Spots Global Cancer Trial Database for Safety Study of Enoblituzumab (MGA271) in Combination With Pembrolizumab or MGA012 in Refractory Cancer
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Trial Identification
Brief Title: Safety Study of Enoblituzumab (MGA271) in Combination With Pembrolizumab or MGA012 in Refractory Cancer
Official Title: A Phase 1, Open-Label, Dose Escalation Study of MGA271 in Combination With Pembrolizumab and in Combination With MGA012 in Patients With Melanoma, Squamous Cell Cancer of the Head and Neck, Non-Small Cell Lung Cancer, Urothelial Cancer, and Other Cancers
Study ID: NCT02475213
Study Description
Brief Summary: The purpose of this study is to evaluate the safety of enoblituzumab (MGA271) in combination with Keytruda (pembrolizumab) when given to patients with B7-H3-expressing melanoma, squamous cell carcinoma of the head and neck (SCCHN), non small cell lung cancer (NSCLC), Urothelial Cancer and other B7-H3 expressing cancers. The study will also evaluate what is the highest dose of enoblituzumab that can be given safely when given with pembrolizumab. Assessments will also be done to see how the drug acts in the body (pharmacokinetics (PK), pharmacodynamics) and to evaluate potential anti-tumor activity of MGA271 in combination with pembrolizumab. Safety and efficacy of enoblituzumab in combination with MGA012 (anti-PD-1 monoclonal antibody; also known as INCMGA00012) will also be evaluated.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Mayo Clinic - AZ, Scottsdale, Arizona, United States
Christiana Care Health Services, Inc., Newark, Delaware, United States
Mayo Clinic - FL, Jacksonville, Florida, United States
Moffitt Cancer Center, Tampa, Florida, United States
Norton Cancer Institute Research Program, Louisville, Kentucky, United States
University of Maryland Greenbaum Cancer Center, Baltimore, Maryland, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
South Texas Accelerated Research Therapeutics, LLC - Midwest, Grand Rapids, Michigan, United States
Mayo Clinic - MN, Rochester, Minnesota, United States
Nebraska Cancer Specialists, Omaha, Nebraska, United States
Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Columbia University Medical Center, New York, New York, United States
Gabrail Cancer Institute, Canton, Ohio, United States
Hospital of the University of Pennsylvania/Abramson Cancer Center, Philadelphia, Pennsylvania, United States
University of Pittsburg, Pittsburgh, Pennsylvania, United States
Rhode Island Hospital, Providence, Rhode Island, United States
Greenville Health System, Greenville, South Carolina, United States
Mary Crowley Cancer Research Center, Dallas, Texas, United States
South Texas Accelerated Research Therapeutics, LLC, San Antonio, Texas, United States
Contact Details
Name: Chet Bohac, PharmD MD MSc
Affiliation: MacroGenics
Role: STUDY_DIRECTOR
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