OncoMatch/Clinical Trials/NCT06661720
Testing the Addition of the Anti-Cancer Drug Tivozanib to Immunotherapy (Pembrolizumab) After Surgery to Remove All Known Sites of Kidney Cancer
Is NCT06661720 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Pembrolizumab and Tivozanib for clear cell renal cell carcinoma.
Treatment: Pembrolizumab · Tivozanib — This phase III trial compares the effect of adding tivozanib to standard therapy pembrolizumab versus pembrolizumab alone for the treatment of patients with high-risk renal cell carcinoma (RCC). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Tivozanib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals tumor cells to multiply. This helps stop the spread of tumor cells. Giving pembrolizumab and tivozanib together may work better than pembrolizumab alone in treating patients with RCC.
Check if I qualifyExtracted eligibility criteria
Cancer type
Renal Cell Carcinoma
Urothelial Carcinoma
Disease stage
Required: Stage PT2 GRADE 4 OR SARCOMATOID FEATURES, N0M0, PT3 ANY GRADE N0, M0, PT4, ANY GRADE, N0, M0, PT, ANY STAGE, ANY GRADE, N+, M0, CM1 NO EVIDENCE OF DISEASE (NED) (AJCC v8)
Intermediate-high risk RCC: pT2 grade 4 or sarcomatoid features, N0M0; pT3 any grade N0, M0; High-risk RCC: pT4, any grade, N0, M0; pT, any stage, any grade, N+, M0; cM1 no evidence of disease (NED)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Lab requirements
Blood counts
ANC >= 1,000/mm^3; Platelet count >= 100,000/mm^3; Hemoglobin >= 8 g/dL
Kidney function
Calculated creatinine clearance >= 30 mL/min (Cockcroft Gault or MDRD equation)
Liver function
Total bilirubin <= 3 x ULN; AST/ALT <= 3 x ULN
Cardiac function
NYHA class IIB or better; no history of myocarditis
ANC >= 1,000/mm^3; Platelet count >= 100,000/mm^3; Hemoglobin >= 8 g/dL; Total bilirubin <= 3 x ULN; AST/ALT <= 3 x ULN; Calculated creatinine clearance >= 30 mL/min; NYHA class IIB or better; no history of myocarditis
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Cancer Center at Saint Joseph's · Phoenix, Arizona
- Banner University Medical Center - Tucson · Tucson, Arizona
- University of Arizona Cancer Center-North Campus · Tucson, Arizona
- NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro · Jonesboro, Arkansas
- University of Arkansas for Medical Sciences · Little Rock, Arkansas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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