Clinical Trials /

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

NCT04592913

Description:

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).

Related Conditions:
  • Adenocarcinoma of the Gastroesophageal Junction
  • Gastric Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Assessing Durvalumab and FLOT Chemotherapy in Resectable Gastric and Gastroesophageal Junction Cancer
  • Official 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)

Clinical Trial IDs

  • ORG STUDY ID: D910GC00001
  • SECONDARY ID: 2019-001555-40
  • NCT ID: NCT04592913

Conditions

  • Gastrointestinal Neoplasms
  • Esophagogastric Junction

Interventions

DrugSynonymsArms
DurvalumabArm A
FLOT chemotherapyArm A

Purpose

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

      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.
    

Trial Arms

NameTypeDescriptionInterventions
Arm BPlacebo Comparatorplacebo product and FLOT chemotherapy
  • FLOT chemotherapy
Arm AExperimentalDurvalumab and FLOT chemotherapy
  • Durvalumab
  • FLOT chemotherapy

Eligibility Criteria

        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.
      
Maximum Eligible Age:200 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

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

Secondary Outcome Measures

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

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:AstraZeneca

Last Updated

May 14, 2021