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The goal of this randomized, double-blind, multi-regional phase 3 study of cadonilimab combined with chemotherapy versus chemotherapy in combination with or without nivolumab for the first-line treatment of participants with HER2-negative, previously untreated, unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma trial is to compare OS between cadonilimab combined with chemotherapy and chemotherapy in combination with or without nivolumab in the ITT population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cadonilimab/placebo+CAPOX | Experimental | Cadonilimab/placebo in combination with oxaliplatin and capecitabine (CAPOX) |
|
| CAPOX±nivolumab/placebo | Active Comparator | Oxaliplatin and capecitabine with or without nivolumab (CAPOX) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cadonilimab | Drug | Anti-PD-1/ CTLA-4 tetrameric bispecific antibody |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | Time from randomization to death from any cause | Approximately up to 14months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival(PFS) | Time from the date of randomization to the date of progressive disease or death from any cause, whichever occurs first. | Approximately up to 8 months |
| Objective response rate (ORR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhifang Yao, MD | Contact | 86-0760-89873999 | clinicaltrials@akesobio.com | |
| Yelena Janjigian, MD | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Jiafu Ji, MD | Peking University Cancer Hospital, Beijing, Beijing 100142, China | Principal Investigator |
| Lin Shen, MD | Peking University Cancer Hospital, Beijing, Beijing 100142, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Phoenix | Arizona | 85054 | United States |
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| CAPOX regimen |
| Drug |
A combination treatment contains oxaliplatin and capecitabine |
|
| Nivolumab | Drug | Anti-PD-1 monoclonal antibody |
|
| Placebo | Drug | Placebo |
|
| Approximately up to 8 months |
| Disease control rate (DCR) | Approximately up to 8 months |
| Duration of response (DoR) | Approximately up to 8 months |
| Safety assessment | Incidence and severity of adverse events (AEs) and clinically significant abnormal laboratory test results | Approximately up to 18 months |
| Markus Mohler, MD | Johannes Gutenberg University Clinic, Germany | Principal Investigator |
| UCLA Health | Los Angeles | California | 90095 | United States |
|
| Rocky Mountain Cancer Centers | Denver | Colorado | 80218 | United States |
|
| Yale School of Medicine | New Haven | Connecticut | 06510 | United States |
|
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| Henry Ford Health | Detroit | Michigan | 48202 | United States |
|
| Mount Sinai | New York | New York | 10029 | United States |
|
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
|
| Sarah Cannon Research Institute (SCRI) - Oncology Partners | Nashville | Tennessee | 37203 | United States |
|
| Baylor Scott & White Health | Dallas | Texas | 75246 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
|
| University of Wisconsin Carbone Cancer Center | Madison | Wisconsin | 53792 | United States |
|
| Beijing Friendship Hospital, Capital Medical University | Beijing | China |
|
| Peking University Cancer Hospital, Gastrointestinal Cancer Center I | Beijing | China |
|
| Peking University Cancer Hospital, Gastrointestinal Oncology | Beijing | China |
|
| Guangdong Provincial People's Hospital | Guangzhou | China |
|
| Zhongshan Hospital Fudan University | Shanghai | China |
|
| Universitaetsklinikum Essen | Essen | North Rhine-Westphalia | Germany |
|
| University Cancer Center Frankfurt | Frankfurt | Germany |
|
| Universitätsmedizin der Johannes Gutenberg-Universität | Mainz | Germany |
|
| Univerity Marburg | Marburg | Germany |
| Pratia MCM Kraków | Krakow | Poland |
| Pratia Poznań | Poznan | Poland |
|
| Narodowy Instytut Onkologii-im. Marii Sklodowskiej Curie Panstwowy Instytut Badawczy - w Warszawie | Warsaw | Poland |
|
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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| ID | Term |
|---|---|
| C519688 | XELOX |
| D000077594 | Nivolumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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