A Study of Pegylated Interferon Alfa-2b (MK-4031) as an Adjuvant Treatment in Japanese Patients With Malignant Melanoma (MK-4031-370)
|ClinicalTrials.gov Identifier: NCT01636960|
Recruitment Status : Terminated (The study was terminated after 118 weeks from the study start, during the maintenance phase, due to regulatory approval in Japan.)
First Posted : July 10, 2012
Results First Posted : February 11, 2015
Last Update Posted : June 14, 2017
|Condition or disease||Intervention/treatment||Phase|
|Malignant Melanoma||Biological: PegIFN alfa-2b||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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)|
|Actual Study Start Date :||December 25, 2012|
|Actual Primary Completion Date :||March 26, 2014|
|Actual Study Completion Date :||November 4, 2015|
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
- Number of Participants Experiencing Dose-limiting Toxicities (DLTs) - Induction Phase [ Time Frame: From first dose to end of induction phase; up to 8 Weeks ]A DLT was an event (clinical or laboratory) that resulted in a change in the given dose.
- Safety: Number of Participants Experiencing Adverse Events (AEs) [ Time Frame: From first dose through follow-up; up to 265 Weeks ]An adverse event was 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: From first dose to last dose of treatment; up to 260 Weeks ]An adverse event was any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01636960
|Study Director:||Medical Director||Merck Sharp & Dohme Corp.|