drugset / Trial / NCT04811027
Combination Study With Eftilagimod Alpha (a Soluble LAG-3 Fusion Protein) and Pembrolizumab in Patients With Recurrent or Metastatic HNSCC
RandomizedParallel-groupOpen-labelTreatment
Summary
Evaluate the safety and efficacy of eftilagimod alpha in combination with pembrolizumab against pembrolizumab alone in 1st line metastatic or recurrent HNSCC with programmed death-ligand 1 (PD-L1) positive (combined positive score \[CPS\] ≥1) tumors, and determine the efficacy and safety of efti plus pembrolizumab in patients with PD-L1 negative tumors.
Timeline
- Start
- 2021-08-27
- Primary completion
- 2024-03-11
- Completion
- 2025-11-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | IMP321 | Protein / enzyme biologic | 30 mg | Subcutaneous |
| Subject | Pembrolizumab | Monoclonal antibody | 400 mg | Intravenous |