This trial is active, not recruiting.

Condition malignant melanoma
Treatment pegifn alfa-2b
Phase phase 1
Sponsor Merck Sharp & Dohme Corp.
Start date December 2012
End date March 2014
Trial size 9 participants
Trial identifier NCT01636960, 132228, MK-4031-370, 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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
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).
pegifn alfa-2b

Primary Outcomes

Number of Participants Experiencing Dose-limiting Toxicities (DLTs) - Induction Phase
time frame: Up to 8 weeks

Secondary Outcomes

Safety: Number of Participants Experiencing Adverse Events (AEs)
time frame: Up to 1 year (to be updated as data collection continues)
Number of Participants Discontinuing Study Drug Because of AEs
time frame: Up to 1 year (to be updated as data collection continues)

Eligibility Criteria

Male or female participants from 20 years up to 75 years old.

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

Additional Information

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)
Description The study is ongoing in Maintenance Phase which is planned to continue for up to 252 weeks after study start.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Merck Sharp & Dohme Corp..