Actively Recruiting
A Phase 3, Randomized, Double-blind Study of Belzutifan plus Zanzalintinib Versus Belzutifan plus Placebo in Advanced Renal Cell Carcinoma After Prior PD-1/L1 and VEGF-TKI Therapies
Led by Merck Sharp & Dohme LLC · Updated on 2026-06-08
758
Participants Needed
25
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Merck Sharp & Dohme LLC
Lead Sponsor
E
Exelixis
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating new treatment options for people with advanced renal cell carcinoma (RCC), a type of kidney cancer that has spread and cannot be removed by surgery. This study compares a standard targeted therapy called belzutifan with a combination of belzutifan and another targeted therapy, zanzalintinib. The goal is to see if adding zanzalintinib helps people live longer overall and prevents the cancer from worsening compared to belzutifan alone. Participants in this study are randomly assigned to receive either 120 mg of belzutifan plus 60 mg of zanzalintinib daily or 120 mg of belzutifan plus a placebo daily. Both treatments are taken orally for about 24 months. This phase 3, double-blind trial aims to evaluate these treatments in people whose cancer has progressed despite prior therapies including PD-1/L1 and VEGF-TKI treatments. During the trial, participants will be monitored regularly for how long they live without cancer progression and their overall survival up to approximately 30 to 50 months. Researchers will also assess responses to treatment, side effects, quality of life, physical and role functioning, and kidney cancer symptoms through questionnaires and clinical evaluations. Safety and treatment tolerability will be tracked, with study visits scheduled throughout the treatment period.
CONDITIONS
Brief Title
A Clinical Study of Belzutifan (MK-6482) and Zanzalintinib in People With Renal Cell Carcinoma (RCC) (LITESPARK-034/LS-034/MK-6482-034)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Histologically confirmed unresectable, advanced renal cell carcinoma with clear cell component
- Measurable disease according to RECIST 1.1 criteria
- Received no more than 3 prior systemic treatments for RCC, including only 1 prior anti-PD-1/PD-L1 therapy
You will not qualify if you...
- Pulse oximeter reading below 92% at rest or need for supplemental oxygen
- Clinically significant cardiovascular disease within 12 months before study
- Recent deep vein thrombosis within 3 months unless stable and treated
- Left ventricular ejection fraction at or below 50% of normal range
- Major surgery within 8 weeks before randomization
- Current pneumonitis or interstitial lung disease
- History of HIV infection
- Hepatitis B or C virus infection
- Additional progressing malignancy requiring treatment within past 3 years
- History of solid organ transplant
- Not fully recovered from major surgery or ongoing surgical complications
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 24 months
Participants receive oral belzutifan and either zanzalintinib or placebo once daily as part of their treatment for advanced renal cell carcinoma.
Visits occur regularly during treatment to monitor health and response
Trial Site Locations
Total: 25 locations
1
Centro Oncologico Korben ( Site 0254)
CABA, Buenos Aires, Argentina, C1426AHB
Actively Recruiting
2
Instituto de Investigaciones Clinicas Mar del Plata ( Site 0250)
Mar del Plata, Buenos Aires, Argentina, B7600FZO
Actively Recruiting
3
Centro Privado de RMI Río Cuarto S.A. II ( Site 0255)
Río Cuarto, Córdoba Province, Argentina, X5800ALB
Actively Recruiting
4
Sanatorio Parque ( Site 0251)
Rosario, Santa Fe Province, Argentina, S2000DSV
Actively Recruiting
5
Centro Oncológico Riojano Integral ( Site 0256)
La Rioja, Argentina, X5004BAL
Actively Recruiting
6
Macquarie University ( Site 2700)
Macquarie University, New South Wales, Australia, 2109
Suspended
7
Masarykuv onkologicky ustav ( Site 0903)
Brno, Brno-mesto, Czechia, 656 53
Actively Recruiting
8
Fakultni nemocnice v Motole ( Site 0900)
Prague, Czechia, 150 06
Actively Recruiting
9
Herlev Hospital ( Site 1002)
Herlev, Capital Region, Denmark, 2730
Actively Recruiting
10
Aarhus Universitetshospital, Skejby ( Site 1001)
Aarhus, Central Jutland, Denmark, 8200
Actively Recruiting
11
Metropolitan Hospital ( Site 1402)
Athens, Attica, Greece, 185 47
Actively Recruiting
12
Rambam Health Care Campus ( Site 1600)
Haifa, Israel, 3109601
Actively Recruiting
13
Rabin Medical Center ( Site 1602)
Petah Tikva, Israel, 4941492
Actively Recruiting
14
Sheba Medical Center ( Site 1601)
Ramat Gan, Israel, 5265601
Actively Recruiting
15
Nederlands Kanker Instituut Antoni van Leeuwenhoek (NKI AVL) ( Site 1900)
Amsterdam, North Holland, Netherlands, 1066 CX
Actively Recruiting
16
Haga Ziekenhuis locatie Leyweg ( Site 1906)
The Hague, South Holland, Netherlands, 2545 AA
Actively Recruiting
17
AIDPORT Sp. z o.o. ( Site 2118)
Skórzewo, Greater Poland Voivodeship, Poland, 60-185
Actively Recruiting
18
MTZ Clinical Research Powered by Pratia ( Site 2107)
Warsaw, Masovian Voivodeship, Poland, 02-172
Actively Recruiting
19
Severance Hospital, Yonsei University Health System ( Site 2903)
Seoul, South Korea, 03722
Actively Recruiting
20
Asan Medical Center ( Site 2901)
Seoul, South Korea, 05505
Actively Recruiting
21
Samsung Medical Center ( Site 2902)
Seoul, South Korea, 06351
Actively Recruiting
22
Institut Català d'Oncologia - L'Hospitalet ( Site 2305)
L'Hospitalet de Llobregat, Barcelona, Spain, 08908
Actively Recruiting
23
HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 2301)
Madrid, Madrid, Comunidad de, Spain, 28007
Actively Recruiting
24
Hospital Insular de Gran Canaria ( Site 2308)
Las Palmas, Spain, 35016
Actively Recruiting
25
Hospital Universitario 12 de Octubre ( Site 2300)
Madrid, Spain, 28041
Actively Recruiting
Research Team
T
Toll Free Number
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here