, Houston, Texas, United States
Name: Eric Jonasch, MD
Affiliation: M.D. Anderson Cancer Center
Role: PRINCIPAL_INVESTIGATOR