Pegylated Interferon-alpha-2a in Patients With Malignant Melanoma Stage IIA-IIIB

Summary

The purpose of this study is to evaluate the efficacy and safety of adjuvant treatment with pegylated interferon-α-2a (PEG-IFN) vs. 'low dose' interferon-α-2a in patients with malignant melanoma in stage IIA (T3a) - IIIB. A total of 880 will be randomized up to three months after first surgical management of their melanoma to either: PEG-IFN-α-2a or low-dose interferon-α-2a.

Timeline

Start

2004-10

Primary completion

2013-05

Completion

2016-12

Outcome

Missed primary endpoint

paper Neither 5-year DMFS [PEG-IFN 61.0% versus IFN 67.3%; hazard ratio (HR) 1.16, P = 0.21] PMID 27287206 ↗

Publications

• Eigentler TK, Gutzmer R, Hauschild A, Heinzerling L, Schadendorf D, Nashan D, Holzle E, Kiecker F, Becker J, Sunderkotter C, Moll I, Richtig E, Ponitzsch I, Pehamberger H, Kaufmann R, Pfohler C, Vogt T, Berking C, Praxmarer M, Garbe C; Dermatologic Cooperative Oncology Group (DeCOG). Adjuvant treatment with pegylated interferon alpha-2a versus low-dose interferon alpha-2a in patients with high-risk melanoma: a randomized phase III DeCOG trial. Ann Oncol. 2016 Aug;27(8):1625-32. doi: 10.1093/annonc/mdw225. Epub 2016 Jun 10.

Drugs

Indications