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

NCT ID: NCT02155322

Last Updated: 2018-08-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-19
• Study Completion Date: 2016-03-21

Brief Summary

This study will assess the safety of Pegylated Interferon Alfa-2b (PEG-IFN) as an adjuvant treatment for melanoma.

Conditions

Melanoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PEG-IFN

6.0 μg/kg/week subcutaneous administration during the Induction Phase of 8 weeks followed by a dose of 3.0 μg/kg/week subcutaneous administration in the Maintenance Period (Week 8 to Month 12)

Group Type: EXPERIMENTAL

Pegylated Interferon Alfa-2b

Intervention Type: BIOLOGICAL

6 μg/kg, weekly dosing, subcutaneous administration, Induction Phase - first 8 weeks

Pegylated Interferon Alfa-2b

Intervention Type: BIOLOGICAL

3 μg/kg SC once weekly for a 42-week maintenance phase (for a total treatment of up to approximately 1 year)

Interventions

Pegylated Interferon Alfa-2b

6 μg/kg, weekly dosing, subcutaneous administration, Induction Phase - first 8 weeks

Intervention Type: BIOLOGICAL

Pegylated Interferon Alfa-2b

3 μg/kg SC once weekly for a 42-week maintenance phase (for a total treatment of up to approximately 1 year)

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

4031-400

Identifier Type: -

Identifier Source: org_study_id