A Phase II Study of Domvanalimab and Zimberelimab Immunotherapy with or without FOLFOX Chemotherapy in People with Esophageal, Gastroesophageal Junction, or Stomach Cancer

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Full Title

A Phase 2 Trial to Evaluate the Safety and Efficacy of Domvanalimab (AB154) and Zimberelimab (AB122) -Based Treatment Combinations in Patients with Advanced Upper Gastrointestinal Tract Malignancies

Purpose

The purpose of this study is to assess the safety and effectiveness of the investigational drugs domvanalimab and zimberelimab given together with or without FOLFOX chemotherapy in people with inoperable or metastatic upper digestive cancers. Both domvanalimab and zimberelimab take the brakes off the immune response by blocking certain proteins, enabling the immune system to find and destroy cancer cells. FOLFOX is a combination of chemotherapy drugs which is commonly used to treat digestive cancers.

Participants in this study who have not received any prior treatment for their cancer will receive domvanalimab, zimberelimab, and FOLFOX. Those who did receive previous therapy will receive domvanalimab and zimberelimab without FOLFOX. The medications used in this study are given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have inoperable or metastatic cancer of the esophagus, stomach, or junction between the esophagus and stomach.
  • Any prior anticancer treatment must have been completed 4 or more weeks before receiving the study therapy.
  • Patients must be physically well enough that they are able to be mobile, take care of themselves, and engage in all but physically strenuous activities. For example, they must be well enough that they could carry out office work or light housework.
  • This study is for people age 18 and older.

Contact

For more information and to ask about eligibility for this study, please contact the office of Dr. Yelena Janjigian at 646-888-4186.

Protocol

22-261

Phase

II

Investigator

Co-Investigators