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
Results First Posted : August 21, 2020
Last Update Posted : August 21, 2020
|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: 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 ]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
- The Number of Participants With Change in Glycoprotein NMB Expression on Tumor Tissue Via Immunohistochemistry [ Time Frame: Baseline to up to 21 days ]Target protein expression change from baseline to after 1 cycle of treatment.
- Progression-free Survival [ Time Frame: From consent to time of progression or death, whichever occurs first, assessed up to 2 years and 10 months ]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
- Number of Participants With Grade 3-4 Adverse Events According to the National Cancer Institute Common Toxicity Criteria Version 4.0 [ Time Frame: through 30 days post-treatment, up to 2 years and 10 months ]Toxicity will be reported by type, frequency, and severity. Only adverse events toxicity with grade 3-4 severity.
- Overall Survival [ Time Frame: From consent to time of progression or death, whichever occurs first, assessed up to 2 years and 10 months ]Overall survival as measured from time of enrollment to time of death due to any cause.
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
|Principal Investigator:||Sapna Patel||University of Texas MD Anderson Cancer Center LAO|