West Cancer Center

MELANOMA: ADJUVANT: Pembro+anti-TIGIT: KEYVIBE-010

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)

Title

Merck MK-7684A-010 (Adjuvant melanoma TIGIT+pembro)

Study Title

Site Link

NCT05665595

Malignancy

Cutaneous Melanoma

Stage

Stage 3

Disease Setting

High risk adjuvant

Line Of Therapy

Adjuvant

Investigational Agent

pembrolizumab and vibostolimab

Drug Class

anti-PD1, anti-TIGIT

David Portnoy, MD

Sponsor

Merck Sharp and Dohme

Phase

Phase 3

Status

Closed to Accrual

Key Eligibility Criteria

Key Eligibility Criteria Details

Surgically resected and histologically or pathologically confirmed melanoma
Must be Stage IIB, IIC, III, or IV cutaneous melanoma
No prior systemic therapy for melanoma
No more than 12 weeks between final surgical resection and randomization
HBV/HCV/HIV are allowed if well controlled
No ocular, conjunctival, or mucosal melanoma
No diagnosis of immunodeficiency or receiving chronic systemic steroids >10mg prednisone or equivalent
No active autoimmune disease
No active CNS disease
No other malignancy that required active treatment in last 3 years

Objective

Primary
- RFS
Secondary
- DMFS
- OS
- Safety
- QOL

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

Melanoma

Dosing Frequency

Control Agents

Study Protocol

Randomized

Yes