Melanoma
Conditions
Brief summary
Patients with malignant melanoma who had undergone surgery will receive adjuvant treatment with high-dose Intron A for one year. The objective of this study is to maximize treatment compliance by proactive management of side effects in a day-to-day healthcare setting.
Interventions
BIOLOGICALIntron A (interferon alfa-2b; SCH 30500)
The recommended regimen includes an induction treatment of 5 consecutive days per week for 4 weeks as a 20-minute intravenous (iv) infusion at a dose of 20 million international units per square meter (MIU/m\^2). The induction treatment should be followed by a maintenance treatment of 3 times per week for 48 weeks as a subcutaneous (sc) injection at a dose of 10 MIU/m\^2. Therapy should be administered for a total of one year unless the disease progresses or the treatment has lead to recurrent unmanageable serious adverse effects.
Sponsors
Merck Sharp & Dohme LLC
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Signed informed consent * Age \> 18 years * Confirmed melanoma * Patient has been prescribed Intron A therapy for High-Risk Stage II & III Melanoma * Intron A therapy started within 70 days of surgery (additional 15 days may be granted by the sponsor upon written approval) * Proper contraception in both male and female subjects and the female partner(s) of male study subjects
Exclusion criteria
* Metastatic disease at the time of diagnosis * Other malignancies * History of non compliance to other therapies * Pregnancy or breast feeding * Previous Intron A therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Completed Treatment | Up to 1 year | Treatment completion was defined as those who completed both the induction and maintenance phases. |
Participant flow
Pre-assignment details
299 participants were enrolled. Of these, 294 were considered efficacy evaluable (5 participants were excluded from efficacy analyses: 2 moved, 1 required radiation, 1 not eligible and 1 missing data).
Participants by arm
| Arm | Count |
|---|---|
| Intron A The recommended regimen included an induction treatment of 5 consecutive days per week for 4 weeks as a 20-minute intravenous (iv) infusion at a dose of 20 MIU/m\^2. The induction treatment was followed by a maintenance treatment of 3 times per week for 48 weeks as a subcutaneous (sc) injection at a dose of 10 MIU/m\^2. Therapy was administered for a total of one year unless the disease progressed or the treatment led to recurrent unmanageable serious adverse effects. | 294 |
| Total | 294 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 88 |
| Overall Study | Disease progression | 48 |
| Overall Study | Physician Decision | 2 |
| Overall Study | Withdrawal by Subject | 36 |
Baseline characteristics
| Characteristic | Intron A |
|---|---|
| Age, Continuous | 52 years |
| Sex: Female, Male Female | 124 Participants |
| Sex: Female, Male Male | 170 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 297 / 299 |
| serious Total, serious adverse events | 21 / 299 |
Outcome results
Primary
Number of Participants Who Completed Treatment
Treatment completion was defined as those who completed both the induction and maintenance phases.
Time frame: Up to 1 year
Population: The number of participants who started the induction phase
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intron A | Number of Participants Who Completed Treatment | 120 Participants |