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Trial Summary

The primary purpose of this study is to compare pembrolizumab/vibostolimab to pembrolizumab with respect to recurrence-free survival (RFS). The primary hypothesis is that pembrolizumab/vibostolimab is superior to pembrolizumab with respect to RFS as assessed by the investigator in participants with high-risk resected Stage IIB, IIC, III and IV melanoma.

Acronym:

MK684a-010KEYVIBE

ACTRN/NCT /ethics:

NCT05665595

Scientific title:

A Study of Adjuvant Pembrolizumab/Vibostolimab (MK-7684A) Versus Pembrolizumab for Resected High-Risk Melanoma in Participants With High-Risk Stage II-IV Melanoma (MK-7684A-010/KEYVIBE-010)

Sponsor / Cooperative group:

Merck Sharp & Dohme LLC

Trial & Patient Characteristics

Cancer TypeMelanoma
Trial TypeTreatment
PhasePhase III
Age Range12 years and older
SexAll
Tumour Stream -
Cancer Stage-
Anticipated Start Date2023-01-19
Anticipated End Date2031-03-31

Participating Hospitals

HospitalRoyal Adelaide Hospital
Clinical Trial CoordinatorAnne Milton
EmailAnne.Milton@sa.gv.au
Phone08 7074 2342
Principal InvestigatorMichael Brown
Recruitment StatusRecruiting