Study of Casdatifan Alone or With Zimberelimab Before Surgery in Patients With Clear Cell Renal Cell Carcinoma

What this Trial Is About

Researchers are evaluating the safety and effectiveness of the drug casdatifan alone and in combination with zimberelimab for people with clear cell renal cell carcinoma ccRCC that can be surgically removed. This phase 2, randomized, open-label trial involves participants with specific stages of ccRCC and aims to understand how these treatments work before surgery. The study drugs casdatifan, which is a HIF-2 inhibitor, and zimberelimab, a monoclonal antibody, have not yet been approved by the FDA for this cancer. Participants will be randomly assigned to one of two groups one group will receive casdatifan alone, and the other will receive casdatifan plus zimberelimab. Both treatments are given in cycles lasting 21 days casdatifan is taken orally daily, while zimberelimab is administered by intravenous infusion on the first day of each cycle for the combination group. After completing three cycles, participants will undergo standard surgical removal of their kidney tumor and then be followed for up to three years. During the study, participants will have multiple visits for screening, blood and urine tests, imaging scans such as CT, MRI, or PET, and other evaluations to monitor health and treatment effects. The main outcome measured is the reduction in tumor size before surgery, assessed around week 11. Safety is closely monitored through reports of side effects during treatment and for several months after surgery. Overall, participant involvement includes treatment cycles, surgery, follow-up visits, and various tests over an extended period.

Pre-NEOSHIFT-RCC: Neoadjuvant HIF-Inhibitor Immunotherapy in RCC