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

• ClinicalTrials.gov Identifier: NCT02155322
• Recruitment Status: Completed
• First Posted: June 4, 2014
• Results First Posted: April 11, 2017
• Last Update Posted: August 23, 2018
• Sponsor: Merck Sharp & Dohme Corp.
• Information provided by (Responsible Party): Merck Sharp & Dohme Corp.

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Melanoma	Biological: Pegylated Interferon Alfa-2b	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 33 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Study of Pegylated Interferon Alfa-2b in AJCC Stage III (TxN1-2M0) Melanoma Subjects After Regional Lymph Node Dissection in Russia
• Actual Study Start Date: August 19, 2014
• Actual Primary Completion Date: March 21, 2016
• Actual Study Completion Date: March 21, 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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)	Biological: Pegylated Interferon Alfa-2b; 6 μg/kg, weekly dosing, subcutaneous administration, Induction Phase - first 8 weeks; 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)

Outcome Measures

Primary Outcome Measures :

1. Percentage of Participants Experiencing Adverse Events (AEs) [ Time Frame: From first dose through follow-up; up to 13 months ]
   An adverse event was any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.
2. Percentage of Participants Discontinuing Study Drug Because of AEs [ Time Frame: From first dose to last dose of treatment; up to 12 months ]
   An adverse event was any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Sponsors and Collaborators

Merck Sharp & Dohme Corp.

Investigators

• Study Director: Medical Director; Merck Sharp & Dohme Corp.

More Information

• Responsible Party: Merck Sharp & Dohme Corp.
• ClinicalTrials.gov Identifier: NCT02155322
• Other Study ID Numbers: 4031-400
• First Posted: June 4, 2014
• Results First Posted: April 11, 2017
• Last Update Posted: August 23, 2018
• Last Verified: July 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
• URL: http://engagezone.msd.com/ds_documentation.php

Additional relevant MeSH terms:

Melanoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Interferons; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2b; Antineoplastic Agents; Antiviral Agents; Anti-Infective Agents; Immunologic Factors; Physiological Effects of Drugs