Spots Global Cancer Trial Database for Study to Compare Tivozanib in Combination With Nivolumab to Tivozanib Monotherapy in Subjects With Renal Cell Carcinoma
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Trial Identification
Brief Title: Study to Compare Tivozanib in Combination With Nivolumab to Tivozanib Monotherapy in Subjects With Renal Cell Carcinoma
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
Study ID: NCT04987203
Conditions
Study Description
Brief 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).
Detailed Description: This will be an open-label, randomized, controlled, multicenter, multi-national, parallel-arm study. The study is designed to compare the progression free survival (PFS), overall survival (OS), Objective response rate (ORR), duration of response (DoR), and safety of tivozanib and the combination of tivozanib with nivolumab. 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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, Saint 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
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, Harrison, 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, Argentina
Centro Oncologico de Rosario, Rosario, Santa Fe, Argentina
Centro para la Atención Integral del paciente Oncológico, San Miguel de Tucumán, Tucumán, 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 Region, Belgium
Jessa Ziekenhuis - Campus Virga Jesse - Medische Oncologie, Hasselt, Limburg, Belgium
UZ Gent - Medische Oncologie, Gent, Oost-Vlaanderen, Belgium
CHU Brugmann - Victor Horta, Bruxelles, , Belgium
AZ Groeninge - Campus Kennedylaan, Kortrijk, , Belgium
Centro Gaucho Integrado de Onc, Porto Alegre, Rio Grande Do Sul, Brazil
Clinica de Neoplasias Litoral, Itajai, Santa Catarina, Brazil
Universidade Estadual de Campi, Campinas, São Paulo, Brazil
Hospital Nossa Senhora da Conc, Porto Alegre, , Brazil
Pontificia Universidade, Porto Alegre, , Brazil
Instituto Brasileiro de Controle do Cancer - ibcc, São Paulo, , 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
Meditek Ltda., Santiago de Chile, Región Metropolitana De Santiago, Chile
Centro de Estudios Clinicos In, Santiago, Región Metropolitana De Santia, Chile
Centro de Estudios Clínicos SAGA SpA, Santiago, Región Metropolitana De Santia, Chile
ACEREY Centro de Investigación Clínica Oncológica, Viña del mar, Valparaíso, Chile
FN Hradec Kralove, Hradec Kralove, , Czechia
FN Kralovske Vinohrady, Praha 10, , Czechia
Fakultni Thomayerova nemocnice, Praha 4, , Czechia
Institut de cancérologie de Strasbourg Europe - ICANS, Strasbourg, Alsace, 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
Hospices Civils de Lyon (HCL) - Centre Hospitalier Lyon-Sud, Pierre-Bénite, Rhône-Alpes, 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, St 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, France
Universitätsklinikum Heidelberg, Heidelberg, Baden-Württemberg, Germany
Medizinische Hochschule Hannover, Hannover, Niedersachsen, Germany
P.O. Ss. Annunziata, Chieti Scalo, Chieti, Italy
IRST, Meldola (Fc), Forli, Italy
Ospedale S.Donato, AUSL 8 di Arezzo, Arezzo, , Italy
Azienda Mater Domini, Catanzaro, , Italy
PO di Cremona, ASST di Cremona - Oncologia medica, Cremona, , Italy
AOUC Azienda Ospedaliero-Universitaria Careggi, Firenze, , Italy
European Institute of Oncology, Milano, , Italy
IRCCS Fondazione "Giovanni Pas, Napoli, , Italy
IRCCS Policlinico San Matteo, Pavia, , Italy
Fondazione Policlinico Universitario Agostino Gemelli, Roma, , Italy
AO S.Camillo-Forlanini, Roma, , Italy
Azienda Ospedaliera Santa Maria di Terni, Terni, , Italy
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Tlalpan, , Mexico
Szpital Specjalistyczny im. L. Rydygiera w Krakowie, Kraków, Malopolskie, Poland
Europejskie Centrum Zdrowia Otwock, Szpital im. F. Chopina, Otwock, Mazowieckie, Poland
Szpital Specjalist. w Brzozowie,Podkarpacki Ośrodek Onkologi, Brzozow, Podkarpackie, Poland
Nzoz Mrukmed Lekarz Beata Madej-Mruk I Partner Sp. P., Rzeszow, Podkarpackie, Poland
COPERNICUS Podmiot Leczn. Sp z o.o.,Wojew. Centrum Onkologii, Gdańsk, Pomorskie, Poland
Szpital Kliniczny Przemienienia Panskiego UM w Poznaniu, Poznan, Wielkopolskie, Poland
Wojewodzki Szpital Specjalistyczny, Biala Podlaska, , Poland
Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych, Warszawa, , Poland
Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy, Warszawa, , Poland
H. Prof. Doutor Fernando Fonseca, Amadora, Lisboa, Portugal
Hospital Particular do Algarve - Gambelas-Faro, Faro, , Portugal
H. de Santa Maria. Centro Hospitalar Lisboa Norte - Oncologia, Lisboa, , Portugal
H. Santo Antonio. Centro Hospitalar do Porto, Porto, , 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, Baleares, Spain
Hospital Universitari Parc Tau, Sabadell, Barcelona, Spain
Hospital Universitario Y Politécnico La Fe, Valencia, Valenciana, Comunidad, Spain
Hospital de La Santa Creu i Sant Pau, Barcelona, , Spain
Hospital Universitario Vall d', Barcelona, , Spain
Institut Catalá d´Oncología (I.C.O.), Barcelona, , Spain
Hospital Del Mar, Barcelona, , Spain
ICO-Hospital Universitari de G, Girona, , Spain
Hospital Universitario Ramón y Cajal, Madrid, , Spain
Hospital Clínico San Carlos, Madrid, , Spain
Hospital U. 12 Octubre, Madrid, , Spain
Hospital Universitario La Paz, Madrid, , Spain
C.H.U. de Orense, Orense, , Spain
Hospital Universitario Virgen, Sevilla, , Spain
Fundación Instituto Valenciano, Valencia, , 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
Royal Marsden - Sutton, Sutton, Surrey, United Kingdom
Royal Marsden Hospital, Sutton, Surrey, United Kingdom
Royal Derby Hospital, Derby, , United Kingdom
Leeds Teaching Hospitals NHS Trust, Leeds, , United Kingdom
The Christie NHS Foundation Trust - Medical Oncology, Manchester, , United Kingdom
New Cross Hospital, Wolverhampton, , United Kingdom
Contact Details
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