Back to resultsSCH 54031 PEG12000 Interferon Alfa-2b (PEG Intron, MK-4031) vs. INTRON®A (SCH 30500, MK-2958) as Adjuvant Therapy for Melanoma (C98-135, MK-4031-002)
Primary Purpose
Melanoma
Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
PEG-Intron
INTRON A
Sponsored by
About this trial
This is an interventional treatment trial for Melanoma
Eligibility Criteria
Inclusion Criteria:
Participants must have histologically documented primary cutaneous melanoma meeting one of the following staging criteria:
- Primary melanoma of any stage in the presence of N1 regional lymph node metastases detected at elective lymph node dissection or sentinel node biopsy, with clinically inapparent regional lymph node metastasis (any pTN1M0).
- Clinically apparent N1 or N2a regional lymph node involvement synchronous with primary melanoma of T1-4 (any pTN1-2aM0).
- Regional lymph node recurrence at any interval after appropriate surgery for primary melanoma of any depth (any primary tumor [pT], r N1-2a M0).
- Participants must have had all known disease completely resected with adequate surgical margins within 56 days prior to randomization into the study
- Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Participants must have adequate hepatic, renal and bone marrow function as defined by the following parameters obtained within 14 days prior to initiation of study treatment:
- Hematology: white blood cells (WBC) ≥3,000 cells/µL and hemoglobin ≥9 g/dL.
- Renal and hepatic function: serum creatinine <2.0 mg/dL; aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) <2 times upper limit of laboratory normal (ULN); and serum bilirubin <2 times ULN
- Participants must sign and date a voluntary informed consent form before study entry, be willing to participate in this study and agree to complete all follow-up assessments.
Exclusion Criteria:
- Participants who have received any prior chemotherapy, immunotherapy hormonal or radiation therapy for melanoma.
- Participants who have evidence of distant or non-regional lymph node metastases, in-transit metastases, or positive lymph nodes with an unknown primary.
- Participants whose disease cannot be completely surgically resected because of gross extracapsular extension.
- Participants who have previously received interferon for any reason.
- Participants who have severe cardiovascular disease, i.e., arrhythmias requiring chronic treatment, congestive heart failure (New York Heart Association [NYHA] Class III or IV) or symptomatic ischemic heart disease.
- Participants who have a history of neuropsychiatric disorder requiring hospitalization.
- Participants with thyroid dysfunction not responsive to therapy.
- Participants with uncontrolled diabetes mellitus.
- Participants with a history of prior malignancy within the past 5 years other than surgically cured non-melanoma skin cancer or cervical carcinoma in situ.
- Participants who have a history of seropositivity for human immunodeficiency virus (HIV).
- Participants who are pregnant, lactating, or of reproductive potential and not practicing an effective means of contraception.
- Participants with active and/or uncontrolled infection, including active hepatitis.
- Participants with a medical condition requiring chronic systemic corticosteroids.
- Participants who are known to be actively abusing alcohol or drugs.
- Participants who have received any experimental therapy within 30 days prior to randomization in this study.
- Participants who have not recovered from the effects of recent surgery.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
PEG-Intron
INTRON A
Arm Description
Participants with stage III node positive cutaneous melanoma will receive subcutaneous PEG-Intron (6.0 ug/kg weekly) for 2 years post-surgery.
Participants with stage III node positive cutaneous melanoma will receive intravenous INTRON A (20 million international units [MIU]/m^2/day, 5 days a week) for 4 weeks followed by subcutaneous INTRON A (10 MIU/m^2 three times per week) for 48 weeks post-surgery.
Outcomes
Primary Outcome Measures
Progression-free Survival (PFS)
Progression-free survival time was defined as the time from the date of randomization to the date of disease progression or the date of death regardless of the cause. PFS was to be assessed by clinical observation, with recurrence documented by appropriate radiographic and histologic methods, and confirmed by Independent Central Review.
Secondary Outcome Measures
Overall Survival
Overall survival (OS) is the time from randomization to death due to any cause. Participants were to be followed for survival every 3 months. Participants without documented death at the time of the final analysis were to be censored at the date of the last follow-up. After the early termination of the study, participants were followed for safety only. Although the OS analysis is not in the clinical study report due to early termination of the study, an OS ad hoc analysis was requested by the FDA and is therefore presented in this outcome measure. Below table presents the median duration of survival for participants.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03552549
Brief Title
SCH 54031 PEG12000 Interferon Alfa-2b (PEG Intron, MK-4031) vs. INTRON®A (SCH 30500, MK-2958) as Adjuvant Therapy for Melanoma (C98-135, MK-4031-002)
Official Title
A Randomized Phase II/III Trial of SCH 54031 PEG12000 Interferon Alfa-2b (PEG Intron) vs. INTRON®A as Adjuvant Therapy for Melanoma
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Terminated
Why Stopped
This study was closed to enrollment prematurely due to sub-optimal accrual.
Study Start Date
August 5, 1998 (Actual)
Primary Completion Date
February 19, 2001 (Actual)
Study Completion Date
February 19, 2001 (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 is a Phase II/III randomized, controlled, multicenter, open-label study designed to assess the safety, efficacy, and impact on quality of life of PEG Intron (MK-4031) and INTRON® A (MK-2958) and the pharmacokinetics of PEG Intron when given as adjuvant (after surgery) therapy in participants with resected (surgically removed) Stage III node-positive cutaneous melanoma.
Detailed Description
This study was closed to enrollment prematurely due to sub-optimal accrual. Participants who were enrolled prior to enrollment closure were allowed to continue to receive study drug; these participants were followed for safety only.
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, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
126 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PEG-Intron
Arm Type
Experimental
Arm Description
Participants with stage III node positive cutaneous melanoma will receive subcutaneous PEG-Intron (6.0 ug/kg weekly) for 2 years post-surgery.
Arm Title
INTRON A
Arm Type
Experimental
Arm Description
Participants with stage III node positive cutaneous melanoma will receive intravenous INTRON A (20 million international units [MIU]/m^2/day, 5 days a week) for 4 weeks followed by subcutaneous INTRON A (10 MIU/m^2 three times per week) for 48 weeks post-surgery.
Intervention Type
Biological
Intervention Name(s)
PEG-Intron
Other Intervention Name(s)
peginterferon alfa-2b, SCH 54031, MK-4031
Intervention Description
Polyethylene glycol (PEG)12000 Interferon alfa 2-b subcutaneous injection.
Intervention Type
Biological
Intervention Name(s)
INTRON A
Other Intervention Name(s)
interferon alfa-2b, SCH 30500, MK-2958
Intervention Description
Interferon alfa-2b, recombinant for intravenous injection.
Primary Outcome Measure Information:
Title
Progression-free Survival (PFS)
Description
Progression-free survival time was defined as the time from the date of randomization to the date of disease progression or the date of death regardless of the cause. PFS was to be assessed by clinical observation, with recurrence documented by appropriate radiographic and histologic methods, and confirmed by Independent Central Review.
Time Frame
From time of randomization to time of progression or death (up to approximately 26 months)
Secondary Outcome Measure Information:
Title
Overall Survival
Description
Overall survival (OS) is the time from randomization to death due to any cause. Participants were to be followed for survival every 3 months. Participants without documented death at the time of the final analysis were to be censored at the date of the last follow-up. After the early termination of the study, participants were followed for safety only. Although the OS analysis is not in the clinical study report due to early termination of the study, an OS ad hoc analysis was requested by the FDA and is therefore presented in this outcome measure. Below table presents the median duration of survival for participants.
Time Frame
From time of randomization to time of death (up to approximately 26 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants must have histologically documented primary cutaneous melanoma meeting one of the following staging criteria:
Primary melanoma of any stage in the presence of N1 regional lymph node metastases detected at elective lymph node dissection or sentinel node biopsy, with clinically inapparent regional lymph node metastasis (any pTN1M0).
Clinically apparent N1 or N2a regional lymph node involvement synchronous with primary melanoma of T1-4 (any pTN1-2aM0).
Regional lymph node recurrence at any interval after appropriate surgery for primary melanoma of any depth (any primary tumor [pT], r N1-2a M0).
Participants must have had all known disease completely resected with adequate surgical margins within 56 days prior to randomization into the study
Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Participants must have adequate hepatic, renal and bone marrow function as defined by the following parameters obtained within 14 days prior to initiation of study treatment:
Hematology: white blood cells (WBC) ≥3,000 cells/µL and hemoglobin ≥9 g/dL.
Renal and hepatic function: serum creatinine <2.0 mg/dL; aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) <2 times upper limit of laboratory normal (ULN); and serum bilirubin <2 times ULN
Participants must sign and date a voluntary informed consent form before study entry, be willing to participate in this study and agree to complete all follow-up assessments.
Exclusion Criteria:
Participants who have received any prior chemotherapy, immunotherapy hormonal or radiation therapy for melanoma.
Participants who have evidence of distant or non-regional lymph node metastases, in-transit metastases, or positive lymph nodes with an unknown primary.
Participants whose disease cannot be completely surgically resected because of gross extracapsular extension.
Participants who have previously received interferon for any reason.
Participants who have severe cardiovascular disease, i.e., arrhythmias requiring chronic treatment, congestive heart failure (New York Heart Association [NYHA] Class III or IV) or symptomatic ischemic heart disease.
Participants who have a history of neuropsychiatric disorder requiring hospitalization.
Participants with thyroid dysfunction not responsive to therapy.
Participants with uncontrolled diabetes mellitus.
Participants with a history of prior malignancy within the past 5 years other than surgically cured non-melanoma skin cancer or cervical carcinoma in situ.
Participants who have a history of seropositivity for human immunodeficiency virus (HIV).
Participants who are pregnant, lactating, or of reproductive potential and not practicing an effective means of contraception.
Participants with active and/or uncontrolled infection, including active hepatitis.
Participants with a medical condition requiring chronic systemic corticosteroids.
Participants who are known to be actively abusing alcohol or drugs.
Participants who have received any experimental therapy within 30 days prior to randomization in this study.
Participants who have not recovered from the effects of recent surgery.
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
Learn more about this trial
SCH 54031 PEG12000 Interferon Alfa-2b (PEG Intron, MK-4031) vs. INTRON®A (SCH 30500, MK-2958) as Adjuvant Therapy for Melanoma (C98-135, MK-4031-002)
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