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

Merck Sharp & Dohme (MSD)

Status and phase: Terminated; Phase 1

Conditions: Malignant Melanoma

Treatments: Biological: PegIFN alfa-2b

Study type: Interventional

Funder types: Industry

Identifiers

NCT01636960

P08556

132228 (Registry Identifier)

MK-4031-370 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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

Enrollment: 9 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

Participants receiving PegIFN alfa-2b

Experimental group

Description:

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).

Treatment:

Biological: PegIFN alfa-2b