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New combo therapy shows promise for Tough-to-Treat kidney cancer

NCT ID NCT04987203

Disease control Sponsor: AVEO Pharmaceuticals, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether adding an immunotherapy drug (nivolumab) to a targeted therapy (tivozanib) helps people with advanced kidney cancer live longer without their cancer growing. The trial included 343 adults whose cancer had worsened after one or two prior treatments, including an immunotherapy. The main goal was to compare how long the cancer stayed under control with the combo versus tivozanib alone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

343 people

The number who actually took part.

Started

Sep 2021

Finished

Jan 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 130 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Disease Progression renal cell carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Renal cell carcinoma

Contacts and locations

Locations

  • ACEREY Centro de Investigación Clínica Oncológica

    Viña del Mar, Valparaiso, 2520612, Chile

  • AO S.Camillo-Forlanini

    Roma, Roma, 00152, Italy

  • AOUC Azienda Ospedaliero-Universitaria Careggi

    Florence, 50134, Italy

  • AZ Groeninge - Campus Kennedylaan

    Kortrijk, 8500, Belgium

  • Addenbrooke's Hospital - Oncology

    Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

  • Allegheny General Hospital (AGH)

    Pittsburgh, Pennsylvania, 15212-4756, United States

  • Azienda Mater Domini

    Catanzaro, Catanzaro, 88100, Italy

  • Azienda Ospedaliera Santa Maria di Terni

    Terni, Terni, 05100, Italy

  • BC Cancer - Vancouver Centre

    Vancouver, British Columbia, V5Z 4E6, Canada

  • C.H.U. de Orense

    Ourense, 32005, Spain

  • CHD Vendee La Roche sur Yon - Gastro-Entérologie

    La Roche-sur-Yon, 85925, France

  • CHU Brugmann - Victor Horta

    Brussels, 1020, Belgium

  • CHU Michallon - Hopital Nord - Cancérologie Et Hématologie

    Grenoble, Isère, 38043, France

  • COPERNICUS Podmiot Leczn. Sp z o.o.,Wojew. Centrum Onkologii

    Gdansk, Pomeranian Voivodeship, 80-219, Poland

  • Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych

    Warsaw, 02-507, Poland

  • Centre Hospitalier de Poitiers

    Poitiers, Poitou-Charentes, 86021, France

  • Centre Leon Berard - departement d'oncologie medicale

    Lyon, Rhône, 69373, France

  • Centre de Lutte Contre le Cancer (CLCC)

    Nice, 06189, France

  • Centre de Lutte Contre le Cancer (CLCC) - Gustave Roussy (Institut de Cancerologie Gustave-Roussy)

    Villejuif, Île-de-France Region, 94805, France

  • Centro Gaucho Integrado de Onc

    Porto Alegre, Rio Grande do Sul, 90110-270, Brazil

  • Centro Oncologico de Rosario

    Rosario, Santa Fe Province, S2000KZE, Argentina

  • Centro Oncológico Korben

    Buenos Aires, Ciudad Autónoma de Buenos Aire, C1280AEB, Argentina

  • Centro de Estudios Clinicos In

    Santiago, Región Metropolitana de Santia, 8420383, Chile

  • Centro de Estudios Clínicos SAGA SpA

    Santiago, Región Metropolitana de Santia, Chile

  • Centro para la Atención Integral del paciente Oncológico

    San Miguel de Tucumán, Tucumán Province, T4000GTB, Argentina

  • Chao Family Comprehensive Cancer Center, UC Irvine

    Irvine, California, 92868, United States

  • Chattanooga Oncology and Hematology Associates

    Chattanooga, Tennessee, 37404, United States

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195-0001, United States

  • Clinica de Neoplasias Litoral

    Itajaí, Santa Catarina, 88301-220, Brazil

  • Clinique Victor Hugo - Hematologie

    Le Mans, Sarthe, 72000, France

  • Clínica Viedma

    Viedma, Río Negro Province, R8500JYJ, Argentina

  • Dana-Farber Cancer Institute - Medicine

    Boston, Massachusetts, 02215, United States

  • European Institute of Oncology

    Milan, Milano, 20141, Italy

  • Europejskie Centrum Zdrowia Otwock, Szpital im. F. Chopina

    Otwock, Masovian Voivodeship, 05-400, Poland

  • FN Hradec Kralove

    Hradec Králové, 500 05, Czechia

  • FN Kralovske Vinohrady

    Prague, 100 34, Czechia

  • Fakultni Thomayerova nemocnice

    Prague, Praha 4, 140 59, Czechia

  • Florida Cancer Specialists & Res Inst

    Fort Myers, Florida, 33901, United States

  • Florida Cancer Specialists & Research Institute (FCS) - Tampa Cancer Center Location

