drugset / Trial / NCT02873819
Safety and Efficacy Study of GL-0817 (With Cyclophosphamide) for the Prevention of Recurrence of Squamous Cell Carcinoma of the Oral Cavity
RandomizedParallel-groupDouble-blindTreatment
Summary
This is a multi-center, randomized, double-blind clinical trial to assess the safety and efficacy of GL-0817 as a means to prevent disease recurrence in patients considered at high-risk following surgery and adjuvant chemoradiotherapy.
Timeline
- Start
- 2017-03-30
- Primary completion
- 2021-05-17
- Completion
- 2021-05-25
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BIROPEPIMUT-S | Vaccine | 1.5 mg | Intravenous |
| Subject | Cyclophosphamide | Other / unclassified | 200 mg/m2 | Intravenous |
| Background | Hiltonol | Other / unclassified | 1.4 mg | Intramuscular |
| Background | sargramostim | Protein / enzyme biologic | 100 ug/m2 | Intramuscular |