A Phase II Study of Pegylated Interferon Alfa-2b for the... | NCT02155322

NCT02155322

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Pegylated Interferon Alfa-2b	Biological	6 μg/kg, weekly dosing, subcutaneous administration, Induction Phase - first 8 weeks	PEG-IFN

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Eligibility Module

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

Name	Affiliation	Role
Medical Director	Merck Sharp & Dohme LLC	Study Director

ID	Title	Description
FG000	PEG-IFN	Participants received PEG-IFN 6 μg/kg subcutaneously (SC) once weekly during an 8-week induction phase followed by 3 μg/kg SC once weekly for a 42-week maintenance phase (treatment up to approximately 1 year).

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	PEG-IFN	Participants received PEG-IFN 6 μg/kg subcutaneously (SC) once weekly during an 8-week induction phase followed by 3 μg/kg SC once weekly for a 42-week maintenance phase (treatment up to approximately 1 year).

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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.

All participants who received at least one dose of study drug.

Posted

Number

Percentage of participants

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

ID	Title	Description
OG000	PEG-IFN	Participants received PEG-IFN 6 μg/kg subcutaneously (SC) once weekly during an 8-week induction phase followed by 3 μg/kg SC once weekly for a 42-week maintenance phase (treatment up to approximately 1 year).

Units

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	PEG-IFN	Participants received PEG-IFN 6 μg/kg subcutaneously (SC) once weekly during an 8-week induction phase followed by 3 μg/kg SC once weekly for a 42-week maintenance phase (treatment up to approximately 1 year).

ID	Term
D018358	Neuroendocrine Tumors
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type