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

Primary Purpose

Renal Cell Carcinoma

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Tivozanib
Nivolumab
Sponsored by
AVEO Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Cell Carcinoma focused on measuring Immune Checkpoint Inhibitor, Open-label, Monotherapy, Disease Progression

Eligibility Criteria

18 Years - 130 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 or returned to 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:

  • More than 2 prior lines of therapy in the advanced or metastatic setting.
  • History of life-threatening toxicity related to prior immune therapy.
  • Active, known, or suspected 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.

Sites / Locations

  • Genesis Cancer and Blood Institute
  • City of Hope Comprehensive Cancer Center
  • Chao Family Comprehensive Cancer Center, UC Irvine
  • University of California San Diego
  • Leland Stanford Junior University
  • Kaiser Permanente Riverside Medical Center
  • US Oncology - Rocky Mountain Cancer Centers - Midtown
  • Florida Cancer Specialists & Res Inst
  • Florida Cancer Specialists & Research Institute (FCS) - Tampa Cancer Center Location
  • The University of Kansas Cancer Center
  • University of Kentucky UK Markey Cancer Center
  • Tulane Cancer Center Clinic - Oncology
  • University of Maryland Medical Center-Greenebaum Cancer Ctr
  • John Hopkins Medicine - Hematology/oncology
  • Maryland Oncology Hematology
  • Dana-Farber Cancer Institute - Medicine
  • Henry Ford Hospital
  • Saint Luke's Hospital - Saint Luke's Cancer Institute - Kans
  • St. Vincent Frontier Cancer Center
  • Oncology Hematology West PC dba Nebraska Cancer Specialists
  • University of New Mexico - Comprehensive Cancer Center
  • Roswell - Roswell Park Cancer Institute - Medical Oncology
  • Memorial Sloan Kettering Cancer Center - Westchester
  • Memorial Sloan Kettering Cancer Center (MSKCC) - Memorial Hospital
  • Memorial Sloan Kettering Cancer Center - Nassau
  • Cleveland Clinic
  • Lehigh Valley Physician Group
  • Allegheny General Hospital (AGH)
  • UH Cleveland Medical Center
  • Chattanooga Oncology and Hematology Associates
  • Baptist Cancer Center
  • Tennessee Oncology, PLLC
  • Vanderbilt-Ingram Cancer Center
  • Texas Oncology - Central Austin Cancer Center
  • Texas Oncology - Baylor Charles A. Sammons Cancer Center
  • US Oncology Texas Oncology (CCC of South Texas) - San Antonio Medical Center
  • Inova Schar Cancer Institute - Medical Oncology
  • Virginia Oncology Associates
  • University Of Washington - Medical Center
  • Northwest Medical Specialties PLLC
  • Centro Oncológico Korben
  • Clínica Viedma
  • Centro Oncologico de Rosario
  • Centro para la Atención Integral del paciente Oncológico
  • Liverpool Hospital Cancer Therapy Centre
  • Mater Misericordiae Limited
  • Princess Alexandra Hospital
  • Flinders Medical Centre
  • Cabrini Health - Cabrini Institute
  • St Vincent's Hospital Melbourne
  • Sunshine Hospital
  • ZNA Jan Palfijn
  • Institut Jules Bordet - Oncologie Médicale
  • Jessa Ziekenhuis - Campus Virga Jesse - Medische Oncologie
  • UZ Gent - Medische Oncologie
  • AZ Sint-Jan Brugge - Oostende AV - Campus Sint-Jan - Oncology
  • CHU Brugmann - Victor Horta
  • AZ Groeninge - Campus Kennedylaan
  • Centro Gaucho Integrado de Onc
  • Clinica de Neoplasias Litoral
  • Universidade Estadual de Campi
  • Hospital Nossa Senhora da Conc
  • Pontificia Universidade
  • Instituto Brasileiro de Controle do Cancer - ibcc
  • Tom Baker Cancer Centre
  • BC Cancer - Vancouver Centre
  • Sunnybrook Research Institute, sunnybrook Health Sciences Ct
