Abstract| Volume 51, SUPPLEMENT 1, S7, March 2015

Download started.


ITOC2 – 019. An open-label multicenter phase II trial of aviscumine in previously treated patients with unresectable stage IV metastatic melanoma

      This paper is only available as a PDF. To read, Please Download here.


      Aviscumine, a recombinant plant protein, inactivates the 28S rRNA (“ribotoxic stress”) after endocytosis. In this way cytokine release and T-cell responses are enhanced. This phase II trial was conducted to test the efficacy and safety of aviscumine in pts with systemically pre-treated metastatic melanoma stage IV.


      32 pts with Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 were enrolled onto a single-arm, multi-centre, open-label, phase II trial. Pts received 350 ng aviscumine twice weekly by subcutaneous (SC) injection until progression. Primary end points were progression-free survival (PFS) and overall survival (OS). Safety was assessed as adverse events (AEs). Tumor response was assessed every eight weeks and survival of patients was followed up to one year after the end of therapy. 31 pts (ITT population) were assessed for efficacy; safety was assessed in the whole population.


      One pt achieved a partial response (PR) and 10 pts showed stable disease (SD). The median progression-free survival (mPFS) was 63 days (95% confidence interval (CI) 57–85) and median overall survival (mOS) was 335 days (95% CI 210–604). Grade 1 or 2 AEs occurred in 72% of pts and were mostly application-site effects such as pruritus Grade 3–4 treatment-emergent drug-related adverse events occurred in 9% of pts.


      These results suggest that aviscumine may have a clinical impact in patients with previously treated metastatic melanoma and provide rationale for further clinical evaluation. In the light of effective new immune checkpoint blockers it might be a candidate for combinations with these agents.
      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'


      Subscribe to European Journal of Cancer
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect