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



Status:Completed
Conditions:Breast Cancer, Lung Cancer, Prostate Cancer, Prostate Cancer, Colorectal Cancer, Skin Cancer, Ovarian Cancer, Cancer, Cancer, Cancer, Pancreatic Cancer, Thyroid Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/27/2019
Start Date:March 26, 2015
End Date:September 26, 2018

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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

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.

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).

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.
We found this trial at
10
sites
630 W 168th St
New York, New York
212-305-2862
Principal Investigator: Naiyer Rizvi, M.D.
Phone: 212-304-5545
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
Principal Investigator: Jason Luke, MD
Phone: 773-834-7617
University of Chicago One of the world's premier academic and research institutions, the University of...
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4805 Northeast Glisan Street
Portland, Oregon 97213
(503) 215-1111
Principal Investigator: Walter J Urba, MD, PhD
Phone: 503-215-5763
Providence Portland Medical Center We strive to give those we serve exceptional, compassionate health care...
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Portland, OR
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6550 Fannin Street
Houston, Texas 77030
Principal Investigator: Luis H Camacho, MD, MPH
Phone: 713-796-1200
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Indianapolis, Indiana 46202
Principal Investigator: Theodore F Logan, MD
Phone: 317-274-3512
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Los Angeles, California 90095
Principal Investigator: Bartosz Chmielowski, MD, PhD
Phone: 310-829-5471
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Los Angeles, CA
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Madison, Wisconsin 53792
(608) 263-2400
Principal Investigator: Justine Bruce, MD
University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
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Miami Beach, Florida 33140
Principal Investigator: Jose Lutzky, MD
Phone: 305-674-2625
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New Haven, Connecticut 6520
(203) 432-4771
Principal Investigator: Paul Eder, MD
Phone: 203-737-3446
Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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660 South Euclid Avenue
Saint Louis, Missouri 63110
Principal Investigator: Jeffrey Ward, MD
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