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Phase II Study of KW2871 Combined With High Dose Interferon-α2b in Patients With Metastatic Melanoma

NCT00679289 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2022-10-12

Study results available
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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

Interventions

DRUG

HDI

20 MU/m\^2 IV QD for 5 days/week for 4 weeks, then 10 MU/m\^2 SC 3 days/week until disease progression

DRUG

KW2871

5 mg/m\^2 IV every 2 weeks until disease progression

DRUG

KW2871

10 mg/m\^2 IV every 2 weeks until disease progression

DRUG

KW2871

20 mg/m\^2 IV every 2 weeks until disease progression

Sponsors & Collaborators

  • University of Pittsburgh

    collaborator OTHER

  • University of Chicago

    collaborator OTHER

  • Life Science Pharmaceuticals

    collaborator UNKNOWN

  • Ludwig Institute for Cancer Research

    lead OTHER

Principal Investigators

  • John M. Kirkwood, MD · University of Pittsburgh

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-28
Primary Completion
2014-02-03
Completion
2014-02-03
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00679289 on ClinicalTrials.gov