drugset / Trial / NCT05899049
A Study of Pembrolizumab (MK-3475) in Combination With Belzutifan (MK-6482) and Lenvatinib (MK-7902), or Pembrolizumab/Quavonlimab (MK-1308A) in Combination With Lenvatinib, vs Pembrolizumab and Lenvatinib, for Treatment of Advanced Clear Cell Renal Cell Carcinoma (MK-6482-012)-China Extension Study
RandomizedParallel-groupOpen-labelTreatment
Summary
The goal of this China extension study is to evaluate the efficacy and safety of pembrolizumab plus belzutifan plus lenvatinib or pembrolizumab/quavonlimab plus lenvatinib versus pembrolizumab plus lenvatinib as first-line treatment in Chinese participants with advanced clear cell renal cell carcinoma (ccRCC). The primary hypotheses are (1) pembrolizumab plus belzutifan plus lenvatinib is superior to pembrolizumab plus lenvatinib with respect to progression-free survival (PFS) and overall survival (OS), in advanced ccRCC participants; and (2) pembrolizumab/quavonlimab plus lenvatinib is superior to pembrolizumab plus lenvatinib with respect to PFS and OS, in advanced ccRCC participants.
Timeline
- Start
- 2022-07-27
- Primary completion
- 2027-06-07
- Completion
- 2027-06-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Belzutifan | Small molecule | 120 mg | Oral |
| Subject | Pembrolizumab/Quavonlimab | Unknown | 25 mg | Intravenous |
| Subject | Pembrolizumab/Quavonlimab | Unknown | 400 mg | Intravenous |
| Background | Lenvatinib | Small molecule | 20 mg | Oral |
| Background | Pembrolizumab | Monoclonal antibody | 400 mg | Intravenous |