drugset / Trial / NCT05814666
Activity and Safety of Danvatirsen and Pembrolizumab in HNSCC
RandomizedParallel-groupOpen-labelTreatment
Summary
Open-label, Phase II, randomized, controlled study evaluating the efficacy and safety of danvatirsen in combination with pembrolizumab compared with pembrolizumab alone as first-line treatment of patients with recurrent/metastatic (R/M) HNSCC. Two-thirds of patients will be randomized to receive danvatirsen and pembrolizumab and one-third will be randomized to receive pembrolizumab alone.
Timeline
- Start
- 2023-05-30
- Primary completion
- 2025-08-14
- Completion
- 2025-08-14
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Danvatirsen | Antisense oligonucleotide | — | Intravenous |
| Subject | Pembrolizumab | Monoclonal antibody | — | Intravenous |