Domvanalimab and zimberelimab versus nivolumab in gastroesophageal cancer (STAR-221) - Clinical Trial

What is the 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.

What is the Condition Being Studied?

Gastroesophageal Adenocarcinoma

Who Can Participate in the Study?

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.

Age Group
Adults

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

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
Medical Oncologist
Protocol Number
IRB: PRO00111508
NCT: NCT05568095
Phase
Phase III
ClinicalTrials.gov
Enrollment Status
Open for Enrollment