  • University Health Network - Princess Margaret Cancer Centre
  • Meditek Ltda.
  • Centro de Estudios Clinicos In
  • Centro de Estudios Clínicos SAGA SpA
  • ACEREY Centro de Investigación Clínica Oncológica
  • University Hospital Brno
  • FN Hradec Kralove
  • FN Kralovske Vinohrady
  • Fakultni Thomayerova nemocnice
  • Institut de cancérologie de Strasbourg Europe - ICANS
  • Institut Paoli Calmettes - Hôpital de jour
  • Hopital Saint-Andre - Service d'Oncologie Medicale
  • Hopital Foch
  • CHU Michallon - Hopital Nord - Cancérologie Et Hématologie
  • Hôpital privé Le Bois
  • Centre Hospitalier de Poitiers
  • Hospices Civils de Lyon (HCL) - Centre Hospitalier Lyon-Sud
  • Centre Leon Berard - departement d'oncologie medicale
  • Clinique Victor Hugo - Hematologie
  • CHD Vendee La Roche sur Yon - Gastro-Entérologie
  • Centre de Lutte Contre le Cancer (CLCC)
  • ICO - Site Rene Gauducheau - Oncologie Medicale
  • Hopital Trousseau - medical oncology
  • Institut de Cancérologie de Lorraine
  • Centre de Lutte Contre le Cancer (CLCC) - Gustave Roussy (Institut de Cancerologie Gustave-Roussy)
  • Universitätsklinikum Heidelberg
  • University Hospital Tuebingen
  • Medizinische Hochschule Hannover
  • Praxis Eckert
  • P.O. Ss. Annunziata
  • IRST
  • Ospedale S.Donato, AUSL 8 di Arezzo
  • Azienda Mater Domini
  • PO di Cremona, ASST di Cremona - Oncologia medica
  • AOUC Azienda Ospedaliero-Universitaria Careggi
  • European Institute of Oncology
  • IRCCS Fondazione "Giovanni Pas
  • IRCCS Policlinico San Matteo
  • Fondazione Policlinico Universitario Agostino Gemelli
  • AO S.Camillo-Forlanini
  • Azienda Ospedaliera Santa Maria di Terni
  • Oaxaca Site Management Organization S.C. (OSMO) - Investigacion Clinica - Pharmacy
  • Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
  • Szpital Specjalistyczny im. L. Rydygiera w Krakowie
  • Europejskie Centrum Zdrowia Otwock, Szpital im. F. Chopina
  • Szpital Specjalist. w Brzozowie,Podkarpacki Ośrodek Onkologi
  • Nzoz Mrukmed Lekarz Beata Madej-Mruk I Partner Sp. P.
  • COPERNICUS Podmiot Leczn. Sp z o.o.,Wojew. Centrum Onkologii
  • Szpital Kliniczny Przemienienia Panskiego UM w Poznaniu
  • Wojewodzki Szpital Specjalistyczny
  • Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych
  • Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy
  • H. Prof. Doutor Fernando Fonseca
  • Hospital Particular do Algarve - Gambelas-Faro
  • H. de Santa Maria. Centro Hospitalar Lisboa Norte - Oncologia
  • H. Santo Antonio. Centro Hospitalar do Porto
  • Instituto Português Oncologia Francisco Gentil do Porto
  • H.G.U. de Elche
  • Hospital Universitario Son Espases
  • Hospital Universitari Parc Tau
  • Hospital Universitario Y Politécnico La Fe
  • Institut Català d'Oncologia-Hospital Universitari Germans Trias i Pujol
  • Hospital de La Santa Creu i Sant Pau
  • Hospital Universitario Vall d'
  • Institut Catalá d´Oncología (I.C.O.)
  • Hospital Del Mar
  • ICO-Hospital Universitari de G
  • Hospital Universitario Ramón y Cajal
  • Hospital Clínico San Carlos
  • Hospital U. 12 Octubre
  • Hospital Universitario La Paz
  • C.H.U. de Orense
  • Hospital Universitario Virgen
  • Fundación Instituto Valenciano
  • Addenbrooke's Hospital - Oncology
  • Mount Vernon Cancer Centre
  • Royal Blackburn Hospital - Oncology
  • Imperial College Healthcare NHS Trust - Hammersmith Hospital
  • Royal Marsden - Sutton
  • Royal Marsden Hospital
  • Royal Derby Hospital
  • Leeds Teaching Hospitals NHS Trust
  • The Christie NHS Foundation Trust - Medical Oncology
  • New Cross Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Tivozanib in Combination with Nivolumab

Tivozanib

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Progression free survival
Comparison of the PFS of tivozanib in combination with nivolumab to tivozanib in subjects with RCC who have progressed following 1 or 2 lines of therapy. PFS is defined as the time from randomization to first documentation of objective tumor progression (progressive disease [PD], radiological) according to Response Evaluation Criteria In Solid Tumors (RECIST), or death due to any reasons whichever comes first.

Secondary Outcome Measures

Overall Survival
Comparsion of the OS of subjects randomized to treatment with tivozanib in combination with nivolumab compared to tivozanib. OS is defined as the time from the date of randomization to date of death due to any cause.
Objective Response Rate
Comparison of ORR of subjects randomized to treatment with tivozanib in combination with nivolumab compared to tivozanib. ORR is defined as the proportion of subjects with confirmed complete response or confirmed partial response according to RECIST relative to the total population of randomized subjects.
Duration of Response
Comparison of DoR of subjects randomized to treatment with tivozanib in combination with nivolumab compared to tivozanib. DoR is defined as the time from the first documentation of objective tumor response to the first documentation of objective tumor progression or to death due to any cause.
Number of subjects with serious and non-serious adverse events
Assessment of the safety and tolerability of tivozanib in combination with nivolumab compared to tivozanib.

Full Information

First Posted
July 23, 2021
Last Updated
September 25, 2023
Sponsor
AVEO Pharmaceuticals, Inc.
Collaborators
Parexel, Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT04987203
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 Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 9, 2021 (Actual)
Primary Completion Date
August 1, 2024 (Anticipated)
Study Completion Date
August 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AVEO Pharmaceuticals, Inc.
Collaborators
Parexel, Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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. A Safety Follow-up Visit will be performed 30 days (± 7 days) after the last dose of study drug.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Cell Carcinoma
Keywords
Immune Checkpoint Inhibitor, Open-label, Monotherapy, Disease Progression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
326 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tivozanib in Combination with Nivolumab
Arm Type
Experimental
Arm Description
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.
Arm Title
Tivozanib
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Tivozanib
Intervention Description
Tivozanib will be administered orally.
Intervention Type
Drug
Intervention Name(s)
Nivolumab
Intervention Description
Nivolumab will be administered via intravenous infusion.
Primary Outcome Measure Information:
Title
Progression free survival
Description
Comparison of the PFS of tivozanib in combination with nivolumab to tivozanib in subjects with RCC who have progressed following 1 or 2 lines of therapy. PFS is defined as the time from randomization to first documentation of objective tumor progression (progressive disease [PD], radiological) according to Response Evaluation Criteria In Solid Tumors (RECIST), or death due to any reasons whichever comes first.
Time Frame
until progressive disease [PD] (Approximately 30 months)
Secondary Outcome Measure Information:
Title
Overall Survival
Description
Comparsion of the OS of subjects randomized to treatment with tivozanib in combination with nivolumab compared to tivozanib. OS is defined as the time from the date of randomization to date of death due to any cause.
Time Frame
From Screening (Days -28 to -1) until death (Approximately 42 months)
Title
Objective Response Rate
Description
Comparison of ORR of subjects randomized to treatment with tivozanib in combination with nivolumab compared to tivozanib. ORR is defined as the proportion of subjects with confirmed complete response or confirmed partial response according to RECIST relative to the total population of randomized subjects.
Time Frame
From Screening (Days -28 to -1) until PD (Approximately 30 months)
Title
Duration of Response
Description
Comparison of DoR of subjects randomized to treatment with tivozanib in combination with nivolumab compared to tivozanib. DoR is defined as the time from the first documentation of objective tumor response to the first documentation of objective tumor progression or to death due to any cause.
Time Frame
From Screening (Days -28 to -1) until PD or death (Approximately 30 months)
Title
Number of subjects with serious and non-serious adverse events
Description
Assessment of the safety and tolerability of tivozanib in combination with nivolumab compared to tivozanib.
Time Frame
From Screening (Day -28 to Day -1) to Follow-up visit (30 days after last dose of study drug ± 7 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
130 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Genesis Cancer and Blood Institute
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
City of Hope Comprehensive Cancer Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
Chao Family Comprehensive Cancer Center, UC Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
University of California San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Leland Stanford Junior University
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
Facility Name
Kaiser Permanente Riverside Medical Center
City
Riverside
State/Province
California
ZIP/Postal Code
92505
Country
United States
Facility Name
US Oncology - Rocky Mountain Cancer Centers - Midtown
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218-1237
Country
United States
Facility Name
Florida Cancer Specialists & Res Inst
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
Florida Cancer Specialists & Research Institute (FCS) - Tampa Cancer Center Location
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Facility Name
The University of Kansas Cancer Center
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66205-2005
Country
United States
Facility Name
University of Kentucky UK Markey Cancer Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Tulane Cancer Center Clinic - Oncology
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
University of Maryland Medical Center-Greenebaum Cancer Ctr
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
John Hopkins Medicine - Hematology/oncology
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Maryland Oncology Hematology
City
Clinton
State/Province
Maryland
ZIP/Postal Code
20735
Country
United States
Facility Name
Dana-Farber Cancer Institute - Medicine
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Saint Luke's Hospital - Saint Luke's Cancer Institute - Kans
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
St. Vincent Frontier Cancer Center
City
Billings
State/Province
Montana
ZIP/Postal Code
59102-6746
Country
United States
Facility Name
Oncology Hematology West PC dba Nebraska Cancer Specialists
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Facility Name
University of New Mexico - Comprehensive Cancer Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131-0001
Country
United States
Facility Name
Roswell - Roswell Park Cancer Institute - Medical Oncology
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center - Westchester
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center (MSKCC) - Memorial Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center - Nassau
City
Uniondale
State/Province
New York
ZIP/Postal Code
11553
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195-0001
Country
United States
Facility Name
Lehigh Valley Physician Group
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103-6218
Country
United States
Facility Name
Allegheny General Hospital (AGH)
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212-4756
Country
United States
Facility Name
UH Cleveland Medical Center
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29210
Country
United States
Facility Name
Chattanooga Oncology and Hematology Associates
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Baptist Cancer Center
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Tennessee Oncology, PLLC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Vanderbilt-Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Texas Oncology - Central Austin Cancer Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Texas Oncology - Baylor Charles A. Sammons Cancer Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
US Oncology Texas Oncology (CCC of South Texas) - San Antonio Medical Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
Inova Schar Cancer Institute - Medical Oncology
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Virginia Oncology Associates
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
University Of Washington - Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Northwest Medical Specialties PLLC
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405-5016
Country
United States
Facility Name
Centro Oncológico Korben
City
Buenos Aires
State/Province
Ciudad Autónoma De Buenos Aire
ZIP/Postal Code
C1280AEB
Country
Argentina
Facility Name
Clínica Viedma
City
Viedma
State/Province
Río Negro
ZIP/Postal Code
R8500JYJ
Country
Argentina
Facility Name
Centro Oncologico de Rosario
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000KZE
Country
Argentina
Facility Name
Centro para la Atención Integral del paciente Oncológico
City
San Miguel de Tucumán
State/Province
Tucumán
ZIP/Postal Code
T4000GTB
Country
Argentina
Facility Name
Liverpool Hospital Cancer Therapy Centre
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Facility Name
Mater Misericordiae Limited
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Flinders Medical Centre
City
Bedford Park
State/Province
South Australia
Country
Australia
Facility Name
Cabrini Health - Cabrini Institute
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
8006
Country
Australia
Facility Name
St Vincent's Hospital Melbourne
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Facility Name
Sunshine Hospital
City
Geelong
State/Province
Victoria
ZIP/Postal Code
3220
Country
Australia
Facility Name
ZNA Jan Palfijn
City
Merksen
State/Province
Antwerpen
ZIP/Postal Code
2170
Country
Belgium
Facility Name
Institut Jules Bordet - Oncologie Médicale
City
Anderlecht
State/Province
Brussels Capital Region
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Jessa Ziekenhuis - Campus Virga Jesse - Medische Oncologie
City
Hasselt
State/Province
Limburg
ZIP/Postal Code
3500
Country
Belgium
Facility Name
UZ Gent - Medische Oncologie
City
Gent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Facility Name
AZ Sint-Jan Brugge - Oostende AV - Campus Sint-Jan - Oncology
City
Brugge
State/Province
West-Vlaanderen
ZIP/Postal Code
8000
Country
Belgium
Facility Name
CHU Brugmann - Victor Horta
City
Bruxelles
ZIP/Postal Code
1020
Country
Belgium
Facility Name
AZ Groeninge - Campus Kennedylaan
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium
Facility Name
Centro Gaucho Integrado de Onc
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90110-270
Country
Brazil
Facility Name
Clinica de Neoplasias Litoral
City
Itajai
State/Province
Santa Catarina
ZIP/Postal Code
88301-220
Country
Brazil
Facility Name
Universidade Estadual de Campi
City
Campinas
State/Province
São Paulo
ZIP/Postal Code
13083-970
Country
Brazil
Facility Name
Hospital Nossa Senhora da Conc
City
Porto Alegre
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Pontificia Universidade
City
Porto Alegre
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Instituto Brasileiro de Controle do Cancer - ibcc
City
São Paulo
ZIP/Postal Code
03102-002
Country
Brazil
Facility Name
Tom Baker Cancer Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
BC Cancer - Vancouver Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
Sunnybrook Research Institute, sunnybrook Health Sciences Ct
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
University Health Network - Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Meditek Ltda.
City
Santiago de Chile
State/Province
Región Metropolitana De Santiago
ZIP/Postal Code
8420383
Country
Chile
Facility Name
Centro de Estudios Clinicos In
City
Santiago
State/Province
Región Metropolitana De Santia
ZIP/Postal Code
8420383
Country
Chile
Facility Name
Centro de Estudios Clínicos SAGA SpA
City
Santiago
State/Province
Región Metropolitana De Santia
Country
Chile
Facility Name
ACEREY Centro de Investigación Clínica Oncológica
City
Viña del mar
State/Province
Valparaíso
ZIP/Postal Code
2520612
Country
Chile
Facility Name
University Hospital Brno
City
Brno
State/Province
Brno-město
ZIP/Postal Code
625 00
Country
Czechia
Facility Name
FN Hradec Kralove
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
FN Kralovske Vinohrady
City
Praha 10
ZIP/Postal Code
100 34
Country
Czechia
Facility Name
Fakultni Thomayerova nemocnice
City
Praha 4
ZIP/Postal Code
140 59
Country
Czechia
Facility Name
Institut de cancérologie de Strasbourg Europe - ICANS
City
Strasbourg
State/Province
Alsace
ZIP/Postal Code
67200
Country
France
Facility Name
Institut Paoli Calmettes - Hôpital de jour
City
Marseille
State/Province
Bouches-du-Rhône
ZIP/Postal Code
13273
Country
France
Facility Name
Hopital Saint-Andre - Service d'Oncologie Medicale
City
Bordeaux
State/Province
Gironde
ZIP/Postal Code
33075
Country
France
Facility Name
Hopital Foch
City
Suresnes
State/Province
Hauts-de-Seine
ZIP/Postal Code
92151
Country
France
Facility Name
CHU Michallon - Hopital Nord - Cancérologie Et Hématologie
City
Grenoble
State/Province
Isère
ZIP/Postal Code
38043
Country
France
Facility Name
Hôpital privé Le Bois
City
Lille
State/Province
Nord
ZIP/Postal Code
59000
Country
France
Facility Name
Centre Hospitalier de Poitiers
City
Poitiers
State/Province
Poitou-Charentes
ZIP/Postal Code
86021
Country
France
Facility Name
Hospices Civils de Lyon (HCL) - Centre Hospitalier Lyon-Sud
City
Pierre-Bénite
State/Province
Rhône-Alpes
ZIP/Postal Code
69495
Country
France
Facility Name
Centre Leon Berard - departement d'oncologie medicale
City
Lyon
State/Province
Rhône
ZIP/Postal Code
69373
Country
France
Facility Name
Clinique Victor Hugo - Hematologie
City
Le Mans
State/Province
Sarthe
ZIP/Postal Code
72000
Country
France
Facility Name
CHD Vendee La Roche sur Yon - Gastro-Entérologie
City
La Roche-sur-Yon
ZIP/Postal Code
85925
Country
France
Facility Name
Centre de Lutte Contre le Cancer (CLCC)
City
Nice
ZIP/Postal Code
06189
Country
France
Facility Name
ICO - Site Rene Gauducheau - Oncologie Medicale
City
St Herblain
ZIP/Postal Code
44805
Country
France
Facility Name
Hopital Trousseau - medical oncology
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
Institut de Cancérologie de Lorraine
City
Vandœuvre-lès-Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Centre de Lutte Contre le Cancer (CLCC) - Gustave Roussy (Institut de Cancerologie Gustave-Roussy)
City
Villejuif
State/Province
Île-de-France
ZIP/Postal Code
94805
Country
France
Facility Name
Universitätsklinikum Heidelberg
City
Heidelberg
State/Province
Baden-Württemberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
University Hospital Tuebingen
City
Tübingen
State/Province
Baden-Württemberg
ZIP/Postal Code
72076
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30625
Country
Germany
Facility Name
Praxis Eckert
City
Lutherstadt Eisleben
State/Province
Sachsen-Anhalt
ZIP/Postal Code
06295
Country
Germany
Facility Name
P.O. Ss. Annunziata
City
Chieti Scalo
State/Province
Chieti
ZIP/Postal Code
66013
Country
Italy
Facility Name
IRST
City
Meldola (Fc)
State/Province
Forli
ZIP/Postal Code
47014
Country
Italy
Facility Name
Ospedale S.Donato, AUSL 8 di Arezzo
City
Arezzo
ZIP/Postal Code
52100
Country
Italy
Facility Name
Azienda Mater Domini
City
Catanzaro
ZIP/Postal Code
88100
Country
Italy
Facility Name
PO di Cremona, ASST di Cremona - Oncologia medica
City
Cremona
Country
Italy
Facility Name
AOUC Azienda Ospedaliero-Universitaria Careggi
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Facility Name
European Institute of Oncology
City
Milano
ZIP/Postal Code
20141
Country
Italy
Facility Name
IRCCS Fondazione "Giovanni Pas
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
IRCCS Policlinico San Matteo
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Fondazione Policlinico Universitario Agostino Gemelli
City
Roma
ZIP/Postal Code
'00168
Country
Italy
Facility Name
AO S.Camillo-Forlanini
City
Roma
ZIP/Postal Code
00152
Country
Italy
Facility Name
Azienda Ospedaliera Santa Maria di Terni
City
Terni
ZIP/Postal Code
05100
Country
Italy
Facility Name
Oaxaca Site Management Organization S.C. (OSMO) - Investigacion Clinica - Pharmacy
City
México
State/Province
Oaxaca
ZIP/Postal Code
68000
Country
Mexico
Facility Name
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
City
Tlalpan
ZIP/Postal Code
14080
Country
Mexico
Facility Name
Szpital Specjalistyczny im. L. Rydygiera w Krakowie
City
Kraków
State/Province
Malopolskie
ZIP/Postal Code
31-826
Country
Poland
Facility Name
Europejskie Centrum Zdrowia Otwock, Szpital im. F. Chopina
City
Otwock
State/Province
Mazowieckie
ZIP/Postal Code
05-400
Country
Poland
Facility Name
Szpital Specjalist. w Brzozowie,Podkarpacki Ośrodek Onkologi
City
Brzozow
State/Province
Podkarpackie
ZIP/Postal Code
36-200
Country
Poland
Facility Name
Nzoz Mrukmed Lekarz Beata Madej-Mruk I Partner Sp. P.
City
Rzeszow
State/Province
Podkarpackie
ZIP/Postal Code
35-021
Country
Poland
Facility Name
COPERNICUS Podmiot Leczn. Sp z o.o.,Wojew. Centrum Onkologii
City
Gdańsk
State/Province
Pomorskie
ZIP/Postal Code
80-219
Country
Poland
Facility Name
Szpital Kliniczny Przemienienia Panskiego UM w Poznaniu
City
Poznan
State/Province
Wielkopolskie
ZIP/Postal Code
60-569
Country
Poland
Facility Name
Wojewodzki Szpital Specjalistyczny
City
Biala Podlaska
ZIP/Postal Code
21-500
Country
Poland
Facility Name
Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych
City
Warszawa
ZIP/Postal Code
02-507
Country
Poland
Facility Name
Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
H. Prof. Doutor Fernando Fonseca
City
Amadora
State/Province
Lisboa
ZIP/Postal Code
2720-276
Country
Portugal
Facility Name
Hospital Particular do Algarve - Gambelas-Faro
City
Faro
ZIP/Postal Code
8005-226
Country
Portugal
Facility Name
H. de Santa Maria. Centro Hospitalar Lisboa Norte - Oncologia
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
H. Santo Antonio. Centro Hospitalar do Porto
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Facility Name
Instituto Português Oncologia Francisco Gentil do Porto
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Facility Name
H.G.U. de Elche
City
Elche
State/Province
Alicante
ZIP/Postal Code
03203
Country
Spain
Facility Name
Hospital Universitario Son Espases
City
Palma de Mallorca
State/Province
Baleares
ZIP/Postal Code
07010
Country
Spain
Facility Name
Hospital Universitari Parc Tau
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
8208
Country
Spain
Facility Name
Hospital Universitario Y Politécnico La Fe
City
Valencia
State/Province
Valenciana, Comunidad
ZIP/Postal Code
46026
Country
Spain
Facility Name
Institut Català d'Oncologia-Hospital Universitari Germans Trias i Pujol
City
Badalona
ZIP/Postal Code
8916
Country
Spain
Facility Name
Hospital de La Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital Universitario Vall d'
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Institut Catalá d´Oncología (I.C.O.)
City
Barcelona
ZIP/Postal Code
08908
Country
Spain
Facility Name
Hospital Del Mar
City
Barcelona
ZIP/Postal Code
8003
Country
Spain
Facility Name
ICO-Hospital Universitari de G
City
Girona
ZIP/Postal Code
17007
Country
Spain
Facility Name
Hospital Universitario Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Clínico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital U. 12 Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
C.H.U. de Orense
City
Orense
ZIP/Postal Code
32005
Country
Spain
Facility Name
Hospital Universitario Virgen
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Fundación Instituto Valenciano
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Addenbrooke's Hospital - Oncology
City
Cambridge
State/Province
Cambridgeshire
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
Mount Vernon Cancer Centre
City
Northwood
State/Province
England
ZIP/Postal Code
HA6 2JW
Country
United Kingdom
Facility Name
Royal Blackburn Hospital - Oncology
City
Preston
State/Province
Lancashire
ZIP/Postal Code
PR2 9HT
Country
United Kingdom
Facility Name
Imperial College Healthcare NHS Trust - Hammersmith Hospital
City
London
State/Province
London, City Of
ZIP/Postal Code
W6 8RF
Country
United Kingdom
Facility Name
Royal Marsden - Sutton
City
Sutton
State/Province
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
Royal Marsden Hospital
City
Sutton
State/Province
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
Royal Derby Hospital
City
Derby
ZIP/Postal Code
DE22 3NE
Country
United Kingdom
Facility Name
Leeds Teaching Hospitals NHS Trust
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
The Christie NHS Foundation Trust - Medical Oncology
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
New Cross Hospital
City
Wolverhampton
ZIP/Postal Code
WV10 0QP
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
35304832
Citation
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.
Results Reference
derived

Learn more about this trial

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

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