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New pill combo aims to fight advanced kidney cancer

NCT ID NCT07489495

Disease control Sponsor: Merck Sharp & Dohme LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Sep 18, 2026 · Updated 19 times

Summary

This Phase 3 trial is testing whether adding the drug zanzalintinib to belzutifan helps people with advanced kidney cancer live longer and keep the cancer from growing. About 758 participants who have already tried standard treatments will receive either the combination or belzutifan alone. The study is currently recruiting.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
belzutifan and zanzalintinib (targeted therapy pills)
What this could lead to
If successful, this combination could offer a new treatment option for people with advanced kidney cancer who have run out of standard therapies, potentially helping them live longer and delay cancer growth.
What could go wrong
This is an early-stage Phase 3 trial, so results are not guaranteed. The combination may not work better than belzutifan alone, and side effects from adding zanzalintinib could be more severe.

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

About 758 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Nov 2030

An estimate. End dates often move.

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 years and older

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: The main inclusion criteria include but are not limited to the following: * Has a histologically confirmed diagnosis of unresectable, advanced renal cell carcinoma (RCC) with clear cell component (with or without sarcomatoid features) ie, Stage IV RCC per American Joint Committee on Cancer (8th Edition) * Has measurable disease per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) * Has received no more than 3 prior systemic regimens for RCC, including only 1 prior anti-Programmed Cell Death-1/Programmed Cell Death 1 Ligand 1 therapy Exclusion Criteria: For exclusion criteria: The main exclusion criteria include but are not limited to the following: * Has any of the following: a pulse oximeter reading \<92% at rest, requires intermittent supplemental oxygen, or required chronic supplemental oxygen * Has clinically significant cardiovascular disease within 12 months from first dose of study intervention * Has deep vein thrombosis within 3 months before randomization unless stable, asymptomatic, and treated with therapeutic anticoagulation for at least 4 weeks before randomization * Has a left ventricular ejection fraction ≤50% or below the institutional (or local laboratory) normal range as determined by multigated acquisition or echocardiogram * Has had major surgery within 8 weeks before randomization * Has current pneumonitis/interstitial lung disease * Has a history of human immunodeficiency virus infection * Has Hepatitis B or Hepatitis C virus infection * Has a known additional malignancy that is progressing or has required active treatment within the past 3 years * Has a history of solid organ transplant * Has not adequately recovered from major surgery or has ongoing surgical complications

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Get notified about this study

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Conditions

The condition(s) this trial relates to.

clear cell renal carcinoma renal cell adenocarcinoma renal cell carcinoma

As listed by the trial registrant

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

Carcinoma, renal cell

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    90 sites in 19 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • A.O.U.C. Policlinico di Bari ( Site 1802)

    RECRUITING

    Bari, 70124, Italy

  • AIDPORT Sp. z o.o. ( Site 2118)

    RECRUITING

    Skórzewo, Greater Poland Voivodeship, 60-185, Poland

  • AO Santa Maria della Misericordia ( Site 1805)

    RECRUITING

    Perugia, 06132, Italy

  • ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 1401)

    RECRUITING

    Athens, Attica, 124 62, Greece

  • Aarhus Universitetshospital, Skejby ( Site 1001)

    RECRUITING

    Aarhus, Central Jutland, 8200, Denmark

  • Adana Medical Park Seyhan Hastanesi ( Site 2505)

    RECRUITING

    Adana, 01140, Turkey (Türkiye)

  • Alexandra General Hospital of Athens ( Site 1400)

    RECRUITING

    Athens, Attica, 115 28, Greece

  • Ankara University Health Practice and Research Hospitals ( Site 2506)

    RECRUITING

    Ankara, 06620, Turkey (Türkiye)

  • Asan Medical Center ( Site 2901)

    RECRUITING

    Seoul, 05505, South Korea

  • Azienda Ospedaliera Universitaria Careggi ( Site 1807)

    RECRUITING

    Florence, Tuscany, 50134, Italy

  • Bradfordhill ( Site 0400)

    RECRUITING

    Santiago, Region M. de Santiago, 8420383, Chile

  • CEDOES ( Site 0303)

    RECRUITING

    Vitória, Espírito Santo, 29055-450, Brazil

  • CHU Angers ( Site 1204)

    RECRUITING

    Angers, Maine-et-Loire, 49933, France

  • CHU de Saint-Etienne ( Site 1202)

    RECRUITING

    Saint Priest En Jarez, Pays de la Loire Region, 42271, France

  • COE (Centro Oncológico de Excelencia) ( Site 0259)

    RECRUITING

    San Juan, J5402BGA, Argentina

  • Centre Antoine Lacassagne ( Site 1209)

    RECRUITING

    Nice, Alpes-Maritimes, 06189, France

  • Centro Oncologico Korben ( Site 0254)

    RECRUITING

    CABA, Buenos Aires, C1426AHB, Argentina

  • Centro Oncológico Riojano Integral ( Site 0256)

    RECRUITING

    La Rioja, X5004BAL, Argentina

  • Centro Privado de RMI Río Cuarto S.A. II ( Site 0255)

    RECRUITING

    Río Cuarto, Córdoba Province, X5800ALB, Argentina

  • Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 1312)

    RECRUITING

    Berlin, 10117, Germany

  • Clinique Victor Hugo Le Mans-Oncology-Radiotherapy ( Site 1203)

    RECRUITING

    Le Mans, Pays de la Loire Region, 72000, France

  • Clínica Puerto Montt ( Site 0404)

    RECRUITING

    Port Montt, Los Lagos Region, 5500243, Chile

  • Fakulti poliklinika ( Site 0906)

    RECRUITING

    Prague, 128 08, Czechia

  • Fakultni nemocnice Hradec Kralove ( Site 0902)

    RECRUITING

    Hradec Králové, 500 05, Czechia

  • Fakultni nemocnice Olomouc ( Site 0901)

    RECRUITING

    Olomouc, 779 00, Czechia

  • Fakultni nemocnice Ostrava ( Site 0904)

    RECRUITING

    Ostrava, Ostrava Mesto, 708 52, Czechia

  • Fakultni nemocnice v Motole ( Site 0900)

    RECRUITING

    Prague, 150 06, Czechia

  • Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1800)

    RECRUITING

    Milan, 20133, Italy

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1801)

    RECRUITING

    Roma, 00168, Italy

  • Fundacion Arturo Lopez Perez ( Site 0401)

    RECRUITING

    Santiago, Region M. de Santiago, 7500921, Chile

  • Fundación Instituto Valenciano de Oncología ( Site 2307)

    RECRUITING

    Valencia, 46009, Spain

  • Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0302)

    RECRUITING

    São José do Rio Preto, São Paulo, 15090-000, Brazil

  • HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 2301)

    RECRUITING

    Madrid, Madrid, Comunidad de, 28007, Spain

  • Hacettepe Universite Hastaneleri ( Site 2500)

    RECRUITING

    Sıhhiye, Ankara, 06230, Turkey (Türkiye)

  • Haga Ziekenhuis locatie Leyweg ( Site 1906)

    RECRUITING

    The Hague, South Holland, 2545 AA, Netherlands

  • Herlev Hospital ( Site 1002)

    RECRUITING

    Herlev, Capital Region, 2730, Denmark

  • Hope - Humanizacao Em Oncologia, Pesquisa E Ensino ( Site 0306)

    RECRUITING

    Ribeirão Preto, São Paulo, 14026-610, Brazil

  • Hopital Europeen Marseille ( Site 1216)

    RECRUITING

    Marseille, Bouches-du-Rhone, 13003, France

  • Hospital Insular de Gran Canaria ( Site 2308)

    RECRUITING

    Las Palmas, 35016, Spain

  • Hospital Italiano de Buenos Aires ( Site 0253)

    RECRUITING

    Ciudad de Buenos Aires, Buenos Aires, 1181, Argentina

  • Hospital Universitari Vall d'Hebron ( Site 2303)

    RECRUITING

    Barcelona, 08035, Spain

  • Hospital Universitario 12 de Octubre ( Site 2300)

    RECRUITING

    Madrid, 28041, Spain

  • Hospital Universitario Virgen del Rocio ( Site 2306)

    RECRUITING

    Seville, Andalusia, 41013, Spain

  • IC La Serena Research ( Site 0405)

    RECRUITING

    La Serena, Coquimbo Region, 1720430, Chile

  • IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" ( Site 1809)

    RECRUITING

    Meldola, Emilia-Romagna, 47014, Italy

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 1803)

    RECRUITING

    Bologna, 40138, Italy

  • Institut Català d'Oncologia - L'Hospitalet ( Site 2305)

    RECRUITING

    L'Hospitalet de Llobregat, Barcelona, 08908, Spain

  • Instituto Alexander Fleming ( Site 0252)

    RECRUITING

    CABA, C1426ANZ, Argentina

  • Instituto de Investigaciones Clinicas Mar del Plata ( Site 0250)

    RECRUITING

    Mar del Plata, Buenos Aires, B7600FZO, Argentina

  • Instituto de Oncología de Rosario ( Site 0257)

    RECRUITING

    Rosario, Santa Fe Province, S2000KZE, Argentina

  • Instituto do Câncer e Transplante de Curitiba ( Site 0300)

    RECRUITING

    Curitiba, Paraná, 80510-130, Brazil

  • Istituto Clinico Humanitas ( Site 1808)

    RECRUITING

    Rozzano, Milano, 20089, Italy

  • Istituto Nazionale Tumori Regina Elena ( Site 1804)

    RECRUITING

    Roma, 00144, Italy

  • Istituto Oncologico Veneto IRCCS ( Site 1806)

