Having a large clinical trial portfolio means giving patients treatment options often not available anywhere else, and years before they become the standard of care. To learn more about Karmanos Cancer Institute clinical trials or to see if a trial is right for you, please call 1-800-KARMANOS (1-800-527-6266) or request an appointment below
  • 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) (MATTERHORN)

    Cancer Categories
    • Gastrointestinal (GI)
    Karmanos Trial ID
    • 2021-034
    NCT ID
    • NCT04592913
    Age Group
    • Adult
    Scope
    • Local
    PhaseClick for Clinical Trial Phase DefinitionPhase III
    Includes trials conducted after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug
    • Phase III
    Principal Investigator
    • Mohammed Najeeb
      Al Hallak, M.D., MS

      Oncology - Medical View Profile

    Objective:

    Primary Objective

    • To compare Arm A relative to Arm B on event-free survival (EFS)

    Key Secondary Objectives

    • To compare Arm A relative to Arm B on overall survival (OS)
    • To compare Arm A relative to Arm B on pathological complete response (pCR) rate

    Secondary Objectives

    • To compare Arm A relative to Arm B on the proportion of patients who undergo gastrectomy or gastroesophagectomy
    • To compare Arm A relative to Arm B on the rate of complete resection (R0)
    • To compare Arm A relative to Arm B on metastasis-free survival (MFS) and disease-specific survival (DSS)
    • To compare Arm A relative to Arm B on disease-free survival (DFS) in patients who undergo R0 resection surgery
    • To compare Arm A relative to Arm B on EFS24, EFS36, OS24, OS36, DFS24, and DFS36
    • To compare Arm A relative to Arm B on efficacy endpoints by PD-L1 expression
    • To compare Arm A relative to Arm B on disease-related symptoms, impacts, and HRQoL
    • To evaluate the PK of Arm A and Arm B
    • To assess the immunogenicity of Arm A and Arm B
  • Locations

    Locations

    Karmanos Cancer Institute - Detroit Headquarters

    4100 John R
    Detroit, MI 48201
    Get Directions
    Phone: 800-527-6266

    Karmanos Cancer Institute at Weisberg Cancer Center - Farmington Hills

    31995 Northwestern Hwy
    Farmington Hills, MI 48334
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    Phone: 800-527-6266