Testing the Addition of the Anti-Cancer Drug Tivozanib to Immunotherapy (Pembrolizumab) After Surgery to Remove All Known Sites of Kidney Cancer

Recruiting now · Phase 3

Conditions studied: Clear Cell Renal Cell Carcinoma, Renal Cell Carcinoma (RCC), Stage II Renal Pelvis Cancer AJCC v8, Stage III Renal Pelvis Cancer AJCC v8

In brief

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.

Key facts

Study ID: NCT06661720
Run by: Alliance for Clinical Trials in Oncology
People needed: 1040
Starts: 2025-03-14
Expected to finish: 2037-11-01
Last updated by the study team: 2026-08-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed diagnosis of RCC with clear cell component with or without sarcomatoid features following complete resection of the primary tumor (radical or partial nephrectomy)
Note: Patients with microscopically positive soft tissue or vascular margins without gross residual disease are permitted
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) RCC
Participants who have had resection of primary tumor (radical or partial nephrectomy) and resection or definitive radiation or ablation of solid, isolated, soft tissue metastases (excluding brain and bone lesions) at the time of primary tumor removal (synchronous) or ≤1 year from primary tumor removal (metachronous)
Surgery (radical or partial nephrectomy or metastasectomy or ablation) > 4 weeks but =< 16 weeks prior to study registration with no ongoing complications from surgery
No evidence of disease at time of randomization as assessed by investigator by either CT or MRI scan of the brain and chest, abdomen and pelvis
No prior systemic treatment for RCC
Age >= 18 years
Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (or Karnofsky >= 60%)
Absolute neutrophil count (ANC) >= 1,000/mm\^3
Platelet count >= 100,000/mm\^3
Hemoglobin >= 8 g/dL
Total bilirubin =< 3 x upper limit of normal (ULN)
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 x upper limit of normal (ULN)
Calculated (calc.) creatinine clearance >= 30 mL/min (using Cockcroft Gault equation or the estimated glomerular filtration rate from the modification of diet in renal disease trial)
Urine protein =< 1+ on urine analysis (UA) or urine protein creatinine ration (UPCR) < 2mg/mg
Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects. Therefore, for women of childbearing potential only, a negative pregnancy test is required =< 14 days prior to registration
HIV status: HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
Hepatitis

Where it is running

Banner University Medical Center - Tucson — Tucson, Arizona, United States (enrolling)
University of Arizona Cancer Center-North Campus — Tucson, Arizona, United States (enrolling)
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro — Jonesboro, Arkansas, United States (enrolling)
University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States (enrolling)
Sutter Auburn Faith Hospital — Auburn, California, United States (enrolling)
Tower Cancer Research Foundation — Beverly Hills, California, United States (enrolling)
City of Hope Comprehensive Cancer Center — Duarte, California, United States (enrolling)
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care — Irvine, California, United States (enrolling)
City of Hope at Irvine Lennar — Irvine, California, United States (enrolling)
UC San Diego Moores Cancer Center — La Jolla, California, United States (enrolling)
City of Hope Antelope Valley — Lancaster, California, United States (enrolling)
Los Angeles General Medical Center — Los Angeles, California, United States (enrolling)
USC / Norris Comprehensive Cancer Center — Los Angeles, California, United States (enrolling)
Cedars-Sinai Medical Center — Los Angeles, California, United States (enrolling)
Memorial Medical Center — Modesto, California, United States (enrolling)
USC Norris Oncology/Hematology-Newport Beach — Newport Beach, California, United States (enrolling)
UC Irvine Health/Chao Family Comprehensive Cancer Center — Orange, California, United States (enrolling)
Palo Alto Medical Foundation Health Care — Palo Alto, California, United States (enrolling)
Sutter Roseville Medical Center — Roseville, California, United States (enrolling)
Sutter Medical Center Sacramento — Sacramento, California, United States (enrolling)
University of California Davis Comprehensive Cancer Center — Sacramento, California, United States (enrolling)
UC San Diego Medical Center - Hillcrest — San Diego, California, United States (enrolling)
California Pacific Medical Center-Pacific Campus — San Francisco, California, United States (enrolling)
Mills Health Center — San Mateo, California, United States (enrolling)
Cancer Center at Saint Joseph's — Phoenix, Arizona, United States (enrolling)

Full record on ClinicalTrials.gov

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