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

Completed · Phase 1/Phase 2

Conditions studied: Gastric Cancer, Stomach Cancer, Esophageal Cancer

In brief

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.

Key facts

Study ID

NCT02689284

Run by

MacroGenics

People needed

95

Starts

2016-01-01

Expected to finish

2021-01-01

Last updated by the study team

2025-03-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed written informed consent.
• Age ≥ 18 years old (or minimum age based upon local regulations)
• Unresectable locally advanced or metastatic histologically proven HER2+ gastroesophageal junction (GEJ) or gastric cancer. Gastric Cancer Expansion Phase will include only gastric cancer patients with 3+ HER2 positivity.
• HER2+ as 3+ (as defined in AJCC staging manual 8th edition) by IHC or in-situ hybridation (ISH) amplified.
• Have received prior treatment with trastuzumab.
• Have received treatment with at least one or more lines of cytotoxic chemotherapy in the metastatic setting.
• Resolution of chemotherapy, immunotherapy or radiation-related toxicities.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Life expectancy ≥ 12 weeks.
• Measurable disease as per RECIST 1.1 criteria.

You may not qualify if…

• Patients with symptomatic central nervous system (CNS) metastases.
• Patients with any history of known or suspected autoimmune disease with the specific exceptions of vitiligo, atopic dermatitis, or psoriasis not requiring systemic treatment.
• History of prior allogeneic bone marrow, stem-cell or solid organ transplantation.
• Treatment with any systemic anti-neoplastic therapy, or investigational therapy within the 3 weeks prior to the initiation of study drug.
• Treatment with radiation therapy within 3 weeks prior to the initiation of study drug administration.
• 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.
• History of clinically-significant cardiovascular disease.
• Clinically-significant pulmonary compromise, including a requirement for supplemental oxygen use to maintain adequate oxygenation.
• History of (non-infectious) pneumonitis that required steroids or presence of active pneumonitis
• Clinically-significant gastrointestinal disorders, such as perforation, gastrointestinal bleeding, or diverticulitis.
• Evidence of active viral, bacterial, or systemic fungal infection.

Where it is running

• Yale School of Medicine — New Haven, Connecticut, United States
• Georgetown University-Lombardi Comprehensive Cancer Center — Washington D.C., District of Columbia, United States
• University of Chicago — Chicago, Illinois, United States
• Johns Hopkins University Medical Center — Baltimore, Maryland, United States
• Dana-Farber Cancer Institute/Harvard University Medical Center — Boston, Massachusetts, United States
• Karmanos Cancer Institute — Detroit, Michigan, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
• Sarah Cannon Research Institute — Nashville, Tennessee, United States
• Swedish Cancer Institute — Seattle, Washington, United States
• Juravinski Cancer Centre - McMaster University — Hamilton, Ontario, Canada
• McGill University Health Centre — Montreal, Quebec, Canada
• National Cancer Centre — Singapore, Singapore
• National University Hospital — Singapore, Singapore
• Raffles Hospital — Singapore, Singapore
• Kyungbuk National University Hospital — Daegu, South Korea
• Gachon University Gil Medical Center — Incheon, South Korea
• Chonbuk National University Hospital — Seoul, South Korea
• Asan Medical Center — Seoul, South Korea
• Korea University Anam Hospital — Seoul, South Korea
• Korea University Guro Hospital — Seoul, South Korea
• Samsung Medical Center — Seoul, South Korea
• Seoul National University Bundang Hospital — Seoul, South Korea
• Seoul National University Hospital — Seoul, South Korea

Full record on ClinicalTrials.gov

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