Safety Study of Enoblituzumab (MGA271) in Combination With Ipilimumab in Refractory Cancer
- Conditions
- MelanomaNon Small Cell Lung Cancer
- Interventions
- Biological: enoblituzumab plus ipilimumab
- Registration Number
- NCT02381314
- Lead Sponsor
- MacroGenics
- Brief Summary
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.
- Detailed Description
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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description enoblituzumab plus ipilimumab enoblituzumab plus ipilimumab Enoblituzumab: Fc-optimized, humanized monoclonal antibody. Ipilimumab: Yervoy; recombinant, fully humanized IgG-1 CTLA-4 blocking antibody approved by the US Food and Drug Administration and the European Medicines Agency for the treatment of unresectable or metastatic melanoma.
- Primary Outcome Measures
Name Time Method Number of participants with adverse events 1 year Adverse events, serious adverse events
- Secondary Outcome Measures
Name Time Method Peak plasma concentration 7 weeks PK of MGA271 in combination with ipilimumab
Number of participants that develop anti-drug antibodies 7 weeks Proportion of patients who develop anti-MGA271 antibodies, immunogenicity
Change in tumor volume Weeks 9, 18, 27, 39, and 51 Anti-tumor activity of MGA271 in combination with ipilimumab using both conventional RECIST 1.1 and immune-related RECIST criteria.
Trial Locations
- Locations (10)
Center for Oncology and Blood Disorders
🇺🇸Houston, Texas, 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
Columbia University Medical Center
🇺🇸New York, New York, United States
Indiana University Simon Cancer Center
🇺🇸Indianapolis, Indiana, United States
Washington University School of Medicine in St. Louis
🇺🇸Saint Louis, Missouri, United States
University of Wisconsin
🇺🇸Madison, Wisconsin, United States
UCLA Hematology-Oncology Clinic
🇺🇸Los Angeles, California, United States
Providence Portland Medical Center
🇺🇸Portland, Oregon, United States