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

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: Completed
• Conditions: Renal Cell Carcinoma
• Intervention / Treatment: Drug: Tivozanib; Drug: Nivolumab

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

Study Locations

• Argentina
  • Ciudad Autónoma de Buenos Aire
    • Buenos Aires, Ciudad Autónoma de Buenos Aire, Argentina, C1280AEB
      • Centro Oncológico Korben
  • Río Negro Province
    • Viedma, Río Negro Province, Argentina, R8500JYJ
      • Clinica Viedma
  • Santa Fe Province
    • Rosario, Santa Fe Province, Argentina, S2000KZE
      • Centro Oncologico de Rosario
  • Tucumán Province
    • San Miguel de Tucumán, Tucumán Province, 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
  • Brussels, Belgium, 1020
    • CHU Brugmann - Victor Horta
  • Kortrijk, Belgium, 8500
    • AZ Groeninge - campus kennedylaan
  • Antwerpen
    • Merksen, Antwerpen, Belgium, 2170
      • ZNA Jan Palfijn
  • Brussels Capital
    • Anderlecht, Brussels Capital, Belgium, 1070
      • Institut Jules Bordet - Oncologie Médicale
  • Limburg
    • Hasselt, Limburg, Belgium, 3500
      • Jessa Ziekenhuis - Campus Virga Jesse - Medische Oncologie
  • Oost-Vlaanderen
    • Ghent, 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
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90110-270
      • Centro Gaucho Integrado de Onc
  • Santa Catarina
    • Itajaí, Santa Catarina, Brazil, 88301-220
      • Clinica de Neoplasias Litoral
  • São Paulo
    • Campinas, São Paulo, Brazil, 13083-970
      • Universidade Estadual de Campi
    • São Paulo, São Paulo, Brazil, 03102-002
      • Instituto Brasileiro De Controle Do Câncer - IBCC
• 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 Clinicos SAGA Spa
  • Santiago Metropolitan
    • Santiago, Santiago Metropolitan, Chile, 8420383
      • Meditek Ltda.
  • Valparaiso
    • Viña del Mar, Valparaiso, Chile, 2520612
      • ACEREY Centro de Investigación Clínica Oncológica
• Czechia
  • Hradec Králové, Czechia, 500 05
    • FN Hradec Králové
  • Prague, Czechia, 100 34
    • FN Kralovske Vinohrady
  • Brno-město
    • Brno, Brno-město, Czechia, 625 00
      • University Hospital Brno
  • Praha 4
    • Prague, 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)
  • Saint-Herblain, France, 44805
    • ICO - Site Rene Gauducheau - Oncologie Medicale
  • Tours, France, 37044
    • Hopital Trousseau - medical oncology
  • Vandœuvre-lès-Nancy, France, 54511
    • Institut de Cancerologie de Lorraine
  • Alsace
    • Strasbourg, Alsace, France, 67200
      • Institut de Cancérologie de Strasbourg Europe - ICANS
  • Auvergne-Rhône-Alpes
    • Pierre-Bénite, Auvergne-Rhône-Alpes, France, 69495
      • Hospices Civils de Lyon (HCL) - Centre Hospitalier Lyon-Sud
  • 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
      • Hopital 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
  • Sarthe
    • Le Mans, Sarthe, France, 72000
      • Clinique Victor Hugo - Hematologie
  • Île-de-France Region
    • Villejuif, Île-de-France Region, France, 94805
      • Centre de Lutte Contre le Cancer (CLCC) - Gustave Roussy (Institut de Cancerologie Gustave-Roussy)
• Germany
  • Baden-Wurttemberg
    • Heidelberg, Baden-Wurttemberg, Germany, 69120
      • UniversitatsKlinikum Heidelberg
  • Lower Saxony
    • Hanover, Lower Saxony, Germany, 30625
      • Medizinische Hochschule Hannover
• Italy
  • Cremona, Italy
    • PO di Cremona, ASST di Cremona - Oncologia medica
  • Florence, Italy, 50134
    • AOUC Azienda Ospedaliero-Universitaria Careggi
  • Naples, Italy, 80131
    • IRCCS Fondazione "Giovanni Pas
  • Arezzo
    • Arezzo, Arezzo, Italy, 52100
      • Ospedale S.Donato, AUSL 8 di Arezzo
  • Catanzaro
    • Catanzaro, Catanzaro, Italy, 88100
      • Azienda Mater Domini
  • Chieti
    • Chieti Scalo, Chieti, Italy, 66013
      • P.O. Ss. Annunziata
  • Forli
    • Meldola (Fc), Forli, Italy, 47014
      • IRST
  • Milano
    • Milan, Milano, Italy, 20141
      • European Institute of Oncology
  • Pavia
    • Pavia, Pavia, Italy, 27100
      • IRCCS Policlinico San Matteo
  • Roma
    • Roma, Roma, Italy, '00168
      • Fondazione Policlinico Universitario Agostino Gemelli
    • Roma, Roma, Italy, 00152
      • AO S.Camillo-Forlanini
  • Terni
    • Terni, Terni, Italy, 05100
      • Azienda Ospedaliera Santa Maria di Terni
• Mexico
  • Tlalpan, Mexico, 14080
    • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
• Poland
  • Biała Podlaska, Poland, 21-500
    • Wojewodzki Szpital Specjalistyczny
  • Warsaw, Poland, 02-781
    • Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy
  • Warsaw, Poland, 02-507
    • Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych
  • Greater Poland Voivodeship
    • Poznan, Greater Poland Voivodeship, Poland, 60-569
      • Szpital Kliniczny Przemienienia Panskiego UM w Poznaniu
  • Lesser Poland Voivodeship
    • Krakow, Lesser Poland Voivodeship, Poland, 31-826
