A Study of Pegylated Interferon Alfa-2b as an Adjuvant Treatment in Japanese Patients With Malignant Melanoma (P08556)
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
First received: July 5, 2012
Last updated: April 29, 2014
Last verified: April 2014
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.
Drug: PegIFN alfa-2b
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||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)
Primary Outcome Measures:
- Safety: Number of Participants Experiencing Adverse Events (AEs) [ Time Frame: Induction (From first dose through 8 weeks) ] [ Designated as safety issue: Yes ]
- Tolerability: Incidence of dose-limiting toxicities (DLTs) [ Time Frame: Induction (From first dose through 8 weeks) ] [ Designated as safety issue: Yes ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Primary Completion Date:
||March 2014 (Final data collection date for primary outcome measure)
Experimental: Participants receiving PegIFN alfa-2b
Drug: PegIFN alfa-2b
PegIFN alfa-2b, subcutaneously, on Day 1 of each week at a dose of 3 or 6 μg/kg for 8 weeks (induction) and 3 μg/kg for up to an additional 252 weeks (maintenance).
|Ages Eligible for Study:
||20 Years to 75 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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
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No publications provided
||Merck Sharp & Dohme Corp.
History of Changes
|Other Study ID Numbers:
||P08556, MK-4031-370, 132228
|Study First Received:
||July 5, 2012
||April 29, 2014
||Japan: Pharmaceuticals and Medical Devices Agency
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 22, 2014
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Physiological Effects of Drugs
Angiogenesis Modulating Agents
Central Nervous System Agents