A Phase III Study of Durvalumab Immunotherapy and FLOT Chemotherapy Before and After Surgery in Patients with Operable Stomach and Gastroesophageal Junction Cancers

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Full Title

A Randomized, Double-blind, Placebo-controlled, Phase III Study of Neoadjuvant-Adjuvant Durvalumab and FLOT Chemotherapy Followed by Adjuvant Durvalumab in Patients with Resectable Gastric and Gastroesophageal Junction Cancer (GC/GEJC) (MATTERHORN) (WIRB)

Purpose

This study is assessing the effectiveness of durvalumab immunotherapy versus placebo therapy combined with FLOT chemotherapy (fluorouracil, leucovorin, oxaliplatin, and docetaxel) given before and after surgery in patients with operable cancer of the stomach (gastric cancer) or the junction between the esophagus and stomach (gastroesophageal cancer).

Patients will be randomly assigned to receive FLOT chemotherapy with durvalumab or a placebo before and after surgery, followed by durvalumab or placebo therapy without FLOT. All medications in this study are given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have gastric or gastroesophageal cancer that can be removed with surgery.
  • Patients may not have received prior anticancer therapy for this cancer.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Yelena Janjigian at 646-888-4186.

Protocol

21-220

Phase

III

Investigator

Co-Investigators