Studie zolbetuximabu spolu s pembrolizumabem a chemoterapií u dospělých s rakovinou žaludku (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) -pozitivní
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.
Přehled studie
Postavení
Podmínky
Detailní popis
Zolbetuximab (Vyloy), has received marketing approval in Japan. The study is considered a post marketing study in Japan.
Typ studie
Zápis (Odhadovaný)
Fáze
- Fáze 3
Rozšířený přístup
Kontakty a umístění
Studijní kontakt
- Jméno: Astellas Pharma Global Development Inc.
- Telefonní číslo: 800-888-7704
- E-mail: astellas.registration@astellas.com
Studijní místa
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Fitzroy, Austrálie
- Nábor
- Site AU61001
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New South Wales
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Kogarah, New South Wales, Austrálie
- Nábor
- Site AU61002
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Queensland
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Brisbane, Queensland, Austrálie
- Nábor
- Site AU61004
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Victoria
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Clayton, Victoria, Austrálie
- Nábor
- Site AU61003
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Bonheiden, Belgie
- Nábor
- Site BE32002
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Brussels, Belgie
- Nábor
- Site BE32001
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Edegem, Belgie
- Staženo
- Site BE32006
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Ghent, Belgie
- Nábor
- Site BE32003
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Leuven, Belgie
- Nábor
- Site BE32005
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Liège, Belgie
- Nábor
- Site BE32004
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Belo Horizonte, Brazílie
- Nábor
- Site BR55014
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Blumenau, Brazílie
- Nábor
- Site BR55002
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Fortaleza, Brazílie
- Nábor
- Site BR55012
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Jaú, Brazílie
- Nábor
- Site BR55008
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Lages, Brazílie
- Nábor
- Site BR55004
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Porto Alegre, Brazílie
- Nábor
- Site BR55003
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São Caetano do Sul, Brazílie
- Nábor
- Site BR55006
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São José do Rio Preto, Brazílie
- Nábor
- Site BR55001
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São Paulo, Brazílie
- Nábor
- Site BR55007
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São Paulo, Brazílie
- Nábor
- Site BR55011
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São Paulo, Brazílie
- Nábor
- BR55009
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São Paulo, Brazílie
- Nábor
- BR55010
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Las Condes, Chile
- Nábor
- Site CL56004
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Santiago, Chile
- Staženo
- Site CL56001
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Bordeaux, Francie
- Nábor
- Site FR33016
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Brest, Francie
- Nábor
- Site FR33008
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Caen, Francie
- Nábor
- Site FR33012
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Carassonne, Francie
- Nábor
- Site FR33009
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Dijon, Francie
- Nábor
- Site FR33005
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Lille, Francie
- Nábor
- Site FR33007
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Lille, Francie
- Nábor
- Site FR33002
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Lyon, Francie
- Nábor
- Site FR33014
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Lyon, Francie
- Nábor
- Site FR33017
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Montpellier, Francie
- Nábor
- Site FR33020
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Nice, Francie
- Nábor
- Site FR33018
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Paris, Francie
- Nábor
- Site FR33003
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Paris, Francie
- Nábor
- Site FR33010
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Paris, Francie
- Nábor
- Site FR33013
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Plérin, Francie
- Nábor
- Site FR33015
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Poitiers, Francie
- Nábor
- Site FR33004
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Rouen, Francie
- Nábor
- Site FR33006
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Saint Herbian Cedex, Francie
- Nábor
- Site FR33019
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Strasbourg, Francie
- Nábor
- Site FR33011
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Leeuwarden, Holandsko
