Dana-Farber Cancer Institute
The purpose of this study is to see whether the drug casdatifan is safe and effective either by itself or in combination with the drug zimberelimab in participants with resectable clear cell renal cell carcinoma (ccRCC). The names of the study drugs involved in this study are: * Casdatifan (a type of HIF-2α inhibitor) * Zimberelimab (a type of monoclonal antibody)
This is a two-arm, open-label, multicenter, randomized trial to evaluate whether the drug casdatifan is safe and effective either by itself or in combination with the drug zimberelimab in participants with resectable clear cell renal cell carcinoma (ccRCC). Participants will be randomized into 1 of 2 study groups: Group A Casdatifan vs. Group B Casdatifan plus Zimberelimab. Randomization means a participant is placed into a study group by chance. The U.S. Food and Drug Administration (FDA) has not approved casdatifan or zimberelimab as a treatment for ccRCC. The research study procedures in…
Inclusion Criteria: * Adult patients age ≥ 18 years. * Histologically confirmed diagnosis of ccRCC by a core-needle biopsy. Patients who have not had prior biopsy may undergo screening if they have suspected RCC but can only proceed to registration if ccRCC (any component) is confirmed on the pre-treatment study biopsy. * Stage cT2 RCC with grade 4 or sarcomatoid features, ≥cT3 Nx RCC, or cTany N+ RCC disease for which partial or radical nephrectomy is planned. For clinical staging, a kidney MRI is highly preferred over a CT Abdomen. * Participants must have measurable disease i.e. a primary…
HIF-2α inhibitor, tablet taken orally per protocol.
monoclonal antibody, multi-dose vial, via intravenous (through the vein) infusion, per protocol.
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