Combination Margetuximab and Pembrolizumab for Advanced, Metastatic HER2(+) Gastric or Gastroesophageal Junction Cancer
NCT ID: NCT02689284
Last Updated: 2025-03-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
95 participants
INTERVENTIONAL
2016-01-31
2021-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Cohort 1: Margetuximab 10 mg/kg plus pembrolizumab 200 mg
margetuximab administered in combination with pembrolizumab
Margetuximab 10 mg/kg
Margetuximab treatment is administered intravenously (IV) once every 21-day cycle
Pembrolizumab
Pembrolizumab treatment is administered IV once every 21-day cycle
Cohort 2: Margetuximab 15 mg/kg plus pembrolizumab 200 mg
margetuximab administered in combination with pembrolizumab
Margetuximab 15 mg
Margetuximab treatment is administered IV once every 21-day cycle
Pembrolizumab
Pembrolizumab treatment is administered IV once every 21-day cycle
Interventions
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Margetuximab 10 mg/kg
Margetuximab treatment is administered intravenously (IV) once every 21-day cycle
Margetuximab 15 mg
Margetuximab treatment is administered IV once every 21-day cycle
Pembrolizumab
Pembrolizumab treatment is administered IV once every 21-day cycle
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age ≥ 18 years old (or minimum age based upon local regulations)
3. 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.
4. HER2+ as 3+ (as defined in AJCC staging manual 8th edition) 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.
Exclusion Criteria
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. History of (non-infectious) pneumonitis that required steroids or 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.
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
MacroGenics
INDUSTRY
Responsible Party
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Locations
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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
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Tri-Service General Hospital
Taipei, , Taiwan
Countries
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References
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Catenacci DV, Kang YK, Uronis HE, Lee KW, Ng MC, Enzinger PC, Park SH, Gold PJ, Lacy J, Hochster HS, Oh SC, Kim YH, Marrone KA, Kelly RJ, Juergens RA, Kim JG, Alcindor T, Sym SJ, Song EK, Chee CE, Chao Y, Kim S, Oh DY, Yen J, Odegaard JI, Lagow E, Li D, Sun J, Kaminker P, Moore PA, Rosales MK, Park H. Circulating Tumor DNA as a Predictive Biomarker for Clinical Outcomes With Margetuximab and Pembrolizumab in Pretreated HER2-Positive Gastric/ Gastroesophageal Adenocarcinoma. Oncology (Williston Park). 2023 Apr 25;37(4):176-183. doi: 10.46883/2023.25920992.
Catenacci DVT, Kang YK, Park H, Uronis HE, Lee KW, Ng MCH, Enzinger PC, Park SH, Gold PJ, Lacy J, Hochster HS, Oh SC, Kim YH, Marrone KA, Kelly RJ, Juergens RA, Kim JG, Bendell JC, Alcindor T, Sym SJ, Song EK, Chee CE, Chao Y, Kim S, Lockhart AC, Knutson KL, Yen J, Franovic A, Nordstrom JL, Li D, Wigginton J, Davidson-Moncada JK, Rosales MK, Bang YJ; CP-MGAH22-5 Study Group. Margetuximab plus pembrolizumab in patients with previously treated, HER2-positive gastro-oesophageal adenocarcinoma (CP-MGAH22-05): a single-arm, phase 1b-2 trial. Lancet Oncol. 2020 Aug;21(8):1066-1076. doi: 10.1016/S1470-2045(20)30326-0. Epub 2020 Jul 9.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CP-MGAH22-05
Identifier Type: -
Identifier Source: org_study_id
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