- Nábor
- Site NL31002
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Nijmegen, Holandsko
- Nábor
- Site NL31001
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Ancona, Itálie
- Staženo
- Site IT39003
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Bergamo, Itálie
- Nábor
- Site IT39019
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Bologna, Itálie
- Nábor
- Site IT39017
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Brescia, Itálie
- Nábor
- Site IT39009
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Candiolo, Itálie
- Nábor
- Site IT39014
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Cremona, Itálie
- Nábor
- Site IT39006
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Florence, Itálie
- Nábor
- Site IT39011
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Meldola, Itálie
- Nábor
- Site IT39007
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Milan, Itálie
- Nábor
- Site IT39012
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Milan, Itálie
- Nábor
- Site IT39018
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Milan, Itálie
- Nábor
- Site IT39020
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Naples, Itálie
- Staženo
- Site IT39021
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Pisa, Itálie
- Nábor
- Site IT39015
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Reggio Emilia, Itálie
- Nábor
- Site IT39004
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Roma, Itálie
- Nábor
- Site IT39016
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Rome, Itálie
- Nábor
- Site IT39001
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Udine, Itálie
- Nábor
- Site IT39022
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Verona, Itálie
- Nábor
- Site IT39002
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Chiba
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Chiba, Chiba, Japonsko
- Aktivní, ne nábor
- Chiba Cancer Center
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Kashiwa, Chiba, Japonsko
- Aktivní, ne nábor
- National Cancer Center Hospital East
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Ehime
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Matsuyama, Ehime, Japonsko
- Aktivní, ne nábor
- National Hospital Organization Shikoku Cancer Center
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Fukuoka
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Fukuoka, Fukuoka, Japonsko
- Aktivní, ne nábor
- Kyushu University Hospital (Hematology, Oncology & Cardiovascular medicine)
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Fukuoka, Fukuoka, Japonsko
- Aktivní, ne nábor
- Kyushu University Hospital(Gastrointestinal Surgery)
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Fukuoka, Fukuoka, Japonsko
- Aktivní, ne nábor
- National Hospital Organization Kyushu Cancer Center
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Gunma
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Maebashi, Gunma, Japonsko
- Aktivní, ne nábor
- Gunma University Hospital
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Hokkaido
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Sapporo, Hokkaido, Japonsko
- Aktivní, ne nábor
- Hokkaido University Hospital
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Hyōgo
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Akashi-shi, Hyōgo, Japonsko
- Aktivní, ne nábor
- Hyogo Cancer Center
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Kobe, Hyōgo, Japonsko
- Aktivní, ne nábor
- Kobe City Medical Center General Hospital
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Kagawa-ken
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Kida-gun, Kagawa-ken, Japonsko
- Aktivní, ne nábor
- Kagawa University Hospital
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Kanagawa
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Kawasaki-shi, Kanagawa, Japonsko
- Aktivní, ne nábor
- St. Marianna University Hospital
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Yokohama, Kanagawa, Japonsko
- Aktivní, ne nábor
- Kanagawa Cancer Ctr Hospital
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Miyagi
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Sendai, Miyagi, Japonsko
- Aktivní, ne nábor
- Tohoku University Hospital
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Osaka
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Osaka, Osaka, Japonsko
- Aktivní, ne nábor
- Osaka General Medical Center
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Osaka, Osaka, Japonsko
- Aktivní, ne nábor
- Osaka International Cancer Institute
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Suita-shi, Osaka, Japonsko
- Aktivní, ne nábor
- Osaka University Hospital
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Saitama
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Hidaka-shi, Saitama, Japonsko
- Aktivní, ne nábor
- Saitama Medical University International Medical Center
