Safety Study of Enoblituzumab (MGA271) in Combination With Pembrolizumab or MGA012 in Refractory Cancer
NCT ID: NCT02475213
Last Updated: 2025-08-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
146 participants
INTERVENTIONAL
2015-07-31
2021-08-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Cohort 1
Enoblituzumab 3 mg/kg IV weekly plus pembrolizumab 2 mg/kg IV every 3 weeks
Enoblituzumab Schedule 1
enoblituzumab is administered by IV infusion once per week for up to 51 doses.
Pembrolizumab
Pembrolizumab is administered by IV infusion every 3 weeks for up to 17 doses.
Cohort 2
Enoblituzumab 10 mg/kg IV weekly plus pembrolizumab 2 mg/kg IV every 3 weeks
Enoblituzumab Schedule 1
enoblituzumab is administered by IV infusion once per week for up to 51 doses.
Pembrolizumab
Pembrolizumab is administered by IV infusion every 3 weeks for up to 17 doses.
Cohort 3
Enoblituzumab 15 mg/kg IV weekly plus pembrolizumab 2 mg/kg IV every 3 weeks
Enoblituzumab Schedule 1
enoblituzumab is administered by IV infusion once per week for up to 51 doses.
Pembrolizumab
Pembrolizumab is administered by IV infusion every 3 weeks for up to 17 doses.
Cohort 4
Enoblituzumab 15 mg/kg IV plus retifanlimab 375 mg IV every 3 weeks
Enoblituzumab Schedule 2
Enoblituzumab is administered by IV infusion every 3 weeks for up to 17 doses
retifanlimab
Retifanlimab is administered by IV infusion every 3 weeks for up to 17 doses
Melanoma Cohort
Enoblituzumab 15 mg/kg IV weekly plus pembrolizumab 2 mg/kg IV every 3 weeks
Enoblituzumab Schedule 1
enoblituzumab is administered by IV infusion once per week for up to 51 doses.
Pembrolizumab
Pembrolizumab is administered by IV infusion every 3 weeks for up to 17 doses.
Urothelial Cancer Cohort
Enoblituzumab 15 mg/kg IV weekly plus pembrolizumab 2 mg/kg IV every 3 weeks
Enoblituzumab Schedule 1
enoblituzumab is administered by IV infusion once per week for up to 51 doses.
Pembrolizumab
Pembrolizumab is administered by IV infusion every 3 weeks for up to 17 doses.
Non-small Cell Cancer (NSCLC) Cohort
Enoblituzumab 15 mg/kg IV weekly plus pembrolizumab 2 mg/kg IV every 3 weeks
Enoblituzumab Schedule 1
enoblituzumab is administered by IV infusion once per week for up to 51 doses.
Pembrolizumab
Pembrolizumab is administered by IV infusion every 3 weeks for up to 17 doses.
Squamous Cell Cancer of Head and Neck (SCCHN) Cohort
Enoblituzumab 15 mg/kg IV weekly plus pembrolizumab 2 mg/kg IV every 3 weeks
Enoblituzumab Schedule 1
enoblituzumab is administered by IV infusion once per week for up to 51 doses.
Pembrolizumab
Pembrolizumab is administered by IV infusion every 3 weeks for up to 17 doses.
Interventions
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Enoblituzumab Schedule 1
enoblituzumab is administered by IV infusion once per week for up to 51 doses.
Pembrolizumab
Pembrolizumab is administered by IV infusion every 3 weeks for up to 17 doses.
Enoblituzumab Schedule 2
Enoblituzumab is administered by IV infusion every 3 weeks for up to 17 doses
retifanlimab
Retifanlimab is administered by IV infusion every 3 weeks for up to 17 doses
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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MacroGenics
INDUSTRY
Responsible Party
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Principal Investigators
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Ashley Ward, MD
Role: STUDY_DIRECTOR
MacroGenics
Locations
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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
Countries
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References
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Aggarwal C, Prawira A, Antonia S, Rahma O, Tolcher A, Cohen RB, Lou Y, Hauke R, Vogelzang N, P Zandberg D, Kalebasty AR, Atkinson V, Adjei AA, Seetharam M, Birnbaum A, Weickhardt A, Ganju V, Joshua AM, Cavallo R, Peng L, Zhang X, Kaul S, Baughman J, Bonvini E, Moore PA, Goldberg SM, Arnaldez FI, Ferris RL, Lakhani NJ. Dual checkpoint targeting of B7-H3 and PD-1 with enoblituzumab and pembrolizumab in advanced solid tumors: interim results from a multicenter phase I/II trial. J Immunother Cancer. 2022 Apr;10(4):e004424. doi: 10.1136/jitc-2021-004424.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CP-MGA271-03
Identifier Type: -
Identifier Source: org_study_id
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