胃癌の成人におけるペンブロリズマブと化学療法と一緒にゾルベトキシマブの研究 (LUCERNA)
腫瘍がHER2-麻痺している（CLOUDN（CLOUDN）1.2-Posiveである参加者である参加者の局所的に進行しない胃または胃食道接合腺癌の局所進行性胃または胃食道接合腺腫の第一系列治療におけるペンブロリズマブおよび化学療法（CAPOXまたはMFOLFOX6）と組み合わせたゾルベトキシキシブの第3相、二重盲検無作為化研究（PD-L1）陽性
Zolbetuximab is being studied in people with cancer in and around the stomach or where the food pipe (esophagus) joins the stomach, called gastroesophageal junction (GEJ) cancer. Zolbetuximab with chemotherapy may be used to treat stomach and GEJ cancer when the cancer cells do not have a protein called HER2 (human epidermal growth factor receptor 2) on their surface (HER2-negative) but do have a protein called Claudin 18.2 (Claudin 18.2-positive). Zolbetuximab is thought to work by attaching to the Claudin 18.2 protein in their tumor, which switches on the body's immune system to attack the tumor. Certain stomach and GEJ cancers may be treated with immunotherapy, which helps the body's immune system fight cancer. This study will give more information about how well zolbetuximab works when given with an immunotherapy medicine called pembrolizumab and chemotherapy. In this study, adults with stomach cancer or GEJ cancer will either be given zolbetuximab with pembrolizumab and chemotherapy or a placebo with pembrolizumab and chemotherapy. A placebo looks like zolbetuximab but doesn't have any medicine in it.
The main aim of the study is to check how long people with stomach cancer and GEJ cancer live after treatment with zolbetuximab with pembrolizumab and chemotherapy compared to placebo with pembrolizumab and chemotherapy.
Adults with locally advanced unresectable or metastatic stomach cancer or GEJ cancer can take part. Locally advanced means the cancer has spread to nearby tissue. Unresectable means the cancer cannot be removed by surgery. Metastatic means the cancer has spread to other parts of the body. A tumor sample (biopsy) of their cancer will have the Claudin 18.2 protein, PD-L1 protein, and be HER2-negative. They may have been previously treated with certain standard therapies. People can also take part if they need to take medicines like steroids to suppress their immune system. They cannot take part if they have blockages or bleeding in their gut, have specific uncontrollable cancers such as symptomatic or untreated cancers in the nervous system, or have a specific heart condition, or infections.
The study treatments are either zolbetuximab with pembrolizumab and chemotherapy, or placebo with pembrolizumab and chemotherapy. People who take part will receive just 1 of the study treatments by chance. The people in the study and the study doctors will not know who takes which of the study treatments. Study treatment will be given in 6-week (42-day) cycles. The study treatment is mainly given to people slowly through a tube into a vein. This is called an infusion. People will receive study treatment as follows: Zolbetuximab or placebo: 1 infusion every 2 or 3 weeks (2 or 3 infusions in a cycle) together with: Chemotherapy (1 of the following types of chemotherapy): 1. CAPOX (capecitabine and oxaliplatin): 1 infusion of oxaliplatin every 3 weeks (2 infusions in a cycle). People will also take 1 tablet of capecitabine twice a day for 2 weeks (14 days) at the start of each cycle (Day 1) and again in the middle of each cycle (Day 22). After 8 study treatments people will receive capecitabine only. 2. Modified FOLFOX6 or mFOLFOX6 (5-fluorouracil, folinic acid and oxaliplatin): 1 infusion every 2 weeks (3 infusions in a cycle). After 12 study treatments people will receive folinic acid and fluorouracil only, instead of mFOLFOX6. Pembrolizumab: 1 infusion every 3 or 6 weeks (1 or 2 infusions in a cycle). People can be in the study and will receive study treatment until their cancer worsens, they cannot tolerate the study treatment, or they need to start another cancer treatment. People may receive pembrolizumab for up to 2 years. People will visit the clinic on certain days to receive their study treatment and have health checks. The study doctors will check if people had any medical problems from taking zolbetuximab or the other study treatments. On some visits they will have scans to check for any changes in their cancer. People will have the option of giving a tumor sample if they stop treatment because their cancer has worsened. People will visit the clinic after they stop their study treatment. People will be asked about any medical problems and will have a health check. People will continue to have scans every 9 or 12 weeks to check for any changes in their cancer. They will have telephone health checks every 3 months. The number of visits and checks done at each visit will depend on the health of each person and whether they completed their study treatment or not.
調査の概要
状態
詳細な説明
Zolbetuximab (Vyloy), has received marketing approval in Japan. The study is considered a post marketing study in Japan.
研究の種類
入学 (推定)
段階
- フェーズ 3
アクセスの拡大
連絡先と場所
研究連絡先
- 名前：Astellas Pharma Global Development Inc.
- 電話番号：800-888-7704
- メール：astellas.registration@astellas.com
研究場所
-
-
Alabama
-
Birmingham、Alabama、アメリカ、35294
- 引きこもった
- UAB Medicine - UAB Hospital
-
-
California
-
Bakersfield、California、アメリカ、93309
- 募集
- CBCC Global Research - Comprehensive Blood & Cancer Center
-
Cerritos、California、アメリカ、90703
- 募集
- TOI Clinical Research
-
La Jolla、California、アメリカ、92037-0845
- 募集
- University of California, San Diego Moores Cancer Center
-
Los Angeles、California、アメリカ、90025
- 募集
- The Angeles Clinic and Research Institute, West Los Angeles Office
-
-
Connecticut
-
Hartford、Connecticut、アメリカ、06102
- 募集
- Hartford HealthCare - Hartford Hospital
-
New Haven、Connecticut、アメリカ、06510
- 募集
- Yale University School of Medicine
-
-
District of Columbia
-
Washington D.C.、District of Columbia、アメリカ、20007
- 募集
- MedStar Georgetown University Hospital / Lombardi Comprehensive Cancer Center
-
-
Georgia
-
Atlanta、Georgia、アメリカ、30318
- 募集
- Piedmont Physician Medical Oncology Atlanta
-
-
Illinois
-
Chicago、Illinois、アメリカ、60611
- 募集
- Northwestern Memorial Hospital
-
-
Indiana
-
Indianapolis、Indiana、アメリカ、46237
- 募集
- Franciscan Health Oncology and Hematology Specialists
-
-
Iowa
-
Iowa City、Iowa、アメリカ、52242
- 募集
- Holden Comprehensive Cancer Center
-
-
Kansas
-
Westwood、Kansas、アメリカ、66205
- 募集
- University of Kansas Cancer Center
-
-
Kentucky
-
Edgewood、Kentucky、アメリカ、41017
- 募集
- Saint Elizabeth Medical Center Edgewood
-
-
Maryland
-
Baltimore、Maryland、アメリカ、21021
- 募集
- University of Maryland Medical System - University of Maryland Medical Center
-
-
Massachusetts
-
Boston、Massachusetts、アメリカ、02215
- 募集
- Dana Farber/Harvard Cancer Center
-
Worcester、Massachusetts、アメリカ、01655
- 募集
- University of Massachusetts - UMass Chan Medical School
-
-
Michigan
-
Ann Arbor、Michigan、アメリカ、48109
- 募集
- University of Michigan Health System
-
Detroit、Michigan、アメリカ、48201
- 募集
- Barbara Ann Karmanos Cancer Center
-
Detroit、Michigan、アメリカ、48201
- 募集
- Henry Ford Cancer Institute-Henry Ford Hospital
-
-
Minnesota
-
Saint Louis Park、Minnesota、アメリカ、55426
- 募集
- Metro Minnesota Community Oncology Research Consortium (MMCORC)
-
-
Nebraska
-
Omaha、Nebraska、アメリカ、68130
- 募集
- Oncology Hematology West PC dba Nebraska Cancer Specialists
-
Omaha、Nebraska、アメリカ、68198
- 引きこもった
- University of Nebraska Medical Center
-
-
New Jersey
-
Pennington、New Jersey、アメリカ、08534
- 募集
- Capital Health - Hematology Oncology Specialists
-
-
New York
-
New York、New York、アメリカ、10016
- 募集
- NYU Langone Medical Center
-
Stony Brook、New York、アメリカ、11794
- 募集
- Stony Brook University Hospital Cancer Center
-
The Bronx、New York、アメリカ、10461
- 募集
- Montefiore Medical Center
-
-
North Carolina
-
Chapel Hill、North Carolina、アメリカ、27599
- 募集
- University of North Carolina at Chapel Hill
-
Durham、North Carolina、アメリカ、27710
- 募集
- Duke University Medical Center - Duke Cancer Centre
-
-
Pennsylvania
-
Pittsburgh、Pennsylvania、アメリカ、15212
- 募集
- Allegheny General Hospital (AGH)-Allegheny Singer Research Institute
-
-
Rhode Island
-
Providence、Rhode Island、アメリカ、02903
- 募集
- Rhode Island Hospital
-
-
Tennessee
-
Knoxville、Tennessee、アメリカ、37920
- 募集
- The University of Tennessee Medical Center
-
Nashville、Tennessee、アメリカ、37232
- 募集
- Vanderbilt University Medical Center
-
-
Texas
-
Dallas、Texas、アメリカ、75246
- 募集
- Texas Oncology-Baylor Charles A Sammons Cancer Center
-
Fort Worth、Texas、アメリカ、76104
- 募集
- The Center For Cancer And Blood Disorders (Texas Cancer Care)
-
Houston、Texas、アメリカ、77030
- 募集
- Houston Methodist Cancer Center
-
-
Utah
-
Salt Lake City、Utah、アメリカ、84106
- 募集
- Utah Cancer Specialists Cancer Center - Medical Oncology
-
-
Virginia
-
Fairfax、Virginia、アメリカ、22031
- 募集
- Inova Schar Cancer Institute Clinical Trials
-
-
-
-
-
Bristol、イギリス
- 募集
- Site UK44001
-
Cardiff、イギリス
- 募集
- Site GB44003
-
Coventry、イギリス
- 募集
- Site GB44002
-
Dundee、イギリス
- 募集
- Site UK44006
-
Glasgow、イギリス
- 募集
- Site GB44004
-
London、イギリス
- 募集
- Site GB44005
-
London、イギリス
- 募集
- Site UK44011
-
London、イギリス
- 募集
- Site UK44014
-
London、イギリス
- 募集
- Site UK44015
-
London、イギリス
- 募集
- Site UK44016
-
Manchester、イギリス
- 募集
- Site UK44009
-
Sheffield、イギリス
- 募集
- Site GB44008
-
-
East Riding Of Yorkshire
-
Cottingham、East Riding Of Yorkshire、イギリス
- 募集
- Site GB44010
-
-
-
-
-
Ancona、イタリア
- 引きこもった
- Site IT39003
-
Bergamo、イタリア
- 募集
- Site IT39019
-
Bologna、イタリア
- 募集
- Site IT39017
-
Brescia、イタリア
- 募集
- Site IT39009
-
Candiolo、イタリア
- 募集
- Site IT39014
-
Cremona、イタリア
- 募集
- Site IT39006
-
Florence、イタリア
- 募集
- Site IT39011
-
Meldola、イタリア
- 募集
- Site IT39007
-
Milan、イタリア
- 募集
- Site IT39012
-
Milan、イタリア
- 募集
- Site IT39018
-
Milan、イタリア
- 募集
- Site IT39020
-
Naples、イタリア
- 引きこもった
- Site IT39021
-
Pisa、イタリア
- 募集
- Site IT39015
-
Reggio Emilia、イタリア
- 募集
- Site IT39004
-
Roma、イタリア
- 募集
- Site IT39016
-
Rome、イタリア
- 募集
- Site IT39001
-
Udine、イタリア
- 募集
- Site IT39022
-
Verona、イタリア
- 募集
- Site IT39002
-
-
-
-
-
Leeuwarden、オランダ
- 募集
- Site NL31002
-
Nijmegen、オランダ
- 募集
- Site NL31001
-
-
-
-
-
Fitzroy、オーストラリア
- 募集
- Site AU61001
-
-
New South Wales
-
Kogarah、New South Wales、オーストラリア
- 募集
- Site AU61002
-
-
Queensland
-
Brisbane、Queensland、オーストラリア
- 募集
- Site AU61004
-
-
Victoria
-
Clayton、Victoria、オーストラリア
- 募集
- Site AU61003
-
-
-
-
-
A Coruña、スペイン
- 募集
- Site ES34005
-
Barcelona、スペイン
- 募集
- Site ES34011
-
Barcelona、スペイン
- 募集
- Site ES34006
-
Barcelona、スペイン
- 募集
- Site ES34009
-
Barcelona、スペイン
- 募集
- Site ES34010
-
Barcelona、スペイン
- 募集
- Site ES34026
-
Barcelona、スペイン
- 募集
- Site ES34028
-
El Palmar、スペイン
- 募集
- Site ES34021
-
Lleida、スペイン
- 募集
- Site ES34014
-
Madrid、スペイン
- 募集
- Site ES34008
-
Madrid、スペイン
- 募集
- Site ES34003
-
Madrid、スペイン
- 募集
- Site ES34031
-
Madrid、スペイン
- 募集
- Site ES34016
-
Madrid、スペイン
- 募集
- Site ES34017
-
Madrid、スペイン
- 引きこもった
- Site ES34024
-
Murcia、スペイン
- 募集
- Site ES34030
-
Pozuelo de Alarcón、スペイン
- 募集
- Site ES34013
-
Santiago de Compostela、スペイン
- 募集
- Site ES34029
-
Seville、スペイン
- 募集
- Site ES34012
-
Seville、スペイン
- 募集
- Site ES34025
-
Valencia、スペイン
- 募集
- Site ES34004
-
Valencia、スペイン
- 募集
- Site ES34007
-
Zaragoza、スペイン
- 募集
- Site ES34018
-
Zaragoza、スペイン
- 募集
- Site ES34015
-
-
Alicante
-
Elche、Alicante、スペイン
- 募集
- Site ES34022
-
-
Cataluyna
-
San Cugat Del Valles Barcelona、Cataluyna、スペイン
- 募集
- Site ES34023
-
-
Madrid
-
Madrid、Madrid、スペイン
- 募集
- Site ES34019
-
Madrid、Madrid、スペイン
- 募集
- Site ES34027
-
-
Pamplona
-
Navarra、Pamplona、スペイン
- 募集
- Site ES34002
-
-
-
-
-
Brno、チェコ
- 募集
- Site CZ42006
-
Olomouc、チェコ
- 募集
- Site CZ42005
-
Prague、チェコ
- 募集
- Site CZ42002
-
Prague、チェコ
- 募集
- Site CZ42003
-
Prague、チェコ
- 募集
- Site CZ42004
-
-
-
-
-
Las Condes、チリ
- 募集
- Site CL56004
-
Santiago、チリ
- 引きこもった
- Site CL56001
-
-
-
-
-
Adana、トルコ（Türkiye）
- 募集
- Site TR90011
-
Ankara、トルコ（Türkiye）
- 募集
- Site TR90001
-
Ankara、トルコ（Türkiye）
- 募集
- Site TR90006
-
Ankara、トルコ（Türkiye）
- 募集
- Site TR90004
-
Bursa、トルコ（Türkiye）
- 募集
- Site TR90014
-
Istanbul、トルコ（Türkiye）
- 募集
- Site TR90005
-
Konya、トルコ（Türkiye）
- 募集
- Site TR90013
-
Samsun、トルコ（Türkiye）
- 募集
- Site TR90009
-
Van、トルコ（Türkiye）
- 募集
- Site TR90015
-
-
-
-
-
Berlin、ドイツ
- 募集
- Site DE49013
-
Essen、ドイツ
- 募集
- Site DE49010
-
Frankfurt am Main、ドイツ
- 募集
- Site DE49017
-
Hanover、ドイツ
- 募集
- Site DE49007
-
Leipzig、ドイツ
- 募集
- Site DE49004
-
Mainz、ドイツ
- 募集
- Site DE49001
-
Munich、ドイツ
- 募集
- Site DE49014
-
Nuremberg、ドイツ
- 募集
- Site DE49006
-
Saarbrücken、ドイツ
- 募集
- Site DE49002
-
Schweinfurt、ドイツ
- 募集
- Site DE49011
-
Wolfsburg、ドイツ
- 引きこもった
- Site DE49016
-
-
-
-
-
Bordeaux、フランス
- 募集
- Site FR33016
-
Brest、フランス
- 募集
- Site FR33008
-
Caen、フランス
- 募集
- Site FR33012
-
Carassonne、フランス
- 募集
- Site FR33009
-
Dijon、フランス
- 募集
- Site FR33005
-
Lille、フランス
- 募集
- Site FR33007
-
Lille、フランス
- 募集
- Site FR33002
-
Lyon、フランス
- 募集
- Site FR33014
-
Lyon、フランス
- 募集
- Site FR33017
-
Montpellier、フランス
- 募集
- Site FR33020
-
Nice、フランス
- 募集
- Site FR33018
-
Paris、フランス
- 募集
- Site FR33003
-
Paris、フランス
- 募集
- Site FR33010
-
Paris、フランス
- 募集
- Site FR33013
-
Plérin、フランス
- 募集
- Site FR33015
-
Poitiers、フランス
- 募集
- Site FR33004
-
Rouen、フランス
- 募集
- Site FR33006
-
Saint Herbian Cedex、フランス
- 募集
- Site FR33019
-
Strasbourg、フランス
- 募集
- Site FR33011
-
-
-
-
-
Belo Horizonte、ブラジル
- 募集
- Site BR55014
-
Blumenau、ブラジル
- 募集
- Site BR55002
-
Fortaleza、ブラジル
- 募集
- Site BR55012
-
Jaú、ブラジル
- 募集
- Site BR55008
-
Lages、ブラジル
- 募集
- Site BR55004
-
Porto Alegre、ブラジル
- 募集
- Site BR55003
-
São Caetano do Sul、ブラジル
- 募集
- Site BR55006
-
São José do Rio Preto、ブラジル
- 募集
- Site BR55001
-
São Paulo、ブラジル
- 募集
- Site BR55007
-
São Paulo、ブラジル
- 募集
- Site BR55011
-
São Paulo、ブラジル
- 募集
- BR55009
-
São Paulo、ブラジル
- 募集
- BR55010
-
-
-
-
-
Bonheiden、ベルギー
- 募集
- Site BE32002
-
Brussels、ベルギー
- 募集
- Site BE32001
-
Edegem、ベルギー
- 引きこもった
- Site BE32006
-
Ghent、ベルギー
- 募集
- Site BE32003
-
Leuven、ベルギー
- 募集
- Site BE32005
-
Liège、ベルギー
- 募集
- Site BE32004
-
-
-
-
-
Almada、ポルトガル
- 募集
- Site PT35106
-
Braga、ポルトガル
- 募集
- Site PT35103
-
Guimarães、ポルトガル
- 募集
- Site PT35104
-
Lisbon、ポルトガル
- 募集
- Site PT35102
-
Lisbon、ポルトガル
- 募集
- Site PT35107
-
Porto、ポルトガル
- 募集
- Site PT35105
-
Porto、ポルトガル
- 募集
- Site PT35108
-
Porto、ポルトガル
- 募集
- Site PT35109
-
-
-
-
-
Gliwice、ポーランド
- 募集
- Site PL48006
-
Olsztyn、ポーランド
- 募集
- Site PL48008
-
Przemyśl、ポーランド
- 募集
- Site PL48002
-
Swidnica、ポーランド
- 募集
- Site PL48009
-
Warsaw、ポーランド
- 募集
- Site PL48007
-
-
Lubusz Voivodeship
-
Lubin、Lubusz Voivodeship、ポーランド
- 募集
- Site PL48005
-
-
Masovian Voivodeship
-
Warsaw、Masovian Voivodeship、ポーランド
- 募集
- Site PL48004
-
-
Woj Podkarpackie
-
Brzozów、Woj Podkarpackie、ポーランド
- 募集
- Site PL48001
-
-
-
-
-
Mexico City、メキシコ
- 募集
- Site MX52003
-
Oaxaca City、メキシコ
- 募集
- Site MX52001
-
-
-
-
-
Kaunas、リトアニア
- 募集
- Site LT37001
-
Vilnius、リトアニア
- 募集
- Site LT37002
-
-
-
-
-
Bucharest、ルーマニア
- 募集
- Site RO40008
-
Cluj-Napoca、ルーマニア
- 募集
- Site RO40001
-
Cluj-Napoca、ルーマニア
- 募集
- Site RO40005
-
Cluj-Napoca、ルーマニア
- 募集
- Site RO40006
-
Craiova、ルーマニア
- 募集
- Site RO40003
-
Floreşti、ルーマニア
- 募集
- Site RO40002
-
Iași、ルーマニア
- 募集
- Site RO40007
-
Timișoara、ルーマニア
- 引きこもった
- Site RO40004
-
-
-
-
-
Baoding、中国、71000
- 積極的、募集していない
- Affiliated Hospital of Hebei University
-
Beijing、中国
- 積極的、募集していない
- Peking Union Medical College Hospital - Dongdan Campus
-
-
Anhui
-
Hefei、Anhui、中国、230031
- 積極的、募集していない
- Anhui Provincial Cancer Hospital
-
-
Fujian
-
Fuzhou、Fujian、中国
- 積極的、募集していない
- Fujian Provincial Hospital - Department of Medical Oncology
-
-
Guangdong
-
Guangzhou、Guangdong、中国、510060
- 積極的、募集していない
- Sun Yat-sen University - Cancer Center
-
Guangzhou、Guangdong、中国、510555
- 積極的、募集していない
- Sun Yat-sen University - Cancer Center
-
-
Heilongjiang
-
Harbin、Heilongjiang、中国
- 積極的、募集していない
- Harbin Medical University Cancer Hospital - Oncology
-
-
Henan
-
Zhenngzhou、Henan、中国
- 積極的、募集していない
- Henan Cancer Hospital - Oncology
-
-
Hubei
-
Wuhan、Hubei、中国、430079
- 積極的、募集していない
- Hubei Cancer Hospital - Oncology
-
-
Qinghai
-
Xining、Qinghai、中国
- 積極的、募集していない
- Qinghai University Affiliated Hospital
-
-
Shanghai Municipality
-
Shanghai、Shanghai Municipality、中国、200127
- 積極的、募集していない
- Renji Hospital Shanghai Jiaotong Univ School of Medicine
-
Shanghai、Shanghai Municipality、中国
- 積極的、募集していない
- Ruijin Hospital of Shanghai Jiaotong University School of Medicine
-
-
Sichuan
-
Chengdu、Sichuan、中国、610200
- 積極的、募集していない
- Sichuan Cancer Hospital
-
-
Tianjin Municipality
-
Tianjin、Tianjin Municipality、中国
- 積極的、募集していない
- Tianjin Medical University General Hospital
-
-
Zhejiang
-
Hangzhou、Zhejiang、中国
- 積極的、募集していない
- The First Affiliated Hospital of Zhejiang University
-
-
-
-
-
Kaohsiung City、台湾
- 積極的、募集していない
- Site TW88604
-
Taichung、台湾
- 積極的、募集していない
- Site TW88601
-
Tainan、台湾
- 積極的、募集していない
- Site TW88606
-
Taipei、台湾
- 積極的、募集していない
- Site TW88605
-
-
Taiwan
-
Dawan、Taiwan、台湾
- 積極的、募集していない
- Site TW88603
-
-
-
-
Chiba
-
Chiba、Chiba、日本
- 積極的、募集していない
- Chiba Cancer Center
-
Kashiwa、Chiba、日本
- 積極的、募集していない
- National Cancer Center Hospital East
-
-
Ehime
-
Matsuyama、Ehime、日本
- 積極的、募集していない
- National Hospital Organization Shikoku Cancer Center
-
-
Fukuoka
-
Fukuoka、Fukuoka、日本
- 積極的、募集していない
- Kyushu University Hospital (Hematology, Oncology & Cardiovascular medicine)
-
Fukuoka、Fukuoka、日本
- 積極的、募集していない
- Kyushu University Hospital(Gastrointestinal Surgery)
-
Fukuoka、Fukuoka、日本
- 積極的、募集していない
- National Hospital Organization Kyushu Cancer Center
-
-
Gunma
-
Maebashi、Gunma、日本
- 積極的、募集していない
- Gunma University Hospital
-
-
Hokkaido
-
Sapporo、Hokkaido、日本
- 積極的、募集していない
- Hokkaido University Hospital
-
-
Hyōgo
-
Akashi-shi、Hyōgo、日本
- 積極的、募集していない
- Hyogo Cancer Center
-
Kobe、Hyōgo、日本
- 積極的、募集していない
- Kobe City Medical Center General Hospital
-
-
Kagawa-ken
-
Kida-gun、Kagawa-ken、日本
- 積極的、募集していない
- Kagawa University Hospital
-
-
Kanagawa
-
Kawasaki-shi、Kanagawa、日本
- 積極的、募集していない
- St. Marianna University Hospital
-
Yokohama、Kanagawa、日本
- 積極的、募集していない
- Kanagawa Cancer Ctr Hospital
-
-
Miyagi
-
Sendai、Miyagi、日本
- 積極的、募集していない
- Tohoku University Hospital
-
-
Osaka
-
Osaka、Osaka、日本
- 積極的、募集していない
- Osaka General Medical Center
-
Osaka、Osaka、日本
- 積極的、募集していない
- Osaka International Cancer Institute
-
Suita-shi、Osaka、日本
- 積極的、募集していない
- Osaka University Hospital
-
-
Saitama
-
Hidaka-shi、Saitama、日本
- 積極的、募集していない
- Saitama Medical University International Medical Center
-
Kitaadachi-gun Ina-machi、Saitama、日本
- 積極的、募集していない
- Saitama Cancer Center
-
-
Shizuoka
-
Sunto-gun、Shizuoka、日本
- 積極的、募集していない
- Shizuoka Cancer Center
-
-
Tokyo
-
Chuo-ku、Tokyo、日本
- 積極的、募集していない
- National Cancer Center Hospital
-
Koto-ku、Tokyo、日本
- 積極的、募集していない
- The Cancer Institute Hospital of JFCR
-
-
-
-
-
Daegu、韓国
- 積極的、募集していない
- Site KR82004
-
Incheon、韓国
- 積極的、募集していない
- Site KR82005
-
Seoul、韓国
- 積極的、募集していない
- Site KR82001
-
Seoul、韓国
- 積極的、募集していない
- Site KR82002
-
Seoul、韓国
- 積極的、募集していない
- Site KR82006
-
Seoul、韓国
- 積極的、募集していない
- Site KR82010
-
Seoul、韓国
- 積極的、募集していない
- Site KR82012
-
Seoul、韓国
- 引きこもった
- Site KR82008
-
-
Gyeonggi-do
-
Goyang-si、Gyeonggi-do、韓国
- 引きこもった
- Site KR82011
-
Seongnam-si、Gyeonggi-do、韓国
- 積極的、募集していない
- Site KR82007
-
Suwon、Gyeonggi-do、韓国
- 積極的、募集していない
- Site KR82013
-
Suwon、Gyeonggi-do、韓国
- 積極的、募集していない
- Site KR82015
-
-
Joellanamdo
-
Hwasungun、Joellanamdo、韓国
- 積極的、募集していない
- Site KR82014
-
-
North Chungcheong
-
Cheongju-si、North Chungcheong、韓国
- 積極的、募集していない
- Site KR82009
-
-
Seoul
-
Seocho-gu、Seoul、韓国
- 積極的、募集していない
- Site KR82003
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
-
Participant has histologically confirmed gastric or Gastroesophageal Junction (GEJ) adenocarcinoma.
