drugset / Trial / NCT04626518

Substudy 03B: A Study of Immune and Targeted Combination Therapies in Participants With Second Line Plus (2L+) Renal Cell Carcinoma (MK-3475-03B/KEYMAKER-U03)

NCT04626518

Phase 1/2 Active not recruiting 370 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2020-12-17
Primary completion
2026-07-17
Completion
2026-07-17

Drugs

EvaluationDrugModalityDoseRoute
Subject Belzutifan Small molecule 120 mg Oral
Subject Favezelimab/Pembrolizumab Unknown 200 mg Intravenous
Subject Favezelimab/Pembrolizumab Unknown 800 mg Intravenous
Subject Lenvatinib Small molecule 20 mg Oral
Subject MK-4830 Unknown 800 mg Intravenous
Subject Pembrolizumab Monoclonal antibody 200 mg Intravenous
Subject Pembrolizumab Monoclonal antibody 400 mg Intravenous
Subject Pembrolizumab/Quavonlimab Unknown 25 mg Intravenous
Subject Pembrolizumab/Quavonlimab Unknown 400 mg Intravenous