Trials / Active Not Recruiting
Active Not RecruitingNCT04195750
A Study of Belzutifan (MK-6482) Versus Everolimus in Participants With Advanced Renal Cell Carcinoma (MK-6482-005)
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
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 755 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
Per protocol, all participants enrolled in the Safety Run-In were not randomized and not included in the protocol-specified analyses for any of the outcome measures.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Belzutifan | Oral tablets |
| DRUG | Everolimus | Oral tablets |
Timeline
- Start date
- 2020-02-27
- Primary completion
- 2024-04-15
- Completion
- 2026-09-17
- First posted
- 2019-12-12
- Last updated
- 2025-04-29
- Results posted
- 2025-04-29
Locations
172 sites across 23 countries: United States, Brazil, 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
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04195750. Inclusion in this directory is not an endorsement.