Trials / Completed
CompletedNCT02689284
Combination Margetuximab and Pembrolizumab for Advanced, Metastatic HER2(+) Gastric or Gastroesophageal Junction Cancer
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
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 95 (actual)
- Sponsor
- MacroGenics · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Margetuximab 10 mg/kg | Margetuximab treatment is administered intravenously (IV) once every 21-day cycle |
| BIOLOGICAL | Margetuximab 15 mg | Margetuximab treatment is administered IV once every 21-day cycle |
| BIOLOGICAL | Pembrolizumab | Pembrolizumab treatment is administered IV once every 21-day cycle |
Timeline
- Start date
- 2016-01-01
- Primary completion
- 2021-01-01
- Completion
- 2021-01-01
- First posted
- 2016-02-23
- Last updated
- 2025-03-17
- Results posted
- 2022-08-04
Locations
28 sites across 5 countries: United States, Canada, Singapore, South Korea, Taiwan
Source: ClinicalTrials.gov record NCT02689284. Inclusion in this directory is not an endorsement.