Safety Study of Enoblituzumab (MGA271) in Combination With Pembrolizumab or MGA012 in Refractory Cancer

Completed · Phase 1

Conditions studied: Melanoma, Head and Neck Cancer, Non Small Cell Lung Cancer, Urothelial Carcinoma

In brief

The purpose of this study is to evaluate the safety of enoblituzumab (MGA271) in combination with Keytruda (pembrolizumab) when given to patients with B7-H3-expressing melanoma, squamous cell carcinoma of the head and neck (SCCHN), non small cell lung cancer (NSCLC), Urothelial Cancer and other B7-H3 expressing cancers. The study will also evaluate what is the highest dose of enoblituzumab that can be given safely when given with pembrolizumab. 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 MGA271 in combination with pembrolizumab. Safety and efficacy of enoblituzumab in combination with MGA012 (anti-PD-1 monoclonal antibody; also known as INCMGA00012) will also be evaluated.

Key facts

Study ID

NCT02475213

Run by

MacroGenics

People needed

146

Starts

2015-07-01

Expected to finish

2021-08-18

Last updated by the study team

2025-08-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• To enroll on cohorts 1-4, participants must have a histologically-proven, previously treated, unresectable, locally advanced or metastatic mesothelioma, urothelial cancer, thyroid cancer, pancreatic cancer, ovarian cancer, colon cancer, prostate cancer, soft tissue sarcoma, triple negative breast cancer, renal clear cell cancer, melanoma, squamous cell cancer of the head and neck, or non-small cell lung cancer.
• Participants on the melanoma cohort must have progressed on or after at least one anti-PD-L1 or anti- PD-1 containing therapy.
• Participants on the SCCHN cohort must have progressed on or after platinum-based systemic therapy
• Participants on the NSCLC cohort must have progressed on or after first line systemic therapy
• Participants on the urothelial cancer cohort must have received at least one platinum-containing regimen and have progressed on or after an anti-PD-L1 or anti-PD-1 containing therapy
• Measurable disease per RECIST 1.1 criteria
• Easter Cooperative Oncology Group (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 such as vitiligo, resolved childhood atopic dermatitis, psoriasis not requiring systemic therapy within the past 2 years, patients with history of Grave's disease that are now euthyroid clinically and by lab testing
• History of allogeneic bone marrow, stem cell, or solid organ transplant
• Treatment with systemic cancer therapy or investigational therapy within 4 weeks of first study drug administration; radiation within 2 weeks; corticosteroids (greater than or equal to 10 mg prednisone or equivalent per day) or other immune suppressive drugs within 2 weeks of first study drug administration
• Trauma or major surgery within 4 weeks of first study drug administration
• History of clinically-significant cardiovascular disease; gastrointestinal perforation; gastrointestinal bleeding, acute pancreatitis or diverticulitis within 4 weeks of first study drug administration
• Active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 7 days of first study drug administration
• Known history of hepatitis B or C infection or known positive test for hepatitis B surface antigen or core antigen, or hepatitis C polymerase chain reaction (PCR)
• Known positive testing for human immunodeficiency virus or history of acquired immune deficiency syndrome
• Known hypersensitivity to recombinant proteins, polysorbate 80, or any excipient contained in the drug or vehicle formulation for MGA271 or pembrolizumab.

Where it is running

• Mayo Clinic - AZ — Scottsdale, Arizona, United States
• Christiana Care Health Services, Inc. — Newark, Delaware, United States
• Mayo Clinic - FL — Jacksonville, Florida, United States
• Moffitt Cancer Center — Tampa, Florida, United States
• Norton Cancer Institute Research Program — Louisville, Kentucky, United States
• University of Maryland Greenbaum Cancer Center — Baltimore, Maryland, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• South Texas Accelerated Research Therapeutics, LLC - Midwest — Grand Rapids, Michigan, United States
• Mayo Clinic - MN — Rochester, Minnesota, United States
• Nebraska Cancer Specialists — Omaha, Nebraska, United States
• Comprehensive Cancer Centers of Nevada — Las Vegas, Nevada, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States
• Columbia University Medical Center — New York, New York, United States
• Gabrail Cancer Institute — Canton, Ohio, United States
• Hospital of the University of Pennsylvania/Abramson Cancer Center — Philadelphia, Pennsylvania, United States
• University of Pittsburg — Pittsburgh, Pennsylvania, United States
• Rhode Island Hospital — Providence, Rhode Island, United States
• Greenville Health System — Greenville, South Carolina, United States
• Mary Crowley Cancer Research Center — Dallas, Texas, United States
• South Texas Accelerated Research Therapeutics, LLC — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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