Phase II Study of KW2871 Combined With High Dose Interferon-Ī±2b in Patients With Metastatic Melanoma (NCT00679289) | Clinical Trial Compass
CompletedPhase 2
Phase II Study of KW2871 Combined With High Dose Interferon-Ī±2b in Patients With Metastatic Melanoma
United States36 participantsStarted 2008-03-28
Plain-language summary
This was a Phase 2, open-label study of KW2871 (ecromeximab) in combination with high-dose interferon-Ī±2b (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 \[PBMCs\]).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
ā. Age ā„ 18 years of age.
ā. Histologically proven metastatic cutaneous, mucosal, or unknown primary melanoma.
ā. Measurable disease using Response Evaluation Criteria in Solid Tumors (RECIST).
ā. Ambulatory (Eastern Cooperative Oncology Group \[ECOG\] performance status 0 or 1) or expected survival ā„ 4 months.
ā. Within the last 2 weeks prior to study day 1, the following laboratory parameters within the ranges specified:
ā. Able and willing to give valid written informed consent.
Exclusion criteria
ā. Other malignancy within 3 years prior to study entry for which the patient received active treatment, except for treated melanoma or non-melanoma skin cancer, cervical cancer, and breast carcinoma in situ.
ā. Mental impairment that may have compromised the ability to give informed consent and comply with the study requirements.
ā. Participation in any other clinical trial involving chemotherapy, radiotherapy, or other immunotherapy within 4 weeks prior to study enrollment.
What they're measuring
1
Median Progression-free Survival (PFS) With 95% Confidence Intervals
Timeframe: From baseline through up to 17 months post-baseline
2
Number of Patients With Treatment-emergent Adverse Events (TEAEs)
Timeframe: From baseline through up to 17 months post-baseline
ā. Women of childbearing potential who refused or were unable to use effective means of contraception.
ā. Active autoimmune or other disorders that required systemic treatment with immunomodulatory or immunosuppressant medications (i.e., corticosteroids, cyclophosphamide, methotrexate, other biologics). Corticosteroids at substitution doses were allowed.
ā. Metastatic brain disease was allowed provided that appropriate treatment had been administered (surgery or irradiation) and 2-month follow-up by brain magnetic resonance imaging (MRI) showed disease control (stability or regression).