    St. Petersburg, Florida, 33705, United States

  • Fondazione Policlinico Universitario Agostino Gemelli

    Roma, Roma, '00168, Italy

  • Fundación Instituto Valenciano

    Valencia, Valencia, 46009, Spain

  • H. Prof. Doutor Fernando Fonseca

    Amadora, Lisbon District, 2720-276, Portugal

  • H. Santo Antonio. Centro Hospitalar do Porto

    Porto, Porto District, 4099-001, Portugal

  • H. de Santa Maria. Centro Hospitalar Lisboa Norte - Oncologia

    Lisbon, Lisbon District, 1649-035, Portugal

  • H.G.U. de Elche

    Elche, Alicante, 03203, Spain

  • Henry Ford Hospital

    Detroit, Michigan, 48202, United States

  • Hopital Foch

    Suresnes, Hauts-de-Seine, 92151, France

  • Hopital Saint-Andre - Service d'Oncologie Medicale

    Bordeaux, Gironde, 33075, France

  • Hopital Trousseau - medical oncology

    Tours, 37044, France

  • Hospices Civils de Lyon (HCL) - Centre Hospitalier Lyon-Sud

    Pierre-Bénite, Auvergne-Rhône-Alpes, 69495, France

  • Hospital Clínico San Carlos

    Madrid, Madrid, 28040, Spain

  • Hospital Del Mar

    Barcelona, Barcelona, 8003, Spain

  • Hospital Nossa Senhora da Conc

    Porto Alegre, 90610-000, Brazil

  • Hospital Particular do Algarve - Gambelas-Faro

    Faro, Faro District, 8005-226, Portugal

  • Hospital U. 12 Octubre

    Madrid, Madrid, 28041, Spain

  • Hospital Universitari Parc Tau

    Sabadell, Barcelona, 8208, Spain

  • Hospital Universitario La Paz

    Madrid, Madrid, 28046, Spain

  • Hospital Universitario Ramón y Cajal

    Madrid, Madrid, 28034, Spain

  • Hospital Universitario Son Espases

    Palma de Mallorca, Balearic Islands, 07010, Spain

  • Hospital Universitario Vall d'

    Barcelona, Barcelona, 08035, Spain

  • Hospital Universitario Virgen

    Seville, Sevilla, 41009, Spain

  • Hospital Universitario Y Politécnico La Fe

    Valencia, Valenciana, Comunidad, 46026, Spain

  • Hospital de La Santa Creu i Sant Pau

    Barcelona, Barcelona, 08025, Spain

  • Hôpital privé Le Bois

    Lille, Nord, 59000, France

  • ICO - Site Rene Gauducheau - Oncologie Medicale

    Saint-Herblain, 44805, France

  • ICO-Hospital Universitari de G

    Girona, Girona, 17007, Spain

  • IRCCS Fondazione "Giovanni Pas

    Naples, 80131, Italy

  • IRCCS Policlinico San Matteo

    Pavia, Pavia, 27100, Italy

  • IRST

    Meldola (Fc), Forli, 47014, Italy

  • Imperial College Healthcare NHS Trust - Hammersmith Hospital

    London, London, City of, W6 8RF, United Kingdom

  • Institut Catalá d´Oncología (I.C.O.)

    Barcelona, Barcelona, 08908, Spain

  • Institut Jules Bordet - Oncologie Médicale

    Anderlecht, Brussels Capital, 1070, Belgium

  • Institut Paoli Calmettes - Hôpital de jour

    Marseille, Bouches-du-Rhône, 13273, France

  • Institut de Cancérologie de Lorraine

    Vandœuvre-lès-Nancy, 54511, France

  • Institut de cancérologie de Strasbourg Europe - ICANS

    Strasbourg, Alsace, 67200, France

  • Instituto Brasileiro de Controle do Cancer - ibcc

    São Paulo, São Paulo, 03102-002, Brazil

  • Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

    Tlalpan, 14080, Mexico

  • Instituto Português Oncologia Francisco Gentil do Porto

    Porto, 4200-072, Portugal

  • Jessa Ziekenhuis - Campus Virga Jesse - Medische Oncologie

    Hasselt, Limburg, 3500, Belgium

  • John Hopkins Medicine - Hematology/oncology

    Baltimore, Maryland, 21287, United States

  • Kaiser Permanente Riverside Medical Center

    Riverside, California, 92505, United States

  • Leeds Teaching Hospitals NHS Trust

    Leeds, LS9 7TF, United Kingdom

  • Lehigh Valley Physician Group

    Allentown, Pennsylvania, 18103-6218, United States

  • Leland Stanford Junior University

    Redwood City, California, 94063, United States

  • Liverpool Hospital Cancer Therapy Centre

    Liverpool, New South Wales, 2170, Australia

  • Maryland Oncology Hematology

    Clinton, Maryland, 20735, United States

  • Mater Misericordiae Limited

    Brisbane, Queensland, 4101, Australia

  • Meditek Ltda.

    Santiago, Santiago Metropolitan, 8420383, Chile

  • Medizinische Hochschule Hannover

    Hanover, Lower Saxony, 30625, Germany

  • Memorial Sloan Kettering Cancer Center (MSKCC) - Memorial Hospital

    New York, New York, 10065, United States

  • Memorial Sloan Kettering Cancer Center - Monmouth - Oncology

    Middletown, New Jersey, 07748-3052, United States

  • Memorial Sloan Kettering Cancer Center - Nassau

    Uniondale, New York, 11553, United States

  • Memorial Sloan Kettering Cancer Center - Westchester

    East White Plains, New York, 10604, United States

  • Mount Vernon Cancer Centre

    Northwood, England, HA6 2JW, United Kingdom

  • Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy

    Warsaw, 02-781, Poland

  • New Cross Hospital

    Wolverhampton, Wolverhampton, WV10 0QP, United Kingdom

  • Northwest Medical Specialties PLLC

    Tacoma, Washington, 98405-5016, United States

  • Nzoz Mrukmed Lekarz Beata Madej-Mruk I Partner Sp. P.

    Rzeszów, Podkarpackie Voivodeship, 35-021, Poland

  • Oncology Hematology West PC dba Nebraska Cancer Specialists

    Omaha, Nebraska, 68130, United States

  • Ospedale S.Donato, AUSL 8 di Arezzo

    Arezzo, Arezzo, 52100, Italy

  • P.O. Ss. Annunziata

    Chieti Scalo, Chieti, 66013, Italy

  • PO di Cremona, ASST di Cremona - Oncologia medica

    Cremona, Italy

  • Pontificia Universidade

    Porto Alegre, 90610-000, Brazil

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102, Australia

  • Roswell - Roswell Park Cancer Institute - Medical Oncology

    Buffalo, New York, 14263, United States

  • Royal Blackburn Hospital - Oncology

    Preston, Lancashire, PR2 9HT, United Kingdom

  • Royal Derby Hospital

    Derby, DE22 3NE, United Kingdom

  • Royal Marsden - Sutton

    Sutton, Surrey, SM2 5PT, United Kingdom

  • Royal Marsden Hospital

    Sutton, Surrey, SM2 5PT, United Kingdom

  • St. Vincent Frontier Cancer Center

    Billings, Montana, 59102-6746, United States

  • Sunnybrook Research Institute, sunnybrook Health Sciences Ct

    Toronto, Ontario, M4N 3M5, Canada

  • Sunshine Hospital

    Geelong, Victoria, 3220, Australia

  • Szpital Kliniczny Przemienienia Panskiego UM w Poznaniu

    Poznan, Greater Poland Voivodeship, 60-569, Poland

  • Szpital Specjalist. w Brzozowie,Podkarpacki Ośrodek Onkologi

    Brzozów, Podkarpackie Voivodeship, 36-200, Poland

  • Szpital Specjalistyczny im. L. Rydygiera w Krakowie

    Krakow, Lesser Poland Voivodeship, 31-826, Poland

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37203, United States

  • Texas Oncology - Baylor Charles A. Sammons Cancer Center

    Dallas, Texas, 75246, United States

  • Texas Oncology - Central Austin Cancer Center

    Austin, Texas, 78731, United States

  • The Christie NHS Foundation Trust - Medical Oncology

    Manchester, Manchester, M20 4BX, United Kingdom

  • The University of Kansas Cancer Center

    Westwood, Kansas, 66205-2005, United States

  • Tom Baker Cancer Centre

    Calgary, Alberta, T2N 4N2, Canada

  • Tulane Cancer Center Clinic - Oncology

    New Orleans, Louisiana, 70112, United States

  • UH Cleveland Medical Center

    Columbia, South Carolina, 29210, United States

  • US Oncology - Rocky Mountain Cancer Centers - Midtown

    Denver, Colorado, 80218-1237, United States

  • US Oncology Texas Oncology (CCC of South Texas) - San Antonio Medical Center

    San Antonio, Texas, 78240, United States

  • UZ Gent - Medische Oncologie

    Ghent, Oost-Vlaanderen, 9000, Belgium

  • Universidade Estadual de Campi

    Campinas, São Paulo, 13083-970, Brazil

  • University Health Network - Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9, Canada

  • University Hospital Brno

    Brno, Brno-město, 625 00, Czechia

  • University Of Washington - Medical Center

    Seattle, Washington, 98109, United States

  • University of California San Diego

    La Jolla, California, 92037, United States

  • University of Kentucky UK Markey Cancer Center

    Lexington, Kentucky, 40536, United States

  • University of Maryland Medical Center-Greenebaum Cancer Ctr

    Baltimore, Maryland, 21201, United States

  • University of New Mexico - Comprehensive Cancer Center

    Albuquerque, New Mexico, 87131-0001, United States

  • Universitätsklinikum Heidelberg

    Heidelberg, Baden-Wurttemberg, 69120, Germany

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232, United States

  • Wojewodzki Szpital Specjalistyczny

    Biała Podlaska, 21-500, Poland

  • ZNA Jan Palfijn

    Merksen, Antwerpen, 2170, Belgium

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