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

This study is currently recruiting participants.
See Contacts and Locations
Verified April 2017 by MacroGenics
Sponsor:
Information provided by (Responsible Party):
MacroGenics
ClinicalTrials.gov Identifier:
NCT02381314
First received: February 20, 2015
Last updated: April 11, 2017
Last verified: April 2017
  Purpose
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.

Condition Intervention Phase
Melanoma Non Small Cell Lung Cancer Biological: enoblituzumab plus ipilimumab Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by MacroGenics:

Primary Outcome Measures:
  • Number of participants with adverse events [ Time Frame: 1 year ]
    Adverse events, serious adverse events


Secondary Outcome Measures:
  • Peak plasma concentration [ Time Frame: 7 weeks ]
    PK of MGA271 in combination with ipilimumab

  • Number of participants that develop anti-drug antibodies [ Time Frame: 7 weeks ]
    Proportion of patients who develop anti-MGA271 antibodies, immunogenicity

  • Change in tumor volume [ Time Frame: Weeks 9, 18, 27, 39, and 51 ]
    Anti-tumor activity of MGA271 in combination with ipilimumab using both conventional RECIST 1.1 and immune-related RECIST criteria.


Estimated Enrollment: 59
Study Start Date: March 2015
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: enoblituzumab plus ipilimumab
Enoblituzumab: Fc-optimized, humanized monoclonal antibody. Ipilimumab: Yervoy; recombinant, fully humanized IgG-1 CTLA-4 blocking antibody approved by the US Food and Drug Administration and the European Medicines Agency for the treatment of unresectable or metastatic melanoma.
Biological: enoblituzumab plus ipilimumab
enoblituzumab is administered by IV infusion once per week. Ipilimumab is administered by IV infusion every 3 weeks for up to 4 doses.
Other Name: enoblituzumab (MGA271); ipilimumab (Yervoy)

Detailed 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).

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02381314

Contacts
Contact: Soyoung Yun 240 552-8058 yuns@macrogenics.com

Locations
United States, California
UCLA Hematology-Oncology Clinic Recruiting
Los Angeles, California, United States, 90095
Contact: Bartosz Chmielowski, MD, PhD    310-829-5471    bchmielowski@mednet.ucla.edu   
Contact: Maria Casado    310-794-6913    mcasado@mednet.ucla.edu   
Principal Investigator: Bartosz Chmielowski, MD, PhD         
United States, Connecticut
Yale University Recruiting
New Haven, Connecticut, United States, 06520
Contact: Alexandra Minnella    203-737-3446    alexandra.minnella@yale.edu   
Principal Investigator: Paul Eder, MD         
United States, Florida
Mount Sinai Medical Center Recruiting
Miami Beach, Florida, United States, 33140
Contact: Christina Estevez    305-674-2625    Christina.Estevez@msmc.com   
Principal Investigator: Jose Lutzky, MD         
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Laura Hoffman    773-834-7617    lhoffman2@medicine.bsd.uchicago.edu   
Principal Investigator: Jason Luke, MD         
United States, Indiana
Indiana University Simon Cancer Center Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Sandra Wilson    317-274-3512    slhooper@iu.edu   
Contact: Namratha Kolur    (317) 278-2356    nkolur@iu.edu   
Principal Investigator: Theodore F Logan, MD         
United States, Missouri
Washington University School of Medicine in St. Louis Not yet recruiting
Saint Louis, Missouri, United States, 63110
Principal Investigator: Jeffrey Ward, MD         
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Molly McGuinness    212-304-5545    mm5016@cumc.columbia.edu   
Principal Investigator: Naiyer Rizvi, M.D.         
United States, Oregon
Providence Portland Medical Center Recruiting
Portland, Oregon, United States, 97213
Contact: Kim Sutcliffe    503-215-5763    kimberly.sutcliffe@providence.org   
Contact: Kim         
Principal Investigator: Walter J Urba, MD, PhD         
United States, Texas
Center for Oncology and Blood Disorders Recruiting
Houston, Texas, United States, 77030
Contact: Paola Sanchez    713-796-1200    psanchez@cobd.us   
Principal Investigator: Luis H Camacho, MD, MPH         
United States, Wisconsin
University of Wisconsin Recruiting
Madison, Wisconsin, United States, 53792
Contact: Amy Forsyth       ajforsyth@medicine.wisc.edu   
Principal Investigator: Justine Bruce, MD         
Sponsors and Collaborators
MacroGenics
Investigators
Study Director: James Vasselli, M.D. MacroGenics
  More Information

Responsible Party: MacroGenics
ClinicalTrials.gov Identifier: NCT02381314     History of Changes
Other Study ID Numbers: CP-MGA271-02
Study First Received: February 20, 2015
Last Updated: April 11, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by MacroGenics:
Other B7-H3 expressing cancers

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Melanoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 18, 2017