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Kitaadachi-gun Ina-machi, Saitama, Japonsko
- Aktivní, ne nábor
- Saitama Cancer Center
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Shizuoka
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Sunto-gun, Shizuoka, Japonsko
- Aktivní, ne nábor
- Shizuoka Cancer Center
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Tokyo
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Chuo-ku, Tokyo, Japonsko
- Aktivní, ne nábor
- National Cancer Center Hospital
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Koto-ku, Tokyo, Japonsko
- Aktivní, ne nábor
- The Cancer Institute Hospital of JFCR
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Daegu, Jižní Korea
- Aktivní, ne nábor
- Site KR82004
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Incheon, Jižní Korea
- Aktivní, ne nábor
- Site KR82005
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Seoul, Jižní Korea
- Aktivní, ne nábor
- Site KR82001
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Seoul, Jižní Korea
- Aktivní, ne nábor
- Site KR82002
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Seoul, Jižní Korea
- Aktivní, ne nábor
- Site KR82006
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Seoul, Jižní Korea
- Aktivní, ne nábor
- Site KR82010
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Seoul, Jižní Korea
- Aktivní, ne nábor
- Site KR82012
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Seoul, Jižní Korea
- Staženo
- Site KR82008
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Gyeonggi-do
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Goyang-si, Gyeonggi-do, Jižní Korea
- Staženo
- Site KR82011
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Seongnam-si, Gyeonggi-do, Jižní Korea
- Aktivní, ne nábor
- Site KR82007
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Suwon, Gyeonggi-do, Jižní Korea
- Aktivní, ne nábor
- Site KR82013
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Suwon, Gyeonggi-do, Jižní Korea
- Aktivní, ne nábor
- Site KR82015
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Joellanamdo
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Hwasungun, Joellanamdo, Jižní Korea
- Aktivní, ne nábor
- Site KR82014
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North Chungcheong
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Cheongju-si, North Chungcheong, Jižní Korea
- Aktivní, ne nábor
- Site KR82009
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Seoul
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Seocho-gu, Seoul, Jižní Korea
- Aktivní, ne nábor
- Site KR82003
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Kaunas, Litva
- Nábor
- Site LT37001
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Vilnius, Litva
- Nábor
- Site LT37002
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Mexico City, Mexiko
- Nábor
- Site MX52003
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Oaxaca City, Mexiko
- Nábor
- Site MX52001
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Berlin, Německo
- Nábor
- Site DE49013
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Essen, Německo
- Nábor
- Site DE49010
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Frankfurt am Main, Německo
- Nábor
- Site DE49017
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Hanover, Německo
- Nábor
- Site DE49007
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Leipzig, Německo
- Nábor
- Site DE49004
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Mainz, Německo
- Nábor
- Site DE49001
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Munich, Německo
- Nábor
- Site DE49014
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Nuremberg, Německo
- Nábor
- Site DE49006
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Saarbrücken, Německo
- Nábor
- Site DE49002
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Schweinfurt, Německo
- Nábor
- Site DE49011
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Wolfsburg, Německo
- Staženo
- Site DE49016
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Gliwice, Polsko
- Nábor
- Site PL48006
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Olsztyn, Polsko
- Nábor
- Site PL48008
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Przemyśl, Polsko
- Nábor
- Site PL48002
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Swidnica, Polsko
- Nábor
- Site PL48009
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Warsaw, Polsko
- Nábor
- Site PL48007
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Lubusz Voivodeship
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Lubin, Lubusz Voivodeship, Polsko
- Nábor
- Site PL48005
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Masovian Voivodeship
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Warsaw, Masovian Voivodeship, Polsko
- Nábor
- Site PL48004
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Woj Podkarpackie
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Brzozów, Woj Podkarpackie, Polsko
