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 September 18, 2014
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Physiological Effects of Drugs