Open Actively Recruiting

Assessing Durvalumab and FLOT Chemotherapy in Resectable Gastric and Gastroesophageal Junction Cancer

About

Brief Summary

This is a Global Study of Neoadjuvant-Adjuvant Durvalumab or Placebo and FLOT Chemotherapy Followed by Adjuvant Durvalumab or Placebo in Patients with Resectable Gastric and Gastroesophageal Cancer (GC/GEJC) (MATTERHORN).

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase III

Eligibility

Gender

All

Healthy Volunteers

Minimum Age

18 Years

Maximum Age

200 Years

Key Inclusion Criteria:

Patients with histologically documented gastric or gastroesophageal junction adenocarcinoma with resectable disease (Stage II or higher per AJCC 8th edition).
Patients must undergo radical surgery.
No prior anti-cancer therapy for the current malignancy.
World Health Organization (WHO)/ECOG performance status of 0 or 1 at enrollment.
Adequate organ and marrow function.
Availability of tumor sample prior to study entry.
Must have a life expectancy of at least 24 weeks.

Key Exclusion Criteria:

Patients with peritoneal dissemination or distant metastasis.
Patients with adenosquamous cell carcinoma, squamous cell carcinoma, or GI stromal tumor.
Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab.
Contra-indication to any of the study drugs.
History of allogeneic organ transplantation.

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