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ACTIVE NOT RECRUITING
NCT04987203
PHASE3

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

Sponsor: AVEO Pharmaceuticals, Inc.

View on ClinicalTrials.gov

Summary

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).

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

Key Details

Gender

All

Age Range

18 Years - 130 Years

Study Type

INTERVENTIONAL

Enrollment

343

Start Date

2021-09-09

Completion Date

2025-12-30

Last Updated

2025-08-22

Healthy Volunteers

No

Interventions

DRUG

Tivozanib

Tivozanib will be administered orally.

DRUG

Nivolumab

Nivolumab will be administered via intravenous infusion.

Locations (139)

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

Cleveland Clinic

Cleveland, Ohio, United States

Lehigh Valley Physician Group

Allentown, Pennsylvania, United States

Allegheny General Hospital (AGH)

Pittsburgh, Pennsylvania, United States

UH Cleveland Medical Center

Columbia, South Carolina, United States

Chattanooga Oncology and Hematology Associates

Chattanooga, Tennessee, United States

Tennessee Oncology, PLLC

Nashville, Tennessee, United States

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

Texas Oncology - Central Austin Cancer Center

Austin, Texas, United States

Texas Oncology - Baylor Charles A. Sammons Cancer Center

Dallas, Texas, United States

US Oncology Texas Oncology (CCC of South Texas) - San Antonio Medical Center

San Antonio, Texas, United States

University Of Washington - Medical Center

Seattle, Washington, United States

Northwest Medical Specialties PLLC

Tacoma, Washington, United States

Centro Oncológico Korben

Buenos Aires, Ciudad Autónoma de Buenos Aire, Argentina

Clínica Viedma

Viedma, Río Negro Province, Argentina

Centro Oncologico de Rosario

Rosario, Santa Fe Province, Argentina

Centro para la Atención Integral del paciente Oncológico

San Miguel de Tucumán, Tucumán Province, Argentina

Liverpool Hospital Cancer Therapy Centre

Liverpool, New South Wales, Australia

Mater Misericordiae Limited

Brisbane, Queensland, Australia

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Sunshine Hospital

Geelong, Victoria, Australia

ZNA Jan Palfijn

Merksen, Antwerpen, Belgium

Institut Jules Bordet - Oncologie Médicale

Anderlecht, Brussels Capital, Belgium

Jessa Ziekenhuis - Campus Virga Jesse - Medische Oncologie

Hasselt, Limburg, Belgium

UZ Gent - Medische Oncologie

Ghent, Oost-Vlaanderen, Belgium

CHU Brugmann - Victor Horta

Brussels, Belgium

AZ Groeninge - Campus Kennedylaan

Kortrijk, Belgium

Centro Gaucho Integrado de Onc

Porto Alegre, Rio Grande do Sul, Brazil

Clinica de Neoplasias Litoral

Itajaí, Santa Catarina, Brazil

Universidade Estadual de Campi

Campinas, São Paulo, Brazil

Instituto Brasileiro de Controle do Cancer - ibcc

São Paulo, São Paulo, Brazil

Hospital Nossa Senhora da Conc

Porto Alegre, Brazil

Pontificia Universidade

Porto Alegre, Brazil

Tom Baker Cancer Centre

Calgary, Alberta, Canada

BC Cancer - Vancouver Centre

Vancouver, British Columbia, Canada

Sunnybrook Research Institute, sunnybrook Health Sciences Ct

Toronto, Ontario, Canada

University Health Network - Princess Margaret Cancer Centre

Toronto, Ontario, Canada

ACEREY Centro de Investigación Clínica Oncológica

Viña del Mar, Región de Valparaíso, Chile

Centro de Estudios Clinicos In

Santiago, Región Metropolitana de Santia, Chile

Centro de Estudios Clínicos SAGA SpA

Santiago, Región Metropolitana de Santia, Chile

Meditek Ltda.

Santiago, Santiago Metropolitan, Chile

University Hospital Brno

Brno, Brno-město, Czechia

Fakultni Thomayerova nemocnice

Prague, Praha 4, Czechia

FN Hradec Kralove

Hradec Králové, Czechia

FN Kralovske Vinohrady

Prague, Czechia

Institut de cancérologie de Strasbourg Europe - ICANS

Strasbourg, Alsace, France

Hospices Civils de Lyon (HCL) - Centre Hospitalier Lyon-Sud

Pierre-Bénite, Auvergne-Rhône-Alpes, France

Institut Paoli Calmettes - Hôpital de jour

Marseille, Bouches-du-Rhône, France

Hopital Saint-Andre - Service d'Oncologie Medicale

Bordeaux, Gironde, France

Hopital Foch

Suresnes, Hauts-de-Seine, France

CHU Michallon - Hopital Nord - Cancérologie Et Hématologie

Grenoble, Isère, France

Hôpital privé Le Bois

Lille, Nord, France

Centre Hospitalier de Poitiers

Poitiers, Poitou-Charentes, France

Centre Leon Berard - departement d'oncologie medicale

Lyon, Rhône, France

Clinique Victor Hugo - Hematologie

Le Mans, Sarthe, France

CHD Vendee La Roche sur Yon - Gastro-Entérologie

La Roche-sur-Yon, France

Centre de Lutte Contre le Cancer (CLCC)

Nice, France

ICO - Site Rene Gauducheau - Oncologie Medicale

Saint-Herblain, France

Hopital Trousseau - medical oncology

Tours, France

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, France

Centre de Lutte Contre le Cancer (CLCC) - Gustave Roussy (Institut de Cancerologie Gustave-Roussy)

Villejuif, Île-de-France Region, France

Universitätsklinikum Heidelberg

Heidelberg, Baden-Wurttemberg, Germany

Medizinische Hochschule Hannover

Hanover, Lower Saxony, Germany

Ospedale S.Donato, AUSL 8 di Arezzo

Arezzo, Arezzo, Italy

Azienda Mater Domini

Catanzaro, Catanzaro, Italy

P.O. Ss. Annunziata

Chieti Scalo, Chieti, Italy

IRST

Meldola (Fc), Forli, Italy

European Institute of Oncology

Milan, Milano, Italy

IRCCS Policlinico San Matteo

Pavia, Pavia, Italy

Fondazione Policlinico Universitario Agostino Gemelli

Roma, Roma, Italy

AO S.Camillo-Forlanini

Roma, Roma, Italy

Azienda Ospedaliera Santa Maria di Terni

Terni, Terni, Italy

PO di Cremona, ASST di Cremona - Oncologia medica

Cremona, Italy

AOUC Azienda Ospedaliero-Universitaria Careggi

Florence, Italy

IRCCS Fondazione "Giovanni Pas

Naples, Italy

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

Tlalpan, Mexico

Szpital Kliniczny Przemienienia Panskiego UM w Poznaniu

Poznan, Greater Poland Voivodeship, Poland

Szpital Specjalistyczny im. L. Rydygiera w Krakowie

Krakow, Lesser Poland Voivodeship, Poland

Europejskie Centrum Zdrowia Otwock, Szpital im. F. Chopina

Otwock, Masovian Voivodeship, Poland

Szpital Specjalist. w Brzozowie,Podkarpacki Ośrodek Onkologi

Brzozów, Podkarpackie Voivodeship, Poland

Nzoz Mrukmed Lekarz Beata Madej-Mruk I Partner Sp. P.

Rzeszów, Podkarpackie Voivodeship, Poland

COPERNICUS Podmiot Leczn. Sp z o.o.,Wojew. Centrum Onkologii

Gdansk, Pomeranian Voivodeship, Poland

Wojewodzki Szpital Specjalistyczny

Biała Podlaska, Poland

Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych

Warsaw, Poland

Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy

Warsaw, Poland

Hospital Particular do Algarve - Gambelas-Faro

Faro, Faro District, Portugal

H. Prof. Doutor Fernando Fonseca

Amadora, Lisbon District, Portugal

H. de Santa Maria. Centro Hospitalar Lisboa Norte - Oncologia

Lisbon, Lisbon District, Portugal

H. Santo Antonio. Centro Hospitalar do Porto

Porto, Porto District, Portugal

Instituto Português Oncologia Francisco Gentil do Porto

Porto, Portugal

H.G.U. de Elche

Elche, Alicante, Spain

Hospital Universitario Son Espases

Palma de Mallorca, Balearic Islands, Spain

Hospital de La Santa Creu i Sant Pau

Barcelona, Barcelona, Spain

Hospital Universitario Vall d'

Barcelona, Barcelona, Spain

Institut Catalá d´Oncología (I.C.O.)

Barcelona, Barcelona, Spain

Hospital Del Mar

Barcelona, Barcelona, Spain

Hospital Universitari Parc Tau

Sabadell, Barcelona, Spain

ICO-Hospital Universitari de G

Girona, Girona, Spain

Hospital Universitario Ramón y Cajal

Madrid, Madrid, Spain

Hospital Clínico San Carlos

Madrid, Madrid, Spain

Hospital U. 12 Octubre

Madrid, Madrid, Spain

Hospital Universitario La Paz

Madrid, Madrid, Spain

Hospital Universitario Virgen

Seville, Sevilla, Spain

Fundación Instituto Valenciano

Valencia, Valencia, Spain

Hospital Universitario Y Politécnico La Fe

Valencia, Valenciana, Comunidad, Spain

C.H.U. de Orense

Ourense, Spain

Addenbrooke's Hospital - Oncology

Cambridge, Cambridgeshire, United Kingdom

Mount Vernon Cancer Centre

Northwood, England, United Kingdom

Royal Blackburn Hospital - Oncology

Preston, Lancashire, United Kingdom

Imperial College Healthcare NHS Trust - Hammersmith Hospital

London, London, City of, United Kingdom

The Christie NHS Foundation Trust - Medical Oncology

Manchester, Manchester, United Kingdom

Royal Marsden - Sutton

Sutton, Surrey, United Kingdom

Royal Marsden Hospital

Sutton, Surrey, United Kingdom

New Cross Hospital

Wolverhampton, Wolverhampton, United Kingdom

Royal Derby Hospital

Derby, United Kingdom

Leeds Teaching Hospitals NHS Trust

Leeds, United Kingdom