PRE-surgical NEOadjuvant Sandwich Immunotherapy With HIF inhibiTion in Renal Cell Carcinoma (PRENEOSHIFT-RCC)
Dana-Farber Cancer Institute
Summary
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)
Description
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugCasdatifan
HIF-2α inhibitor, tablet taken orally per protocol.
- DrugZimberelimab
monoclonal antibody, multi-dose vial, via intravenous (through the vein) infusion, per protocol.
Locations (3)
- Beth Israel Deaconess Medical CenterBoston, Massachusetts
- Brigham and Women's HospitalBoston, Massachusetts
- Dana-Farber Cancer InstituteBoston, Massachusetts