Combination Margetuximab and Pembrolizumab for Advanced, Metastatic HER2(+) Gastric or Gastroesophageal Junction Cancer
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02689284 |
Recruitment Status :
Active, not recruiting
First Posted : February 23, 2016
Last Update Posted : October 9, 2020
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Condition or disease | Intervention/treatment | Phase |
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Gastric Cancer Stomach Cancer Esophageal Cancer | Biological: Margetuximab plus pembrolizumab | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 95 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Study Start Date : | January 2016 |
Estimated Primary Completion Date : | February 2021 |
Estimated Study Completion Date : | March 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Margetuximab plus pembrolizumab
margetuximab administered in combination with pembrolizumab
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Biological: Margetuximab plus pembrolizumab
margetuximab in combination with pembrolizumab; combination treatment is administered once every 21-day cycle
Other Name: Keytruda |
- Determine the recommended expansion phase dose of margetuximab in combination with pembrolizumab [ Time Frame: 9 months ]Characterize maximum tolerated dose (MTD) or maximum administered dose (MAD) (if no MTD is defined) of margetuximab when administered in combination with pembrolizumab
- Anti-Tumor Activity [ Time Frame: 12 months ]Investigate the preliminary anti-tumor activity as measured by response duration of margetuximab when administered in combination with pembrolizumab, using both conventional Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and immune-related response criteria (irRC).
- Anti-Tumor Activity [ Time Frame: 12 Months ]Investigate the preliminary anti-tumor activity, as measured by objective response rate (ORR) of margetuximab when administered in combination with pembrolizumab, using conventional Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and immune-related response criteria (irRC).
- Overall Survival (OS) [ Time Frame: 24 Months ]To investigate the preliminary effect of the combination treatment on OS
- Progression Free Survival (PFS) [ Time Frame: 24 Months ]To investigate the preliminary effect of the combination treatment on PFS

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02689284

Study Director: | Minori Rosales, M.D., PhD | MacroGenics |
Responsible Party: | MacroGenics |
ClinicalTrials.gov Identifier: | NCT02689284 |
Other Study ID Numbers: |
CP-MGAH22-05 |
First Posted: | February 23, 2016 Key Record Dates |
Last Update Posted: | October 9, 2020 |
Last Verified: | October 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Stomach Cancer Gastroesophageal Junction Gastric Cancer Cancer of the Stomach Cancer of Stomach Stomach Pembrolizumab Keytruda HER2+ GEJ HER2 positive Metastatic Margetuximab |
Immunotherapy Trastuzumab Human epidermal growth factor receptor 2 Human epidermal growth factor receptor 2-positive gastroesophageal junction cancer Pembro PD-L1 PD-1 PD Tumor Cancer KEYNOTE MK3475-PN197 |
Stomach Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases |
Gastrointestinal Diseases Stomach Diseases Pembrolizumab Antineoplastic Agents, Immunological Antineoplastic Agents |