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

Sponsor: AstraZeneca

Sponsor score: 40

ClinicalTrials ID:NCT04592913

The MATTERHORN study evaluates the safety and efficacy of neoadjuvant and adjuvant durvalumab or placebo with FLOT chemotherapy in resectable gastric or gastroesophageal cancer. Eligible patients have Stage II or higher adenocarcinoma, undergo radical surgery, and meet specific health criteria. Interventions include durvalumab, a monoclonal antibody, and FLOT chemotherapy.

Patient Parameters

Program Overview

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).

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.

Eligibility Criteria

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.

Locations

FACILITYZIPCITYSTATE
Research Site91010DuarteCalifornia
Research Site90027Los AngelesCalifornia
Research Site90095Los AngelesCalifornia
Research Site91342SylmarCalifornia
Research Site33705St. PetersburgFlorida
Research Site32308TallahasseeFlorida
Research Site33401West Palm BeachFlorida
Research Site46804Fort WayneIndiana
Research Site40217LouisvilleKentucky
Research Site02215BostonMassachusetts

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