NCT07397611

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

PRE-surgical NEOadjuvant Sandwich Immunotherapy With HIF inhibiTion in Renal Cell Carcinoma (PRENEOSHIFT-RCC)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Detailed 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 include screening for eligibility, in-clinic visits, blood tests, urine tests, Computerized Tomography (CT) scans, Magnetic Resonance Imaging (MRI) scans, or Positron Emission (PET) scans, and X-rays. It is expected that about 32 people will take part in this research study. Arcus Biosciences, Inc. is supporting this research study by providing the study drugs casdatifan and zimberelimab.

Conditions

• Renal Cell Carcinoma
• Kidney Cancer
• Kidney Neoplasm
• Renal Carcinoma

Interventions

Type	Name	Description
DRUG	Casdatifan	HIF-2α inhibitor, tablet taken orally per protocol.
DRUG	Zimberelimab	monoclonal antibody, multi-dose vial, via intravenous (through the vein) infusion, per protocol.

Timeline

• Start date: 2026-03-09
• Primary completion: 2028-01-31
• Completion: 2029-09-30
• First posted: 2026-02-09
• Last updated: 2026-03-20

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study