- Nábor
- Site PL48001
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Almada, Portugalsko
- Nábor
- Site PT35106
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Braga, Portugalsko
- Nábor
- Site PT35103
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Guimarães, Portugalsko
- Nábor
- Site PT35104
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Lisbon, Portugalsko
- Nábor
- Site PT35102
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Lisbon, Portugalsko
- Nábor
- Site PT35107
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Porto, Portugalsko
- Nábor
- Site PT35105
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Porto, Portugalsko
- Nábor
- Site PT35108
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Porto, Portugalsko
- Nábor
- Site PT35109
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Bucharest, Rumunsko
- Nábor
- Site RO40008
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Cluj-Napoca, Rumunsko
- Nábor
- Site RO40001
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Cluj-Napoca, Rumunsko
- Nábor
- Site RO40005
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Cluj-Napoca, Rumunsko
- Nábor
- Site RO40006
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Craiova, Rumunsko
- Nábor
- Site RO40003
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Floreşti, Rumunsko
- Nábor
- Site RO40002
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Iași, Rumunsko
- Nábor
- Site RO40007
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Timișoara, Rumunsko
- Staženo
- Site RO40004
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Bristol, Spojené království
- Nábor
- Site UK44001
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Cardiff, Spojené království
- Nábor
- Site GB44003
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Coventry, Spojené království
- Nábor
- Site GB44002
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Dundee, Spojené království
- Nábor
- Site UK44006
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Glasgow, Spojené království
- Nábor
- Site GB44004
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London, Spojené království
- Nábor
- Site GB44005
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London, Spojené království
- Nábor
- Site UK44011
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London, Spojené království
- Nábor
- Site UK44014
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London, Spojené království
- Nábor
- Site UK44015
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London, Spojené království
- Nábor
- Site UK44016
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Manchester, Spojené království
- Nábor
- Site UK44009
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Sheffield, Spojené království
- Nábor
- Site GB44008
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East Riding Of Yorkshire
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Cottingham, East Riding Of Yorkshire, Spojené království
- Nábor
- Site GB44010
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Alabama
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Birmingham, Alabama, Spojené státy, 35294
- Staženo
- UAB Medicine - UAB Hospital
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California
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Bakersfield, California, Spojené státy, 93309
- Nábor
- CBCC Global Research - Comprehensive Blood & Cancer Center
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Cerritos, California, Spojené státy, 90703
- Nábor
- TOI Clinical Research
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La Jolla, California, Spojené státy, 92037-0845
- Nábor
- University of California, San Diego Moores Cancer Center
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Los Angeles, California, Spojené státy, 90025
- Nábor
- The Angeles Clinic and Research Institute, West Los Angeles Office
-
-
Connecticut
-
Hartford, Connecticut, Spojené státy, 06102
- Nábor
- Hartford HealthCare - Hartford Hospital
-
New Haven, Connecticut, Spojené státy, 06510
- Nábor
- Yale University School of Medicine
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District of Columbia
-
Washington D.C., District of Columbia, Spojené státy, 20007
- Nábor
- MedStar Georgetown University Hospital / Lombardi Comprehensive Cancer Center
-
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Georgia
-
Atlanta, Georgia, Spojené státy, 30318
- Nábor
- Piedmont Physician Medical Oncology Atlanta
-
-
Illinois
-
Chicago, Illinois, Spojené státy, 60611
- Nábor
- Northwestern Memorial Hospital
-
-
Indiana
-
Indianapolis, Indiana, Spojené státy, 46237
- Nábor
- Franciscan Health Oncology and Hematology Specialists
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-
Iowa
-
Iowa City, Iowa, Spojené státy, 52242
- Nábor
- Holden Comprehensive Cancer Center
-
-
Kansas
-
Westwood, Kansas, Spojené státy, 66205
- Nábor
- University of Kansas Cancer Center
