drugset / Trial / NCT05814666

Activity and Safety of Danvatirsen and Pembrolizumab in HNSCC

NCT05814666

Phase 2 Terminated 69 enrolled Flamingo Therapeutics NV
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

EvaluationDrugModalityDoseRoute
Subject Danvatirsen Antisense oligonucleotide Intravenous
Subject Pembrolizumab Monoclonal antibody Intravenous