A Phase 3, Randomized, Double-blind, Study of Belzutifan + Zanzalintinib Versus Belzutifan + Placebo in Participants With Advanced RCC Who Have Progressed on or After Both PD-1/L1 and VEGF-TKI Therapies in Sequence or in Combination (LITESPARK-034)
Status: Recruiting
Location: See all (79) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
⁃ 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
Locations
United States
Georgia
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0102)
RECRUITING
Marietta
Tennessee
The West Clinic, P.C. ( Site 0115)
RECRUITING
Germantown
Other Locations
Argentina
Centro Oncologico Korben ( Site 0254)
RECRUITING
Caba
Instituto Alexander Fleming ( Site 0252)
RECRUITING
Caba
Hospital Italiano de Buenos Aires ( Site 0253)
RECRUITING
Ciudad De Buenos Aires
Centro Oncológico Riojano Integral ( Site 0256)
RECRUITING
La Rioja
Instituto de Investigaciones Clinicas Mar del Plata ( Site 0250)
RECRUITING
Mar Del Plata
Centro Privado de RMI Río Cuarto S.A. II ( Site 0255)
RECRUITING
Río Cuarto
Instituto de Oncología de Rosario ( Site 0257)
RECRUITING
Rosario
Sanatorio Parque ( Site 0251)
RECRUITING
Rosario
COE (Centro Oncológico de Excelencia) ( Site 0259)
RECRUITING
San Juan
Australia
Macquarie University ( Site 2700)
SUSPENDED
Macquarie University
Peter MacCallum Cancer Centre ( Site 2702)
SUSPENDED
Melbourne
Princess Alexandra Hospital ( Site 2703)
SUSPENDED
Woolloongabba
Brazil
Instituto do Câncer e Transplante de Curitiba ( Site 0300)
RECRUITING
Curitiba
Liga Norte Riograndense Contra o Câncer ( Site 0307)
RECRUITING
Natal
Hope - Humanizacao Em Oncologia, Pesquisa E Ensino ( Site 0306)
RECRUITING
Ribeirão Preto
Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0302)
RECRUITING
São José Do Rio Preto
CEDOES ( Site 0303)
RECRUITING
Vitória
Chile
IC La Serena Research ( Site 0405)
RECRUITING
La Serena
Clínica Puerto Montt ( Site 0404)
RECRUITING
Port Montt
Bradfordhill ( Site 0400)
RECRUITING
Santiago
Fundacion Arturo Lopez Perez ( Site 0401)
RECRUITING
Santiago
ONCOCENTRO APYS ( Site 0403)
RECRUITING
Viña Del Mar
Denmark
Aarhus Universitetshospital, Skejby ( Site 1001)
RECRUITING
Aarhus
Herlev Hospital ( Site 1002)
RECRUITING
Herlev
France
CHU Angers ( Site 1204)
RECRUITING
Angers
Clinique Victor Hugo Le Mans-Oncology-Radiotherapy ( Site 1203)
RECRUITING
Le Mans
BIOGROUP PROVENCE ( Site 1216)
RECRUITING
Marseille
Centre Antoine Lacassagne ( Site 1209)
RECRUITING
Nice
CHU de Saint-Etienne ( Site 1202)
RECRUITING
Saint Priest En Jarez
LBM ONCOPOLE CLAUDIUS REGAUD ( Site 1215)
RECRUITING
Toulouse
Germany
Universitaetsklinikum Augsburg ( Site 1316)
RECRUITING
Augsburg
Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 1312)
RECRUITING
Berlin
Universitätsklinikum Jena ( Site 1313)
RECRUITING
Jena
klinikum rechts der isar der technischen universität münchen ( Site 1315)
RECRUITING
Munich
Greece
Alexandra General Hospital of Athens ( Site 1400)
RECRUITING
Athens
ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 1401)
RECRUITING
Athens
Metropolitan Hospital ( Site 1402)
RECRUITING
Athens
Israel
Rambam Health Care Campus ( Site 1600)
RECRUITING
Haifa
Meir Medical Center. ( Site 1603)
RECRUITING
Kfar Saba
Rabin Medical Center ( Site 1602)
RECRUITING
Petah Tikva
Sheba Medical Center ( Site 1601)
