Trial Information
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)
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Incidence of dose-limiting toxicities (DLTs)
Outcome Time Frame:
From first dose through 8 weeks
Safety Issue:
Yes
Authority:
Japan: Pharmaceuticals and Medical Devices Agency
Study ID:
P08556
NCT ID:
NCT01636960
Start Date:
December 2012
Completion Date:
October 2018
Related Keywords:
- Malignant Melanoma
- Melanoma