The purpose of this study is to evaluate the safety of enoblituzumab (MGA271) in combination with Yervoy (ipilimumab) when given to patients with B7-H3-expressing melanoma, squamous cell carcinoma of the head and neck (SCCHN), non small cell lung cancer (NSCLC) and other B7-H3 expressing cancers. The study will also evaluate what is the best dose of enoblituzumab to use when given with ipilimumab. 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 enoblituzumab in combination with ipilimumab.
This study is a Phase 1 open-label, dose escalation, and cohort expansion study of enoblituzumab administered intravenously (IV) on a weekly schedule for up to 51 doses in combination with IV ipilimumab administered on an every-3-week schedule for 4 doses. The dose escalation phase is designed to characterize the safety and tolerability of the combination of enoblituzumab and ipilimumab and to define the maximum tolerated or administered dose (MTD/MAD) in patients with B7-H3 expressing mesothelioma, urothelial cancer, NSCLC, SCCHN, Clear cell renal cell carcinoma (ccRCC), ovarian cancer, melanoma, thyroid cancer, Triple negative breast cancer (TNBC), pancreatic cancer, colon cancer, soft tissue sarcoma, or prostate cancer. The cohort expansion phase, 2 cohorts of 16 patients each will be enrolled to further evaluate the safety and potential efficacy of the combination administered at the MTD/MAD dose in patients with melanoma and NSCLC. All tumor evaluations will be carried out by both Response Evaluation Criteria in Solid Tumors (RECIST) and immune-related response criteria (irRC).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
enoblituzumab is administered by IV infusion once per week. Ipilimumab is administered by IV infusion every 3 weeks for up to 4 doses.
UCLA Hematology-Oncology Clinic
Los Angeles, California, United States
Yale University
New Haven, Connecticut, United States
Mount Sinai Medical Center
Miami Beach, Florida, United States
University of Chicago
Chicago, Illinois, United States
Indiana University Simon Cancer Center
Indianapolis, Indiana, United States
Washington University School of Medicine in St. Louis
St Louis, Missouri, United States
Columbia University Medical Center
New York, New York, United States
Providence Portland Medical Center
Portland, Oregon, United States
Center for Oncology and Blood Disorders
Houston, Texas, United States
University of Wisconsin
Madison, Wisconsin, United States
Number of participants with adverse events
Adverse events, serious adverse events
Time frame: 1 year
Peak plasma concentration
PK of MGA271 in combination with ipilimumab
Time frame: 7 weeks
Number of participants that develop anti-drug antibodies
Proportion of patients who develop anti-MGA271 antibodies, immunogenicity
Time frame: 7 weeks
Change in tumor volume
Anti-tumor activity of MGA271 in combination with ipilimumab using both conventional RECIST 1.1 and immune-related RECIST criteria.
Time frame: Weeks 9, 18, 27, 39, and 51
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