Stage IV Uveal Melanoma AJCC v7 Clinical Trial
Official title:
A Phase 2 Study of CDX-011 (Glembatumumab Vedotin) for Metastatic Uveal Melanoma
This phase II trial studies how well glembatumumab vedotin works in treating patients with middle layer of the wall of the eye (uveal) melanoma that has spread to other parts of the body (metastatic) or has returned at or near the same place after a period of time during which the cancer could not be detected (locally recurrent). Glembatumumab vedotin may shrink the tumor by binding to tumor cells and delivering tumor-killing substances to them.
PRIMARY OBJECTIVES:
I. To characterize the clinical anti-tumor activity of CDX-011 (glembatumumab vedotin) as a
single-agent in the treatment of patients with metastatic uveal melanoma.
SECONDARY OBJECTIVES:
I. Description of the clinical safety and benefit of CDX-011 (glembatumumab vedotin) and
pharmacodynamics changes in glycoprotein NMB (glycoprotein [transmembrane] NMB) (GPNMB)
expression.
TERTIARY OBJECTIVES:
I. Characterization of the anti-tumor immunophenotype of patients receiving treatment.
II. Post hoc, correlation of rash with clinical benefit, or lack of rash with lack of
benefit, will also be explored.
OUTLINE:
Patients receive glembatumumab vedotin intravenously (IV) over 90 minutes every 3 weeks in
the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 30 days.
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