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

Part of paid clinical trials in Duarte, California.

Sponsor
AstraZeneca
Study ID
NCT04592913
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Esophagogastric Junction
  • Gastrointestinal Neoplasms

Eligibility Criteria

Sex
ALL
Age
18 Years - 200 Years
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab — DRUG
    Human monoclonal antibody
  • FLOT chemotherapy — DRUG
    A combination treatment made up of flurouroacil + leucovorin + oxaliplatin + docetaxel

Study Details

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).

Key Dates

Start date
Nov 17, 2020
Status verified
Dec 2025
Primary completion
Dec 20, 2024
Completion
Sep 27, 2027

Study Design

Enrollment
957 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Arm B
    placebo product and FLOT chemotherapy
  • Experimental: Arm A
    Durvalumab and FLOT chemotherapy

Primary Outcome Measure

Event-free survival (EFS) [ Time Frame: Up to 5 years ]

Locations (16)

FacilityCityStateZIPSite coordinators
Research SiteDuarteCalifornia91010-
Research SiteLos AngelesCalifornia90027-
Research SiteLos AngelesCalifornia90095-
Research SiteSylmarCalifornia91342-
Research SiteSt. PetersburgFlorida33705-
Research SiteTallahasseeFlorida32308-
Research SiteWest Palm BeachFlorida33401-
Research SiteFort WayneIndiana46804-
Research SiteLouisvilleKentucky40217-
Research SiteBostonMassachusetts02215-
Research SiteNew YorkNew York10065-
Research SiteRochesterNew York14642-
Research SiteNashvilleTennessee37203-
Research SiteDallasTexas75390-
Research SiteLancasterTexas75216-
Research SiteSeattleWashington98109-

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