Summary

Eligibility
for people ages 18-120 (full criteria)
Location
at UCSF
Dates
study started
completion around

Description

Summary

Substudy 03B is part of a larger research study that is testing experimental treatments for renal cell carcinoma (RCC). The larger study is the umbrella study (U03).

The goal of substudy 03B is to evaluate the safety and efficacy of experimental combinations of investigational agents in participants with advanced second line plus (2L+) clear cell renal cell carcinoma (ccRCC).

This substudy will have two phases: a safety lead-in phase and an efficacy phase. The safety lead-in phase will be used to demonstrate a tolerable safety profile for the combination of investigational agents. There will be no hypothesis testing in this study.

Official Title

A Phase 1b/2 Study of Immune and Targeted Combination Therapies in Participants With RCC (KEYMAKER-U03): Substudy 03B in Second-Line Metastatic Participants

Keywords

Carcinoma, Renal Cell, receptor tyrosine kinase inhibitor, programmed cell death 1 (PD-1, PD1), programmed cell death ligand 1 (PD-L1, PDL1), Carcinoma, Renal Cell Carcinoma, Pembrolizumab, Lenvatinib, Belzutifan, Pembrolizumab/Quavonlimab, Favezelimab/Pembrolizumab, Coformulation Pembrolizumab/Quavonlimab, Coformulation Favezelimab/Pembrolizumab, Pembrolizumab + MK-4830, Pembrolizumab + Belzutifan, Belzutifan + Lenvatinib, Pembrolizumab + Lenvatinib

Eligibility

Locations

  • University of California at San Francisco ( Site 3008)
    San Francisco California 94158 United States
  • UTSW Medical Center ( Site 3003)
    Dallas Texas 75390-7208 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
NCT04626518
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
Expecting 370 study participants
Last Updated