Kidney Cancer Clinical Trial

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

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).

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Full 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Radiographic disease progression during or following at least 6 weeks of treatment with ICI for locally advanced or metastatic RCC with a clear cell component either in first- or second-line treatment.
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:

Subjects who received: a. A single agent tyrosine kinase inhibitor (TKI) in the first line setting followed by a single agent immune checkpoint inhibitor (ICI) in the second line setting; b. More than 2 prior lines of therapy in the advanced or metastatic setting.
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.

Study is for people with:

Kidney Cancer

Phase:

Phase 3

Estimated Enrollment:

343

Study ID:

NCT04987203

Recruitment Status:

Active, not recruiting

Sponsor:

AVEO Pharmaceuticals, Inc.

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There are 132 Locations for this study

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City of Hope Comprehensive Cancer Center
Duarte California, 91010, United States
Chao Family Comprehensive Cancer Center, UC Irvine
Irvine California, 92868, United States
University of California San Diego
La Jolla California, 92037, United States
Leland Stanford Junior University
Redwood City California, 94063, United States
Kaiser Permanente Riverside Medical Center
Riverside California, 92505, United States
US Oncology - Rocky Mountain Cancer Centers - Midtown
Denver Colorado, 80218, United States
Florida Cancer Specialists & Res Inst
Fort Myers Florida, 33901, United States
Florida Cancer Specialists & Research Institute (FCS) - Tampa Cancer Center Location
Saint Petersburg Florida, 33705, United States
The University of Kansas Cancer Center
Westwood Kansas, 66205, United States
University of Kentucky UK Markey Cancer Center
Lexington Kentucky, 40536, United States
Tulane Cancer Center Clinic - Oncology
New Orleans Louisiana, 70112, United States
University of Maryland Medical Center-Greenebaum Cancer Ctr
Baltimore Maryland, 21201, United States
John Hopkins Medicine - Hematology/oncology
Baltimore Maryland, 21287, United States
Maryland Oncology Hematology
Clinton Maryland, 20735, United States
Dana-Farber Cancer Institute - Medicine
Boston Massachusetts, 02215, United States
Henry Ford Hospital
Detroit Michigan, 48202, United States
St. Vincent Frontier Cancer Center
Billings Montana, 59102, United States
Oncology Hematology West PC dba Nebraska Cancer Specialists
Omaha Nebraska, 68130, United States
University of New Mexico - Comprehensive Cancer Center
Albuquerque New Mexico, 87131, United States
Roswell - Roswell Park Cancer Institute - Medical Oncology
Buffalo New York, 14263, United States
Memorial Sloan Kettering Cancer Center - Westchester
Harrison New York, 10604, United States
Memorial Sloan Kettering Cancer Center (MSKCC) - Memorial Hospital
New York New York, 10065, United States
Memorial Sloan Kettering Cancer Center - Nassau
Uniondale New York, 11553, United States
Cleveland Clinic
Cleveland Ohio, 44195, United States
Lehigh Valley Physician Group
Allentown Pennsylvania, 18103, United States
Allegheny General Hospital (AGH)
Pittsburgh Pennsylvania, 15212, United States
UH Cleveland Medical Center
Columbia South Carolina, 29210, United States
Chattanooga Oncology and Hematology Associates
Chattanooga Tennessee, 37404, United States
Tennessee Oncology, PLLC
Nashville Tennessee, 37203, United States
Vanderbilt-Ingram Cancer Center
Nashville Tennessee, 37232, United States
Texas Oncology - Central Austin Cancer Center
Austin Texas, 78731, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas Texas, 75246, United States
US Oncology Texas Oncology (CCC of South Texas) - San Antonio Medical Center
San Antonio Texas, 78240, United States
Virginia Oncology Associates
Norfolk Virginia, 23502, United States
University Of Washington - Medical Center
Seattle Washington, 98109, United States
Northwest Medical Specialties PLLC
Tacoma Washington, 98405, United States
Centro Oncológico Korben
Buenos Aires Ciudad Autónoma De Buenos Aire, C1280, Argentina
Clínica Viedma
Viedma Río Negro, R8500, Argentina
Centro Oncologico de Rosario
Rosario Santa Fe, S2000, Argentina
Centro para la Atención Integral del paciente Oncológico
San Miguel de Tucumán Tucumán, T4000, Argentina
Liverpool Hospital Cancer Therapy Centre
Liverpool New South Wales, 2170, Australia
Mater Misericordiae Limited
Brisbane Queensland, 4101, Australia
Princess Alexandra Hospital
Woolloongabba Queensland, 4102, Australia
Sunshine Hospital
Geelong Victoria, 3220, Australia
ZNA Jan Palfijn
Merksen Antwerpen, 2170, Belgium
Institut Jules Bordet - Oncologie Médicale
Anderlecht Brussels Capital Region, 1070, Belgium
Jessa Ziekenhuis - Campus Virga Jesse - Medische Oncologie
Hasselt Limburg, 3500, Belgium
UZ Gent - Medische Oncologie
Gent Oost-Vlaanderen, 9000, Belgium
CHU Brugmann - Victor Horta
Bruxelles , 1020, Belgium
AZ Groeninge - Campus Kennedylaan
Kortrijk , 8500, Belgium
Centro Gaucho Integrado de Onc
Porto Alegre Rio Grande Do Sul, 90110, Brazil
Clinica de Neoplasias Litoral
Itajai Santa Catarina, 88301, Brazil
Universidade Estadual de Campi
Campinas São Paulo, 13083, Brazil
Hospital Nossa Senhora da Conc
Porto Alegre , 90610, Brazil
Pontificia Universidade
Porto Alegre , 90610, Brazil
Instituto Brasileiro de Controle do Cancer - ibcc
São Paulo , 03102, Brazil
Tom Baker Cancer Centre
Calgary Alberta, T2N 4, Canada
BC Cancer - Vancouver Centre
Vancouver British Columbia, V5Z 4, Canada
Sunnybrook Research Institute, sunnybrook Health Sciences Ct
Toronto Ontario, M4N 3, Canada
University Health Network - Princess Margaret Cancer Centre
Toronto Ontario, M5G 2, Canada
Meditek Ltda.
Santiago de Chile Región Metropolitana De Santiago, 84203, Chile
Centro de Estudios Clinicos In
Santiago Región Metropolitana De Santia, 84203, Chile
Centro de Estudios Clínicos SAGA SpA
Santiago Región Metropolitana De Santia, , Chile
ACEREY Centro de Investigación Clínica Oncológica
Viña del mar Valparaíso, 25206, Chile
FN Hradec Kralove
Hradec Kralove , 500 0, Czechia
FN Kralovske Vinohrady
Praha 10 , 100 3, Czechia
Fakultni Thomayerova nemocnice
Praha 4 , 140 5, Czechia
Institut de cancérologie de Strasbourg Europe - ICANS
Strasbourg Alsace, 67200, France
Institut Paoli Calmettes - Hôpital de jour
Marseille Bouches-du-Rhône, 13273, France
Hopital Saint-Andre - Service d'Oncologie Medicale
Bordeaux Gironde, 33075, France
Hopital Foch
Suresnes Hauts-de-Seine, 92151, France
CHU Michallon - Hopital Nord - Cancérologie Et Hématologie
Grenoble Isère, 38043, France
Hôpital privé Le Bois
Lille Nord, 59000, France
Centre Hospitalier de Poitiers
Poitiers Poitou-Charentes, 86021, France
Hospices Civils de Lyon (HCL) - Centre Hospitalier Lyon-Sud
Pierre-Bénite Rhône-Alpes, 69495, France
Centre Leon Berard - departement d'oncologie medicale
Lyon Rhône, 69373, France
Clinique Victor Hugo - Hematologie
Le Mans Sarthe, 72000, France
CHD Vendee La Roche sur Yon - Gastro-Entérologie
La Roche-sur-Yon , 85925, France
Centre de Lutte Contre le Cancer (CLCC)
Nice , 06189, France
ICO - Site Rene Gauducheau - Oncologie Medicale
St Herblain , 44805, France
Hopital Trousseau - medical oncology
Tours , 37044, France
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy , 54511, France
Centre de Lutte Contre le Cancer (CLCC) - Gustave Roussy (Institut de Cancerologie Gustave-Roussy)
Villejuif Île-de-France, 94805, France
Universitätsklinikum Heidelberg
Heidelberg Baden-Württemberg, 69120, Germany
Medizinische Hochschule Hannover
