Spots Global Cancer Trial Database for Glembatumumab Vedotin in Treating Patients With Metastatic or Locally Recurrent Uveal Melanoma
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Trial Identification
Brief Title: Glembatumumab Vedotin in Treating Patients With Metastatic or Locally Recurrent Uveal Melanoma
Official Title: A Phase 2 Study of CDX-011 (Glembatumumab Vedotin) for Metastatic Uveal Melanoma
Study ID: NCT02363283
Study Description
Brief 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States
Brigham and Women's Hospital, Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Mayo Clinic, Rochester, Minnesota, United States
Barnes-Jewish Hospital, Saint Louis, Missouri, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
Penn State Milton S Hershey Medical Center, Hershey, Pennsylvania, United States
University of Pennsylvania/Abramson Cancer Center, Philadelphia, Pennsylvania, United States
UT Southwestern/Simmons Cancer Center-Dallas, Dallas, Texas, United States
M D Anderson Cancer Center, Houston, Texas, United States
Huntsman Cancer Institute/University of Utah, Salt Lake City, Utah, United States
Contact Details
Name: Sapna Patel
Affiliation: University of Texas MD Anderson Cancer Center LAO
Role: PRINCIPAL_INVESTIGATOR
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