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Phase II Study of KW2871 Combined With High Dose Interferon-α2b in Patients With Metastatic Melanoma
NCT00679289 · View on ClinicalTrials.gov ↗
Study 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 \[PBMCs\]).
Conditions Studied
Interventions
- DRUG HDI
- DRUG KW2871
Study Locations (2)
Illinois
- University of Chicago Hospital — Chicago
Pennsylvania
- University of Pittsburgh Cancer Institute — Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2008-03-28 |
| Est. Completion | 2014-02-03 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00679289
The ClinicalTrials.gov registry entry for NCT00679289 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ludwig Institute for Cancer Research, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Metastatic Melanoma appearing as the primary indexed condition, and to 2 interventions — of which HDI is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00679289 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Illinois, Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00679289 about?
NCT00679289 is a clinical study titled "Phase II Study of KW2871 Combined With High Dose Interferon-α2b in Patients With Metastatic Melanoma". 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 ...
What is the current status of trial NCT00679289?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2008-03-28. Estimated completion is 2014-02-03.
What conditions does trial NCT00679289 study?
This clinical trial studies the following conditions: Metastatic Melanoma, Cutaneous Melanoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00679289?
The interventions under investigation include: HDI (DRUG), KW2871 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00679289?
This trial is sponsored by Ludwig Institute for Cancer Research, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00679289 being conducted?
This trial has 2 study locations across Illinois, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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