Phase II Study of KW2871 Combined With High Dose Interferon-α2b in Patients With Metastatic Melanoma
Status:
Completed
Trial end date:
2014-02-03
Target enrollment:
Participant gender:
Summary
This was a Phase 2, open-label study of KW2871 (ecromeximab) in combination with high-dose
interferon-α2b (HDI) in patients with metastatic melanoma. The primary objectives of this
study were to assess progression-free survival (PFS) and safety. The secondary objectives
were to assess the objective response rate, KW2871 pharmacokinetics (PK), and other
exploratory immunology as indicated (e.g., development of human anti-chimeric antibodies
[HACA], activity of antibody-dependent cell-mediated cytotoxicity [ADCC] and
complement-dependent cytotoxicity [CDC] in peripheral blood, number and functional state of
tumor-infiltrating immune cells and expression of GD3 in immune and tumor cells of tumor
biopsies, and markers of interferon [IFN] response/resistance and markers of resistance to
ADCC/CDC in peripheral blood mononuclear cells [PBMCs]).
Phase:
Phase 2
Details
Lead Sponsor:
Ludwig Institute for Cancer Research
Collaborators:
Life Science Pharmaceuticals Life Sciences Pharmaceuticals University of Chicago University of Pittsburgh