Melanoma
Conditions
Brief summary
This study will assess the safety of Pegylated Interferon Alfa-2b (PEG-IFN) as an adjuvant treatment for melanoma.
Interventions
BIOLOGICALPegylated Interferon Alfa-2b
6 μg/kg, weekly dosing, subcutaneous administration, Induction Phase - first 8 weeks
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Experiencing Adverse Events (AEs) | 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. |
| Percentage of Participants Discontinuing Study Drug Because of AEs | 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. |
Participant flow
Recruitment details
This study enrolled Russian participants with malignant melanoma who had undergone surgical resection and lymphadenectomy.
Participants by arm
| Arm | Count |
|---|---|
| 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). | 33 |
| Total | 33 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Relapse/Recurrence | 8 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | PEG-IFN |
|---|---|
| Age, Continuous | 51.4 Years STANDARD_DEVIATION 12.86 |
| Sex: Female, Male Female | 19 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 32 / 32 |
| serious Total, serious adverse events | 5 / 32 |
Outcome results
Primary
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.
Time frame: From first dose to last dose of treatment; up to 12 months
Population: All participants who received at least one dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PEG-IFN | Percentage of Participants Discontinuing Study Drug Because of AEs | 3.1 Percentage of participants |
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.
Time frame: From first dose through follow-up; up to 13 months
Population: All participants who received at least one dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PEG-IFN | Percentage of Participants Experiencing Adverse Events (AEs) | 100.0 Percentage of participants |