A Study of Belzutifan (MK-6482) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Clear Cell Renal Cell Carcinoma Post Nephrectomy (MK-6482-022)

Summary

The purpose of this study is to assess the efficacy and safety of oral belzutifan (MK-6482) plus intravenous (IV) pembrolizumab (MK-3475) compared to placebo plus pembrolizumab, in the adjuvant treatment of Clear Cell Renal Cell Carcinoma (ccRCC) post nephrectomy. The primary study hypothesis is that belzutifan plus pembrolizumab is superior to placebo plus pembrolizumab with respect to disease-free survival (DFS).

Timeline

Start

2022-03-15

Primary completion

2026-10-28

Completion

2029-09-28

Outcome

Met primary endpoint

paper Disease-free survival was significantly higher with pembrolizumab-belzutifan than with pembrolizumab-placebo PMID 42384869 ↗

release “LITESPARK-022 enrolled 1,841 patients and demonstrated that KEYTRUDA in combination with WELIREG significantly improved disease-free survival (DFS), the trial’s primary endpoint” merck.com ↗

Publications

• Choueiri TK, Motzer RJ, Karam JA, Yip W, Suarez C, Ye D, He Z, Caglevic C, Ferguson T, Chang YH, Rojas C, Iacovelli R, Urun Y, Verzoni E, Vazquez Limon JC, Porta C, Uzzo RG, Lee JL, Venugopal B, McKay RR, Hammers H, Miyake H, Chahoud J, Liu H, Burgents JE, Sharma M, Powles TB; LITESPARK-022 Investigators. Adjuvant Pembrolizumab plus Belzutifan for Renal-Cell Carcinoma. N Engl J Med. 2026 Jul 2;395(1):32-43. doi: 10.1056/NEJMoa2518245.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Belzutifan	Small molecule	120 mg	Oral
Background	Pembrolizumab	Monoclonal antibody	400 mg	Intravenous

Indications