A Phase II Study of Pegylated Interferon Alfa-2b for the Adjuvant Treatment of Melanoma Subjects in Russia (MK-4031-400)

Exclusion Criteria

• •Mucous membrane melanoma or ocular melanoma
• •Known hypersensitivity to the components of study drug (including acetaminophen), or its analogs
• •Evidence of distant or non-regional lymph node metastases or in-transit metastases
• •Disease that cannot be completely surgically resected
• •Prior malignancy within the past 5 years other than surgically cured non-melanoma skin cancer or cervical carcinoma in situ
• •Severe cardiovascular disease, i.e. arrhythmias, requiring chronic treatment, congestive heart failure or symptomatic ischemic heart disease
• •Hepatic decompensation
• •Thyroid dysfunction not responsive to therapy
• •Uncontrolled diabetes mellitus
• •Clinically active autoimmune disease
• •Clinically active and/or uncontrolled infection, including active hepatitis
• •Human immunodeficiency virus (HIV)
• •History of neuropsychiatric disorder requiring hospitalization
• •Actively abusing alcohol or drugs
• •Pregnant, lactating, or of reproductive potential and not using an effective means of contraception
• •Medical condition requiring chronic systemic corticosteroids
• •Received any experimental therapy within 30 days prior to enrolling in this study
• •Received any prior chemotherapy, immunotherapy, hormonal or radiation therapy for melanoma
• •Previously received interferon-α for any reason
• •Known serious hypersensitivity reaction to PEG-IFN or interferon alfa-2b