Hannover Niedersachsen, 30625, Germany
P.O. Ss. Annunziata
Chieti Scalo Chieti, 66013, Italy
IRST
Meldola (Fc) Forli, 47014, Italy
Ospedale S.Donato, AUSL 8 di Arezzo
Arezzo , 52100, Italy
Azienda Mater Domini
Catanzaro , 88100, Italy
PO di Cremona, ASST di Cremona - Oncologia medica
Cremona , , Italy
AOUC Azienda Ospedaliero-Universitaria Careggi
Firenze , 50134, Italy
European Institute of Oncology
Milano , 20141, Italy
IRCCS Fondazione "Giovanni Pas
Napoli , 80131, Italy
IRCCS Policlinico San Matteo
Pavia , 27100, Italy
Fondazione Policlinico Universitario Agostino Gemelli
Roma , '0016, Italy
AO S.Camillo-Forlanini
Roma , 00152, Italy
Azienda Ospedaliera Santa Maria di Terni
Terni , 05100, Italy
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Tlalpan , 14080, Mexico
Szpital Specjalistyczny im. L. Rydygiera w Krakowie
Kraków Malopolskie, 31-82, Poland
Europejskie Centrum Zdrowia Otwock, Szpital im. F. Chopina
Otwock Mazowieckie, 05-40, Poland
Szpital Specjalist. w Brzozowie,Podkarpacki Ośrodek Onkologi
Brzozow Podkarpackie, 36-20, Poland
Nzoz Mrukmed Lekarz Beata Madej-Mruk I Partner Sp. P.
Rzeszow Podkarpackie, 35-02, Poland
COPERNICUS Podmiot Leczn. Sp z o.o.,Wojew. Centrum Onkologii
Gdańsk Pomorskie, 80-21, Poland
Szpital Kliniczny Przemienienia Panskiego UM w Poznaniu
Poznan Wielkopolskie, 60-56, Poland
Wojewodzki Szpital Specjalistyczny
Biala Podlaska , 21-50, Poland
Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych
Warszawa , 02-50, Poland
Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy
Warszawa , 02-78, Poland
H. Prof. Doutor Fernando Fonseca
Amadora Lisboa, 2720-, Portugal
Hospital Particular do Algarve - Gambelas-Faro
Faro , 8005-, Portugal
H. de Santa Maria. Centro Hospitalar Lisboa Norte - Oncologia
Lisboa , 1649-, Portugal
H. Santo Antonio. Centro Hospitalar do Porto
Porto , 4099-, Portugal
Instituto Português Oncologia Francisco Gentil do Porto
Porto , 4200-, Portugal
H.G.U. de Elche
Elche Alicante, 03203, Spain
Hospital Universitario Son Espases
Palma de Mallorca Baleares, 07010, Spain
Hospital Universitari Parc Tau
Sabadell Barcelona, 8208, Spain
Hospital Universitario Y Politécnico La Fe
Valencia Valenciana, Comunidad, 46026, Spain
Hospital de La Santa Creu i Sant Pau
Barcelona , 08025, Spain
Hospital Universitario Vall d'
Barcelona , 08035, Spain
Institut Catalá d´Oncología (I.C.O.)
Barcelona , 08908, Spain
Hospital Del Mar
Barcelona , 8003, Spain
ICO-Hospital Universitari de G
Girona , 17007, Spain
Hospital Universitario Ramón y Cajal
Madrid , 28034, Spain
Hospital Clínico San Carlos
Madrid , 28040, Spain
Hospital U. 12 Octubre
Madrid , 28041, Spain
Hospital Universitario La Paz
Madrid , 28046, Spain
C.H.U. de Orense
Orense , 32005, Spain
Hospital Universitario Virgen
Sevilla , 41009, Spain
Fundación Instituto Valenciano
Valencia , 46009, Spain
Addenbrooke's Hospital - Oncology
Cambridge Cambridgeshire, CB2 0, United Kingdom
Mount Vernon Cancer Centre
Northwood England, HA6 2, United Kingdom
Royal Blackburn Hospital - Oncology
Preston Lancashire, PR2 9, United Kingdom
Imperial College Healthcare NHS Trust - Hammersmith Hospital
London London, City Of, W6 8R, United Kingdom
Royal Marsden - Sutton
Sutton Surrey, SM2 5, United Kingdom
Royal Marsden Hospital
Sutton Surrey, SM2 5, United Kingdom
Royal Derby Hospital
Derby , DE22 , United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds , LS9 7, United Kingdom
The Christie NHS Foundation Trust - Medical Oncology
Manchester , M20 4, United Kingdom
New Cross Hospital
Wolverhampton , WV10 , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Kidney Cancer

Phase:

Phase 3

Estimated Enrollment:

343

Study ID:

NCT04987203

Recruitment Status:

Active, not recruiting

Sponsor:


AVEO Pharmaceuticals, Inc.

How clear is this clinincal trial information?

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