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Trial 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.

Acronym:

MK-6482-022

ACTRN/NCT /ethics:

NCT05239728

Scientific title:

A Multicenter, Double-blind, Randomized Phase 3 Study to Compare the Efficacy and Safety of Belzutifan (MK-6482) Plus Pembrolizumab (MK- 3475) Versus Placebo Plus Pembrolizumab, in the Adjuvant Treatment of Clear Cell Renal Cell Carcinoma (ccRCC) Post Nephrectomy

Sponsor / Cooperative group:

Merck Sharp & Dohme Corp.

Trial & Patient Characteristics

Cancer TypeKidney
Trial TypeTreatment
PhasePhase III
Age Range18 years and older
SexAll
Tumour Stream -
Cancer StageLocally Recurrent or Locally Advanced; Metastatic or Widespread
Anticipated Start Date2022-03-15
Anticipated End Date2030-01-25

Participating Hospitals

HospitalLyell McEwin Hospital
Clinical Trial CoordinatorAndy Phay
Emailandy.phay@sa.gov.au
Phone08 8282 0833
Principal InvestigatorDr Christopher Hocking
Recruitment StatusRecruiting