Study to Compare Tivozanib in Combination With Nivolumab to Tivozanib Monotherapy in Subjects With Renal Cell Carcinoma

Completed · Phase 3

Conditions studied: Renal Cell Carcinoma

In brief

This study will be comparing tivozanib in combination with nivolumab to tivozanib alone in subjects with advanced Renal Cell Carcinoma (RCC) who have had 1 or 2 prior lines of therapy, one of which was an Immune Checkpoint Inhibitor (ICI).

Key facts

Study ID

NCT04987203

Run by

AVEO Pharmaceuticals, Inc.

People needed

343

Starts

2021-09-09

Expected to finish

2026-01-20

Last updated by the study team

2026-05-08

Who can join

Age: 18 and older, up to 130. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Radiographic disease progression during or following at least 6 weeks of treatment with ICI for locally advanced or metastatic RCC with a clear cell component either in first- or second-line treatment.
• Subjects must have recovered from the adverse events of prior therapy to grade ≤ 1 or baseline.
• Histologically or cytologically confirmed RCC with a clear cell component.
• Measurable disease per RECIST criteria Version 1.1.
• Eastern Cooperative Oncology Group performance status of 0 or 1.
• All participants must follow protocol defined contraceptive measures.

You may not qualify if…

• Subjects who received: a. A single agent tyrosine kinase inhibitor (TKI) in the first line setting followed by a single agent immune checkpoint inhibitor (ICI) in the second line setting; b. More than 2 prior lines of therapy in the advanced or metastatic setting.
• History of life-threatening toxicity related to prior immune therapy.
• Active autoimmune disease as well as those that required discontinuation of prior immuno-oncological (IO) therapy due to immune mediated AEs.
• Uncontrolled hypertension.
• More than 1 prior line of therapy with a checkpoint inhibitor in the metastatic setting.
• Subjects on immune suppressive therapy for organ transplant or subjects with a history of genetic or acquired immune suppression disease such as human immunodeficiency virus (HIV) [Patients with HIV who have CD4+ T-cell counts >350 cells/µL, without a history of acquired immune deficiency syndrome (AIDS)-defining opportunistic infections, and are on established antiretroviral therapy which does not include a cytochrome P450 (CYP)3A4 inducer, for at least 4 weeks and have an HIV viral load less than 400 copies/mL, are eligible].
• History of clinically significant interstitial lung disease or current non-infectious pneumonitis.

Where it is running

• City of Hope Comprehensive Cancer Center — Duarte, California, United States
• Chao Family Comprehensive Cancer Center, UC Irvine — Irvine, California, United States
• University of California San Diego — La Jolla, California, United States
• Leland Stanford Junior University — Redwood City, California, United States
• Kaiser Permanente Riverside Medical Center — Riverside, California, United States
• US Oncology - Rocky Mountain Cancer Centers - Midtown — Denver, Colorado, United States
• Florida Cancer Specialists & Res Inst — Fort Myers, Florida, United States
• Florida Cancer Specialists & Research Institute (FCS) - Tampa Cancer Center Location — St. Petersburg, Florida, United States
• The University of Kansas Cancer Center — Westwood, Kansas, United States
• University of Kentucky UK Markey Cancer Center — Lexington, Kentucky, United States
• Tulane Cancer Center Clinic - Oncology — New Orleans, Louisiana, United States
• University of Maryland Medical Center-Greenebaum Cancer Ctr — Baltimore, Maryland, United States
• John Hopkins Medicine - Hematology/oncology — Baltimore, Maryland, United States
• Maryland Oncology Hematology — Clinton, Maryland, United States
• Dana-Farber Cancer Institute - Medicine — Boston, Massachusetts, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• St. Vincent Frontier Cancer Center — Billings, Montana, United States
• Oncology Hematology West PC dba Nebraska Cancer Specialists — Omaha, Nebraska, United States
• Memorial Sloan Kettering Cancer Center - Monmouth - Oncology — Middletown, New Jersey, United States
• University of New Mexico - Comprehensive Cancer Center — Albuquerque, New Mexico, United States
• Roswell - Roswell Park Cancer Institute - Medical Oncology — Buffalo, New York, United States
• Memorial Sloan Kettering Cancer Center - Westchester — East White Plains, New York, United States
• Memorial Sloan Kettering Cancer Center (MSKCC) - Memorial Hospital — New York, New York, United States
• Memorial Sloan Kettering Cancer Center - Nassau — Uniondale, New York, United States
• CHU Brugmann - Victor Horta — Brussels, Belgium

Full record on ClinicalTrials.gov

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