STAR-221: 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: Rachel Lerner, MD
Study sponsor: Arcus Biosciences, Gilead
Location: HealthPartners Cancer Center at Regions Hospital, HealthPartners Frauenshuh Cancer Center
Phase of Study: Phase 3
Purpose of study: The purpose of the study is to test the effectiveness of using the drugs Domvanalimab and Zimberelimab in combination with Chemotherapy to treat your type of cancer, compared to the effectiveness of standard of care Nivolumab and Chemotherapy. Since this is a treatment study, you will be randomly assigned to either the standard of care arm, or the experimental arm.
Inclusion Criteria:
Participant must:
– Be at least 18 years or older
– Be diagnosed with any of the following cancer types; locally advanced unresectable or metastatic gastric cancer, Gastroesophageal Junction, or esophageal adenocarcinoma
– Have an ECOG status of 0-1
– Have at least 1 measurable target lesion per RECIST v1.1
Exclusion Criteria:
– Excluded if the patient has an underlying medical condition such as, but not limited to, the following; history of lung disease or non-infectious pneumonitis, Cardiac Disease NYHA class II or greater, unstable or newly-onset Angina within 3 months of randomization.
– Has had a history of solid-organ transplant or allogenic bone marrow transplantation.
– Has dementia, or a psychiatric or substance abuse condition that would interfere with participants ability to satisfy study requirements.
– Has known HER-2 positive tumor.
– Has untreated, symptomatic, or actively progressing brain metastasis
– Has been previously treated for metastatic gastric, GEJ, or esophageal adenocarcinoma.
– Has had disease progress within 6-months while on neoadjuvant or adjuvant chemotherapy.
*Additional inclusion/exclusion may apply and will be discussed with the provider or research team.
Study Contact
Alissa Gavenda
(952) 992-5705
Alissa.Gavenda@ParkNicollet.com
