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

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


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.

Trial Description

Primary Outcome:

  • Determine the recommended expansion phase dose of margetuximab in combination with pembrolizumab
  • Anti-Tumour Activity
  • Anti-Tumour Activity
Secondary Outcome:
  • Overall Survival (OS)
  • Progression Free Survival (PFS)
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 in patients with gastric or gastroesophageal cancer once the final dose and schedule are defined. In addition, a cohort of patients with HER2+ 3+ gastric cancer patients will be enrolled in the Dose Expansion Phase. Patients may receive margetuximab monotherapy for an additional 2 years beyond the 2 years of margetuximab/pembrolizumab combination therapy.

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Canadian Cancer Society

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