    RECRUITING

    Catselfranco Veneto, Padova, 31033, Italy

  • Koc Universitesi Hastanesi ( Site 2501)

    RECRUITING

    Istanbul, 34010, Turkey (Türkiye)

  • LBM ONCOPOLE CLAUDIUS REGAUD ( Site 1215)

    RECRUITING

    Toulouse, Haute-Garonne, 31059, France

  • Leicester Royal Infirmary ( Site 2604)

    RECRUITING

    Leicester, Leicestershire, LE1 5WW, United Kingdom

  • Liga Norte Riograndense Contra o Câncer ( Site 0307)

    RECRUITING

    Natal, Rio Grande do Norte, 59062-000, Brazil

  • MTZ Clinical Research Powered by Pratia ( Site 2107)

    RECRUITING

    Warsaw, Masovian Voivodeship, 02-172, Poland

  • Maastricht UMC+ ( Site 1901)

    RECRUITING

    Maastricht, Limburg, 6229 HX, Netherlands

  • Macquarie University ( Site 2700)

    SUSPENDED

    Macquarie University, New South Wales, 2109, Australia

  • Masarykuv onkologicky ustav ( Site 0903)

    RECRUITING

    Brno, Brno-mesto, 656 53, Czechia

  • Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 2102)

    RECRUITING

    Siedlce, Masovian Voivodeship, 08-110, Poland

  • Meir Medical Center. ( Site 1603)

    RECRUITING

    Kfar Saba, 4428164, Israel

  • Memorial Sloan Kettering Cancer Center ( Site 0126)

    RECRUITING

    New York, New York, 10065, United States

  • Metropolitan Hospital ( Site 1402)

    RECRUITING

    Athens, Attica, 185 47, Greece

  • Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 2106)

    RECRUITING

    Gliwice, Silesian Voivodeship, 44-102, Poland

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Układu Moczowego ( Site 2100)

    RECRUITING

    Warsaw, Masovian Voivodeship, 02-781, Poland

  • Nederlands Kanker Instituut Antoni van Leeuwenhoek (NKI AVL) ( Site 1900)

    RECRUITING

    Amsterdam, North Holland, 1066 CX, Netherlands

  • Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0102)

    RECRUITING

    Marietta, Georgia, 30060, United States

  • ONCOCENTRO APYS ( Site 0403)

    RECRUITING

    Viña del Mar, Valparaiso, 2520598, Chile

  • Peter MacCallum Cancer Centre ( Site 2702)

    SUSPENDED

    Melbourne, Victoria, 3000, Australia

  • Pratia MCM Krakow ( Site 2115)

    RECRUITING

    Krakow, Lesser Poland Voivodeship, 30-727, Poland

  • Princess Alexandra Hospital ( Site 2703)

    SUSPENDED

    Woolloongabba, Queensland, 4102, Australia

  • Rabin Medical Center ( Site 1602)

    RECRUITING

    Petah Tikva, 4941492, Israel

  • Rambam Health Care Campus ( Site 1600)

    RECRUITING

    Haifa, 3109601, Israel

  • Samsung Medical Center ( Site 2902)

    RECRUITING

    Seoul, 06351, South Korea

  • Sanatorio Parque ( Site 0251)

    RECRUITING

    Rosario, Santa Fe Province, S2000DSV, Argentina

  • Severance Hospital, Yonsei University Health System ( Site 2903)

    RECRUITING

    Seoul, 03722, South Korea

  • Sheba Medical Center ( Site 1601)

    RECRUITING

    Ramat Gan, 5265601, Israel

  • The Christie Hospital NHS Foundation Trust ( Site 2601)

    RECRUITING

    Withington, Manchester, M20 4BX, United Kingdom

  • The Ottawa Hospital Cancer Centre ( Site 0003)

    RECRUITING

    Ottawa, Ontario, K1H 8L6, Canada

  • The West Clinic, P.C. ( Site 0115)

    RECRUITING

    Germantown, Tennessee, 38138, United States

  • Trakya University Medical Faculty Hospital ( Site 2502)

    RECRUITING

    Edirne, 22030, Turkey (Türkiye)

  • Universitaetsklinikum Augsburg ( Site 1316)

    RECRUITING

    Augsburg, Bavaria, 86156, Germany

  • University Hospitals Birmingham NHS Foundation Trust ( Site 2610)

    RECRUITING

    Birmingham, B15 2GW, United Kingdom

  • Universitätsklinikum Jena ( Site 1313)

    RECRUITING

    Jena, Thuringia, 07747, Germany

  • Washington University School of Medicine ( Site 0114)

    RECRUITING

    St Louis, Missouri, 63110, United States

  • Western General Hospital ( Site 2608)

    RECRUITING

    Edinburgh, Edinburgh, City of, EH4 2XU, United Kingdom

  • klinikum rechts der isar der technischen universität münchen ( Site 1315)

    RECRUITING

    Munich, Bavaria, 81675, Germany

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