SCH 54031 PEG12000 Interferon Alfa-2b (PEG Intron, MK-4031) vs. INTRON®A (SCH 30500, MK-2958) as Adjuvant Therapy for Melanoma (C98-135, MK-4031-002)
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|ClinicalTrials.gov Identifier: NCT03552549|
Recruitment Status : Terminated (This study was closed to enrollment prematurely due to sub-optimal accrual.)
First Posted : June 12, 2018
Results First Posted : July 24, 2019
Last Update Posted : July 24, 2019
|Condition or disease||Intervention/treatment||Phase|
|Melanoma||Biological: PEG-Intron Biological: INTRON A||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||126 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Phase II/III Trial of SCH 54031 PEG12000 Interferon Alfa-2b (PEG Intron) vs. INTRON®A as Adjuvant Therapy for Melanoma|
|Actual Study Start Date :||August 5, 1998|
|Actual Primary Completion Date :||February 19, 2001|
|Actual Study Completion Date :||February 19, 2001|
Participants with stage III node positive cutaneous melanoma will receive subcutaneous PEG-Intron (6.0 ug/kg weekly) for 2 years post-surgery.
Polyethylene glycol (PEG)12000 Interferon alfa 2-b subcutaneous injection.
Other Name: peginterferon alfa-2b, SCH 54031, MK-4031
Experimental: INTRON A
Participants with stage III node positive cutaneous melanoma will receive intravenous INTRON A (20 million international units [MIU]/m^2/day, 5 days a week) for 4 weeks followed by subcutaneous INTRON A (10 MIU/m^2 three times per week) for 48 weeks post-surgery.
Biological: INTRON A
Interferon alfa-2b, recombinant for intravenous injection.
Other Name: interferon alfa-2b, SCH 30500, MK-2958
- Progression-free Survival (PFS) [ Time Frame: From time of randomization to time of progression or death (up to approximately 26 months) ]Progression-free survival time was defined as the time from the date of randomization to the date of disease progression or the date of death regardless of the cause. PFS was to be assessed by clinical observation, with recurrence documented by appropriate radiographic and histologic methods, and confirmed by Independent Central Review.
- Overall Survival [ Time Frame: From time of randomization to time of death (up to approximately 26 months) ]Overall survival (OS) is the time from randomization to death due to any cause. Participants were to be followed for survival every 3 months. Participants without documented death at the time of the final analysis were to be censored at the date of the last follow-up. After the early termination of the study, participants were followed for safety only. Although the OS analysis is not in the clinical study report due to early termination of the study, an OS ad hoc analysis was requested by the FDA and is therefore presented in this outcome measure. Below table presents the median duration of survival for participants.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03552549
|Study Director:||Medical Director||Merck Sharp & Dohme Corp.|