Informations générales (source: ClinicalTrials.gov)
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)
Interventional
Phase 3
Merck Sharp & Dohme LLC (Voir sur ClinicalTrials)
avril 2026
novembre 2030
07 octobre 2026
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Laurence ALBIGES | 02/10/2026 13:10:04 | Contacter | ||
Critères
Tous
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