A Study of Pegylated Interferon Alfa-2b as an Adjuvant Treatment in Japanese Patients With Malignant Melanoma (P08556)
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.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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)|
- Number of Participants Experiencing Dose-limiting Toxicities (DLTs) - Induction Phase [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: Yes ]A DLT is an event (clinical or laboratory) that results in a change in the given dose.
- Safety: Number of Participants Experiencing Adverse Events (AEs) [ Time Frame: Up to 1 year (to be updated as data collection continues) ] [ Designated as safety issue: Yes ]An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.
- Number of Participants Discontinuing Study Drug Because of AEs [ Time Frame: Up to 1 year (to be updated as data collection continues) ] [ Designated as safety issue: Yes ]An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.
|Study Start Date:||December 2012|
|Estimated Study Completion Date:||October 2016|
|Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
Experimental: Participants receiving PegIFN alfa-2b
Participants receive PegIFN alfa-2b 6 µg/kg subcutaneously (SC) on Day 1 of each week for 8 weeks (Induction) and then 3 µg/kg SC once weekly for up to 252 weeks (Maintenance).
|Biological: PegIFN alfa-2b|
The study is ongoing in Maintenance Phase which is planned to continue for up to 252 weeks after study start.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01636960
|Study Director:||Medical Director||Merck Sharp & Dohme Corp.|