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
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
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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Study Stats
Protocol No.
21-000907
Category
Hematology-Oncology
Oncology
Principal Investigator
Contact
Location
- TRIO-US - Ft. Wayne IN
- TRIO-US - Redondo Beach
- TRIO-US - Sylmar
- UCLA Westwood