Phase 3 Study of Cadonilimab Combined With Chemotherapy vs Chemotherapy in Combination With or Without Nivolumab for the 1L Treatment of Participants With HER2-negative, Previously Untreated, Unresectable or Metastatic Gastric/GEJ Adenocarcinoma
Start Date
9/24/2026
Completion Date
8/18/2030
Summary
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Cadonilimab
CAPOX regimen
Nivolumab
Placebo
Conditions
Locations
Mayo Clinic
Phoenix, Arizona 85054
United States
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