Safety Study of Enoblituzumab (MGA271) in Combination With Ipilimumab in Refractory Cancer
A Phase 1, Open-Label, Dose Escalation Study of MGA271 in Combination With Ipilimumab in Patients With Melanoma, Non-Small Cell Lung Cancer, and Other Cancers
1 other identifier
interventional
24
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Mar 2015
Typical duration for phase_1
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 20, 2015
CompletedFirst Posted
Study publicly available on registry
March 6, 2015
CompletedStudy Start
First participant enrolled
March 26, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 9, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 26, 2018
CompletedFebruary 8, 2022
February 1, 2022
2.6 years
February 20, 2015
February 4, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of participants with adverse events
Adverse events, serious adverse events
1 year
Secondary Outcomes (3)
Peak plasma concentration
7 weeks
Number of participants that develop anti-drug antibodies
7 weeks
Change in tumor volume
Weeks 9, 18, 27, 39, and 51
Study Arms (1)
enoblituzumab plus ipilimumab
EXPERIMENTALEnoblituzumab: 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.
Interventions
enoblituzumab is administered by IV infusion once per week. Ipilimumab is administered by IV infusion every 3 weeks for up to 4 doses.
Eligibility Criteria
You may qualify if:
- Histologically-proven, unresectable, locally advanced or metastatic melanoma or NSCLC
- Melanoma: Advanced or metastatic melanoma patients may be systemic therapy naïve or may have received systemic treatment for unresectable locally advanced or metastatic disease. A patient who previously received systemic therapy must have had progression on a checkpoint inhibitor (e.g., anti-PD-L1, anti-PD-1, anti-CTLA-4) as the most recent prior therapy.
- NSCLC: NSCLC that has progressed during or following 1 or more prior systemic therapies for unresectable locally advanced or metastatic disease. Patients who are intolerant of, or have refused treatment with standard first line cancer therapy, will be allowed to enroll. Patients must not have had more than 5 prior systemic regimens (excluding experimental therapies) for unresectable locally advanced or metastatic disease.
- B7-H3 expression is not required for eligibility in this study; however, tumor expression of B7-H3 will be evaluated for all patients.
- Measurable disease per RECIST 1.1 criteria
- ECOG performance status 0 or 1
- Acceptable laboratory parameters and adequate organ reserve.
You may not qualify if:
- Patients with a history of symptomatic central nervous system metastases, unless treated and asymptomatic
- Patients with history of autoimmune disease with certain exceptions
- History of allogeneic bone marrow, stem cell, or solid organ transplant
- Treatment with systemic cancer therapy or investigational therapy within 4 weeks; radiation within 2 weeks; trauma or major surgery within 4 weeks
- History of clinically-significant cardiovascular disease; gastrointestinal perforation; gastrointestinal bleeding, acute pancreatitis or diverticulitis within 4 weeks;
- Active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 7 days; positive for human immunodeficiency virus or AIDS, hepatitis B or C.
- Known hypersensitivity to recombinant proteins, polysorbate 80, or any excipient contained in the drug or vehicle formulation for MGA271 or ipilimumab.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MacroGenicslead
Study Sites (10)
UCLA Hematology-Oncology Clinic
Los Angeles, California, 90095, United States
Yale University
New Haven, Connecticut, 06520, United States
Mount Sinai Medical Center
Miami Beach, Florida, 33140, United States
University of Chicago
Chicago, Illinois, 60637, United States
Indiana University Simon Cancer Center
Indianapolis, Indiana, 46202, United States
Washington University School of Medicine in St. Louis
St Louis, Missouri, 63110, United States
Columbia University Medical Center
New York, New York, 10032, United States
Providence Portland Medical Center
Portland, Oregon, 97213, United States
Center for Oncology and Blood Disorders
Houston, Texas, 77030, United States
University of Wisconsin
Madison, Wisconsin, 53792, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Chief Medical Officer
MacroGenics
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 20, 2015
First Posted
March 6, 2015
Study Start
March 26, 2015
Primary Completion
November 9, 2017
Study Completion
September 26, 2018
Last Updated
February 8, 2022
Record last verified: 2022-02