drugset / Trial / NCT04811027

Combination Study With Eftilagimod Alpha (a Soluble LAG-3 Fusion Protein) and Pembrolizumab in Patients With Recurrent or Metastatic HNSCC

NCT04811027

Phase 2 Completed 171 enrolled Immutep S.A.S. Merck Sharp & Dohme LLC · collab
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

EvaluationDrugModalityDoseRoute
Subject IMP321 Protein / enzyme biologic 30 mg Subcutaneous
Subject Pembrolizumab Monoclonal antibody 400 mg Intravenous