A Phase II Study of Pegylated Interferon Alfa-2b for the Adjuvant Treatment of Melanoma Subjects in Russia (MK-4031-400)
Primary Purpose
Melanoma
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Pegylated Interferon Alfa-2b
Pegylated Interferon Alfa-2b
Sponsored by

About this trial
This is an interventional treatment trial for Melanoma
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PEG-IFN
Arm Description
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)
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02155322
Brief Title
A Phase II Study of Pegylated Interferon Alfa-2b for the Adjuvant Treatment of Melanoma Subjects in Russia (MK-4031-400)
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
August 19, 2014 (Actual)
Primary Completion Date
March 21, 2016 (Actual)
Study Completion Date
March 21, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will assess the safety of Pegylated Interferon Alfa-2b (PEG-IFN) as an adjuvant treatment for melanoma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PEG-IFN
Arm Type
Experimental
Arm Description
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)
Intervention Type
Biological
Intervention Name(s)
Pegylated Interferon Alfa-2b
Intervention Description
6 μg/kg, weekly dosing, subcutaneous administration, Induction Phase - first 8 weeks
Intervention Type
Biological
Intervention Name(s)
Pegylated Interferon Alfa-2b
Intervention Description
3 μg/kg SC once weekly for a 42-week maintenance phase (for a total treatment of up to approximately 1 year)
Primary Outcome Measure Information:
Title
Percentage of Participants Experiencing Adverse Events (AEs)
Description
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.
Time Frame
From first dose through follow-up; up to 13 months
Title
Percentage of Participants Discontinuing Study Drug Because of AEs
Description
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.
Time Frame
From first dose to last dose of treatment; up to 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Learn more about this trial
A Phase II Study of Pegylated Interferon Alfa-2b for the Adjuvant Treatment of Melanoma Subjects in Russia (MK-4031-400)
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