NCT02363283

Glembatumumab Vedotin in Treating Patients With Metastatic or Locally Recurrent Uveal Melanoma

A Phase 2 Study of CDX-011 (Glembatumumab Vedotin) for Metastatic Uveal Melanoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Recurrent Uveal Melanoma
• Stage IV Uveal Melanoma AJCC v7

Interventions

Type	Name	Description
DRUG	Glembatumumab Vedotin	Given IV
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Pharmacological Study	Correlative studies

Timeline

• Start date: 2015-09-16
• Primary completion: 2018-07-02
• Completion: 2018-07-02
• First posted: 2015-02-16
• Last updated: 2020-08-21
• Results posted: 2020-08-21

Locations

25 sites across 1 country: United States