drugset / Trial / NCT03435302
HDI Versus Chemotherapy as Systemic Adjuvant Therapy for Resected Mucosal Melanoma
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a a multicenter, randomized, controlled, phase III trial comparing High-Dose IFN-a2b with Temozolomide Plus Cisplatin as Systemic Adjuvant Therapy for Resected Mucosal Melanoma.The study objective is to compare efficacy and safety of High-dose IFN-a2b and temozolomide-based chemotherapy as adjuvant therapy.
Timeline
- Start
- 2014-02
- Primary completion
- 2018-02
- Completion
- 2019-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cisplatin | Other / unclassified | 75 mg/m2 | Intravenous |
| Subject | Temozolomide | Small molecule | 200 mg/m2 | Oral |
| Comparator | interferon alfa-2b | Protein / enzyme biologic | 9e+06 iu | Intravenous |