Study to Compare Tivozanib in Combination With Nivolumab to Tivozanib Monotherapy in Subjects With Renal Cell Carcinoma
NCT ID: NCT04987203
Last Updated: 2025-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
343 participants
INTERVENTIONAL
2021-09-09
2025-12-30
Brief Summary
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Detailed Description
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Approximately 326 subjects with refractory advanced RCC at approximately 190 sites will be randomized in a 1:1 ratio to treatment with tivozanib plus nivolumab (163 subjects) or tivozanib (163 subjects). Subjects will be randomly assigned to a treatment.
Subjects will receive 1.34 mg/day (monotherapy arm) or 0.89mg/day (combination arm) of tivozanib once daily (QD) for 3 weeks followed by 1 week off study drug. One cycle will be defined as 4 weeks: 3 weeks on treatment and 1 week off treatment. Subjects who receive nivolumab will be infused with 1 treatment of nivolumab at specified dose on specified days of each Cycle.
Subjects with documented stable disease or an objective response may continue to receive both tivozanib and nivolumab therapy at the same dose and schedule until progression as long as the tolerability is acceptable. Nivolumab will be discontinued in all subjects after 2 years; Tivozanib may be continued after discontinuation of nivolumab until other withdrawal criteria are met. A Safety Follow-up Visit will be performed 30 days (± 7 days) after the last dose of study drug.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Tivozanib in Combination with Nivolumab
Subjects with advanced RCC will receive 0.89 mg of tivozanib once daily (QD) for 3 weeks followed by 1 week off study drug and nivolumab every 4 weeks on Day 1 of each Cycle, until disease progression or unacceptable toxicities occur, other withdrawal criteria are met, or completion of 2 years of treatment \[for nivolumab\] whichever occurs first.
Tivozanib
Tivozanib will be administered orally.
Nivolumab
Nivolumab will be administered via intravenous infusion.
Tivozanib
Subjects with advanced RCC will receive 1.34 mg of tivozanib once daily (QD) for 3 weeks followed by 1 week off study drug until disease progression or unacceptable toxicities occur, or other withdrawal criteria are met.
Tivozanib
Tivozanib will be administered orally.
Interventions
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Tivozanib
Tivozanib will be administered orally.
Nivolumab
Nivolumab will be administered via intravenous infusion.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
130 Years
ALL
No
Sponsors
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Parexel
INDUSTRY
Bristol-Myers Squibb
INDUSTRY
AVEO Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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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
Napoli, , 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
Countries
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References
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Choueiri TK, Albiges L, Barthelemy P, Iacovelli R, Emambux S, Molina-Cerrillo J, Garmezy B, Barata P, Basu A, Bourlon MT, Moon H, Ratta R, McKay RR, Chehrazi-Raffle A, Hammers H, Heng DYC, Braendle E, Beckermann KE, McGregor BA, Motzer RJ. Tivozanib plus nivolumab versus tivozanib monotherapy in patients with renal cell carcinoma following an immune checkpoint inhibitor: results of the phase 3 TiNivo-2 Study. Lancet. 2024 Oct 5;404(10460):1309-1320. doi: 10.1016/S0140-6736(24)01758-6. Epub 2024 Sep 13.
Yang Y, Psutka SP, Parikh AB, Li M, Collier K, Miah A, Mori SV, Hinkley M, Tykodi SS, Hall E, Thompson JA, Yin M. Combining immune checkpoint inhibition plus tyrosine kinase inhibition as first and subsequent treatments for metastatic renal cell carcinoma. Cancer Med. 2022 Aug;11(16):3106-3114. doi: 10.1002/cam4.4679. Epub 2022 Mar 18.
Other Identifiers
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AV-951-20-304
Identifier Type: -
Identifier Source: org_study_id
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