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)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-501417-31-01

Acronym

MK-7684A-010

Enrollment

462

Registered

2023-07-24

Start date

2023-08-01

Completion date

2025-09-04

Last updated

2025-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

melanoma

Brief summary

Recurrence-Free Survival (RFS)

Detailed description

Distant Metastasis-Free Survival (DMFS), Overall Survival (OS), Number of Participants Who Experienced at Least One Adverse Event (AE), Number of Participants Who Discontinued Study Treatment Due to an AE, Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30) Combined Score, Change from Baseline in the EORTC QLQ-C30 Physical Functioning (Items 1-5) Combined Score, Change from Baseline in the EORTC QLQ-C30 Role Functioning (Items 6 and 7) Combined Score

Interventions

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

DRUGMK-7684A

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Recurrence-Free Survival (RFS)	—

Secondary

Measure	Time frame
Distant Metastasis-Free Survival (DMFS), Overall Survival (OS), Number of Participants Who Experienced at Least One Adverse Event (AE), Number of Participants Who Discontinued Study Treatment Due to an AE, Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30) Combined Score, Change from Baseline in the EORTC QLQ-C30 Physical Functioning (Items 1-5) Combined Score, Change from Baseline in the EORTC QLQ-C30 Role Functioning (Items 6 and 7) Combined Score	—

Measure

Time frame

—

Countries

Austria, Belgium, France, Germany, Ireland, Italy, Poland, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026