RecruitingPhase III🇵🇱 PolandEN originalKidney cancer

A Clinical Study of Belzutifan (MK-6482) and Zanzalintinib in People With Renal Cell Carcinoma (RCC) (LITESPARK-034/LS-034/MK-6482-034)

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This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

Researchers are looking for new ways to treat advanced renal cell carcinoma (RCC). A standard (usual) treatment for certain people with RCC is belzutifan (a study medicine), which is a targeted therapy. Targeted therapy is a treatment that works to control how specific types of cancer cells grow and spread. Researchers want to learn if adding another targeted therapy called zanzalintinib (another study medicine) can treat more people with advanced RCC than belzutifan alone. The goal of this study is to learn if people who receive belzutifan and zanzalintinib live longer overall and without the cancer getting worse compared to people who receive belzutifan and placebo.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Zdiagnozowany nieoperacyjny, zaawansowany rak nerki potwierdzony badaniem histologicznym.
  • Rak nerki w stadium IV.
  • Choroba jest widoczna w badaniach obrazowych.
  • Pacjent otrzymał maksymalnie 3 wcześniejsze metody leczenia systemowego raka nerki, w tym tylko 1 terapię anty-PD-1/PD-L1.

✗ Disqualifies

  • Poziom tlenu we krwi poniżej 92% w spoczynku, potrzeba tlenu dodatkowego lub stałego.
  • Znaczące choroby serca w ciągu ostatniego roku.
  • Zakrzepica żył głębokich w ciągu ostatnich 3 miesięcy (chyba że jest stabilna, bez objawów i leczona antykoagulantami od 4 tygodni).
  • Osłabiona funkcja lewej komory serca (poniżej 50%).
  • Duża operacja w ciągu ostatnich 8 tygodni.
  • Aktywne zapalenie płuc lub choroby śródmiąższowej płuc.
  • Zakażenie wirusem HIV, wirusem zapalenia wątroby typu B lub C.
  • Inny czynny nowotwór złośliwy w ciągu ostatnich 3 lat.

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
July 20, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (59)

Centro Oncologico Korben ( Site 0254)

CABA, Argentina

Hospital Italiano de Buenos Aires ( Site 0253)

Ciudad de Buenos Aires, Argentina

Instituto de Investigaciones Clinicas Mar del Plata ( Site 0250)

Mar del Plata, Argentina

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

Río Cuarto, Argentina

Sanatorio Parque ( Site 0251)

Rosario, Argentina

Instituto de Oncología de Rosario ( Site 0257)

Rosario, Argentina

Instituto Alexander Fleming ( Site 0252)

CABA, Argentina

Centro Oncológico Riojano Integral ( Site 0256)

La Rioja, Argentina

COE (Centro Oncológico de Excelencia) ( Site 0259)

San Juan, Argentina

Macquarie University ( Site 2700)

Macquarie University, Australia

Instituto do Câncer e Transplante de Curitiba ( Site 0300)

Curitiba, Brazil

Masarykuv onkologicky ustav ( Site 0903)

Brno, Czechia

Fakultni nemocnice Ostrava ( Site 0904)

Ostrava, Czechia

Fakultni nemocnice Hradec Kralove ( Site 0902)

Hradec Králové, Czechia

Fakultni nemocnice v Motole ( Site 0900)

Prague, Czechia

Herlev Hospital ( Site 1002)

Herlev, Denmark

Aarhus Universitetshospital, Skejby ( Site 1001)

Aarhus, Denmark

Centre Antoine Lacassagne ( Site 1209)

Nice, France

Hopital Europeen Marseille ( Site 1216)

Marseille, France

LBM ONCOPOLE CLAUDIUS REGAUD ( Site 1215)

Toulouse, France

CHU Angers ( Site 1204)

Angers, France

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

Le Mans, France

CHU de Saint-Etienne ( Site 1202)

Saint Priest En Jarez, France

Universitätsklinikum Jena ( Site 1313)

Jena, Germany

Alexandra General Hospital of Athens ( Site 1400)

Athens, Greece

ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 1401)

Athens, Greece

Metropolitan Hospital ( Site 1402)

Athens, Greece

Rambam Health Care Campus ( Site 1600)

Haifa, Israel

Meir Medical Center. ( Site 1603)

Kfar Saba, Israel

Rabin Medical Center ( Site 1602)

Petah Tikva, Israel

Sheba Medical Center ( Site 1601)

Ramat Gan, Israel

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

Meldola, Italy

Azienda Ospedaliera Universitaria Careggi ( Site 1807)

Florence, Italy

Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1800)

Milan, Italy

AO Santa Maria della Misericordia ( Site 1805)

Perugia, Italy

Istituto Nazionale Tumori Regina Elena ( Site 1804)

Roma, Italy

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

Roma, Italy

Maastricht UMC+ ( Site 1901)

Maastricht, Netherlands

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

Amsterdam, Netherlands

Haga Ziekenhuis locatie Leyweg ( Site 1906)

The Hague, Netherlands

AIDPORT Sp. z o.o. ( Site 2118)

Skórzewo, Poland

Pratia MCM Krakow ( Site 2115)

Krakow, Poland

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

Siedlce, Poland

MTZ Clinical Research Powered by Pratia ( Site 2107)

Warsaw, Poland

Severance Hospital, Yonsei University Health System ( Site 2903)

Seoul, South Korea

Asan Medical Center ( Site 2901)

Seoul, South Korea

Samsung Medical Center ( Site 2902)

Seoul, South Korea

Hospital Universitario Virgen del Rocio ( Site 2306)

Seville, Spain

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

L'Hospitalet de Llobregat, Spain

HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 2301)

Madrid, Spain

Hospital Universitari Vall d'Hebron ( Site 2303)

Barcelona, Spain

Hospital Insular de Gran Canaria ( Site 2308)

Las Palmas, Spain

Hospital Universitario 12 de Octubre ( Site 2300)

Madrid, Spain

Fundación Instituto Valenciano de Oncología ( Site 2307)

Valencia, Spain

Hacettepe Universite Hastaneleri ( Site 2500)

Sıhhiye, Turkey (Türkiye)

Adana Medical Park Seyhan Hastanesi ( Site 2505)

Adana, Turkey (Türkiye)

Trakya University Medical Faculty Hospital ( Site 2502)

Edirne, Turkey (Türkiye)

Koc Universitesi Hastanesi ( Site 2501)

Istanbul, Turkey (Türkiye)

The Christie Hospital NHS Foundation Trust ( Site 2601)

Withington, United Kingdom

Trial contact

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/7/2026.

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