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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
37
Given IV
Correlative studies
Correlative studies
Overall Response Rate Using Response Evaluation Criteria in Solid Tumors Version 1.1
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI and/or CT: Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (PD); PD, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Complete Response (CR), Disappearance of all target lesions
Time frame: From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years and 10 months
The Number of Participants With Change in Glycoprotein NMB Expression on Tumor Tissue Via Immunohistochemistry
Target protein expression change from baseline to after 1 cycle of treatment.
Time frame: Baseline to up to 21 days
Progression-free Survival
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Time frame: From consent to time of progression or death, whichever occurs first, assessed up to 2 years and 10 months
Number of Participants With Grade 3-4 Adverse Events According to the National Cancer Institute Common Toxicity Criteria Version 4.0
Toxicity will be reported by type, frequency, and severity. Only adverse events toxicity with grade 3-4 severity.
Time frame: through 30 days post-treatment, up to 2 years and 10 months
Overall Survival
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Mayo Clinic Hospital
Phoenix, Arizona, United States
Mayo Clinic in Arizona
Scottsdale, Arizona, United States
University of Colorado Hospital
Aurora, Colorado, United States
Mayo Clinic in Florida
Jacksonville, Florida, United States
Northwestern University
Chicago, Illinois, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
UC Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois, United States
University of Chicago Medicine-Orland Park
Orland Park, Illinois, United States
University of Kansas Clinical Research Center
Fairway, Kansas, United States
University of Kansas Cancer Center
Kansas City, Kansas, United States
...and 15 more locations
Overall survival as measured from time of enrollment to time of death due to any cause.
Time frame: From consent to time of progression or death, whichever occurs first, assessed up to 2 years and 10 months