Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02155322 | A Phase II Study of Pegylated Interferon Alfa-2b for the Adjuvant Treatment of Melanoma Subjects in Russia (MK-4031-400) | PHASE2 | COMPLETED | 33 | — | — | Aug 19, 2014 | Mar 21, 2016 | Aug 23, 2018 | - | — |
| NCT00861406 | Adjuvant Therapy of Pegylated Interferon- 2b Plus Melanoma Peptide Vaccine | PHASE1 | COMPLETED | 38 | — | — | Mar 10, 2009 | Feb 24, 2017 | Mar 3, 2017 | 1 | United States |
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.
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.
| Arm | Type | Description |
|---|---|---|
| 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) |
| Group 1 | EXPERIMENTAL | Pegylated Interferon alfa-2b (Once week x 4 weeks) + GP-100 Peptide |
| Group 2 | EXPERIMENTAL | Pegylated Interferon alfa-2b (Once week x 8 weeks) + GP-100 Peptide |
| Group 3 | EXPERIMENTAL | Pegylated Interferon alfa-2b (Once week x 12 weeks) + GP-100 Peptide |
| Name | Type | Description |
|---|---|---|
| Pegylated Interferon Alfa-2b | BIOLOGICAL | 6 μg/kg, weekly dosing, subcutaneous administration, Induction Phase - first 8 weeks |
| Pegylated Interferon-Alfa 2b (PEG Intron) | DRUG | Group 1: 6 mcg/kg by injection under skin once weekly for 4 weeks, followed by Maintenance Phase of 3 mcg/kg weekly for 20 weeks. Group 2: 6 mcg/kg by injection under skin once weekly for 8 weeks, followed by Maintenance Phase of 3 mcg/kg weekly for 16 weeks. Group 3: 6 mcg/kg by injection under skin once weekly for 12 weeks followed by Maintenance Phase of 3 mcg/kg weekly for 12 weeks. |
| GP-100 Peptide Vaccine | DRUG | Injection under skin once every 3 weeks (Weeks 1, 4, 7, 10, 13, 16, 19, and 22), for a total of 8 injections. |
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 s...