At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2, Multicenter, Multi Arm, Study to Evaluate MK-1308A (Co-formulated Quavonlimab (MK-1308)/Pembrolizumab) Versus Other Treatments in Participants With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Cancer: (MK-1308A-008)
In Brief
A Phase 2 clinical trial evaluating Pembrolizumab, Pembrolizumab/Quavonlimab, and 3 other interventions for Colorectal Cancer. Active but no longer recruiting, targeting 302 participants across 109 sites in 22 countries.
Signals
Detailed Summary
The purpose of this study is to assess the efficacy and safety of co-formulated pembrolizumab/quavonlimab versus other treatments in participants with MSI-H or dMMR Metastatic Stage IV Colorectal Cancer.
Study Details
Timeline
Arms & Interventions
Participants in Cohort A receive co-formulated pembrolizumab/quavonlimab (400 mg/25 mg) every 6 weeks (Q6W) for up to approximately 2 years.
Participants in Cohort A receive pembrolizumab 400 mg intravenously (IV) Q6W for up to approximately 2 years.
Participants received co-formulated pembrolizumab/quavonlimab (400 mg/25 mg) Q6W for up to approximately 2 years.
Participants receive pembrolizumab 200 mg plus MK-4830 800 mg Q3W for up to approximately 2 years.
Participants receive co-formulated pembrolizumab/favezelimab (200 mg/800 mg) every 3 weeks (Q3W) for up to approximately 2 years.
Participants receive co-formulated pembrolizumab/vibostolimab (200 mg/200 mg) Q3W for up to approximately 2 years.
Participants in Cohort B receive pembrolizumab 400 mg IV Q6W for up to approximately 2 years.
Interventions
400 mg or 200 mg pembrolizumab administered via IV infusion.
Co-formulated pembrolizumab/quavonlimab (400 mg/25 mg) fixed-dose combination (FDC) administered via IV infusion.
Co-formulated pembrolizumab/favezelimab (200 mg/800 mg) FDC administered via IV infusion
Co-formulated pembrolizumab/vibostolimab (200 mg/200 mg) FDC administered via IV infusion
800 mg MK-4830 administered via IV infusion