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AzTrials

Carcinoma, Renal CellPhase 3NCT02627963

A Study to Compare Tivozanib Hydrochloride to Sorafenib in Participants With Refractory Advanced Renal Cell Carcinoma (RCC)

A Phase 3 study testing Tivozanib hydrochloride and Sorafenib in people with Carcinoma, Renal Cell, run by AVEO Pharmaceuticals, Inc. at 191 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a Phase 3, open-label, randomized, controlled, multi-national, multi-center, parallel-arm study comparing tivozanib to sorafenib in participants with refractory advanced renal cell carcinoma (RCC). Participants will be randomized (1:1) to treatment with tivozanib or sorafenib. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Renal Cell
What is being tested?
Tivozanib hydrochloride and Sorafenib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
350 participants
Where
191 sitesin 12 countries
Study dates
24 May 2016to 21 Jun 2021
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 years or older
  • Participants with metastatic RCC who have failed 2 or 3 prior systemic regimens, one of which includes a VEGFR TKI other than sorafenib or tivozanib.
  • Histologically or cytologically confirmed RCC with a clear cell component (participants with pure papillary cell tumor or other non-clear cell histologies, including collecting duct, medullary, chromophobe, and unclassified RCC are excluded).
  • Measurable disease per the Response Evaluation Criteria in Solid Tumors (RECIST) criteria Version 1.1.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Life expectancy ≥ 3 months.

Who cannot join

  • Prior treatment with sorafenib or tivozanib.
  • More than 3 prior regimens for metastatic RCC.
  • Known central nervous system (CNS) metastases other than stable, treated brain metastases. Participants with previously treated brain metastasis will be allowed if the brain metastasis has been stable by neuroimaging without steroid treatment for at least 3 months following prior treatment (radiotherapy or surgery).
  • Significant hematologic, gastrointestinal, thromboembolic, vascular, bleeding, or coagulation disorders.
  • Significant serum chemistry abnormalities
  • Significant cardiovascular disease, including: Active clinically symptomatic left ventricular failure, uncontrolled hypertension, myocardial infarction, severe angina, or unstable angina within 6 months prior to administration of first dose of study drug, history of serious ventricular arrhythmia, cardiac arrhythmias requiring anti-arrhythmic medications.
  • Inadequate recovery from any prior surgical procedure or major surgical procedure within 4 weeks prior to administration of first dose of study drug.
  • Currently active second primary malignancy.

Trial locations and contacts

191 sites in 12 countries.

191 sites in 12 countries

United States56 sites

  • New York Oncology Hematology, P.C.

    Albany, New York, 12206

  • New York Oncology Hematology, PC

    Albany, New York, 12208

  • Texas Oncology - Austin Midtown

    Austin, Texas, 78705

  • Texas Oncology-Central Austin Cancer Center

    Austin, Texas, 78731

  • Texas Oncology - South Austin Cancer Center

    Austin, Texas, 78745

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • New York Oncology Hematology, P.C.

    Clifton Park, New York, 12065

  • Texas Oncology - Baylor Charles A. Sammons Cancer Center

    Dallas, Texas, 75246

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • City of Hope Comprehensive Breast Cancer Center

    Duarte, California, 91010

  • St. Luke University Health Network

    Easton, Pennsylvania, 18045

  • Texas Oncology - Fort Worth 12th Ave

    Fort Worth, Texas, 76104

  • Texas Oncology SW Fort Worth Cancer Center

    Fort Worth, Texas, 76132

  • Arizona Oncology Associates, PC - HAL

    Fort Worth, Texas, 76177

  • Comprehensive Cancer Centers of Nevada (CCCN)

    Fort Worth, Texas, 76177

  • Comprehensive Cancer Centers of Nevada

    Fort Worth, Texas, 76177

  • Nebraska Cancer Specialists (NCS) - Midwest Cancer Center

    Fort Worth, Texas, 76177

  • Texas Oncology - El Paso Cancer Treatment Center

    Fort Worth, Texas, 76177

  • Texas Oncology-El Paso Cancer Treatment Center

    Fort Worth, Texas, 76177

  • Long Beach Memorial Medical Center

    Fountain Valley, California, 92708

  • Texas Oncology-Garland

    Garland, Texas, 75042

  • Marin Cancer Care

    Greenbrae, California, 94904

  • Hackensack University Medical Center - John Theurer Cancer

    Hackensack, New Jersey, 07601

  • Comprehensive Cancer Center Of Nevada

    Henderson, Nevada, 89052

  • Comprehensive Cancer Centers of Nevada

    Henderson, Nevada, 89074

  • Baylor College of Medicine - Baylor Clinic

    Houston, Texas, 77030

  • Investigative Clinical Research of Indiana

    Indianapolis, Indiana, 46260

  • Comprehensive Cancer Center Of Nevada

    Las Vegas, Nevada, 89128

  • Comprehensive Cancer Center of Nevada

    Las Vegas, Nevada, 89148

  • Texas Oncology - Longview Cancer Center

    Longview, Texas, 75601

  • UCLA

    Los Angeles, California, 90095

  • Ohio Cancer Specialists

    Mansfield, Ohio, 44906

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • University of Miami Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136

  • Mount Sinai Comprehensive Cancer Center

    Miami Beach, Florida, 33140

  • New York Presbyterian Hospital

    New York, New York, 10021

  • Columbia University Medical Center - Herbert Irving Pavilion

    New York, New York, 10032

  • Nebraska Methodist Hospital

    Omaha, Nebraska, 68114

  • Midwest Cancer Center

    Omaha, Nebraska, 68130

  • Urology Cancer Center, PC

    Omaha, Nebraska, 68130

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • University Of UA Cancer Center(UACC)/DH-SJHMC

    Phoenix, Arizona, 85004

  • Arizona Oncology Associates, PC - HAL

    Phoenix, Arizona, 85016

  • Arizona Oncology - Phoenix - Deer Valley Women's Center Loca

    Phoenix, Arizona, 85027

  • University of Pittsburgh Medical Center (UPMC)

    Pittsburgh, Pennsylvania, 15232

  • Texas Oncology, P.A.

    Plano, Texas, 75093

  • University of Rochester Medical Center

    Rochester, New York, 14642

  • North Coast Cancer Care, Inc

    Sandusky, Ohio, 44870

  • Arizona Oncology - Scottsdale

    Scottsdale, Arizona, 85258

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • Texas Oncology - Tyler

    Tyler, Texas, 75702

  • MedStar Georgetown University Hospital

    Washington D.C., District of Columbia, 20007

  • Wake Forest University Baptist Medical Center (WFUBMC)

    Winston-Salem, North Carolina, 27157

  • Wooster Specialty and Surgery Center

    Wooster, Ohio, 44691

Other trials in United States

Spain28 sites

  • H.U.F. Alcorcón

    Alcorcón, Madrid, 28922

  • Institut Català d'Oncologia-Hospital Universitari Germans Trias i Pujol

    Badalona, Barcelona, 08916

  • H.del Mar

    Barcelona, 08003

  • H.Sta.Creu i St.Pau

    Barcelona, 08025

  • H.U.Vall d'Hebrón

    Barcelona, 08035

  • H. Clinic de Barcelona

    Barcelona, 08036

  • H.U. Reina Sofía

    Córdoba, 14004

  • H.G.U. de Elche

    Elche, Alicante, 03203

  • ICO-H.U.Dr.J.Trueta

    Girona, 17007

  • C.H. de Jaén

    Jaén, 23007

  • Institut Catalá d´Oncología (I.C.O.)

