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A Study of Pegylated Interferon Alfa-2b (MK-4031) as an Adjuvant Treatment in Japanese Patients With Malignant Melanoma (MK-4031-370)

Malignant Melanoma Clinical Trial

Official title:
An Open-Label, Single-arm, Multicenter Phase I Study of SCH 54031 (Pegylated Interferon Alfa-2b) as an Adjuvant Treatment in Japanese Patients With Malignant Melanoma (Protocol No. MK-4031 370 Also Known as SCH 54031, P08556)

Clinical Trial Summary

This is a study to evaluate the safety and tolerability of peginterferon alfa-2b (PegIFN alfa-2b) as adjuvant treatment in Japanese participants with malignant melanoma after definitive surgical resection including complete lymphadenectomy. Participants on this study will initially receive PegIFN alfa-2b for 8 weeks (Induction Phase) and then may continue to receive PegIFN alfa-2b (Maintenance Phase) as long as they are experiencing clinical benefit (Up to 252 weeks). The primary hypothesis is that peginterferon alfa-2b administered on a weekly basis is safe and tolerated.

Clinical Trial Description

The study was terminated after 118 weeks from the study start, during the maintenance phase, due to regulatory approval in Japan. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01636960
Study type Interventional
Source Merck Sharp & Dohme Corp.
Contact
Status Terminated
Phase Phase 1
Start date December 25, 2012
Completion date November 4, 2015
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