Malignant Melanoma
Conditions
Brief summary
This is a study to evaluate the safety and tolerability of peginterferon alfa-2b (PegIFN alfa-2b) as adjuvant treatment in Japanese participants with malignant melanoma after definitive surgical resection including complete lymphadenectomy. Participants on this study will initially receive PegIFN alfa-2b for 8 weeks (Induction Phase) and then may continue to receive PegIFN alfa-2b (Maintenance Phase) as long as they are experiencing clinical benefit (Up to 252 weeks). The primary hypothesis is that peginterferon alfa-2b administered on a weekly basis is safe and tolerated.
Detailed description
The study was terminated after 118 weeks from the study start, during the maintenance phase, due to regulatory approval in Japan.
Interventions
BIOLOGICALPegIFN alfa-2b
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Stage II or III melanoma * Primary melanoma completely excised * Full lymphadenectomy within 84 days prior to initiation of study treatment * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Exclusion criteria
* Ocular melanoma or melanoma of the mucous membranes * Evidence of distant or non-regional lymph node metastases * In-transit melanoma * Previously treated with interferon alpha/beta, chemotherapy, hormonal therapy, radiotherapy or immunotherapy/vaccine for melanoma
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Experiencing Dose-limiting Toxicities (DLTs) - Induction Phase | From first dose to end of induction phase; up to 8 Weeks | A DLT was an event (clinical or laboratory) that resulted in a change in the given dose. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety: Number of Participants Experiencing Adverse Events (AEs) | From first dose through follow-up; up to 265 Weeks | 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. |
| Number of Participants Discontinuing Study Drug Because of AEs | From first dose to last dose of treatment; up to 260 Weeks | 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 Japanese participants with Stage II or III malignant melanoma who had undergone surgical resection and lymphadenectomy.
Participants by arm
| Arm | Count |
|---|---|
| Participants Receiving PegIFN Alfa-2b Participants received PegIFN alfa-2b 6 µg/kg subcutaneously (SC) on Day 1 of each week for 8 weeks (Induction) and then 3 µg/kg SC once weekly for up to 252 weeks (Maintenance). | 9 |
| Total | 9 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Induction Phase | Adverse Event | 2 |
| Maintenance Phase | Adverse Event | 3 |
| Maintenance Phase | Continued drug after regulatory approval | 3 |
| Maintenance Phase | Progressive disease | 1 |
Baseline characteristics
| Characteristic | Participants Receiving PegIFN Alfa-2b |
|---|---|
| Age, Continuous | 43.3 Years STANDARD_DEVIATION 13.7 |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 9 / 9 |
| serious Total, serious adverse events | 0 / 9 |
Outcome results
Primary
Number of Participants Experiencing Dose-limiting Toxicities (DLTs) - Induction Phase
A DLT was an event (clinical or laboratory) that resulted in a change in the given dose.
Time frame: From first dose to end of induction phase; up to 8 Weeks
Population: All participants in the induction phase of the study
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants Receiving PegIFN Alfa-2b | Number of Participants Experiencing Dose-limiting Toxicities (DLTs) - Induction Phase | 2 Participants |
Secondary
Number 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 260 Weeks
Population: All participants receiving at least one dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants Receiving PegIFN Alfa-2b | Number of Participants Discontinuing Study Drug Because of AEs | 5 Participants |
Secondary
Safety: Number 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 265 Weeks
Population: All participants who received at least one dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants Receiving PegIFN Alfa-2b | Safety: Number of Participants Experiencing Adverse Events (AEs) | 9 Participants |