Melanoma Clinical Trial
Official title:
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
Verified date | February 2022 |
Source | MacroGenics |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 24 |
Est. completion date | September 26, 2018 |
Est. primary completion date | November 9, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Chicago | Chicago | Illinois |
United States | Center for Oncology and Blood Disorders | Houston | Texas |
United States | Indiana University Simon Cancer Center | Indianapolis | Indiana |
United States | UCLA Hematology-Oncology Clinic | Los Angeles | California |
United States | University of Wisconsin | Madison | Wisconsin |
United States | Mount Sinai Medical Center | Miami Beach | Florida |
United States | Yale University | New Haven | Connecticut |
United States | Columbia University Medical Center | New York | New York |
United States | Providence Portland Medical Center | Portland | Oregon |
United States | Washington University School of Medicine in St. Louis | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
MacroGenics |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants with adverse events | Adverse events, serious adverse events | 1 year | |
Secondary | Peak plasma concentration | PK of MGA271 in combination with ipilimumab | 7 weeks | |
Secondary | Number of participants that develop anti-drug antibodies | Proportion of patients who develop anti-MGA271 antibodies, immunogenicity | 7 weeks | |
Secondary | Change in tumor volume | Anti-tumor activity of MGA271 in combination with ipilimumab using both conventional RECIST 1.1 and immune-related RECIST criteria. | Weeks 9, 18, 27, 39, and 51 |
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