Eine Studie über Zolbetuximab zusammen mit Pembrolizumab und Chemotherapie bei Erwachsenen mit Magenkrebs (LUCERNA)
A Phase 3, Double-blind, Randomized Study of Zolbetuximab in Combination With Pembrolizumab and Chemotherapy (CAPOX or mFOLFOX6) in First-line Treatment of Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma in Participants Whose Tumors Are HER2-negative, Claudin (CLDN) 18.2-positive and Programmed Death-ligand 1 (PD-L1) -Positiv
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.
Studienübersicht
Status
Status
Bedingungen
Bedingungen
- Lokal fortgeschrittenes, nicht resezierbares Adenokarzinom oder Krebs der gastroösophagealen Junction (GEJ).
- Lokal fortgeschrittenes, nicht resezierbares Adenokarzinom oder Krebs des Magens
- Metastasierendes Adenokarzinom des Magens oder Krebs
- Metastasierendes Adenokarzinom des gastroösophagealen Übergangs (GEJ).
Intervention / Behandlung
Intervention / Behandlung
Detaillierte Beschreibung
Zolbetuximab (Vyloy), has received marketing approval in Japan. The study is considered a post marketing study in Japan.
Studientyp
Studientyp
Einschreibung (Geschätzt)
Einschreibung
Phase
Phase
- Phase 3
Erweiterter Zugriff
Erweiterter Zugriff
Verfügbar
- Verfügbar: Für diese Prüfbehandlung ist derzeit ein erweiterter Zugang verfügbar, und Patienten, die nicht an der klinischen Studie teilnehmen, können möglicherweise Zugang zu dem Medikament, Biologikum oder Medizinprodukt erhalten wird untersucht.
- Nicht mehr verfügbar: Erweiterter Zugriff war früher für diese Intervention verfügbar, ist aber derzeit nicht verfügbar und wird auch in Zukunft nicht verfügbar sein.
- Vorübergehend nicht verfügbar: Erweiterter Zugang ist derzeit für diese Intervention nicht verfügbar, wird aber voraussichtlich in Zukunft verfügbar sein.
- Zur Vermarktung zugelassen: Die Intervention wurde von der U.S. Food and Drug Administration für die Verwendung durch die Öffentlichkeit zugelassen.
Kontakte und Standorte
Studienkontakt
Studienkontakt
- Name: Astellas Pharma Global Development Inc.
- Telefonnummer: 800-888-7704
- E-Mail: astellas.registration@astellas.com
Studienorte
-
-
-
Fitzroy, Australien
- Rekrutierung
- Site AU61001
-
-
New South Wales
-
Kogarah, New South Wales, Australien
- Rekrutierung
- Site AU61002
-
-
Queensland
-
Brisbane, Queensland, Australien
- Rekrutierung
- Site AU61004
-
-
Victoria
-
Clayton, Victoria, Australien
- Rekrutierung
- Site AU61003
-
-
-
-
-
Bonheiden, Belgien
- Rekrutierung
- Site BE32002
-
Brussels, Belgien
- Rekrutierung
- Site BE32001
-
Edegem, Belgien
- Zurückgezogen
- Site BE32006
-
Ghent, Belgien
- Rekrutierung
- Site BE32003
-
Leuven, Belgien
- Rekrutierung
- Site BE32005
-
Liège, Belgien
- Rekrutierung
- Site BE32004
-
-
-
-
-
Belo Horizonte, Brasilien
- Rekrutierung
- Site BR55014
-
Blumenau, Brasilien
- Rekrutierung
- Site BR55002
-
Fortaleza, Brasilien
- Rekrutierung
- Site BR55012
-
Jaú, Brasilien
- Rekrutierung
- Site BR55008
-
Lages, Brasilien
- Rekrutierung
- Site BR55004
-
Porto Alegre, Brasilien
