Glembatumumab Vedotin in Treating Patients With Metastatic or Locally Recurrent Uveal Melanoma
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|ClinicalTrials.gov Identifier: NCT02363283|
Recruitment Status : Completed
First Posted : February 16, 2015
Last Update Posted : October 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Uveal Melanoma Stage IV Uveal Melanoma AJCC v7||Drug: Glembatumumab Vedotin Other: Laboratory Biomarker Analysis Other: Pharmacological Study||Phase 2|
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.
I. Description of the clinical safety and benefit of CDX-011 (glembatumumab vedotin) and pharmacodynamics changes in glycoprotein NMB (glycoprotein [transmembrane] NMB) (GPNMB) expression.
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.
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 (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Study of CDX-011 (Glembatumumab Vedotin) for Metastatic Uveal Melanoma|
|Actual Study Start Date :||September 16, 2015|
|Actual Primary Completion Date :||July 2, 2018|
|Actual Study Completion Date :||July 2, 2018|
Experimental: Treatment (glembatumumab vedotin)
Patients receive glembatumumab vedotin IV over 90 minutes every 3 weeks in the absence of disease progression or unacceptable toxicity.
Drug: Glembatumumab Vedotin
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study
- Overall response rate using Response Evaluation Criteria in Solid Tumors version 1.1 [ Time Frame: Up to 30 days post-treatment ]
- Change in glycoprotein NMB expression on tumor tissue via immunohistochemistry [ Time Frame: Baseline to up to 21 days on study ]Changes in percentage of glycoprotein NMB -positive tumor cells will be reported and descriptive statistics will be used to further report staining intensity and frequency in baseline and on-treatment tumor samples.
- Progression-free survival [ Time Frame: From start of treatment to time of progression or death, whichever occurs first, assessed up to 30 days ]Progression-free survival curves will be calculated using the method of Kaplan-Meier. Median progression-free survival will be reported with 95% confidence intervals.
- Overall survival [ Time Frame: Up to 30 days post-treatment ]Overall survival curves will be calculated using the method of Kaplan-Meier. Median overall survival will be reported with 95% confidence intervals.
- Incidence of adverse events according to the National Cancer Institute Common Toxicity Criteria version 5.0 [ Time Frame: Up to 30 days post-treatment ]Toxicity will be reported by type, frequency, and severity.
- Anti-tumor immunophenotype of patients receiving glembatumumab vedotin [ Time Frame: Up to 30 days post-treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02363283
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|Principal Investigator:||Sapna Patel||University of Texas MD Anderson Cancer Center LAO|