Combination Margetuximab and Pembrolizumab for Advanced, Metastatic HER2(+) Gastric or Gastroesophageal Junction Cancer
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|ClinicalTrials.gov Identifier: NCT02689284|
Recruitment Status : Active, not recruiting
First Posted : February 23, 2016
Last Update Posted : June 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|Gastric Cancer Stomach Cancer Esophageal Cancer||Biological: Margetuximab plus pembrolizumab||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||95 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 :||September 2020|
|Estimated Study Completion Date :||September 2020|
Experimental: Margetuximab plus pembrolizumab
margetuximab administered in combination with pembrolizumab
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
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|