OncoMatch/Clinical Trials/NCT07397611
Pre-NEOSHIFT-RCC: Neoadjuvant HIF-Inhibitor Immunotherapy in RCC
Is NCT07397611 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Casdatifan and Zimberelimab for renal cell carcinoma.
Treatment: Casdatifan · Zimberelimab — 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)
Check if I qualifyExtracted eligibility criteria
Cancer type
Renal Cell Carcinoma
Disease stage
Required: Stage CT2 WITH GRADE 4 OR SARCOMATOID FEATURES, ≥CT3 NX, CTANY N+ (clinical TNM)
Grade: grade 4 or sarcomatoid features
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
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic therapy
Any prior systemic therapy for treatment of renal cell carcinoma.
Cannot have received: radiation therapy
Any radiation therapy within 4 weeks before the first dose of study treatment.
Lab requirements
Blood counts
ANC ≥ 1.0 × 10^9/L without G-CSF; Platelet count ≥ 100 × 10^9/L without transfusion; Hemoglobin ≥ 10.0 g/dL
Kidney function
Calculated creatinine clearance ≥ 40 mL/min (Cockcroft-Gault equation)
Liver function
AST ≤ 2.5 × ULN; ALT ≤ 2.5 × ULN; Bilirubin ≤ 1.5 × ULN (except Gilbert syndrome < 3.0 mg/dL)
Cardiac function
LVEF greater than institutional lower limit of normal (LLN) by echocardiogram or MUGA
Participants must have adequate organ and marrow function, based upon meeting all of the following laboratory criteria within 14 days before first dose of study treatment: ... Screening echocardiogram or MUGA scan must demonstrate a left ventricular ejection fraction (LVEF) greater than the institutional lower limit of normal (LLN).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Beth Israel Deaconess Medical Center · Boston, Massachusetts
- Brigham and Women's Hospital · Boston, Massachusetts
- Dana-Farber Cancer Institute · Boston, Massachusetts
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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