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)

NCT03552549

Phase 2/3 Terminated 126 enrolled Merck Sharp & Dohme LLC
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

EvaluationDrugModalityDoseRoute
Subject Peginterferon alfa-2b Protein / enzyme biologic 6 ug/kg Subcutaneous
Subject interferon alfa-2b Protein / enzyme biologic 10 unknown Intravenous

Indications