      • Szpital Specjalistyczny im. L. Rydygiera w Krakowie
  • Masovian Voivodeship
    • Otwock, Masovian Voivodeship, Poland, 05-400
      • Europejskie Centrum Zdrowia Otwock, Szpital im. F. Chopina
  • Podkarpackie Voivodeship
    • Brzozów, Podkarpackie Voivodeship, Poland, 36-200
      • Szpital Specjalist. w Brzozowie,Podkarpacki Ośrodek Onkologi
    • Rzeszów, Podkarpackie Voivodeship, Poland, 35-021
      • Nzoz Mrukmed Lekarz Beata Madej-Mruk I Partner Sp. P.
  • Pomeranian Voivodeship
    • Gdansk, Pomeranian Voivodeship, Poland, 80-219
      • COPERNICUS Podmiot Leczn. Sp z o.o.,Wojew. Centrum Onkologii
• Portugal
  • Porto, Portugal, 4200-072
    • Instituto Português Oncologia Francisco Gentil do Porto
  • Faro District
    • Faro, Faro District, Portugal, 8005-226
      • Hospital Particular do Algarve - Gambelas-Faro
  • Lisbon District
    • Amadora, Lisbon District, Portugal, 2720-276
      • H. Prof. Doutor Fernando Fonseca
    • Lisbon, Lisbon District, Portugal, 1649-035
      • H. de Santa Maria. Centro Hospitalar Lisboa Norte - Oncologia
  • Porto District
    • Porto, Porto District, Portugal, 4099-001
      • H. Santo Antonio. Centro Hospitalar do Porto
• Spain
  • Ourense, Spain, 32005
    • C.H.U. de Orense
  • Alicante
    • Elche, Alicante, Spain, 03203
      • H.G.U. de Elche
  • Balearic Islands
    • Palma de Mallorca, Balearic Islands, Spain, 07010
      • Hospital Universitario Son Espases
  • Barcelona
    • Barcelona, Barcelona, Spain, 08025
      • Hospital de la Santa Creu i Sant Pau
    • Barcelona, Barcelona, Spain, 8003
      • Hospital Del Mar
    • Barcelona, Barcelona, Spain, 08035
      • Hospital Universitario Vall d'
    • Barcelona, Barcelona, Spain, 08908
      • Institut Catalá d´Oncología (I.C.O.)
    • Sabadell, Barcelona, Spain, 8208
      • Hospital Universitari Parc Tau
  • Girona
    • Girona, Girona, Spain, 17007
      • ICO-Hospital Universitari de G
  • Madrid
    • Madrid, Madrid, Spain, 28040
      • Hospital Clinico San Carlos
    • Madrid, Madrid, Spain, 28046
      • Hospital Universitario La Paz
    • Madrid, Madrid, Spain, 28034
      • Hospital Universitario Ramon y Cajal
    • Madrid, Madrid, Spain, 28041
      • Hospital U. 12 Octubre
  • Sevilla
    • Seville, Sevilla, Spain, 41009
      • Hospital Universitario Virgen
  • Valencia
    • Valencia, Valencia, Spain, 46009
      • Fundación Instituto Valenciano
  • Valenciana, Comunidad
    • Valencia, Valenciana, Comunidad, Spain, 46026
      • Hospital Universitario y Politecnico La Fe
• United Kingdom
  • Derby, United Kingdom, DE22 3NE
    • Royal Derby Hospital
  • Leeds, United Kingdom, LS9 7TF
    • Leeds Teaching Hospitals NHS Trust
  • 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
  • Manchester
    • Manchester, Manchester, United Kingdom, M20 4BX
      • The Christie NHS Foundation Trust - Medical Oncology
  • Surrey
    • Sutton, Surrey, United Kingdom, SM2 5PT
      • Royal Marsden Hospital
    • Sutton, Surrey, United Kingdom, SM2 5PT
      • Royal Marsden - Sutton
  • Wolverhampton
    • Wolverhampton, Wolverhampton, United Kingdom, WV10 0QP
      • New Cross Hospital
• 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
    • St. 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 Jersey
    • Middletown, New Jersey, United States, 07748-3052
      • Memorial Sloan Kettering Cancer Center - Monmouth - Oncology
  • 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
    • East White Plains, 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
  • Washington
    • Seattle, Washington, United States, 98109
      • University Of Washington - Medical Center
    • Tacoma, Washington, United States, 98405-5016
      • Northwest Medical Specialties PLLC

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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	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	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	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	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	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

• Sponsor: AVEO Pharmaceuticals, Inc.
• Collaborators: Bristol-Myers Squibb; Parexel

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2021
• Primary Completion (Actual): January 20, 2026
• Study Completion (Actual): January 20, 2026

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 (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Open-label; Disease Progression; Monotherapy; Immune Checkpoint Inhibitor
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Disease Attributes; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Urologic Neoplasms; Carcinoma; Kidney Neoplasms; Pathological Conditions, Signs and Symptoms; Disease Progression; Carcinoma, Renal Cell; Amino Acids, Peptides, and Proteins; Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Nivolumab; tivozanib
• 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
• product manufactured in and exported from the U.S.: No