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.
Additional locations may be listed on ClinicalTrials.gov for NCT06661720 .
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Phone: 610-402-9543
Johnstown UPMC-Johnstown/John P. Murtha Regional Cancer Center Status: Active
Contact: Site Public Contact
Phone: 814-534-4724
Lewisburg Geisinger Medical Oncology-Lewisburg Status: Active
Contact: Site Public Contact
Phone: 570-374-8555
Mechanicsburg UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion Status: Active
Contact: Site Public Contact
Phone: 412-389-5208
Monroeville UPMC Hillman Cancer Center - Monroeville Status: Active
Contact: Site Public Contact
Phone: 412-389-5208
Philadelphia Jefferson Torresdale Hospital Status: Active
Contact: Site Public Contact
Phone: 215-600-9151
Thomas Jefferson University Hospital Status: Active
Contact: Site Public Contact
Phone: 215-600-9151
Pittsburgh UPMC-Passavant Hospital Status: Active
Contact: Site Public Contact
Phone: 412-367-6454
UPMC-Saint Clair Hospital Cancer Center Status: Active
Contact: Site Public Contact
Phone: 412-502-3920
University of Pittsburgh Cancer Institute (UPCI) Status: Active
Contact: Site Public Contact
Phone: 412-647-8073
Scranton Community Medical Center Status: Active
Contact: Site Public Contact
Phone: 570-703-4768
Wilkes-Barre Geisinger Wyoming Valley/Henry Cancer Center Status: Active
Contact: Site Public Contact
Phone: 570-271-5251
Williamsport Divine Providence Hospital Status: Active
Contact: Site Public Contact
Phone: 773-702-9171
Rhode Island Westerly Smilow Cancer Hospital Care Center - Westerly Status: Active
Contact: Site Public Contact
Phone: 203-785-5702
South Carolina Boiling Springs Prisma Health Cancer Institute - Spartanburg Status: Active
Contact: Site Public Contact
Phone: 864-522-4317
Charleston Medical University of South Carolina Status: Active
Contact: Site Public Contact
Phone: 843-792-9321
Easley Prisma Health Cancer Institute - Easley Status: Active
Contact: Site Public Contact
Phone: 864-522-4317
Georgetown Tidelands Georgetown Memorial Hospital Status: Active
Contact: Site Public Contact
Phone: 843-545-5600
Greenville Prisma Health Cancer Institute - Butternut Status: Active
Contact: Site Public Contact
Phone: 864-522-4317
Prisma Health Cancer Institute - Eastside Status: Active
Contact: Site Public Contact
Phone: 864-522-4317
Prisma Health Cancer Institute - Faris Status: Active
Contact: Site Public Contact
Phone: 864-522-4317
Greer Prisma Health Cancer Institute - Greer Status: Active
Contact: Site Public Contact
Phone: 864-522-4317
Seneca Prisma Health Cancer Institute - Seneca Status: Active
Contact: Site Public Contact
Phone: 864-522-4317
South Dakota Sioux Falls Sanford USD Medical Center - Sioux Falls Status: Active
Contact: Site Public Contact
Phone: 605-312-3320
Sanford Cancer Center Oncology Clinic Status: Active
Contact: Site Public Contact
Phone: 605-312-3320
Tennessee Collierville Baptist Memorial Hospital and Cancer Center-Collierville Status: Active
Contact: Site Public Contact
Phone: 901-226-1366
Memphis Baptist Memorial Hospital and Cancer Center-Memphis Status: Active
Contact: Site Public Contact
Phone: 901-226-1366
Nashville Vanderbilt University/Ingram Cancer Center Status: Active
Contact: Site Public Contact
Phone: 800-811-8480
Texas Amarillo The Don and Sybil Harrington Cancer Center Status: Active
Contact: Site Public Contact
Phone: 806-212-1985
Baytown Houston Methodist San Jacinto Hospital Status: Active
Contact: Site Public Contact
Phone: 773-702-9171
Cypress Houston Methodist Cypress Hospital Status: Active
Contact: Site Public Contact
Phone: 346-356-1413
Houston Methodist Willowbrook Hospital Status: Active
Contact: Site Public Contact
Phone: 773-702-9171
Houston Methodist Hospital Status: Active
Contact: Site Public Contact
Phone: 713-790-2700
Houston Methodist West Hospital Status: Active
Contact: Site Public Contact
Phone: 832-522-2873
Nassau Bay Houston Methodist Saint John Hospital Status: Active
Contact: Site Public Contact
Phone: 773-702-9171
Sugar Land Houston Methodist Sugar Land Hospital Status: Active
Contact: Site Public Contact
Phone: 281-242-2873
The Woodlands Houston Methodist The Woodlands Hospital Status: Active
Contact: Site Public Contact
Phone: 713-790-2700
Vermont Burlington University of Vermont and State Agricultural College Status: Active
Contact: Site Public Contact
Phone: 802-656-8990
Saint Johnsbury Dartmouth Cancer Center - North Status: Active
Contact: Site Public Contact
Phone: 800-639-6918
Virginia Mechanicsville Bon Secours Memorial Regional Medical Center Status: Active
Contact: Site Public Contact
Phone: 804-893-8978
Midlothian Bon Secours Saint Francis Medical Center Status: Active
Contact: Site Public Contact
Phone: 804-893-8978
Richmond Bon Secours Saint Mary's Hospital Status: Active
Contact: Site Public Contact
Phone: 804-893-8978
Bon Secours Richmond Community Hospital Status: Active
Contact: Site Public Contact
Phone: 804-893-8978
VCU Massey Cancer Center at Stony Point Status: Active
Contact: Site Public Contact
VCU Massey Comprehensive Cancer Center Status: Active
Contact: Site Public Contact
Phone: 804-628-6430
West Virginia Bridgeport United Hospital Center Status: Active
Contact: Site Public Contact
Phone: 304-293-7374
Charleston West Virginia University Charleston Division Status: Active
Contact: Site Public Contact
Phone: 304-388-9944
Martinsburg WVUH-Berkely Medical Center Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 304-293-7374
Morgantown West Virginia University Healthcare Status: Active
Contact: Site Public Contact
Phone: 304-293-7374
Parkersburg Camden Clark Medical Center Status: Active
Contact: Site Public Contact
Phone: 304-293-7374
Wisconsin Ashland Duluth Clinic Ashland Status: Active
Contact: Site Public Contact
Phone: 218-786-3308
Burlington Aurora Cancer Care-Southern Lakes VLCC Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Cudahy Aurora Saint Luke's South Shore Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Germantown Aurora Health Care Germantown Health Center Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Grafton Aurora Cancer Care-Grafton Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Green Bay Aurora BayCare Medical Center Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Kenosha Aurora Cancer Care-Kenosha South Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
La Crosse Gundersen Lutheran Medical Center Status: Active
Contact: Site Public Contact
Phone: 608-775-2385
Marinette Aurora Bay Area Medical Group-Marinette Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Menomonee Falls Froedtert Menomonee Falls Hospital Status: Active
Contact: Site Public Contact
Phone: 262-257-5100
Milwaukee Aurora Sinai Medical Center Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Aurora Saint Luke's Medical Center Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Aurora Cancer Care-Milwaukee Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Medical College of Wisconsin Status: Active
Contact: Site Public Contact
Phone: 414-805-3666
Mukwonago ProHealth D N Greenwald Center Status: Active
Contact: Site Public Contact
Oak Creek Drexel Town Square Health Center Status: Active
Contact: Site Public Contact
Phone: 414-805-0505
Oconomowoc ProHealth Oconomowoc Memorial Hospital Status: Active
Contact: Site Public Contact
Phone: 262-928-7878
Oshkosh Vince Lombardi Cancer Clinic - Oshkosh Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Racine Aurora Cancer Care-Racine Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Sheboygan Vince Lombardi Cancer Clinic-Sheboygan Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Summit Aurora Medical Center in Summit Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Two Rivers Vince Lombardi Cancer Clinic-Two Rivers Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Waukesha UW Cancer Center at ProHealth Care Status: Active
Contact: Site Public Contact
Phone: 262-928-5539
ProHealth Waukesha Memorial Hospital Status: Active
Contact: Site Public Contact
Phone: 262-928-7632
Wauwatosa Aurora Cancer Care-Milwaukee West Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
West Allis Aurora West Allis Medical Center Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
West Bend Froedtert West Bend Hospital/Kraemer Cancer Center Status: Active
Contact: Site Public Contact
Phone: 414-805-0505
PRIMARY OBJECTIVE:
I. To compare disease free survival (DFS) as assessed by the investigator for high-risk renal cell carcinoma patients treated with adjuvant pembrolizumab and tivozanib versus those receiving pembrolizumab alone.
SECONDARY OBJECTIVES:
I. To compare overall survival (OS) for patients treated with adjuvant pembrolizumab and tivozanib versus those receiving pembrolizumab alone.
II. To assess adverse events in each study arm by Common Terminology Criteria for Adverse Events (CTCAE) 5.0.
BIOBANKING OBJECTIVE:
I. To bank specimens for future unspecified research.
QUALITY OF LIFE (QOL) OBJECTIVES:
I. To compare global quality of life (QOL) for patients treated with pembrolizumab and tivozanib versus those receiving pembrolizumab alone.
II. To compare patient-reported fatigue for patients treated with pembrolizumab and tivozanib versus those receiving pembrolizumab alone.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive pembrolizumab intravenously (IV) on days 1 and 43 of each cycle, or on days 1, 22, 43 and 64 of each cycle. Cycles repeat every 12 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection and magnetic resonance imaging (MRI) or computed tomography (CT) throughout the trial and may undergo tissue biopsy on study.
ARM II: Patients receive pembrolizumab IV on days 1 and 43 of each cycle and tivozanib orally (PO) once daily (QD) on days 1-21, days 29-49, and days 57-77 of each cycle for up to 6 months. Cycles repeat every 12 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection and MRI or CT throughout the trial and may undergo tissue biopsy on study.
After completion of study treatment, patients are followed up every 4 months for 2 years, then every 6 months for 3 years, then every subsequent year for 5 years.
Lead Organization Alliance for Clinical Trials in Oncology
Principal Investigator Bradley A. McGregor