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MASTER KEY プロジェクト > プロジェクトについて > MASTER KEY Project Overview

MASTER KEY Project Overview

MASTER KEY Project Overview

MASTER KEY Project

MASTER_KEY_Project

Why rare cancer?

  • Delayed treatment development
    • Difficult to conduct a randomized trial due to limited number of patients
    • Industries are rarely interested in such a small market
    • Molecular background is not well investigated
    • Few hospitals with sufficient function for precise diagnosis and treatment
  • Rare cancer is not so rare
    • The annual incidence of all rare cancer occupies 15% of all cancer diagnosis in Japan

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Rare Cancer Center in NCC (since 2014)

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NCC Rare Cancer Hotline

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MASTER KEY Project

 MASTER_KEY_Project_Registry_Part

Registry part

  • Aim
    • Comprehensive database for rare cancer
         Molecular background, natural history, treatment outcomes, etc
    • Use the data for applications for regulatory approval
         Reliable historical control data
    • Assignment to clinical trials
         -Biomarker-targeted and non-biomarker-targeted clinical trials
         -If no clinical trial is available patients will receive treatment options outside of clinical trials
  • Collaboration with industries
    • Joint project with 12 industries
      • Funding, study drugs
      • Industry-sponsored sub-study
  • Accrual target
    • >= 700patients/year

Registry part: Eligibility Criteria

Main inclusion criteria

Main_inclusion_criteria

Registry Part: Progress

Opened in May 2017

  • Expected accrual rate: 700patients per year
  • Study period:10 years and more (continuous development)

Progress as of June 2024

  • Accrual: more than 4000 patients
  • Interim study reports: every six months

MASTER KEY Project

MK_Clinical_Trial_part

Sub-study (Clinical trial part)

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  • Several sub-studies are conducted as a basket trial
    • Marker(+): BRAF-V600, ALK, MDM2, HER2 etc.
    • Marker(-): Immune checkpoint inhibitors, etc
  • Aim
    • to expand drug indication to rare cancer Typical sub-study design
  • Single-arm phase 2
    • Primary endpoint, response rate
    • 15-25 patients with bayesiandesign

Sub-study

 Sub-studyの1つ目の表

 

Sub-studyの2つ目の表

 

Sub-studyの3つ目の表

 

Collaboration between industries and academia

大学の所在地の画像

Collaborating institutions

  • National Cancer Center Hospital
  • Kyoto University Hospital (Joined August 2018)
  • Hokkaido University Hospital (Joined April 2019)
  • Kyushu University Hospital (Joined April 2019)
  • Tohoku University Hospital (Joined February 2020)
  • National Center for Child Health and Development (Joined February November 2021)
  • Aichi Cancer Center (Joined May 2022)
  • Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital (Joined April 2024)
  • Toyama University Hospital (Joined May 2024)

Collaborating industries

参加企業ロゴ

Collaboration with 12 industries

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Advantages for academia

  • Obtain stable funding from industries for the registry
  • Obtain investigational drug/funding for investigator-initiated sub-studies
  • Propose industry-sponsored sub-studies for the registered patients

Advantages for industries

  • Obtain interim study reports periodically
  • Request detailed analysis of the registry data
  • Utilize the registry data as a reliable historical control for industry-sponsored trials
  • Accelerate the patient accrual for the industry-sponsored sub-studies

Summary: MASTER KEY Project

MASTER KEY Registry

  • Collaboration with 12 industries and 9 institutions
  • Started since May 2017
  • More than 700 patients/year
  • Accrual: more than 4000 patients

MASTER KEY Sub-study

  • 31 trials are being conducted
  • Collaboration with industries