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

NCT02155322 | Completed Phase 2 Results

• 1 other identifier: 4031-400
• Study Type: interventional
• Target: 33
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Melanoma

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants Experiencing Adverse Events (AEs)

  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.

  From first dose through follow-up; up to 13 months

• Percentage of Participants Discontinuing Study Drug Because of AEs

  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.

  From first dose to last dose of treatment; up to 12 months

Study Arms (1)

PEG-IFN

EXPERIMENTAL

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

Interventions

Pegylated Interferon Alfa-2b BIOLOGICAL

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

PEG-IFN

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Melanoma

Interventions

peginterferon alfa-2b

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2014
• First Posted: June 4, 2014
• Study Start: August 19, 2014
• Primary Completion: March 21, 2016
• Study Completion: March 21, 2016
• Last Updated: August 23, 2018
• Results First Posted: April 11, 2017

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will share