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

NCT ID: NCT01636960

Last Updated: 2018-08-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-25
• Study Completion Date: 2015-11-04

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.

Conditions

Malignant Melanoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

PegIFN alfa-2b

Intervention Type: BIOLOGICAL

Interventions

PegIFN alfa-2b

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Yamazaki N, Uhara H, Wada H, Matsuda K, Yamamoto K, Shimamoto T, Kiyohara Y. Phase I study of pegylated interferon-alpha-2b as an adjuvant therapy in Japanese patients with malignant melanoma. J Dermatol. 2016 Oct;43(10):1146-1153. doi: 10.1111/1346-8138.13338.

Reference Type: RESULT

PMID: 27087489 (View on PubMed)

Study Documents

Document Type: CSR Synopsis

View Document

Other Identifiers

MK-4031-370

Identifier Type: OTHER

Identifier Source: secondary_id

132228

Identifier Type: REGISTRY

Identifier Source: secondary_id

P08556

Identifier Type: -

Identifier Source: org_study_id