Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSD
Dates
study started
completion around

Description

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.

Official Title

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

Keywords

Carcinoma, Renal Cell, Hypoxia inducible Factor (HIF), Hypoxia inducible factor 1B (HIF-1B), Hypoxia inducible factor 2 alpha (HIF-2 alpha), Hypoxia inducible factor 2α (HIF-2α), Renal Cell Carcinoma (RCC), Kidney Cancer, PT-2977, PT2977, MK6482, Carcinoma, Renal Cell Carcinoma, Everolimus, Belzutifan

Eligibility

Locations

  • University of California San Diego Moores Cancer Center ( Site 1546)
    La Jolla California 92093-0698 United States
  • St Joseph Heritage Healthcare ( Site 1531)
    Santa Rosa California 95403 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Merck Sharp & Dohme LLC
Links
Merck Clinical Trials Information Plain Language Summary
ID
NCT04195750
Phase
Phase 3 research study
Study Type
Interventional
Participants
About 755 people participating
Last Updated