drugset / Trial / NCT03552549
SCH 54031 PEG12000 Interferon Alfa-2b (PEG Intron, MK-4031) vs. INTRON®A (SCH 30500, MK-2958) as Adjuvant Therapy for Melanoma (C98-135, MK-4031-002)
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a Phase II/III randomized, controlled, multicenter, open-label study designed to assess the safety, efficacy, and impact on quality of life of PEG Intron (MK-4031) and INTRON® A (MK-2958) and the pharmacokinetics of PEG Intron when given as adjuvant (after surgery) therapy in participants with resected (surgically removed) Stage III node-positive cutaneous melanoma.
Timeline
- Start
- 1998-08-05
- Primary completion
- 2001-02-19
- Completion
- 2001-02-19
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Peginterferon alfa-2b | Protein / enzyme biologic | 6 ug/kg | Subcutaneous |
| Subject | interferon alfa-2b | Protein / enzyme biologic | 10 unknown | Intravenous |