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NCT04592913 · CITED IN SOURCE DOCUMENTS

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

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
ACTIVE NOT RECRUITING
Registry last update
2025-12-24

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).

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
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.
healthy Volunteers
false
maximum Age
200 Years
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    placebo product and FLOT chemotherapy
    intervention Names
    1. Drug: FLOT chemotherapy
    label
    Arm B
    type
    PLACEBO_COMPARATOR
  2. description
    Durvalumab and FLOT chemotherapy
    intervention Names
    1. Drug: Durvalumab
    2. Drug: FLOT chemotherapy
    label
    Arm A
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Arm A
    description
    Human monoclonal antibody
    name
    Durvalumab
    type
    DRUG
  2. arm Group Labels
    1. Arm A
    2. Arm B
    description
    A combination treatment made up of flurouroacil + leucovorin + oxaliplatin + docetaxel
    name
    FLOT chemotherapy
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
intervention Model Description
Randomized, Double-blind, Placebo-controlled study
masking Info
masking
QUADRUPLE
who Masked
  1. PARTICIPANT
  2. CARE_PROVIDER
  3. INVESTIGATOR
  4. OUTCOMES_ASSESSOR
primary Purpose
TREATMENT
Enrollment
count
957
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    EFS is the time from date of randomization until the date of disease progression or death.
    measure
    Event-free survival (EFS)
    time Frame
    Up to 5 years
secondary Outcomes
  1. 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 overall survival (OS)
    time Frame
    Up to 5 years
  2. description
    pCR rate is the proportion of patients who have no residual viable tumor in the resected specimens.
    measure
    To compare Arm A relative to Arm B on pathological complete response (pCR) rate
    time Frame
    Up to 5 years
Full study description
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).
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.
Source references
references
  1. citation
    Janjigian YY, Al-Batran SE, Wainberg ZA, Muro K, Molena D, Van Cutsem E, Hyung WJ, Wyrwicz L, Oh DY, Omori T, Moehler M, Garrido M, Oliveira SCS, Liberman M, Oliden VC, Smyth EC, Stein A, Bilici M, Alvarenga ML, Kozlov V, Rivera F, Kawazoe A, Serrano O, Heilbron E, Negro A, Kurland JF, Tabernero J; MATTERHORN Investigators. Perioperative Durvalumab in Gastric and Gastroesophageal Junction Cancer. N Engl J Med. 2025 Jul 17;393(3):217-230. doi: 10.1056/NEJMoa2503701. Epub 2025 Jun 1.
    pmid
    40454643
    type
    DERIVED
  2. citation
    Chang X, Ge X, Zhang Y, Xue X. The current management and biomarkers of immunotherapy in advanced gastric cancer. Medicine (Baltimore). 2022 May 27;101(21):e29304. doi: 10.1097/MD.0000000000029304.
    pmid
    35623069
    type
    DERIVED
  3. citation
    Janjigian YY, Van Cutsem E, Muro K, Wainberg Z, Al-Batran SE, Hyung WJ, Molena D, Marcovitz M, Ruscica D, Robbins SH, Negro A, Tabernero J. MATTERHORN: phase III study of durvalumab plus FLOT chemotherapy in resectable gastric/gastroesophageal junction cancer. Future Oncol. 2022 Jun;18(20):2465-2473. doi: 10.2217/fon-2022-0093. Epub 2022 May 10.
    pmid
    35535555
    type
    DERIVED
  4. citation
    Cowzer D, Janjigian YY. Top advances in esophageal/gastroesophageal junction cancers in 2021. Cancer. 2022 May 15;128(10):1894-1899. doi: 10.1002/cncr.34140. Epub 2022 Feb 18. No abstract available.
    pmid
    35179774
    type
    DERIVED
Source notices and limitations
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        ATTERHORN Study The efficacy of IMFINZI with FLOT as neoadjuvant and adjuvant treatment, followed by IMFINZI as a single agent, was investigated in MATTERHORN (NCT04592913), a randomized, double-blind, placebo-controlled, multicenter study conducted in 948 patients with previously untreated and resectable GC/GEJC (Stage II to Sta
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        d on <a href="https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm">Drugs@FDA</a>.</p><h2>Efficacy and Safety</h2><p>Efficacy was evaluated in MATTERHORN (NCT04592913), a randomized, double-blind, placebo-controlled, multicenter trial conducted in 948 patients with previously untreated and resectable, Stage II to Stage IVA,
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    Preserved source evidence · Not medical advice