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

Inclusion Criteria: * Competent to self-administer the subcutaneous injections of PEG-IFN * Histologically documented involved regional lymph nodes of a primary cutaneous melanoma or unknown primary, meeting the study's staging criteria * Had the primary melanoma completely resected with adequate surgical margins and undergone operation for positive regional lymph nodes within 84 days of study start * Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1 * Adequate hepatic, renal and bone marrow function as defined by study parameters obtained within 4 weeks prior to study start * For a female subject who is of childbearing potential or male participant with female sexual partner who is of childbearing potential, agree to use acceptable methods of contraception for at least 2 weeks prior to study start and continue until at least 6 months after last dose of study medication, or longer if dictated by local regulations 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