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

Study Overview
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Brief Summary
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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).

Detailed Description
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This study investigates treatment of durvalumab or placebo therapy combined with FLOT chemotherapy (flurouroacil + leucovorin + oxaliplatin + docetaxel) given before surgery (neoadjuvant) and durvalumab or placebo therapy combined with FLOT chemotherapy after surgery (adjuvant), will work and be safe for the treatment of resectable (removable by surgery) gastric or gastroesophageal cancer, and also to better understand the studied disease and associated health problems.

Official Title
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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)

Conditions
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Gastrointestinal Neoplasms, Esophagogastric Junction

Intervention / Treatment
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* Drug: Durvalumab
* Drug: FLOT chemotherapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 200 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, Double-blind, Placebo-controlled study
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Arm B<br>placebo product and FLOT chemotherapy | Drug: FLOT chemotherapy<br>* A combination treatment made up of flurouroacil + leucovorin + oxaliplatin + docetaxel<br>|
| Experimental: Arm A<br>Durvalumab and FLOT chemotherapy | Drug: Durvalumab<br>* Human monoclonal antibody<br>Drug: FLOT chemotherapy<br>* A combination treatment made up of flurouroacil + leucovorin + oxaliplatin + docetaxel<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Event-free survival (EFS) | EFS is the time from date of randomization until the date of disease progression or death. | Up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare Arm A relative to Arm B on overall survival (OS) | Overall survival is length of time from randomization until the date of death due to any cause. | Up to 5 years | 
| To compare Arm A relative to Arm B on pathological complete response (pCR) rate | pCR rate is the proportion of patients who have no residual viable tumor in the resected specimens. | Up to 5 years |