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)
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |