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)
Status: Active_not_recruiting
Location: See all (156) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 200
Healthy Volunteers: f
View:
• 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.
Locations
United States
California
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Duarte
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Los Angeles
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Los Angeles
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Sylmar
Florida
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St. Petersburg
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Tallahassee
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West Palm Beach
Indiana
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Fort Wayne
Kentucky
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Louisville
Massachusetts
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Boston
New York
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New York
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Rochester
Tennessee
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Nashville
Texas
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Dallas
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Lancaster
Washington
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Seattle
Other Locations
Argentina
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Buenos Aires
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Buenos Aires
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Ciudad Autonoma Buenos Aires
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Ciudad De Buenos Aires
Research Site
Rosario
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Rosario
Belgium
Research Site
Charleroi
Research Site
Edegem
Research Site
Leuven
Research Site
Liège
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Roeselare
Brazil
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Barretos
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Natal
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Porto Alegre
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Porto Alegre
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Rio De Janeiro
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São José Do Rio Preto
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São Paulo
Canada
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Edmonton
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Montreal
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Montreal
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North York
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Oshawa
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Toronto
Chile
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La Serena
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Santiago
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Santiago
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Talca
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Temuco
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Temuco
Denmark
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Aalborg
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København Ø
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Odense
France
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Avignon
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Besançon
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Brest
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Dijon
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Lyon
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Montpellier
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Nantes
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Nice
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Paris
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Paris
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Paris
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Rennes
Germany
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Berlin
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Dresden
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Frankfurt
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Hamburg
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Hamburg
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Heidelberg
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Heilbronn
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Jena
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Mainz Am Rhein
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München
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Schweinfurt
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Tübingen
Hungary
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Budapest
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Győr
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Kecskemét
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Szekszárd
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Szolnok
Japan
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Chūōku
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Hidaka-shi
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Hirakata-shi
Research Site
Hiroshima
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Kashiwa
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Kitaadachi-gun
Research Site
Kochi
Research Site
Kurume-shi
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Nagoya
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Niigata
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Ogaki-shi
Research Site
Osaka
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Osaka
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Suita-shi
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Sunto-gun
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Tokyo
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Toyoake-shi
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Wakayama
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Yokohama
Netherlands
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Amsterdam
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Eindhoven
Research Site
Rotterdam
Peru
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Bellavista
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Lima
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Lima
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Lima
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San Isidro
Poland
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Bialystok
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Gdansk
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Krakow
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Lodz
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Poznan
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Poznan
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Warsaw
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Warsaw
Republic of Korea
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Hwasun-gun
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Seongnam-si
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Seoul
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Seoul
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Seoul
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Seoul
Russian Federation
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Kaluga
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Moscow
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Moscow
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Moscow
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Novosibirsk
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Obninsk
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Saint Petersburg
Spain
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Barcelona
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Barcelona
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Barcelona
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Madrid
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Madrid
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Málaga
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Ourense
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Santander
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Seville
Research Site
Valencia
Taiwan
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Kaohsiung City
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Taichung
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Tainan
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Taipei
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Taipei
Research Site
Taoyuan
Turkey
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Adana
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Ankara
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Erzurum
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Istanbul
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Istanbul
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Samsun
United Kingdom
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Cambridge
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Dundee
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Glasgow
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Leicester
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London
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Manchester
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Oxford
Research Site
Surrey
Time Frame
Start Date: 2020-11-17
Completion Date: 2027-09-27
Participants
Target number of participants: 957
Treatments
Placebo_comparator: Arm B
placebo product and FLOT chemotherapy
Experimental: Arm A
Durvalumab and FLOT chemotherapy
Related Therapeutic Areas
Sponsors
Leads: AstraZeneca