An Open-label, Randomized Phase 3 Study to Evaluate Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Belzutifan (MK-6482) and Lenvatinib (MK-7902), or MK-1308A in Combination With Lenvatinib, Versus Pembrolizumab and Lenvatinib, as First-Line Treatment in Participants With Advanced Clear Cell Renal Cell Carcinoma (ccRCC)
Latest Information Update: 21 Aug 2026
At a glance
- Drugs Belzutifan (Primary) ; Lenvatinib (Primary) ; Pembrolizumab (Primary) ; Pembrolizumab/Quavonlimab (Primary)
- Indications Renal cell carcinoma
- Focus Registrational; Therapeutic Use
- Acronyms LITESPARK-012
- Sponsors Merck Sharp & Dohme; Merck Sharp & Dohme Corp.
Most Recent Events
- 14 Aug 2026 Planned End Date changed from 29 Oct 2026 to 22 Apr 2027.
- 21 Apr 2026 Primary endpoint has not been met. (Overall Survival (OS))
- 21 Apr 2026 Primary endpoint has not been met. (Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR))