Combination Margetuximab and Pembrolizumab for Advanced, Metastatic HER2(+) Gastric or Gastroesophageal Junction Cancer



Status:Recruiting
Conditions:Cancer, Cancer, Cancer, Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:7/27/2017
Start Date:January 2016
End Date:March 2020
Contact:Alice Drumheller
Email:drumhellera@MacroGenics.com

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A Phase 1b/2, Open Label, Dose Escalation Study of Margetuximab in Combination With Pembrolizumab in Patients With Relapsed/Refractory Advanced HER2+ Gastroesophageal Junction or Gastric Cancer

This main purpose of this clinical study is to learn about the safety and activity of
margetuximab and pembrolizumab combination treatment in patients with HER2+ gastric and
gastroesophageal junction cancer.

Detailed Description: Both margetuximab and pembrolizumab are monoclonal antibodies used in
combination to treat HER2+ gastric and gastroesophageal junction cancer. This study has two
parts: Dose Escalation and Dose Expansion. The Dose Escalation phase of the study will
evaluate safety of escalating doses of the combination treatment. The Dose Expansion phase
will evaluate safety and activity of the combination once the final dose and schedule are
defined.

Inclusion Criteria:

1. Signed written informed consent.

2. Age ≥ 18 years old.

3. Unresectable locally advanced or metastatic histologically proven HER2+
gastroesophageal junction (GEJ) or gastric adenocarcinoma.

4. HER2+ as 3+ by IHC or in-situ hybridation (ISH) amplified.

5. Have received prior treatment with trastuzumab.

6. Have received treatment with at least one or more lines of cytotoxic chemotherapy in
the metastatic setting.

7. Resolution of chemotherapy, immunotherapy or radiation-related toxicities.

8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

9. Life expectancy ≥ 12 weeks.

10. Measurable disease as per RECIST 1.1 criteria.

11. Archival or newly obtained tissue sample of a tumor lesion.

12. Adequate organ function as determined by following laboratory parameters:

1. Heme: Plt Ct ≥ 100 x 103/µL, ANC ≥ 1.5 x 103/µL, and Hemoglobin ≥ 9 g/dL

2. Chemistry: ALT/AST ≤ 3.0 x ULN, TBili ≤1.5 x ULN, and Cr < 2 mg/dL

13. Female patients of childbearing potential must have a negative pregnancy test and
agree to use two forms of acceptable contraceptive measures from the time of consent
through 120 days after discontinuation of study drug administration.

14. Male patients with partners of childbearing potential must use barrier contraception.

Exclusion Criteria:

1. Patients with symptomatic central nervous system (CNS) metastases.

2. Patients with any history of known or suspected autoimmune disease with the specific
exceptions of vitiligo, atopic dermatitis, or psoriasis not requiring systemic
treatment.

3. History of prior allogeneic bone marrow, stem-cell or solid organ transplantation.

4. Treatment with any systemic anti-neoplastic therapy, or investigational therapy within
the 3 weeks prior to the initiation of study drug.

5. Treatment with radiation therapy within 3 weeks prior to the initiation of study drug
administration.

6. Treatment with corticosteroids (≥10 mg per day prednisone or equivalent) or other
immune suppressive drugs within the 14 days prior to the initiation of study drug
administration.

7. History of clinically-significant cardiovascular disease.

8. Clinically-significant pulmonary compromise, including a requirement for supplemental
oxygen use to maintain adequate oxygenation.

9. Presence of active pneumonitis

10. Clinically-significant gastrointestinal disorders, such as perforation,
gastrointestinal bleeding, or diverticulitis.

11. Evidence of active viral, bacterial, or systemic fungal infection.

12. Known positive testing for human immunodeficiency virus (HIV)or history of acquired
immune deficiency syndrome (AIDS).

13. Known history of or positive test for hepatitis B or hepatitis C infection.

14. Second primary invasive malignancy that has not been in remission for greater than 2
years.

15. Known hypersensitivity to recombinant proteins, polysorbate 80 or any excipient
contained in the drug or vehicle formulation for margetuximab or pembrolizumab.

16. Female patient who is breastfeeding.
We found this trial at
12
sites
5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
Principal Investigator: Daniel Catenacci, M.D.
University of Chicago One of the world's premier academic and research institutions, the University of...
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Baltimore, Maryland 21205
Principal Investigator: Ronan Kelly, M.D.
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Boston, Massachusetts 02215
Principal Investigator: Peter C Enzinger, MD
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Boston, MA
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Detroit, Michigan 48202
Principal Investigator: Philip A Philip, M.D.
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Detroit, MI
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Hope Uronis, MD
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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699 Concession Street
Hamilton, Ontario L8V 5C2
Principal Investigator: Rosalyn Juergens, MD
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Hamilton,
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3322 West End Avenue
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Principal Investigator: Johanna Bendell, M.D.
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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Nashville, TN
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New Haven, Connecticut 06520
Principal Investigator: Howard Hochster, MD
Phone: 203-200-4422
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Philadelphia, Pennsylvania 19111
Principal Investigator: Crystal Denlinger, M.D.
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Philadelphia, PA
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: A. Craig Lockhart, M.D.
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Seattle, Washington 98104
Principal Investigator: Philip Gold, MD
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Seattle, WA
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3970 Reservoir Road Northwest
Washington, D.C., District of Columbia 20007
Principal Investigator: Sunnie Kim, MD
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