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

Phase 1

Terminated

• Conditions: Malignant Melanoma
• Interventions: Biological: PegIFN alfa-2b

• Registration Number: NCT01636960
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief 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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2012-07-05
• Study First Submitted QC: 2012-07-05
• Study First Posted: 2012-07-10
• Study Start: 2012-12-25
• Primary Completion: 2014-03-26
• Results First Submitted: 2015-01-26
• Results First Submitted QC: 2015-01-26
• Results First Posted: 2015-02-11
• Study Completion: 2015-11-04
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-12
• Last Update Posted: 2018-08-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

• Stage II or III melanoma
• Primary melanoma completely excised
• Full lymphadenectomy within 84 days prior to initiation of study treatment
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

Exclusion Criteria

• Ocular melanoma or melanoma of the mucous membranes
• Evidence of distant or non-regional lymph node metastases
• In-transit melanoma
• Previously treated with interferon alpha/beta, chemotherapy, hormonal therapy, radiotherapy or immunotherapy/vaccine for melanoma

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Participants receiving PegIFN alfa-2b	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).

Primary Outcome Measures

Name	Time	Method
Number of Participants Experiencing Dose-limiting Toxicities (DLTs) - Induction Phase	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Discontinuing Study Drug Because of AEs	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.
Safety: Number of Participants Experiencing Adverse Events (AEs)	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.