drugset / Trial / NCT02052960
CetuGEX™ in Comparison to Cetuximab for the Treatment of Patients With Head and Neck Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
The aim of the study is to evaluate the efficacy of CetuGEX™ for the treatment of patients with stage III/IV recurrent and/or metastatic SCCHN as compared to cetuximab (both in combination with platinum-based chemotherapy) in terms of progression-free survival (PFS).
Timeline
- Start
- 2014-02
- Primary completion
- 2017-08-28
- Completion
- 2017-10-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Cetuximab | Monoclonal antibody | 250 mg/m2 | Intravenous |
| Subject | Tomuzotuximab | Monoclonal antibody | 720 mg | Intravenous |
| Background | Carboplatin | Small molecule | — | — |
| Background | Cisplatin | Other / unclassified | — | — |
| Background | fluorouracil | Small molecule | — | — |