-
-
Kentucky
-
Edgewood, Kentucky, Spojené státy, 41017
- Nábor
- Saint Elizabeth Medical Center Edgewood
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Maryland
-
Baltimore, Maryland, Spojené státy, 21021
- Nábor
- University of Maryland Medical System - University of Maryland Medical Center
-
-
Massachusetts
-
Boston, Massachusetts, Spojené státy, 02215
- Nábor
- Dana Farber/Harvard Cancer Center
-
Worcester, Massachusetts, Spojené státy, 01655
- Nábor
- University of Massachusetts - UMass Chan Medical School
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-
Michigan
-
Ann Arbor, Michigan, Spojené státy, 48109
- Nábor
- University of Michigan Health System
-
Detroit, Michigan, Spojené státy, 48201
- Nábor
- Barbara Ann Karmanos Cancer Center
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Detroit, Michigan, Spojené státy, 48201
- Nábor
- Henry Ford Cancer Institute-Henry Ford Hospital
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-
Minnesota
-
Saint Louis Park, Minnesota, Spojené státy, 55426
- Nábor
- Metro Minnesota Community Oncology Research Consortium (MMCORC)
-
-
Nebraska
-
Omaha, Nebraska, Spojené státy, 68130
- Nábor
- Oncology Hematology West PC dba Nebraska Cancer Specialists
-
Omaha, Nebraska, Spojené státy, 68198
- Staženo
- University of Nebraska Medical Center
-
-
New Jersey
-
Pennington, New Jersey, Spojené státy, 08534
- Nábor
- Capital Health - Hematology Oncology Specialists
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-
New York
-
New York, New York, Spojené státy, 10016
- Nábor
- NYU Langone Medical Center
-
Stony Brook, New York, Spojené státy, 11794
- Nábor
- Stony Brook University Hospital Cancer Center
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The Bronx, New York, Spojené státy, 10461
- Nábor
- Montefiore Medical Center
-
-
North Carolina
-
Chapel Hill, North Carolina, Spojené státy, 27599
- Nábor
- University of North Carolina at Chapel Hill
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Durham, North Carolina, Spojené státy, 27710
- Nábor
- Duke University Medical Center - Duke Cancer Centre
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, Spojené státy, 15212
- Nábor
- Allegheny General Hospital (AGH)-Allegheny Singer Research Institute
-
-
Rhode Island
-
Providence, Rhode Island, Spojené státy, 02903
- Nábor
- Rhode Island Hospital
-
-
Tennessee
-
Knoxville, Tennessee, Spojené státy, 37920
- Nábor
- The University of Tennessee Medical Center
-
Nashville, Tennessee, Spojené státy, 37232
- Nábor
- Vanderbilt University Medical Center
-
-
Texas
-
Dallas, Texas, Spojené státy, 75246
- Nábor
- Texas Oncology-Baylor Charles A Sammons Cancer Center
-
Fort Worth, Texas, Spojené státy, 76104
- Nábor
- The Center For Cancer And Blood Disorders (Texas Cancer Care)
-
Houston, Texas, Spojené státy, 77030
- Nábor
- Houston Methodist Cancer Center
-
-
Utah
-
Salt Lake City, Utah, Spojené státy, 84106
- Nábor
- Utah Cancer Specialists Cancer Center - Medical Oncology
-
-
Virginia
-
Fairfax, Virginia, Spojené státy, 22031
- Nábor
- Inova Schar Cancer Institute Clinical Trials
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-
-
-
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Kaohsiung City, Tchaj-wan
- Aktivní, ne nábor
- Site TW88604
-
Taichung, Tchaj-wan
- Aktivní, ne nábor
- Site TW88601
-
Tainan, Tchaj-wan
- Aktivní, ne nábor
- Site TW88606
-
Taipei, Tchaj-wan
- Aktivní, ne nábor
- Site TW88605
-
-
Taiwan
-
Dawan, Taiwan, Tchaj-wan
- Aktivní, ne nábor
- Site TW88603
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-
-
-
-
Adana, Turecko (Türkiye)
- Nábor
- Site TR90011
-
Ankara, Turecko (Türkiye)
- Nábor
- Site TR90001
-
Ankara, Turecko (Türkiye)
- Nábor
- Site TR90006
-
Ankara, Turecko (Türkiye)
- Nábor
- Site TR90004
-
Bursa, Turecko (Türkiye)
- Nábor
- Site TR90014
-
Istanbul, Turecko (Türkiye)
- Nábor
- Site TR90005
-
Konya, Turecko (Türkiye)
- Nábor
- Site TR90013
-
Samsun, Turecko (Türkiye)
- Nábor
- Site TR90009
-
Van, Turecko (Türkiye)
- Nábor
- Site TR90015
-
-
-
-
-
Brno, Česko
- Nábor
- Site CZ42006
-
Olomouc, Česko
- Nábor
- Site CZ42005
-
Prague, Česko
- Nábor
- Site CZ42002
-
Prague, Česko
- Nábor
- Site CZ42003
-
Prague, Česko
- Nábor
- Site CZ42004
-
-
-
-
-
Baoding, Čína, 71000
- Aktivní, ne nábor
- Affiliated Hospital of Hebei University
-
Beijing, Čína
- Aktivní, ne nábor
- Peking Union Medical College Hospital - Dongdan Campus
-
-
Anhui
-
Hefei, Anhui, Čína, 230031
- Aktivní, ne nábor
- Anhui Provincial Cancer Hospital
-
-
Fujian
-
Fuzhou, Fujian, Čína
- Aktivní, ne nábor
- Fujian Provincial Hospital - Department of Medical Oncology
-
-
Guangdong
-
Guangzhou, Guangdong, Čína, 510060
- Aktivní, ne nábor
- Sun Yat-sen University - Cancer Center
-
Guangzhou, Guangdong, Čína, 510555
- Aktivní, ne nábor
- Sun Yat-sen University - Cancer Center
-
-
Heilongjiang
-
Harbin, Heilongjiang, Čína
- Aktivní, ne nábor
- Harbin Medical University Cancer Hospital - Oncology
-
-
Henan
-
Zhenngzhou, Henan, Čína
- Aktivní, ne nábor
- Henan Cancer Hospital - Oncology
-
-
Hubei
-
Wuhan, Hubei, Čína, 430079
- Aktivní, ne nábor
- Hubei Cancer Hospital - Oncology
-
-
Qinghai
-
Xining, Qinghai, Čína
- Aktivní, ne nábor
- Qinghai University Affiliated Hospital
-
-
Shanghai Municipality
-
Shanghai, Shanghai Municipality, Čína, 200127
- Aktivní, ne nábor
- Renji Hospital Shanghai Jiaotong Univ School of Medicine
-
Shanghai, Shanghai Municipality, Čína
- Aktivní, ne nábor
- Ruijin Hospital of Shanghai Jiaotong University School of Medicine
-
-
Sichuan
-
Chengdu, Sichuan, Čína, 610200
- Aktivní, ne nábor
- Sichuan Cancer Hospital
-
-
Tianjin Municipality
-
Tianjin, Tianjin Municipality, Čína
- Aktivní, ne nábor
- Tianjin Medical University General Hospital
-
-
Zhejiang
-
Hangzhou, Zhejiang, Čína
- Aktivní, ne nábor
- The First Affiliated Hospital of Zhejiang University
-
-
-
-
-
A Coruña, Španělsko
- Nábor
- Site ES34005
-
Barcelona, Španělsko
- Nábor
- Site ES34011
-
Barcelona, Španělsko
- Nábor
- Site ES34006
-
Barcelona, Španělsko
- Nábor
- Site ES34009
-
Barcelona, Španělsko
- Nábor
- Site ES34010
-
Barcelona, Španělsko
- Nábor
- Site ES34026
-
Barcelona, Španělsko
- Nábor
- Site ES34028
-
El Palmar, Španělsko
- Nábor
- Site ES34021
-
Lleida, Španělsko
- Nábor
- Site ES34014
-
Madrid, Španělsko
- Nábor
- Site ES34008
-
Madrid, Španělsko
- Nábor
- Site ES34003
-
Madrid, Španělsko
- Nábor
- Site ES34031
-
Madrid, Španělsko
- Nábor
- Site ES34016
-
Madrid, Španělsko
- Nábor
- Site ES34017
-
Madrid, Španělsko
- Staženo
- Site ES34024
-
Murcia, Španělsko
- Nábor
- Site ES34030
-
Pozuelo de Alarcón, Španělsko
- Nábor
- Site ES34013
-
Santiago de Compostela, Španělsko
- Nábor
- Site ES34029
-
Seville, Španělsko
- Nábor
- Site ES34012
-
Seville, Španělsko
- Nábor
- Site ES34025
-
Valencia, Španělsko
- Nábor
- Site ES34004
-
Valencia, Španělsko
- Nábor
- Site ES34007
-
Zaragoza, Španělsko
- Nábor
- Site ES34018
-
Zaragoza, Španělsko
- Nábor
- Site ES34015
-
-
Alicante
-
Elche, Alicante, Španělsko
- Nábor
- Site ES34022
-
-
Cataluyna
-
San Cugat Del Valles Barcelona, Cataluyna, Španělsko
- Nábor
- Site ES34023
-
-
Madrid
-
Madrid, Madrid, Španělsko
- Nábor
- Site ES34019
-
Madrid, Madrid, Španělsko
- Nábor
- Site ES34027
-
-
Pamplona
-
Navarra, Pamplona, Španělsko
- Nábor
- Site ES34002
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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.
Ostatní jména:
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. |
|
Aktivní komparátor: 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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Overall Survival (OS)
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Počet účastníků s pozitivními protilátkami proti léku (ADA) na Zolbetuximab
Časové okno: Až 57 měsíců
|
Až 57 měsíců
|
|
|
Progression Free Survival (PFS)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: Up to 57 Months
|
Ctrough will be derived from the PK serum samples collected. |
Up to 57 Months
|
Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Ředitel studie: Medical Monitor, Astellas Pharma Global Development, Inc.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
- PD-L1
- zolbetuximab
- Receptor 2 lidského epidermálního růstového faktoru (HER2) Negativní
- Claudin 18.2
- Lokálně pokročilý neresekovatelný gastroezofageální křižovatku (GEJ) adenokarcinom rakovina
- Lokálně pokročilý neresekovatelný rakovina adenokarcinomu žaludku
- Metastatický rakovina adenokarcinomu žaludku
- Metastatický gastroezofageální křižovatku (GEJ) adenokarcinom
Další relevantní podmínky MeSH
- Novotvary podle histologického typu
- Novotvary, žlázové a epiteliální
- Karcinom
- Novotvary
- Adenokarcinom
- Organické chemikálie
- Heterocyklické sloučeniny, 1 kruh
- Heterocyklické sloučeniny
- Heterocyklické sloučeniny, 2-prsten
- Heterocyklické sloučeniny, fúzované kroužek
- Nukleové kyseliny, nukleotidy a nukleosidy
- Enzymy a koenzymy
- Koordinační komplexy
- Deoxycytidin
- Cytidin
- Pyrimidinové nukleosidy
- Pyrimidiny
- Nukleosidy
- Formyltetrahydrofoláty
- Tetrahydrofoláty
- Kyselina listová
- Pteriny
- Pteridiny
- Uracil
- Pyrimidinony
- Koenzymy
- Deoxyribonukleosidy
- Kapecitabin
- Oxaliplatina
- Fluorouracil
- Leukovorin
- Pembrolizumab
- Zolbetuximab
Další identifikační čísla studie
- 8951-CL-0305
- 2024-519773-19 (Identifikátor registru: CTIS (EU))
- jRCT2031250021 (Identifikátor registru: Japan Registry of Clinical Trials (jRCT))
- CTR20253090 (Identifikátor registru: ChinaDrugTrials.org.cn)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
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/.
Časový rámec sdílení IPD
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.
Kritéria přístupu pro sdílení IPD
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.
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
- CSR
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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