At a glance
ClinicalIndex Comparison Record- ✓Surgically resected and histologically/pathologically confirmed stage IIB, IIC, III, or IV cutaneous melanoma per AJCC 8th edition
- ✓No prior systemic therapy for melanoma beyond surgical resection
- ✓Randomization within 12 weeks of final surgical resection
- ✓If HIV-positive: well-controlled on anti-retroviral therapy (ART)
- ✕Ocular, mucosal, or conjunctival melanoma
- ✕Known active CNS metastases and/or carcinomatous meningitis
- ✕Immunodeficiency or chronic systemic steroid therapy (>10 mg daily prednisone equivalent) or other immunosuppressive therapy within 7 days prior to first dose
- ✕History of noninfectious pneumonitis/interstitial lung disease requiring steroids or current pneumonitis/interstitial lung disease
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 3 clinical trial evaluating Pembrolizumab/Vibostolimab and Pembrolizumab for Melanoma. Completed, enrolled 1,594 participants across 205 sites in 26 countries.
Detailed 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.
Study Details
Timeline
Interventions
Co-formulation of pembrolizumab 200 mg/20 mL vial and vibostolimab 200 mg administered as IV infusion for up to 17 administrations
Pembrolizumab 25 mg/mL administered as IV infusion for up to 17 administrations