- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02155322
A Phase II Study of Pegylated Interferon Alfa-2b for the Adjuvant Treatment of Melanoma Subjects in Russia (MK-4031-400)
July 24, 2018 updated by: Merck Sharp & Dohme LLC
A Phase II Study of Pegylated Interferon Alfa-2b in AJCC Stage III (TxN1-2M0) Melanoma Subjects After Regional Lymph Node Dissection in Russia
This study will assess the safety of Pegylated Interferon Alfa-2b (PEG-IFN) as an adjuvant treatment for melanoma.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
33
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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)
|
6 μg/kg, weekly dosing, subcutaneous administration, Induction Phase - first 8 weeks
3 μg/kg SC once weekly for a 42-week maintenance phase (for a total treatment of up to approximately 1 year)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
From first dose through follow-up; up to 13 months
|
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.
|
From first dose to last dose of treatment; up to 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 19, 2014
Primary Completion (Actual)
March 21, 2016
Study Completion (Actual)
March 21, 2016
Study Registration Dates
First Submitted
June 2, 2014
First Submitted That Met QC Criteria
June 2, 2014
First Posted (Estimate)
June 4, 2014
Study Record Updates
Last Update Posted (Actual)
August 23, 2018
Last Update Submitted That Met QC Criteria
July 24, 2018
Last Verified
July 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Neuroendocrine Tumors
- Nevi and Melanomas
- Melanoma
- Physiological Effects of Drugs
- Anti-Infective Agents
- Antiviral Agents
- Antineoplastic Agents
- Immunologic Factors
- Interferons
- Interferon-alpha
- Interferon alpha-2
- Peginterferon alfa-2b
Other Study ID Numbers
- 4031-400
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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