RECRUITING
Ramat Gan
Italy
A.O.U.C. Policlinico di Bari ( Site 1802)
RECRUITING
Bari
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 1803)
RECRUITING
Bologna
Azienda Ospedaliera Universitaria Careggi ( Site 1807)
RECRUITING
Florence
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) Dino Amadori ( Site 1809)
RECRUITING
Meldola
Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1800)
RECRUITING
Milan
AO Santa Maria della Misericordia ( Site 1805)
RECRUITING
Perugia
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1801)
RECRUITING
Roma
Istituto Nazionale Tumori Regina Elena ( Site 1804)
RECRUITING
Roma
Istituto Clinico Humanitas ( Site 1808)
RECRUITING
Rozzano
Netherlands
Nederlands Kanker Instituut Antoni van Leeuwenhoek (NKI AVL) ( Site 1900)
RECRUITING
Amsterdam
Maastricht UMC+ ( Site 1901)
RECRUITING
Maastricht
Haga Ziekenhuis locatie Leyweg ( Site 1906)
RECRUITING
The Hague
Poland
Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 2106)
RECRUITING
Gliwice
Pratia MCM Krakow ( Site 2115)
RECRUITING
Krakow
Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 2102)
RECRUITING
Siedlce
AIDPORT Sp. z o.o. ( Site 2118)
RECRUITING
Skórzewo
MTZ Clinical Research Powered by Pratia ( Site 2107)
RECRUITING
Warsaw
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Układu Moczowego ( Site 2100)
RECRUITING
Warsaw
Republic of Korea
Asan Medical Center ( Site 2901)
RECRUITING
Seoul
Samsung Medical Center ( Site 2902)
RECRUITING
Seoul
Severance Hospital, Yonsei University Health System ( Site 2903)
RECRUITING
Seoul
Spain
Hospital Universitari Vall d'Hebron ( Site 2303)
RECRUITING
Barcelona
Institut Català d'Oncologia - L'Hospitalet ( Site 2305)
RECRUITING
L'hospitalet De Llobregat
Hospital Insular de Gran Canaria ( Site 2308)
RECRUITING
Las Palmas
HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 2301)
RECRUITING
Madrid
Hospital Universitario 12 de Octubre ( Site 2300)
RECRUITING
Madrid
Hospital Universitario Virgen del Rocio ( Site 2306)
RECRUITING
Seville
Fundación Instituto Valenciano de Oncología ( Site 2307)
RECRUITING
Valencia
Turkey
Adana Medical Park Seyhan Hastanesi ( Site 2505)
RECRUITING
Adana
Ankara University Health Practice and Research Hospitals ( Site 2506)
RECRUITING
Ankara
Trakya University Medical Faculty Hospital ( Site 2502)
RECRUITING
Edirne
Koc Universitesi Hastanesi ( Site 2501)
RECRUITING
Istanbul
Hacettepe Universite Hastaneleri ( Site 2500)
RECRUITING
Sıhhiye
United Kingdom
Western General Hospital ( Site 2608)
RECRUITING
Edinburgh
Leicester Royal Infirmary ( Site 2604)
RECRUITING
Leicester
The Christie Hospital NHS Foundation Trust ( Site 2601)
RECRUITING
Withington
Contact Information
Primary
Toll Free Number
Trialsites@msd.com
1-888-577-8839
Time Frame
Start Date: 2026-04-09
Estimated Completion Date: 2030-11-27
Participants
Target number of participants: 758
Treatments
Experimental: Belzutifan + Zanzalintinib
Participants will receive 120 mg belzutifan orally and 60 mg zanzalintinib once daily for approximately 24 months.
Active_comparator: Belzutifan + Placebo
Participants will receive 120 mg belzutifan orally and zanzalintinib-matching placebo once daily for approximately 24 months.
Related Therapeutic Areas
Sponsors
Leads: Merck Sharp & Dohme LLC
Collaborators: Exelixis