A Phase 3 Study of Domvanalimab, Zimberelimab, and Chemotherapy Versus Nivolumab and Chemotherapy in People with Previously Untreated Inoperable or Metastatic Stomach, Gastroesophageal Junction, or Esophageal Cancer

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 (WCG IRB)

Purpose

Researchers are comparing two different combination treatments for previously untreated digestive cancers. The people in this study have cancer of the esophagus, gastric (stomach), or junction of the stomach and esophagus. Their cancers are inoperable (unable to be removed surgically) or metastatic (have spread). One treatment includes the drugs domvanalimab and zimberelimab plus chemotherapy. The other treatment includes the immunotherapy drug nivolumab plus chemotherapy.

In you join this study, you will be randomly assigned to get one of these treatments:

• Domvanalimab plus zimberelimab once every 4 weeks with FOLFOX chemotherapy once every 2 weeks
• Domvanalimab plus zimberelimab with CAPOX chemotherapy once every 3 weeks
• Nivolumab with FOLFOX chemotherapy once every 2 weeks
• Nivolumab with CAPOX chemotherapy once every 3 weeks

Who Can Join

To join this study, there are a few conditions. You must:

• Have inoperable or metastatic cancer of the stomach, esophagus, or gastroesophageal junction.
• Not have had prior treatment for your cancer.
• Not have a cancer that makes a protein called HER2. These cancers can be treated with other medications.
• Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
• Be age 18 or older.

Contact

For more information or to see if you can join this study, please call Dr. Yelena Janjigian’s office at 646-888-4186.