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



Status:Active, not recruiting
Conditions:Breast Cancer, Lung Cancer, Lung 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:3/28/2019
Start Date:July 2015
End Date:August 2020

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A Phase 1, Open-Label, Dose Escalation Study of MGA271 in Combination With Pembrolizumab in Patients With B7-H3-Expressing Melanoma, Squamous Cell Cancer of the Head and Neck, Non-Small Cell Lung Cancer and Other B7-H3-Expressing Cancers

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.

This study is a Phase 1 open-label, dose escalation, cohort expansion, and efficacy follow-up
study of enoblituzumab administered intravenously (IV) on a weekly schedule for up to 51
doses in combination with IV pembrolizumab administered on an every-3-week schedule for up to
17 doses.

The dose escalation phase is designed to characterize the safety and tolerability of the
combination of enoblituzumab and pembrolizumab and to define the maximum tolerated or maximum
administered dose (MTD/MAD). Patients with methothelioma, urethelial cancer, NSCLC, SCCHN,
clear cell renal cell carcinoma (ccRCC), ovarian cancer, melanoma, thyroid cancer, triple
negative breast cancer (TBNC), pancreatic cancer, colon cancer, soft tissue sarcoma, or
prostate cancer will be enrolled in this study phase.

During the Cohort Expansion Phase, additional cohorts of patients with B7-H3 expressing
unresectable, locally-advanced or metastatic melanoma (up to n=16), 2 cohorts of NSCLC (n= up
to 20 in each cohort), 2 cohorts of SCCHN (up to n=20 in each cohort) or urothelial cancer
(up to n=16) will be enrolled to receive MGA271 in combination with pembrolizumab at the MTD
(or MAD) established from the Dose Escalation Phase of the study.

The efficacy follow-up period consists of the 2-year period after the final dose of study
drug.

All tumor evaluations will be carried out by both Response Evaluation Criteria in Solid
Tumors (RECIST) and immune-related response criteria (irRC).

Inclusion Criteria:

- Histologically-proven, unresectable, locally advanced or metastatic melanoma, SCCHN,
NSCLC, and other cancers that express B7-H3.

- Melanoma that has progressed during or following at least 1 and up to 5 prior systemic
treatments for unresectable locally advanced or metastatic disease, or melanoma
patients who are intolerable of or have refused standard cancer therapy. Pre- and
on-study biopsy required.

- SCCHN that has progressed during or following at least 1 and up to 5 prior systemic
treatments for metastatic or recurrent disease deemed to be incurable. Patient who
refuse radical resection for recurrent disease or are intolerant of or refused
standard first line therapy are eligible to enroll

- NSCLC that has progressed during or following 1 - 5 prior systemic therapies for
unresectable locally advanced or metastatic disease (at least one docetaxel,
gemcitabine, or platinum analogue based therapy), or are intolerant of or refused
standard cancer therapy. For squamous cell carcinoma, or adenocarcinoma without known
activating mutation: the prior systemic therapy is at least one platinum analogue. For
adenocarcinoma with known activating driver mutation: the prior systemic therapy is at
least TKI directed

- Urothelial cancer arising in the bladder, renal pelvis, ureter or urethra that has
progressed during or following at least 1 and up to 5 prior systemic treatments for
unresectable locally advanced or metastatic disease (includes anti-PD-L1,anti-PD-1,
but excludes other experimental therapies). Patients must have received at least one
platinum-containing regimen (e.g., gemcitabine/cisplatin [GC], dose-dense
methotrexate/vinblastine/doxorubicin/cisplatin [DDMVAC], or
carboplatinum/gemcitabine). No more than 5 prior systemic regimens allowed.

- 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 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 chilhood 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.
We found this trial at
21
sites
4500 San Pablo Road South
Jacksonville, Florida 32224
Principal Investigator: Yanyan Lou, MD, PhD
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666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Principal Investigator: Gurkamal Chatta, MD
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
Principal Investigator: Ariel Birnbaum, MD
Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
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Baltimore, Maryland 21201
Principal Investigator: Dan Zandberg, MD
Phone: 410-328-7680
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Boca Raton, Florida 33486
Principal Investigator: Edgardo Santos Castillero, MD
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Osama Rahma, MD
Phone: 617-632-1991
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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4875 Higbee Avenue Northwest
Canton, Ohio 44718
Principal Investigator: Nashat Gabrail, MD
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Dallas, Texas 75246
Principal Investigator: James Strauss, MD
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4383 Medical Drive
Grand Rapids, Michigan 49503
Principal Investigator: Nehal Lakhani, MD, PhD
Phone: 616-954-5551
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Greenville, South Carolina 29615
Principal Investigator: Jeffery Edenfield, MD
Phone: 864-455-3735
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9280 W. Sunset Road Suite 100
Las Vegas, Nevada 89148
702.952.1251
Principal Investigator: Nicholas Vogelzang, MD
Phone: 702-952-3443
Comprehensive Cancer Centers of Nevada Comprehensive Cancer Centers of Nevada (CCCN) is the award-winning multidisciplinary...
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629 South Floyd Street
Louisville, Kentucky 40202
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630 W 168th St
New York, New York
212-305-2862
Principal Investigator: Naiyer Rizvi, MD
Phone: 212-304-5552
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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Newark, Delaware 19713
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Omaha, Nebraska 68114
Principal Investigator: Ralph Hauke, MD
Phone: 402-690-6972
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Philadelphia, Pennsylvania 19104
Principal Investigator: Charu Aggarwal, MD
Phone: 215-662-7758
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Pittsburgh, Pennsylvania 15524
Principal Investigator: Robert Ferris, MD
Phone: 412-623-6650
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221 1st Avenue Southwest
Rochester, Minnesota 55902
Principal Investigator: Alex Adjei, MD, PhD
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San Antonio, Texas 78229
Principal Investigator: Anthony Tolcher, M.D.
Phone: 210-593-5242
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Scottsdale, Arizona 85259
Principal Investigator: Ramesh Ramanathan, MD
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Tampa, Florida 33612
Principal Investigator: Scott Antonia, MD
Phone: 813-745-4673
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