- Rekrutierung
- Site BR55003
-
São Caetano do Sul, Brasilien
- Rekrutierung
- Site BR55006
-
São José do Rio Preto, Brasilien
- Rekrutierung
- Site BR55001
-
São Paulo, Brasilien
- Rekrutierung
- Site BR55007
-
São Paulo, Brasilien
- Rekrutierung
- Site BR55011
-
São Paulo, Brasilien
- Rekrutierung
- BR55009
-
São Paulo, Brasilien
- Rekrutierung
- BR55010
-
-
-
-
-
Las Condes, Chile
- Rekrutierung
- Site CL56004
-
Santiago, Chile
- Zurückgezogen
- Site CL56001
-
-
-
-
-
Baoding, China, 71000
- Aktiv, nicht rekrutierend
- Affiliated Hospital of Hebei University
-
Beijing, China
- Aktiv, nicht rekrutierend
- Peking Union Medical College Hospital - Dongdan Campus
-
-
Anhui
-
Hefei, Anhui, China, 230031
- Aktiv, nicht rekrutierend
- Anhui Provincial Cancer Hospital
-
-
Fujian
-
Fuzhou, Fujian, China
- Aktiv, nicht rekrutierend
- Fujian Provincial Hospital - Department of Medical Oncology
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510060
- Aktiv, nicht rekrutierend
- Sun Yat-sen University - Cancer Center
-
Guangzhou, Guangdong, China, 510555
- Aktiv, nicht rekrutierend
- Sun Yat-sen University - Cancer Center
-
-
Heilongjiang
-
Harbin, Heilongjiang, China
- Aktiv, nicht rekrutierend
- Harbin Medical University Cancer Hospital - Oncology
-
-
Henan
-
Zhenngzhou, Henan, China
- Aktiv, nicht rekrutierend
- Henan Cancer Hospital - Oncology
-
-
Hubei
-
Wuhan, Hubei, China, 430079
- Aktiv, nicht rekrutierend
- Hubei Cancer Hospital - Oncology
-
-
Qinghai
-
Xining, Qinghai, China
- Aktiv, nicht rekrutierend
- Qinghai University Affiliated Hospital
-
-
Shanghai Municipality
-
Shanghai, Shanghai Municipality, China, 200127
- Aktiv, nicht rekrutierend
- Renji Hospital Shanghai Jiaotong Univ School of Medicine
-
Shanghai, Shanghai Municipality, China
- Aktiv, nicht rekrutierend
- Ruijin Hospital of Shanghai Jiaotong University School of Medicine
-
-
Sichuan
-
Chengdu, Sichuan, China, 610200
- Aktiv, nicht rekrutierend
- Sichuan Cancer Hospital
-
-
Tianjin Municipality
-
Tianjin, Tianjin Municipality, China
- Aktiv, nicht rekrutierend
- Tianjin Medical University General Hospital
-
-
Zhejiang
-
Hangzhou, Zhejiang, China
- Aktiv, nicht rekrutierend
- The First Affiliated Hospital of Zhejiang University
-
-
-
-
-
Berlin, Deutschland
- Rekrutierung
- Site DE49013
-
Essen, Deutschland
- Rekrutierung
- Site DE49010
-
Frankfurt am Main, Deutschland
- Rekrutierung
- Site DE49017
-
Hanover, Deutschland
- Rekrutierung
- Site DE49007
-
Leipzig, Deutschland
- Rekrutierung
- Site DE49004
-
Mainz, Deutschland
- Rekrutierung
- Site DE49001
-
Munich, Deutschland
- Rekrutierung
- Site DE49014
-
Nuremberg, Deutschland
- Rekrutierung
- Site DE49006
-
Saarbrücken, Deutschland
- Rekrutierung
- Site DE49002
-
Schweinfurt, Deutschland
- Rekrutierung
- Site DE49011
-
Wolfsburg, Deutschland
- Zurückgezogen
- Site DE49016
-
-
-
-
-
Bordeaux, Frankreich
- Rekrutierung
- Site FR33016
-
Brest, Frankreich
- Rekrutierung
- Site FR33008
-
Caen, Frankreich
- Rekrutierung
- Site FR33012
-
Carassonne, Frankreich
- Rekrutierung
- Site FR33009
-
Dijon, Frankreich
- Rekrutierung
- Site FR33005
-
Lille, Frankreich
- Rekrutierung
- Site FR33007
-
Lille, Frankreich
- Rekrutierung
- Site FR33002
-
Lyon, Frankreich
- Rekrutierung
- Site FR33014
-
Lyon, Frankreich
- Rekrutierung
- Site FR33017
-
Montpellier, Frankreich
- Rekrutierung
- Site FR33020
-
Nice, Frankreich
- Rekrutierung
- Site FR33018
-
Paris, Frankreich
- Rekrutierung
- Site FR33003
-
Paris, Frankreich
- Rekrutierung
- Site FR33010
-
Paris, Frankreich
- Rekrutierung
- Site FR33013
-
Plérin, Frankreich
- Rekrutierung
- Site FR33015
-
Poitiers, Frankreich
- Rekrutierung
- Site FR33004
-
Rouen, Frankreich
- Rekrutierung
- Site FR33006
-
Saint Herbian Cedex, Frankreich
- Rekrutierung
- Site FR33019
-
Strasbourg, Frankreich
- Rekrutierung
- Site FR33011
-
-
-
-
-
Ancona, Italien
- Zurückgezogen
- Site IT39003
-
Bergamo, Italien
- Rekrutierung
- Site IT39019
-
Bologna, Italien
- Rekrutierung
- Site IT39017
-
Brescia, Italien
- Rekrutierung
- Site IT39009
-
Candiolo, Italien
- Rekrutierung
- Site IT39014
-
Cremona, Italien
- Rekrutierung
- Site IT39006
-
Florence, Italien
- Rekrutierung
- Site IT39011
-
Meldola, Italien
- Rekrutierung
- Site IT39007
-
Milan, Italien
- Rekrutierung
- Site IT39012
-
Milan, Italien
- Rekrutierung
- Site IT39018
-
Milan, Italien
- Rekrutierung
- Site IT39020
-
Naples, Italien
- Zurückgezogen
- Site IT39021
-
Pisa, Italien
- Rekrutierung
- Site IT39015
-
Reggio Emilia, Italien
- Rekrutierung
- Site IT39004
-
Roma, Italien
- Rekrutierung
- Site IT39016
-
Rome, Italien
- Rekrutierung
- Site IT39001
-
Udine, Italien
- Rekrutierung
- Site IT39022
-
Verona, Italien
- Rekrutierung
- Site IT39002
-
-
-
-
Chiba
-
Chiba, Chiba, Japan
- Aktiv, nicht rekrutierend
- Chiba Cancer Center
-
Kashiwa, Chiba, Japan
- Aktiv, nicht rekrutierend
- National Cancer Center Hospital East
-
-
Ehime
-
Matsuyama, Ehime, Japan
- Aktiv, nicht rekrutierend
- National Hospital Organization Shikoku Cancer Center
-
-
Fukuoka
-
Fukuoka, Fukuoka, Japan
- Aktiv, nicht rekrutierend
- Kyushu University Hospital (Hematology, Oncology & Cardiovascular medicine)
-
Fukuoka, Fukuoka, Japan
- Aktiv, nicht rekrutierend
- Kyushu University Hospital(Gastrointestinal Surgery)
-
Fukuoka, Fukuoka, Japan
- Aktiv, nicht rekrutierend
- National Hospital Organization Kyushu Cancer Center
-
-
Gunma
-
Maebashi, Gunma, Japan
- Aktiv, nicht rekrutierend
- Gunma University Hospital
-
-
Hokkaido
-
Sapporo, Hokkaido, Japan
- Aktiv, nicht rekrutierend
- Hokkaido University Hospital
-
-
Hyōgo
-
Akashi-shi, Hyōgo, Japan
- Aktiv, nicht rekrutierend
- Hyogo Cancer Center
-
Kobe, Hyōgo, Japan
- Aktiv, nicht rekrutierend
- Kobe City Medical Center General Hospital
-
-
Kagawa-ken
-
Kida-gun, Kagawa-ken, Japan
- Aktiv, nicht rekrutierend
- Kagawa University Hospital
-
-
Kanagawa
-
Kawasaki-shi, Kanagawa, Japan
- Aktiv, nicht rekrutierend
- St. Marianna University Hospital
-
Yokohama, Kanagawa, Japan
- Aktiv, nicht rekrutierend
- Kanagawa Cancer Ctr Hospital
-
-
Miyagi
-
Sendai, Miyagi, Japan
- Aktiv, nicht rekrutierend
- Tohoku University Hospital
-
-
Osaka
-
Osaka, Osaka, Japan
- Aktiv, nicht rekrutierend
- Osaka General Medical Center
-
Osaka, Osaka, Japan
- Aktiv, nicht rekrutierend
- Osaka International Cancer Institute
-
Suita-shi, Osaka, Japan
- Aktiv, nicht rekrutierend
- Osaka University Hospital
-
-
Saitama
-
Hidaka-shi, Saitama, Japan
- Aktiv, nicht rekrutierend
- Saitama Medical University International Medical Center
-
Kitaadachi-gun Ina-machi, Saitama, Japan
- Aktiv, nicht rekrutierend
- Saitama Cancer Center
-
-
Shizuoka
-
Sunto-gun, Shizuoka, Japan
- Aktiv, nicht rekrutierend
- Shizuoka Cancer Center
-
-
Tokyo
-
Chuo-ku, Tokyo, Japan
- Aktiv, nicht rekrutierend
- National Cancer Center Hospital
-
Koto-ku, Tokyo, Japan
- Aktiv, nicht rekrutierend
- The Cancer Institute Hospital of JFCR
-
-
-
-
-
Kaunas, Litauen
- Rekrutierung
- Site LT37001
-
Vilnius, Litauen
- Rekrutierung
- Site LT37002
-
-
-
-
-
Mexico City, Mexiko
- Rekrutierung
- Site MX52003
-
Oaxaca City, Mexiko
- Rekrutierung
- Site MX52001
-
-
-
-
-
Leeuwarden, Niederlande
- Rekrutierung
- Site NL31002
-
Nijmegen, Niederlande
- Rekrutierung
- Site NL31001
-
-
-
-
-
Gliwice, Polen
- Rekrutierung
- Site PL48006
-
Olsztyn, Polen
- Rekrutierung
- Site PL48008
-
Przemyśl, Polen
- Rekrutierung
- Site PL48002
-
Swidnica, Polen
- Rekrutierung
- Site PL48009
-
Warsaw, Polen
- Rekrutierung
- Site PL48007
-
-
Lubusz Voivodeship
-
Lubin, Lubusz Voivodeship, Polen
- Rekrutierung
- Site PL48005
-
-
Masovian Voivodeship
-
Warsaw, Masovian Voivodeship, Polen
- Rekrutierung
- Site PL48004
-
-
Woj Podkarpackie
-
Brzozów, Woj Podkarpackie, Polen
- Rekrutierung
- Site PL48001
-
-
-
-
-
Almada, Portugal
- Rekrutierung
- Site PT35106
-
Braga, Portugal
- Rekrutierung
- Site PT35103
-
Guimarães, Portugal
- Rekrutierung
- Site PT35104
-
Lisbon, Portugal
- Rekrutierung
- Site PT35102
-
Lisbon, Portugal
- Rekrutierung
- Site PT35107
-
Porto, Portugal
- Rekrutierung
- Site PT35105
-
Porto, Portugal
- Rekrutierung
- Site PT35108
-
Porto, Portugal
- Rekrutierung
- Site PT35109
-
-
-
-
-
Bucharest, Rumänien
- Rekrutierung
- Site RO40008
-
Cluj-Napoca, Rumänien
- Rekrutierung
- Site RO40001
-
Cluj-Napoca, Rumänien
- Rekrutierung
- Site RO40005
-
Cluj-Napoca, Rumänien
- Rekrutierung
- Site RO40006
-
Craiova, Rumänien
- Rekrutierung
- Site RO40003
-
Floreşti, Rumänien
- Rekrutierung
- Site RO40002
-
Iași, Rumänien
- Rekrutierung
- Site RO40007
-
Timișoara, Rumänien
- Zurückgezogen
- Site RO40004
-
-
-
-
-
A Coruña, Spanien
- Rekrutierung
- Site ES34005
-
Barcelona, Spanien
- Rekrutierung
- Site ES34011
-
Barcelona, Spanien
- Rekrutierung
- Site ES34006
-
Barcelona, Spanien
- Rekrutierung
- Site ES34009
-
Barcelona, Spanien
- Rekrutierung
- Site ES34010
-
Barcelona, Spanien
- Rekrutierung
- Site ES34026
-
Barcelona, Spanien
- Rekrutierung
- Site ES34028
-
El Palmar, Spanien
- Rekrutierung
- Site ES34021
-
Lleida, Spanien
- Rekrutierung
- Site ES34014
-
Madrid, Spanien
- Rekrutierung
- Site ES34008
-
Madrid, Spanien
- Rekrutierung
- Site ES34003
-
Madrid, Spanien
- Rekrutierung
- Site ES34031
-
Madrid, Spanien
- Rekrutierung
- Site ES34016
-
Madrid, Spanien
- Rekrutierung
- Site ES34017
-
Madrid, Spanien
- Zurückgezogen
- Site ES34024
-
Murcia, Spanien
- Rekrutierung
- Site ES34030
-
Pozuelo de Alarcón, Spanien
- Rekrutierung
- Site ES34013
-
Santiago de Compostela, Spanien
- Rekrutierung
- Site ES34029
-
Seville, Spanien
- Rekrutierung
- Site ES34012
-
Seville, Spanien
- Rekrutierung
- Site ES34025
-
Valencia, Spanien
- Rekrutierung
- Site ES34004
-
Valencia, Spanien
- Rekrutierung
- Site ES34007
-
Zaragoza, Spanien
- Rekrutierung
- Site ES34018
-
Zaragoza, Spanien
- Rekrutierung
- Site ES34015
-
-
Alicante
-
Elche, Alicante, Spanien
- Rekrutierung
- Site ES34022
-
-
Cataluyna
-
San Cugat Del Valles Barcelona, Cataluyna, Spanien
- Rekrutierung
- Site ES34023
-
-
Madrid
-
Madrid, Madrid, Spanien
- Rekrutierung
- Site ES34019
-
Madrid, Madrid, Spanien
- Rekrutierung
- Site ES34027
-
-
Pamplona
-
Navarra, Pamplona, Spanien
- Rekrutierung
- Site ES34002
-
-
-
-
-
Daegu, Südkorea
- Aktiv, nicht rekrutierend
- Site KR82004
-
Incheon, Südkorea
- Aktiv, nicht rekrutierend
- Site KR82005
-
Seoul, Südkorea
- Aktiv, nicht rekrutierend
- Site KR82001
-
Seoul, Südkorea
- Aktiv, nicht rekrutierend
- Site KR82002
-
Seoul, Südkorea
- Aktiv, nicht rekrutierend
- Site KR82006
-
Seoul, Südkorea
- Aktiv, nicht rekrutierend
- Site KR82010
-
Seoul, Südkorea
- Aktiv, nicht rekrutierend
- Site KR82012
-
Seoul, Südkorea
- Zurückgezogen
- Site KR82008
-
-
Gyeonggi-do
-
Goyang-si, Gyeonggi-do, Südkorea
- Zurückgezogen
- Site KR82011
-
Seongnam-si, Gyeonggi-do, Südkorea
- Aktiv, nicht rekrutierend
- Site KR82007
-
Suwon, Gyeonggi-do, Südkorea
- Aktiv, nicht rekrutierend
- Site KR82013
-
Suwon, Gyeonggi-do, Südkorea
- Aktiv, nicht rekrutierend
- Site KR82015
-
-
Joellanamdo
-
Hwasungun, Joellanamdo, Südkorea
- Aktiv, nicht rekrutierend
- Site KR82014
-
-
North Chungcheong
-
Cheongju-si, North Chungcheong, Südkorea
- Aktiv, nicht rekrutierend
- Site KR82009
-
-
Seoul
-
Seocho-gu, Seoul, Südkorea
- Aktiv, nicht rekrutierend
- Site KR82003
-
-
-
-
-
Kaohsiung City, Taiwan
- Aktiv, nicht rekrutierend
- Site TW88604
-
Taichung, Taiwan
- Aktiv, nicht rekrutierend
- Site TW88601
-
Tainan, Taiwan
- Aktiv, nicht rekrutierend
- Site TW88606
-
Taipei, Taiwan
- Aktiv, nicht rekrutierend
- Site TW88605
-
-
Taiwan
-
Dawan, Taiwan, Taiwan
- Aktiv, nicht rekrutierend
- Site TW88603
-
-
-
-
-
Brno, Tschechien
- Rekrutierung
- Site CZ42006
-
Olomouc, Tschechien
- Rekrutierung
- Site CZ42005
-
Prague, Tschechien
- Rekrutierung
- Site CZ42002
-
Prague, Tschechien
- Rekrutierung
- Site CZ42003
-
Prague, Tschechien
- Rekrutierung
- Site CZ42004
-
-
-
-
-
Adana, Türkei (türkiye)
- Rekrutierung
- Site TR90011
-
Ankara, Türkei (türkiye)
- Rekrutierung
- Site TR90001
-
Ankara, Türkei (türkiye)
- Rekrutierung
- Site TR90006
-
Ankara, Türkei (türkiye)
- Rekrutierung
- Site TR90004
-
Bursa, Türkei (türkiye)
- Rekrutierung
- Site TR90014
-
Istanbul, Türkei (türkiye)
- Rekrutierung
- Site TR90005
-
Konya, Türkei (türkiye)
- Rekrutierung
- Site TR90013
-
Samsun, Türkei (türkiye)
- Rekrutierung
- Site TR90009
-
Van, Türkei (türkiye)
- Rekrutierung
- Site TR90015
-
-
-
-
Alabama
-
Birmingham, Alabama, Vereinigte Staaten, 35294
- Zurückgezogen
- UAB Medicine - UAB Hospital
-
-
California
-
Bakersfield, California, Vereinigte Staaten, 93309
- Rekrutierung
- CBCC Global Research - Comprehensive Blood & Cancer Center
-
Cerritos, California, Vereinigte Staaten, 90703
- Rekrutierung
- TOI Clinical Research
-
La Jolla, California, Vereinigte Staaten, 92037-0845
- Rekrutierung
- University of California, San Diego Moores Cancer Center
-
Los Angeles, California, Vereinigte Staaten, 90025
- Rekrutierung
- The Angeles Clinic and Research Institute, West Los Angeles Office
-
-
Connecticut
-
Hartford, Connecticut, Vereinigte Staaten, 06102
- Rekrutierung
- Hartford HealthCare - Hartford Hospital
-
New Haven, Connecticut, Vereinigte Staaten, 06510
- Rekrutierung
- Yale University School of Medicine
-
-
District of Columbia
-
Washington D.C., District of Columbia, Vereinigte Staaten, 20007
- Rekrutierung
- MedStar Georgetown University Hospital / Lombardi Comprehensive Cancer Center
-
-
Georgia
-
Atlanta, Georgia, Vereinigte Staaten, 30318
- Rekrutierung
- Piedmont Physician Medical Oncology Atlanta
-
-
Illinois
-
Chicago, Illinois, Vereinigte Staaten, 60611
- Rekrutierung
- Northwestern Memorial Hospital
-
-
Indiana
-
Indianapolis, Indiana, Vereinigte Staaten, 46237
- Rekrutierung
- Franciscan Health Oncology and Hematology Specialists
-
-
Iowa
-
Iowa City, Iowa, Vereinigte Staaten, 52242
- Rekrutierung
- Holden Comprehensive Cancer Center
-
-
Kansas
-
Westwood, Kansas, Vereinigte Staaten, 66205
- Rekrutierung
- University of Kansas Cancer Center
-
-
Kentucky
-
Edgewood, Kentucky, Vereinigte Staaten, 41017
- Rekrutierung
- Saint Elizabeth Medical Center Edgewood
-
-
Maryland
-
Baltimore, Maryland, Vereinigte Staaten, 21021
- Rekrutierung
- University of Maryland Medical System - University of Maryland Medical Center
-
-
Massachusetts
-
Boston, Massachusetts, Vereinigte Staaten, 02215
- Rekrutierung
- Dana Farber/Harvard Cancer Center
-
Worcester, Massachusetts, Vereinigte Staaten, 01655
- Rekrutierung
- University of Massachusetts - UMass Chan Medical School
-
-
Michigan
-
Ann Arbor, Michigan, Vereinigte Staaten, 48109
- Rekrutierung
- University of Michigan Health System
-
Detroit, Michigan, Vereinigte Staaten, 48201
- Rekrutierung
- Barbara Ann Karmanos Cancer Center
-
Detroit, Michigan, Vereinigte Staaten, 48201
- Rekrutierung
- Henry Ford Cancer Institute-Henry Ford Hospital
-
-
Minnesota
-
Saint Louis Park, Minnesota, Vereinigte Staaten, 55426
- Rekrutierung
- Metro Minnesota Community Oncology Research Consortium (MMCORC)
-
-
Nebraska
-
Omaha, Nebraska, Vereinigte Staaten, 68130
- Rekrutierung
- Oncology Hematology West PC dba Nebraska Cancer Specialists
-
Omaha, Nebraska, Vereinigte Staaten, 68198
- Zurückgezogen
- University of Nebraska Medical Center
-
-
New Jersey
-
Pennington, New Jersey, Vereinigte Staaten, 08534
- Rekrutierung
- Capital Health - Hematology Oncology Specialists
-
-
New York
-
New York, New York, Vereinigte Staaten, 10016
- Rekrutierung
- NYU Langone Medical Center
-
Stony Brook, New York, Vereinigte Staaten, 11794
- Rekrutierung
- Stony Brook University Hospital Cancer Center
-
The Bronx, New York, Vereinigte Staaten, 10461
- Rekrutierung
- Montefiore Medical Center
-
-
North Carolina
-
Chapel Hill, North Carolina, Vereinigte Staaten, 27599
- Rekrutierung
- University of North Carolina at Chapel Hill
-
Durham, North Carolina, Vereinigte Staaten, 27710
- Rekrutierung
- Duke University Medical Center - Duke Cancer Centre
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, Vereinigte Staaten, 15212
- Rekrutierung
- Allegheny General Hospital (AGH)-Allegheny Singer Research Institute
-
-
Rhode Island
-
Providence, Rhode Island, Vereinigte Staaten, 02903
- Rekrutierung
- Rhode Island Hospital
-
-
Tennessee
-
Knoxville, Tennessee, Vereinigte Staaten, 37920
- Rekrutierung
- The University of Tennessee Medical Center
-
Nashville, Tennessee, Vereinigte Staaten, 37232
- Rekrutierung
- Vanderbilt University Medical Center
-
-
Texas
-
Dallas, Texas, Vereinigte Staaten, 75246
- Rekrutierung
- Texas Oncology-Baylor Charles A Sammons Cancer Center
-
Fort Worth, Texas, Vereinigte Staaten, 76104
- Rekrutierung
- The Center For Cancer And Blood Disorders (Texas Cancer Care)
-
Houston, Texas, Vereinigte Staaten, 77030
- Rekrutierung
- Houston Methodist Cancer Center
-
-
Utah
-
Salt Lake City, Utah, Vereinigte Staaten, 84106
- Rekrutierung
- Utah Cancer Specialists Cancer Center - Medical Oncology
-
-
Virginia
-
Fairfax, Virginia, Vereinigte Staaten, 22031
- Rekrutierung
- Inova Schar Cancer Institute Clinical Trials
-
-
-
-
-
Bristol, Vereinigtes Königreich
- Rekrutierung
- Site UK44001
-
Cardiff, Vereinigtes Königreich
- Rekrutierung
- Site GB44003
-
Coventry, Vereinigtes Königreich
- Rekrutierung
- Site GB44002
-
Dundee, Vereinigtes Königreich
- Rekrutierung
- Site UK44006
-
Glasgow, Vereinigtes Königreich
- Rekrutierung
- Site GB44004
-
London, Vereinigtes Königreich
- Rekrutierung
- Site GB44005
-
London, Vereinigtes Königreich
- Rekrutierung
- Site UK44011
-
London, Vereinigtes Königreich
- Rekrutierung
- Site UK44014
-
London, Vereinigtes Königreich
- Rekrutierung
- Site UK44015
-
London, Vereinigtes Königreich
- Rekrutierung
- Site UK44016
-
Manchester, Vereinigtes Königreich
- Rekrutierung
- Site UK44009
-
Sheffield, Vereinigtes Königreich
- Rekrutierung
- Site GB44008
-
-
East Riding Of Yorkshire
-
Cottingham, East Riding Of Yorkshire, Vereinigtes Königreich
- Rekrutierung
- Site GB44010
-
-
Teilnahmekriterien
Zulassungskriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Anzahl der Arme
Waffen und Interventionen
Teilnehmergruppe / ArmTeilnehmergruppe / Arm |
Intervention / BehandlungIntervention / Behandlung |
|---|---|
|
Experimental: 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.
Andere Namen:
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. |
|
Aktiver Komparator: 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. |
Was misst die Studie?
Primäre Ergebnismessungen
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Overall Survival (OS)
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Anzahl der Teilnehmer mit positiven Antidrugantikörpern (ADA) gegen Zolbetuximab
Zeitfenster: Bis zu 57 Monate
|
Bis zu 57 Monate
|
|
|
Progression Free Survival (PFS)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: Up to 57 Months
|
Ctrough will be derived from the PK serum samples collected. |
Up to 57 Months
|
Mitarbeiter und Ermittler
Sponsor
Sponsor
Ermittler
Ermittler
- Studienleiter: Medical Monitor, Astellas Pharma Global Development, Inc.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Studienbeginn
Primärer Abschluss (Geschätzt)
Primärer Abschluss
Studienabschluss (Geschätzt)
Studienabschluss
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Zuerst gepostet
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes Update gepostet
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
- PD-L1
- Zolbetuximab
- Rezeptor 2 des menschlichen epidermalen Wachstumsfaktors (HER2) Negativ
- Claudin 18.2
- Lokal fortgeschrittene nicht resezierbare gastroösophageale Junction (GEJ) Adenokarzinomkrebs
- Lokal fortgeschrittene nicht resezierbare Magen -Adenokarzinomkrebs
- Metastasierter Magenadenokarzinomkrebs
- Metastasierendes Gastroösophageal (GEJ) Adenokarzinom
Zusätzliche relevante MeSH-Bedingungen
- Neubildungen nach histologischem Typ
- Neubildungen, Drüsen und Epithelien
- Karzinom
- Neubildungen
- Adenokarzinom
- Organische Chemikalien
- Heterocyclische Verbindungen, 1-Ring
- Heterocyclische Verbindungen
- Heterocyclische Verbindungen, 2-Ring
- Heterocyclische Verbindungen, Fusionsring
- Nukleinsäuren, Nukleotide und Nukleoside
- Enzyme und Coenzyme
- Koordinationskomplexe
- Desoxycytidin
- Cytidin
- Pyrimidin -Nucleoside
- Pyrimidine
- Nukleoside
- Formyltetrahydrofolate
- Tetrahydrofolate
- Folsäure
- Pterins
- Pteridine
- Uracil
- Pyrimidinone
- Coenzyme
- Desoxyribonukleoside
- Capecitabin
- Oxaliplatin
- Fluoruracil
- Leucovorin
- Pembrolizumab
- Zolbetuximab
Andere Studien-ID-Nummern
Andere Studien-ID-Nummern
- 8951-CL-0305
- 2024-519773-19 (Registrierungskennung: CTIS (EU))
- jRCT2031250021 (Registrierungskennung: Japan Registry of Clinical Trials (jRCT))
- CTR20253090 (Registrierungskennung: ChinaDrugTrials.org.cn)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
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-Sharing-Zeitrahmen
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-Sharing-Zugriffskriterien
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.
Art der unterstützenden IPD-Freigabeinformationen
- STUDIENPROTOKOLL
- SAFT
- CSR
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .