At a glance
ClinicalIndex Comparison RecordPhase 3Active· 755 enrolled
Drug / intervention
Belzutifan +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-label, Randomized Phase 3 Study of MK-6482 Versus Everolimus in Participants With Advanced Renal Cell Carcinoma That Has Progressed After Prior PD-1/L1 and VEGF-Targeted Therapies
In Brief
A Phase 3 clinical trial evaluating Belzutifan and Everolimus for Carcinoma, Renal Cell. Active but no longer recruiting, targeting 755 participants across 172 sites in 23 countries.
Detailed Summary
The primary objective of this study is to compare belzutifan to everolimus with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR) and to compare everolimus with respect to overall survival (OS). The hypothesis is that belzutifan is superior to everolimus with respect to PFS and OS.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoma, Renal Cell
CountriesBrazil, Canada, Chile, Colombia, Czechia, Denmark, Finland, France, Germany, Hong Kong, Hungary, Italy, Japan, Norway, Russia, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom, United States
Collaborators--
Timeline
Phase 3Active
2020202120222023202420252026
First PostedDec 2019
Enrollment StartFeb 2020
Primary CompletionApr 2024
TodayJul 2026
Study CompletionSep 2026
First PostedDec 12, 2019
Enrollment StartFeb 27, 2020
Primary CompletionApr 15, 2024
Study CompletionSep 17, 2026
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 6.6 years ago
Interventions
Belzutifandrug
Oral tablets
Everolimusdrug
Oral tablets