-
Participant has radiographically confirmed, locally advanced, unresectable or metastatic disease within 28 days prior to randomization.
-
Participant has radiologically evaluable disease (measurable and/or nonmeasurable) according to Response Evaluation Criteria in Solid Tumors (RECIST) V1.1, ≤ 28 days prior to randomization. For participants with only 1 evaluable lesion and prior radiotherapy ≤ 3 months before randomization, the lesion must either be outside the field of prior radiotherapy or have documented progression following radiation therapy.
-
Participant has Eastern Cooperative Oncology Group Performance Status (ECOG) performance status 0 to 1.
-
Participant has predicted life expectancy ≥ 12 weeks.
-
Participant must be a candidate to receive mFOLFOX6 or CAPOX and pembrolizumab.
-
Female participant is not pregnant and at least 1 of the following conditions apply:
- Not a woman of child bearing potential (WOCBP)
- WOCBP who has a negative urine or serum pregnancy test at screening (Specific to Japan: with a medical interview), and agrees to follow the contraceptive guidance from the time of informed consent through at least 9 months after the final oxaliplatin administration and 6 months after the final administration of all other study interventions.
- Female participant must not be breastfeeding or lactating starting at screening and throughout the investigational period and for 5 half-lives (at least 9 months after the final oxaliplatin administration and 6 months after the final administration of all other study interventions).
- Female participant must not donate ova starting at first administration of study intervention and throughout the investigational period, and for 9 months after the final administration of oxaliplatin and for 6 months after final administration of all other study interventions.
-
Male participant must agree to use contraception with female partner(s) of childbearing potential (including breastfeeding partner) throughout the treatment period, and for 6 months after final investigational study intervention administration.
-
Male participant must agree to remain abstinent or use a condom with pregnant partner(s) for the duration of the pregnancy throughout the investigational period and for 6 months after the final investigational study intervention administration.
-
Male participant must not donate sperm during the treatment period and for 6 months after the final investigational study intervention administration
-
Participant has a Human Epidermal Growth Factor Receptor 2 (HER2) -negative tumor.
-
Participant's tumor expresses Claudin18.2 (CLDN18.2) in ≥ 75% of tumor cells demonstrating moderate to strong membranous staining as determined by central immunohistochemistry (IHC) testing.
-
Participant's tumor expresses Programmed death ligand (PD-L1) combined positive score (CPS) ≥ 1 as determined by central IHC testing.
-
Participants with known microsatellite instability-high or mismatch repair deficient status may enroll as long as they meet the PD-L1 positivity criteria.
-
Participant must meet all of the criteria based on the centrally or locally analyzed laboratory tests collected within 14 days prior to randomization. In case of multiple central laboratory data within this period, the most recent data should be used.
-
Participant agrees not to participate in another interventional study while receiving study intervention in the present study.
Exclusion Criteria:
-
Participant has prior severe allergic reaction or intolerance to zolbetuximab or other monoclonal antibodies, pembrolizumab, mFOLFOX6 or CAPOX.
-
Participant has a complete gastric outlet syndrome or a partial gastric outlet syndrome with persistent recurrent vomiting.
-
Participant has significant gastric bleeding and/or untreated gastric ulcers that would preclude the participant from participation.
-
Participant has unresolved pneumonitis or history of non-infectious pneumonitis such as immune-related pneumonitis, radiation induced pneumonitis.
-
Participant has history of central nervous system metastases and/or carcinomatous meningitis from gastric/GEJ cancer.
-
Participant has a known history of a positive test for Human Immunodeficiency Virus (HIV) infection or known active Hepatitis B Surface Antigen (positive HBsAg) or hepatitis C infection. NOTE: Screening for these infections should be conducted per local requirements.
- For participants who are negative for HBsAg, but hepatitis B core antibody (HBcAb) positive, a hepatitis B DNA test will be performed and if positive the participant will be excluded.
- Participants with positive Hepatitis C virus (HCV) serology, but negative HCV RNA test results are eligible.
- Participants treated for HCV with undetectable viral load results are eligible.
-
Participant has active infection requiring systemic therapy that has not completely resolved within 7 days prior to randomization.
-
Participant has active autoimmune disease that has required systemic treatment within the past 3 months prior to randomization. Participants with stable autoimmune disease who are receiving physiologic replacement doses of hydrocortisone or its equivalent are allowed.
-
Participant has a clinically significant disease or comorbidity that may adversely affect the safe delivery of treatment within this study or make the participant unsuitable for study participation.
-
Participant has another malignancy for which treatment is required.
-
Participant has known complete Dihydropyrimidine Dehydrogenase (DPD) deficiency (screening for DPD deficiency should be conducted per local requirements).
-
Participant has known peripheral neuropathy > grade 1 (absence of deep tendon reflexes as the sole neurological abnormality does not render the participant ineligible).
-
Participant has sinusoidal obstruction syndrome, formerly known as veno-occlusive disease, if present, should be stable or improving.
-
Participant has significant cardiovascular disease, including any of the following:
- Congestive heart failure (defined as New York Heart Association Class III or IV), myocardial infarction, unstable angina, coronary angioplasty, coronary stenting, coronary artery bypass graft, cerebrovascular accident or hypertensive crisis within 6 months prior to randomization.
- History of clinically significant ventricular arrhythmias (i.e., sustained; ventricular tachycardia, ventricular fibrillation, or Torsades de Pointes).
- QTc interval > 450 msec for male participants; QTc interval > 470 msec for female participants.
- History or family history of congenital long QT syndrome.
- Cardiac arrhythmias requiring anti-arrhythmic medications (participants with rate controlled atrial fibrillation for > 1 month prior to randomization are eligible).
-
Participant has ongoing or previous interstitial lung disease, active diverticulitis or peptic ulcerative disease, or solid organ or stem cell transplant or other uncontrolled or clinically significant medical disorders.
-
Participant has type 1 diabetes mellitus, endocrinopathies stably maintained on appropriate replacement therapy or skin disorders (e.g., vitiligo, psoriasis or alopecia) not requiring systemic treatment are allowed.
-
Participant has received prior systemic chemotherapy and/or immunotherapy for locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma, except for a maximum of 1 treatment course of mFOLFOX6 (day 1 to 14) or CAPOX (day 1 to 21) with or without pembrolizumab. However, participants may have received either neo-adjuvant or adjuvant chemotherapy, immunotherapy or other systemic anticancer therapies as long as their disease progression occurred at least 6 months after the last dose. Participant who has received treatment with herbal medications that have known antitumor activity > 28 days prior to randomization is allowed.
-
Participant has received systemic immunosuppressive therapy, including systemic corticosteroids 14 days prior to randomization. Participant using a physiologic replacement dose of hydrocortisone or its equivalent (defined as up to 30 mg per day of hydrocortisone or up to 10 mg per day of prednisone), receiving a single-dose of systemic corticosteroids or receiving systemic corticosteroids as premedication for radiologic imaging contrast use is allowed.
-
Participant has had major surgical procedure ≤ 28 days before randomization and has not completely recovered from the surgical procedure ≤ 14 days before randomization.
-
Participant has received radiotherapy for locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma ≤ 14 days prior to randomization and has NOT recovered from any related toxicity. Palliative radiotherapy is allowed and must be completed > 14 days prior to randomization.
-
Participant has received prior CLDN18.2 agents.
-
Participant received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention.
-
Participant has received other investigational agents or devices concurrently or within 28 days prior to randomization or within 5 half-lives of the drug, whichever is longer.
-
Participant has any condition which makes the participant unsuitable for study participation.
-
Participant has any concurrent disease, infection, or co-morbid condition that interferes with the ability of the participant to participate in the study, which places the participant at undue risk or complicates the interpretation of data.
-
Treatment with brivudine, sorivudine or their chemically related analogues within 28 days prior to randomization or within 5 half-lives of the drug, whichever is shorter, is strictly prohibited.
-
Pernicious anemia or other anemias due to vitamin B12 deficiency.
-
Participant has a known history of a positive test for tuberculosis or known active tuberculosis infection. NOTE: Screening for these infections should be conducted per local requirements.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Arm A: zolbetuximab in combination with pembrolizumab and chemotherapy
Participants will receive zolbetuximab as an intravenous (via a vein) infusion at 800 mg/m2 loading dose at C1D1 followed by subsequent doses of 400 mg/m2 every 2 weeks; or 800 mg/m2 loading dose at C1D1 followed by subsequent doses of 600 mg/m2 every 3 weeks, followed by an intravenous infusion of pembrolizumab at a dose of 200 mg every 3 weeks or 400 mg every 6 weeks. Participants will then receive chemotherapy over 4 or more cycles of either up to 8 CAPOX treatments (oxaliplatin: 130 mg/m2 once every 3 weeks, capecitabine: 1000 mg/m2 twice daily on days 1 through 14 and days 22 through 35 of each cycle), or, up to 12 mFOLFOX6 treatments (oxaliplatin: 85 mg/m2, Folinic acid (leucovorin/local equivalent): 400 mg/m2, 5-FU bolus: 400 mg/m2, 5-FU infusion: 2400 mg/m2) once every 2 weeks (or components of mFOLFOX6 if some components are discontinued due to toxicity). The choice of chemotherapy for each participant is based on investigator's judgment. Each cycle is approximately 42 days. |
Participants will receive an IV infusion of zolbetuximab on Cycle 1 Day 1 (C1D1) followed by subsequent IV infusion every 2 weeks or every 3 weeks.
他の名前：
Participants will receive an IV infusion of pembrolizumab every 3 weeks or every 6 weeks. Participants receiving CAPOX regimen of chemotherapy will receive capecitabine Tablet twice daily orally on days 1 through 14 and days 22 through 35 of each cycle. Participants receiving CAPOX or mFOLFOX6 regimen of chemotherapy will receive an IV infusion of oxaliplatin once every 2 or 3 weeks. Participants receiving mFOLFOX6 regimen of chemotherapy will receive an IV infusion of Folinic acid (leucovorin or local equivalent) once every 2 weeks. Participants receiving mFOLFOX6 regimen of chemotherapy will receive an IV infusion, or IV bolus of 5-FU once every 2 weeks. |
|
アクティブコンパレータ：Arm B: Placebo in combination with pembrolizumab and chemotherapy
Participants will receive matching placebo as an intravenous (via a vein) infusion followed by an intravenous infusion of pembrolizumab at a dose of 200 mg every 3 weeks or 400 mg every 6 weeks. Participants will then receive chemotherapy over 4 or more cycles of either up to 8 CAPOX treatments (oxaliplatin: 130 mg/m2 once every 3 weeks, capecitabine: 1000 mg/m2 twice daily on days 1 through 14 and days 22 through 35 of each cycle), or, up to 12 mFOLFOX6 treatments (oxaliplatin: 85 mg/m2, Folinic acid (leucovorin/local equivalent): 400 mg/m2, 5-FU bolus: 400 mg/m2, 5-FU infusion: 2400 mg/m2) once every 2 weeks (or components of mFOLFOX6 if some components are discontinued due to toxicity). The choice of chemotherapy for each participant is based on investigator's judgment. Each cycle is approximately 42 days. |
Participants will receive an IV infusion of pembrolizumab every 3 weeks or every 6 weeks. Participants receiving CAPOX regimen of chemotherapy will receive capecitabine Tablet twice daily orally on days 1 through 14 and days 22 through 35 of each cycle. Participants receiving CAPOX or mFOLFOX6 regimen of chemotherapy will receive an IV infusion of oxaliplatin once every 2 or 3 weeks. Participants receiving mFOLFOX6 regimen of chemotherapy will receive an IV infusion of Folinic acid (leucovorin or local equivalent) once every 2 weeks. Participants receiving mFOLFOX6 regimen of chemotherapy will receive an IV infusion, or IV bolus of 5-FU once every 2 weeks. Participants will receive an IV infusion of placebo (0.9% of sodium chloride) on C1D1 followed by subsequent IV infusion every 2 weeks or every 3 weeks. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Overall Survival (OS)
時間枠：Up to 72 months
|
OS is defined as the time from the date of randomization until the date of death from any cause. |
Up to 72 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
陽性の抗抗抗体（ADA）からゾルベトゥキシブを持つ参加者の数
時間枠：最大57か月
|
最大57か月
|
|
|
Progression Free Survival (PFS)
時間枠：Up to 72 Months
|
Defined as the time from the date of randomization until the date of radiologic disease progression [investigator-assessed per Response Evaluation Criteria in Solid Tumors (RECIST) V1.1] or death from any cause, whichever is earlier. |
Up to 72 Months
|
|
Objective Response Rate (ORR)
時間枠：Up to 57 Months
|
Defined as the proportion of participants who have a Best Overall Response (BOR) or Complete Response (CR) or Partial Response (PR) as investigator assessed per RECIST V1.1. |
Up to 57 Months
|
|
Duration of Response (DOR)
時間枠：Up to 72 Months
|
Defined as the time from the date of the first response (CR/PR) until the date of disease progression as investigator-assessed per RECIST V1.1 or date of death from any cause, whichever is earlier. |
Up to 72 Months
|
|
Number of participants with adverse Events (AEs)
時間枠：Up to 57 Months
|
Adverse events (AEs) will coded using MedDRA. An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. This includes events related to the comparator, if applicable, and events related to the (study) procedures. |
Up to 57 Months
|
|
Number of participants with electrocardiograms (ECG) abnormalities and/or AEs
時間枠：Up to 57 Months
|
Number of participants with potentially clinically significant ECG values. |
Up to 57 Months
|
|
Number of Participants with Vital Sign abnormalities and/or AEs
時間枠：Up to 57 Months
|
Number of participants with potentially clinically significant vital sign values. |
Up to 57 Months
|
|
Number of participants at each grade of Eastern Cooperative Oncology Group (ECOG) performance status score
時間枠：Up to 57 Months
|
The ECOG scale will be used to assess performance status. Grades range from 0 (fully active) to 5 (dead). Negative change scores indicate an improvement. Positive scores indicate a decline in performance. |
Up to 57 Months
|
|
Number of participants with laboratory assessments abnormalities and/ or AEs
時間枠：Up to 57 Months
|
Number of participants with potentially clinically significant laboratory values. |
Up to 57 Months
|
|
Pharmacokinetics (PK) of zolbetuximab in serum: End of Infusion Concentration
時間枠：Up to 57 Months
|
Concentration will be derived from the PK serum samples collected at time of end of infusion. |
Up to 57 Months
|
|
Pharmacokinetics (PK) of zolbetuximab in serum: Concentration Immediately Prior to Dosing at multiple dosing (Ctrough)
時間枠：Up to 57 Months
|
Ctrough will be derived from the PK serum samples collected. |
Up to 57 Months
|
協力者と研究者
捜査官
- スタディディレクター：Medical Monitor、Astellas Pharma Global Development, Inc.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- 8951-CL-0305
- 2024-519773-19 (レジストリ識別子：CTIS (EU))
- jRCT2031250021 (レジストリ識別子：Japan Registry of Clinical Trials (jRCT))
- CTR20253090 (レジストリ識別子：ChinaDrugTrials.org.cn)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
IPD 共有時間枠
Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
IPD 共有アクセス基準
Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- CSR
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。