drugset / Trial / NCT04165083
KEYMAKER-U01 Substudy 2: Efficacy and Safety Study of Pembrolizumab (MK-3475) When Used With Investigational Agents in Treatment-naïve Participants With Anti-programmed Cell Death Receptor Ligand 1 (PD-L1) Positive Advanced Non-small Cell Lung Cancer (NSCLC) (MK-3475-01B/KEYMAKER-U01B)
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) in combination with MK-4830 in treatment-naïve participants with advanced squamous or non-squamous NSCLC that is PD-L1 positive. This study is one of three pembrolizumab substudies being conducted under one pembrolizumab umbrella master protocol (MK-3475-U01/KEYMAKER-U01). The pembrolizumab+ MK-0482 arm was added with Amendment 6.
Timeline
- Start
- 2019-12-19
- Primary completion
- 2025-10-31
- Completion
- 2025-10-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MK-0482 | Unknown | — | Intravenous |
| Subject | MK-4830 | Unknown | — | Intravenous |
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |