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Completed Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT04987203

Public ClinicalTrials.gov record NCT04987203. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 26, 2026, 4:55 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

TiNivo-2: A Phase 3, Randomized, Controlled, Multicenter, Open-label Study to Compare Tivozanib in Combination With Nivolumab to Tivozanib Monotherapy in Subjects With Renal Cell Carcinoma Who Have Progressed Following One or Two Lines of Therapy Where One Line Has an Immune Checkpoint Inhibitor

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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).

Study identification

NCT ID
NCT04987203
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
AVEO Pharmaceuticals, Inc.
Industry
Enrollment
343 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 130 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 8, 2021
Primary completion
Jan 19, 2026
Completion
Jan 19, 2026
Last update posted
May 7, 2026

2021 – 2026

United States locations

U.S. sites
36
U.S. states
20
U.S. cities
34
Facility City State ZIP Site status
City of Hope Comprehensive Cancer Center Duarte California 91010 —
Chao Family Comprehensive Cancer Center, UC Irvine Irvine California 92868 —
University of California San Diego La Jolla California 92037 —
Leland Stanford Junior University Redwood City California 94063 —
Kaiser Permanente Riverside Medical Center Riverside California 92505 —
US Oncology - Rocky Mountain Cancer Centers - Midtown Denver Colorado 80218-1237 —
Florida Cancer Specialists & Res Inst Fort Myers Florida 33901 —
Florida Cancer Specialists & Research Institute (FCS) - Tampa Cancer Center Location St. Petersburg Florida 33705 —
The University of Kansas Cancer Center Westwood Kansas 66205-2005 —
University of Kentucky UK Markey Cancer Center Lexington Kentucky 40536 —
Tulane Cancer Center Clinic - Oncology New Orleans Louisiana 70112 —
University of Maryland Medical Center-Greenebaum Cancer Ctr Baltimore Maryland 21201 —
John Hopkins Medicine - Hematology/oncology Baltimore Maryland 21287 —
Maryland Oncology Hematology Clinton Maryland 20735 —
Dana-Farber Cancer Institute - Medicine Boston Massachusetts 02215 —
Henry Ford Hospital Detroit Michigan 48202 —
St. Vincent Frontier Cancer Center Billings Montana 59102-6746 —
Oncology Hematology West PC dba Nebraska Cancer Specialists Omaha Nebraska 68130 —
Memorial Sloan Kettering Cancer Center - Monmouth - Oncology Middletown New Jersey 07748-3052 —
University of New Mexico - Comprehensive Cancer Center Albuquerque New Mexico 87131-0001 —
Roswell - Roswell Park Cancer Institute - Medical Oncology Buffalo New York 14263 —
Memorial Sloan Kettering Cancer Center - Westchester East White Plains New York 10604 —
Memorial Sloan Kettering Cancer Center (MSKCC) - Memorial Hospital New York New York 10065 —
Memorial Sloan Kettering Cancer Center - Nassau Uniondale New York 11553 —
Cleveland Clinic Cleveland Ohio 44195-0001 —
Lehigh Valley Physician Group Allentown Pennsylvania 18103-6218 —
Allegheny General Hospital (AGH) Pittsburgh Pennsylvania 15212-4756 —
UH Cleveland Medical Center Columbia South Carolina 29210 —
Chattanooga Oncology and Hematology Associates Chattanooga Tennessee 37404 —
Tennessee Oncology, PLLC Nashville Tennessee 37203 —
Vanderbilt-Ingram Cancer Center Nashville Tennessee 37232 —
Texas Oncology - Central Austin Cancer Center Austin Texas 78731 —
Texas Oncology - Baylor Charles A. Sammons Cancer Center Dallas Texas 75246 —
US Oncology Texas Oncology (CCC of South Texas) - San Antonio Medical Center San Antonio Texas 78240 —
University Of Washington - Medical Center Seattle Washington 98109 —
Northwest Medical Specialties PLLC Tacoma Washington 98405-5016 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 103 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04987203, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 7, 2026 · Synced Sep 26, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04987203 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →