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

February 21, 2024 updated by: AVEO Pharmaceuticals, Inc.

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

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

343

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 130 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Tivozanib
Tivozanib will be administered orally.
Drug: Nivolumab
Nivolumab will be administered via intravenous infusion.
Experimental: 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.
Drug: Tivozanib
Tivozanib will be administered orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival
Time Frame: Until progressive disease [PD] (Approximately 30 months)
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.
Until progressive disease [PD] (Approximately 30 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: From Screening (Days -28 to -1) until death (Approximately 42 months)
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.
From Screening (Days -28 to -1) until death (Approximately 42 months)
Objective Response Rate
Time Frame: From Screening (Days -28 to -1) until PD (Approximately 30 months)
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.
From Screening (Days -28 to -1) until PD (Approximately 30 months)
Duration of Response
Time Frame: From Screening (Days -28 to -1) until PD or death (Approximately 30 months)
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.
From Screening (Days -28 to -1) until PD or death (Approximately 30 months)
Number of subjects with serious and non-serious adverse events
Time Frame: From Screening (Day -28 to Day -1) to Follow-up visit (30 days after last dose of study drug ± 7 days)
Assessment of the safety and tolerability of tivozanib in combination with nivolumab compared to tivozanib.
From Screening (Day -28 to Day -1) to Follow-up visit (30 days after last dose of study drug ± 7 days)
Progression free survival
Time Frame: Until progressive disease [PD] (Approximately 30 months)
PFS is defined as the time from randomization to first documentation of objective tumor progression (progressive disease [PD], radiological) according to RECIST, or death due to any reasons whichever comes first. PFS as assessed by investigator.
Until progressive disease [PD] (Approximately 30 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AVEO Pharmaceuticals, Inc.

Collaborators

Bristol-Myers Squibb
Parexel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 9, 2021

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

July 23, 2021

First Submitted That Met QC Criteria

July 23, 2021

First Posted (Actual)

August 3, 2021

Study Record Updates

Last Update Posted (Estimated)

February 22, 2024

Last Update Submitted That Met QC Criteria

February 21, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AV-951-20-304

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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