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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
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    June 2, 2014
    Last Updated
    July 24, 2018
    Sponsor
    Merck Sharp & Dohme LLC
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    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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