drugset / Trial / NCT06064877
A Study of Ficlatuzumab in Combination With Cetuximab in Participants With Recurrent or Metastatic (R/M) HPV Negative Head and Neck Squamous Cell Carcinoma
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to compare the efficacy and safety of ficlatuzumab plus cetuximab compared to placebo plus cetuximab in participants with recurrent/metastatic (R/M) HPV-negative Head and Neck Cancer. The primary hypothesis is that ficlatuzumab combined with cetuximab is superior to cetuximab alone in terms of progression-free survival and/or overall survival.
Timeline
- Start
- 2024-01-11
- Primary completion
- 2027-08
- Completion
- 2027-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ficlatuzumab | Monoclonal antibody | — | Intravenous |
| Background | Cetuximab | Monoclonal antibody | — | Intravenous |