    L'Hospitalet de Llobregat, Barcelona, 08907

  • H.G.U. G. Marañón

    Madrid, 28007

  • H.U. Infanta Leonor

    Madrid, 28031

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034

  • H.C. S.Carlos

    Madrid, 28040

  • H.U. F. Jiménez Díaz

    Madrid, 28040

  • H.U. 12 de Octubre

    Madrid, 28041

  • H.U. La Paz

    Madrid, 28046

  • H. Madrid Norte Sanchinarro

    Madrid, 28050

  • H.U.P Hierro-Majadahonda

    Majadahonda, Madrid, 28222

  • H.U. Virgen de la Victoria

    Málaga, 29010

  • H.U.Son Espases

    Palma, Balearic Islands, 07010

  • C.H. de Navarra

    Pamplona, Navarre, 31008

  • C.S. Parc Taulí

    Sabadell, Barcelona, 08208

  • H.U.V. Macarena

    Seville, 41009

  • F.I. Valenciano de Oncología

    Valencia, 46009

  • H.U.P.La Fe

    Valencia, 46026

  • H.U. Miguel Servet

    Zaragoza, 50009

Other trials in Spain

Italy23 sites

  • Ospedale S.Donato, AUSL 8 di Arezzo

    Arezzo, 52100

  • Centro di Riferimento Oncologico IRCCS

    Aviano, 33081

  • AO Spedali Civili di Brescia, PO Spedali Civili

    Brescia, 25123

  • Istituto di Candiolo, IRCCS

    Candiolo, Torino, 10060

  • P.O. Ss. Annunziata

    Chieti, 66013

  • ASST-Istituti Ospitalieri di Cremona, AO di Cremona

    Cremona, 26100

  • AOU Careggi

    Florence

  • IRCCS AOU San Martino-IST Istituto Nazionale per la Ricerca

    Genova, 16132

  • Ospedale Vito Fazzi, ASL Lecce

    Lecce, 73100

  • Irccs Irst

    Meldola, Forli, 47014

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133

  • Ieo, Irccs

    Milan

  • AOU Policlinico di Modena

    Modena, 41124

  • IRCCS Fondazione "Giovanni Pascale"

    Naples, 80131

  • Istituto Oncologico Veneto IOV-IRCCS

    Padova, 35128

  • IRCCS Policlinico San Matteo

    Pavia, 27100

  • Usl 7 Siena - Ospedale Alta Valdelsa ASL TOSCANA SUD-EST

    Poggibonsi, Siena, 53100

  • PU Campus Bio-medico di Roma

    Roma, 00128

  • Regina Elena, Istituto Nazionale dei Tumori, IFO, IRCCS

    Roma, 144

  • Azienda Ospedaliera San Camillo Forlanini

    Roma, 151

  • Istituto Clinico Humanitas Rozzano, IRCCS

    Rozzano, Milano, 20089

  • Casa Sollievo della Sofferenza, IRCCS

    San Giovanni Rotondo, Foggia, 71013

  • Azienda Ospedaliera S. Maria di Terni

    Terni, 5100

Other trials in Italy

United Kingdom17 sites

  • East Lancashire Hospitals NHS Trust

    Blackburn, Lancashire, BB2 3HH

  • Addenbrooke's Hospital

    Cambridge, Cambridgeshire, CB2 0QQ

  • Cheltenham General Hospital

    Cheltenham, Gloucestershire, GL53 7AN

  • Beatson West Of Scotland Cancer Centre

    Glasgow, Glasgow City, G12 0YN

  • St James's University Hospital / Leeds Teaching Hospitals

    Leeds, LS9 7TF

  • The Royal Marsden NHS Foundation Trust

    London, SW36JJ

  • Charing Cross Hospital

    London, W6 8RF

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX

  • Mount Vernon Cancer Care

    Middlesex, HA6 2RN

  • Nottingham University Hospitals NHS Trust - City Hospital

    Nottingham, NG5 1PB

  • Churchill Hospital [Oncology]

    Oxford, OX3 7LJ

  • Lancashire Teaching Hospitals NHS Foundation Trust

    Preston, Lancashire, PR2 9HT

  • Southampton University Hospitals Nhs Trust

    Southampton, Hampshire, SO16 6YD

  • Royal Stroke Center

    Stoke-on-Trent, Staffordshire, ST4 6QG

  • The Royal Marsden NHS Foundation Trust

    Sutton, Surrey, SM2 5PT

  • Singleton Hospital

    Swansea, SA2 8QA

  • New Cross Hospital

    Wolverhampton, WV10 0QP

Other trials in United Kingdom

Germany15 sites

  • Universitätsklinikum Aachen

    Aachen, 52074

  • Evangelisches Krankenhaus Bielefeld

    Bielefeld, North Rhine-Westphalia, 33611

  • SZB Study Center University Hospital Bonn

    Bonn, North Rhine-Westphalia, D-53127

  • Uniklinik Köln Klinik und Poliklinik für Urologie

    Cologne, North Rhine-Westphalia, 50937

  • Universitätsklinikum Carl Gustav Carus

    Dresden, Saxony, 1307

  • Johann Wolfgang Goethe Universität

    Frankfurt am Main, Hesse, 60590

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, 20246

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Univesitaetsklinik Heidelberg

    Heidelberg, Baden-Wurttemberg, 69120

  • Universitätsklinikum des Saarlandes

    Homburg, Saarland, 66421

  • Jena University Hospital

    Jena, Thuringia, 7743

  • Universitaetsklinikum Muenster

    Münster, 48149

  • Universität Tübingen

    Tübingen, 72076

  • Kliniken Nordoberpfalz AG, Klinikum Weiden

    Weiden, Bavaria, 92637

Other trials in Germany

Hungary14 sites

  • Szent Margit Kórház

    Budapest, 1032

  • Magyar Honvédség Egészségügyi Központ

    Budapest, 1062

  • Semmelweis Egyetem

    Budapest, 1082

  • Semmelweis Egyetem

    Budapest, 1083

  • Országos Onkológiai Intézet

    Budapest, 1122

  • Egyesített Szent István és Szent László Kórház-Rendelőintéze

    Budapest, H-1096

  • Debreceni Egyetem Klinikai Központ

    Debrecen, Hajdú-Bihar, 4032

  • Békés Megyei Pándy Kálmán Kórház

    Gyula, Bekes County, 5700

  • Somogy Megyei Kaposi Mór Oktató Kórház

    Kaposvár, 7400

  • Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház

    Miskolc, Borsod-Abauj Zemplen county, 3526

  • Pécsi Tudományegyetem Klinikai Központ

    Pécs, Baranya, 7624

  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpo

    Szeged, Csongrád megye, 6720

  • Markusovszky Egyetemi Oktatókórház

    Szombathely, H-9700

  • Zala Megyei Korhaz

    Zalaegerszeg, H-8900

Other trials in Hungary

France11 sites

  • Institut de Cancérologie de l'Ouest Site Paul Papin

    Angers, Maine-et-Loire, 49000

  • Hopital Saint-André

    Bordeaux, Gironde, 33075

  • Clinique Victor Hugo

    Le Mans, Pays de la Loire Region, 72000

  • centre Oscar Lambret

    Lille, Hauts-de-France, 59020

  • Institut Paoli-Calmettes

    Marseille, 13273

  • Chu De Poitiers

    Poitiers, 86021

  • ICO

    Saint-Herblain, 44805

  • Institut de Cancerologie de la Loire

    Saint-Priest-en-Jarez, Pays de la Loire Region, 42271

  • CHRU de Tours - Hopital Bretonneau TOURS

    Tours, Indre-et-Loire, 37000

  • Institut de cancérologie de Lorraine

    Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54519

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

Belgium8 sites

  • AZ Sint-Jan Brugge - Oostende - Campus Sint-Jan

    Bruges, West-Vlaanderen, 8000

  • Institut Jules Bordet

    Brussels, Brussels Capital, 1000

  • Grand Hôpital de Charleroi - Site Notre-Dame

    Charleroi, Hainaut, 6000

  • UZ Antwerpen

    Edegem, Antwerpen, 2650

  • UZ Gent

    Ghent, Oost-Vlaanderen, 9000

  • Jessa Ziekenhuis - Campus Virga Jesse

    Hasselt, Limburg, 3500

  • CHU Ambroise Paré

    Mons, Hainaut, 7000

  • CHU Dinant Godinne UCL Namur

    Yvoir, Namur, 5530

Other trials in Belgium

Poland7 sites

  • Szpital Specjalist w Brzozowie Podkarpacki Ośrodek Onkologiczny

    Brzozów, 36-200

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

    Gdansk, 80-219

  • NZOZ Vesalius Sp. z o.o.

    Krakow, 31-216

  • Europejskie Centrum Zdrowia Otwock, Szpital im. F. Chopina

    Otwock, Masovian Voivodeship, 05-400

  • Centrum Onkologii - Instytut im. Marii Sklodowskiej - Curie

    Warsaw, Masovian Voivodeship, 02-781

  • MAGODENT Sp. z o.o. Szpital Onkologiczno-Kardiologiczny

    Warsaw, Masovian Voivodeship, 04-125

  • Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego

    Wroclaw, 50-556

Other trials in Poland

Czechia5 sites

  • Masarykuv onkologicky ustav

    Brno, Brno-město, 656 53

  • Fakultni nemocnice u sv. Anny v Brne

    Brno, 656 91

  • FN Hradec Kralove

    Hradec Králové, Hradec Králové Region, 500 05

  • Fakultni nemocnice Olomouc

    Olomouc, Olomouc Region, 779 00

  • Fakultni nemocnice v Motole

    Prague, 150 06

Other trials in Czechia

Canada4 sites

  • London Health Sciences Center

    London, Ontario, N6A 4L6

  • Dr. Leon Richard Oncology Centre

    Moncton, New Brunswick, E1C 8X3

  • Sunnybrook

    Toronto, Ontario, M4N3M5

  • British Columbia Cancer Agency (BCCA)

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

Denmark3 sites

  • Aarhus Universitetshospital

    Aarhus C, Central Jutland, 8000

  • Herlev Hospital

    Herlev, Capital, 2730

  • Odense Universitetshospital

    Odense, Region Syddanmark, 5000

Other trials in Denmark

About this study

Official title: A Phase 3, Randomized, Controlled, Multi-Center, Open-Label Study to Compare Tivozanib Hydrochloride to Sorafenib in Subjects With Refractory Advanced Renal Cell Carcinoma

This is a Phase 3, open-label, randomized, controlled, multi-national, multi-center, parallel-arm study comparing tivozanib to sorafenib in participants with refractory advanced renal cell carcinoma (RCC).

Participants will be randomized (1:1) to treatment with tivozanib or sorafenib.

Read more

Participants will be stratified by International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk category (favorable; intermediate; poor) and prior therapy (two prior vascular endothelial growth factor receptor tyrosine kinase inhibitors (VEGFR TKI); a prior checkpoint inhibitor [programmed cell death -1 protein (PD-1) or PD-1 ligand (PD1-L) inhibitor] plus a prior VEGFR TKI; a prior VEGFR TKI plus any other systemic agent).

All participants will be evaluated for progression free survival, overall survival, objective response rate, and the duration of response as well as safety and tolerability.

Pharmacokinetic (PK) analyses are also included in study.

Being tested
Tivozanib hydrochloride, Sorafenib
Medical subject headings
Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tivozanib hydrochlorideDrug

    Tivozanib hydrochloride

  • SorafenibDrug

    Sorafenib

Study groups in NCT02627963
Study groupRoleWhat they receive
Tivozanib hydrochlorideExperimentalParticipants randomized to this arm will receive the study drug, tivozanib hydrochloride.
Receives: Drug: Tivozanib hydrochloride
SorafenibActive comparatorParticipants randomized to this arm will receive the comparator drug, sorafenib.
Receives: Drug: Sorafenib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free Survival (PFS)

    The PFS, as assessed by a blinded independent radiological review (IRR), is defined as the time from randomization to first documentation of objective tumor progression (progressive disease) or death due to any reasons whichever comes first. Disease progression per RECIST 1.1 criteria is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

    Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first. Disease progression was assessed every 8 weeks (up to approximately 5 years)

Secondary outcomes (3)

  1. Overall Survival (OS)

    The OS is defined as the time from the date of randomization to date of death due to any cause.

    Measured: Date of randomization to date of death (up to approximately 5 years)

  2. Objective Response Rate (ORR)

    The ORR is defined as the percentage of participants who have at least a 30% reduction in the sum of diameters per RECIST (Version 1.1).

    Measured: Every 8 weeks from date of randomization until disease progression (up to approximately 5 years)

  3. Duration of Response (DOR)

    The DOR is defined as the time from the first documentation of objective tumor response to the first documentation of tumor progression per RECIST 1.1 or to death due to any cause.

    Measured: Assessed every 8 weeks from date of randomization until date of progression (up to approximately 5 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2015 (estimated)
  2. Study start24 May 2016
  3. Primary completion4 Oct 2018
  4. Study completion21 Jun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
350 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02627963
Sponsor's protocol ID
AV-951-15-303
Status last verified
Jun 2023
First submitted
9 Dec 2015
Last updated
18 Jul 2023
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • Beckermann KE, Asnis-Alibozek AG, Atkins MB, Escudier B, Hutson TE, Kasturi V, McDermott DF, Pal SK, Porta C, Rini BI, Verzoni E. Long-Term Survival in Patients With Relapsed/Refractory Advanced Renal Cell Carcinoma Treated With Tivozanib: Analysis of the Phase III TIVO-3 Trial. Oncologist. 2024 Mar 4;29(3):254-262. doi: 10.1093/oncolo/oyad348.

    PubMed 38262444

  • Meza L, McDermott DF, Escudier B, Hutson TE, Porta C, Verzoni E, Atkins MB, Kasturi V, Pal SK, Rini B. Tivozanib in Patients with Advanced Renal Cell Carcinoma Previously Treated With Axitinib: Subgroup Analysis from TIVO-3. Oncologist. 2023 Mar 17;28(3):e167-e170. doi: 10.1093/oncolo/oyac255.

    PubMed 36576430

  • Szarek M, Needle MN, Rini BI, Pal SK, McDermott DF, Atkins MB, Hutson TE, Escudier BJ. Q-TWiST Analysis of Tivozanib Versus Sorafenib in Patients With Advanced Renal Cell Carcinoma in the TIVO-3 Study. Clin Genitourin Cancer. 2021 Oct;19(5):468.e1-468.e5. doi: 10.1016/j.clgc.2021.03.018. Epub 2021 Apr 3.

    PubMed 33980467

  • Rini BI, Pal SK, Escudier BJ, Atkins MB, Hutson TE, Porta C, Verzoni E, Needle MN, McDermott DF. Tivozanib versus sorafenib in patients with advanced renal cell carcinoma (TIVO-3): a phase 3, multicentre, randomised, controlled, open-label study. Lancet Oncol. 2020 Jan;21(1):95-104. doi: 10.1016/S1470-2045(19)30735-1. Epub 2019 Dec 3.

    PubMed 31810797

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tivozanib hydrochloride and Sorafenib in people with Carcinoma, Renal Cell, run by AVEO Pharmaceuticals, Inc. at 191 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 191 sites in United States, Spain, Italy, United Kingdom, Germany and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival (PFS) (time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first. Disease progression was assessed every 8 weeks (up to approximately 5 years)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02627963, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2023.

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