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RecruitingLast updated:15 August 2023

Keyvibe-010: This study testing whether combination immunotherapy and targeted therapy (pembrolizumab + vibostolimab) is more effective than immunotherapy alone (pembrolizumab) at preventing cancer recurrence in people high-risk melanoma who have had their cancer removedA Phase 3, Randomized, Double-blind, Active-Comparator-Controlled Clinical Study of Adjuvant MK-7684A (Vibostolimab With Pembrolizumab) Versus Adjuvant Pembrolizumab in Participants With High-risk Stage II-IV Melanoma (KEYVIBE-010)

Clinical summary Eligibilty Participating hospital Support

Clinical summary

Summary

Eligible participants will be randomly allocated to either the Experimental or Active Comparator Arms. In the Experimental Arm, participants will receive a co-formulation of 200mg pembrolizumab and 200mg vibostolimab administered as an intravenous infusion on Day 1 of each 3 week cycle for up to 17 cycles. In the Active Comparator Arm, participants will receive pembrolizumab alone (adults will receive 200mg and adolescent participants weigh less than 40kg will receive 2/mg/kg up to a maximum of 200mg) administered as an intravenous infusion on Day 1 of each 3 week cycle for up to 17 cycles.

Age

People 12+

Phase

III

Trial Acronym

Keyvibe-010

More information

Trial Identifiers

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NCT05665595

Commercial Sponsor

Merck Sharp & Dohme LLC

Scientific Title

A Phase 3, Randomized, Double-blind, Active-Comparator-Controlled Clinical Study of Adjuvant MK-7684A (Vibostolimab With Pembrolizumab) Versus Adjuvant Pembrolizumab in Participants With High-risk Stage II-IV Melanoma (KEYVIBE-010)

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