CompletedPhase 1NCT02381314

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

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.

Checked against the public recordLast updated Feb 8, 2022 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 1
U.S. locations10
SponsorMacroGenics
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
MacroGenics
Interventions being studied
Biological: enoblituzumab plus ipilimumab
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • UCLA Hematology-Oncology ClinicLos Angeles, California
  • Yale UniversityNew Haven, Connecticut
  • Mount Sinai Medical CenterMiami Beach, Florida
  • University of ChicagoChicago, Illinois
  • Indiana University Simon Cancer CenterIndianapolis, Indiana
  • Washington University School of Medicine in St. LouisSt Louis, Missouri
  • Columbia University Medical CenterNew York, New York
  • Providence Portland Medical CenterPortland, Oregon
  • Center for Oncology and Blood DisordersHouston, Texas
  • University of WisconsinMadison, Wisconsin

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Feb 8, 2022. Always confirm current availability with the study team.

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