Coformulation of Pembrolizumab/Vibostolimab (MK-7684A) Versus Pembrolizumab (MK-3475) Monotherapy for Programmed Cell Death 1 Ligand 1 (PD-L1) Positive Metastatic Non-Small Cell Lung Cancer (MK-7684A-003, KEYVIBE-003)
Summary
Researchers are looking for new ways to treat people with metastatic non-small cell lung cancer (NSCLC) that is PD-L1 positive. * Metastatic means cancer that has spread to other parts of the body. * PD-L1 positive means that PD-L1 is found on the cancer cells. PD-L1 is a protein that can help the cancer hide from the body's immune system. The goal of this study is to learn if people who receive vibostolimab and pembrolizumab live longer overall and without the cancer getting worse than people who receive pembrolizumab alone.
Timeline
- Start
- 2021-04-07
- Primary completion
- 2024-09-05
- Completion
- 2026-01-27
Outcome
Missed primary endpoint
Stopped (Business): “Business Reasons”
registry analysis (superiority test); Pembrolizumab/Vibostolimab vs Pembrolizumab; p = 0.6712; Hazard Ratio (HR) 1.06 (95% CI 0.83 to 1.35) NCT04738487 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |
| Subject | Vibostolimab | Monoclonal antibody | 200 mg | Intravenous |