Purpose of this Study
We are doing this study to see if the study drugs, domvanalimab and zimberelimab, are safe and effective for treating advanced or metastatic gastroesophageal adenocarcinoma.
Who Can Participate?
Eligibility
Adults with one of the following types of cancer:
- Esophageal adenocarcinoma (a common type of cancer of the esophagus)
- Gastroesophageal junction adenocarcinoma (cancer where the esophagus meets the stomach)
- Gastric adenocarcinoma (stomach cancer)
The cancer must not be treatable with surgery alone.
For more information about who can join this study, please contact the study team at gi-oncology-cru@dm.duke.edu or 919-668-1861.
- Esophageal adenocarcinoma (a common type of cancer of the esophagus)
- Gastroesophageal junction adenocarcinoma (cancer where the esophagus meets the stomach)
- Gastric adenocarcinoma (stomach cancer)
The cancer must not be treatable with surgery alone.
For more information about who can join this study, please contact the study team at gi-oncology-cru@dm.duke.edu or 919-668-1861.
What is Involved?
If you choose to join this study, you will:
- Receive the study drugs, domvanalimab and zimberelimab, through an IV once every 3 or 4 weeks
- Receive nivolumab and standard chemotherapy every 2 or 3 weeks in addition to the study drugs (if not previously treated)
- Have blood draws
- Have imaging scans (CT or MRI) every 6 to 12 weeks
- Receive the study drugs, domvanalimab and zimberelimab, through an IV once every 3 or 4 weeks
- Receive nivolumab and standard chemotherapy every 2 or 3 weeks in addition to the study drugs (if not previously treated)
- Have blood draws
- Have imaging scans (CT or MRI) every 6 to 12 weeks
Study Details
Full Title
A Randomized, Open-Label, Multicenter Phase 3 Trial of Domvanalimab, Zimberelimab, and Chemotherapy Versus Nivolumab and Chemotherapy in Participants with Previously Untreated Locally Advanced Unresectable or Metastatic Gastric, Gastroesophageal Junction, and Esophageal Adenocarcinoma
Principal Investigator
Hope
Uronis
Protocol Number
PRO00111508
NCT ID
NCT05568095
Phase
III
Enrollment Status
OPEN TO ACCRUAL