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
No
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.

Join this Trial

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Study Stats
Protocol No.
21-000907
Category
Hematology-Oncology
Oncology
Contact
Lisa Yonemoto
Location
  • TRIO-US - Ft. Wayne IN
  • TRIO-US - Redondo Beach
  • TRIO-US - Sylmar
  • UCLA Westwood
For Providers
NCT No.
NCT04592913
For detailed technical eligibility, visit ClinicalTrials.gov.