Lung Cancer Clinical Trial

Safety Study of Enoblituzumab (MGA271) in Combination With Ipilimumab in Refractory Cancer

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.

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Full 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).

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria - Cohort Expansion Phase:

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.

Exclusion Criteria - Cohort Expansion Phase:

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.

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

24

Study ID:

NCT02381314

Recruitment Status:

Completed

Sponsor:

MacroGenics

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There are 10 Locations for this study

See Locations Near You

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
Saint 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

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

24

Study ID:

NCT02381314

Recruitment Status:

Completed

Sponsor:


MacroGenics

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