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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
Sponsor: Akeso
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.
Official title: A 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
900
Start Date
2026-08-20
Completion Date
2030-08-18
Last Updated
2026-07-14
Healthy Volunteers
No
Interventions
Cadonilimab
Anti-PD-1/ CTLA-4 tetrameric bispecific antibody
CAPOX regimen
A combination treatment contains oxaliplatin and capecitabine
Nivolumab
Anti-PD-1 monoclonal antibody
Placebo
Placebo
Locations (25)
Mayo Clinic
Phoenix, Arizona, United States
UCLA Health
Los Angeles, California, United States
Rocky Mountain Cancer Centers
Denver, Colorado, United States
Yale School of Medicine
New Haven, Connecticut, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Henry Ford Health
Detroit, Michigan, United States
Mount Sinai
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Oregon Health and Science University
Portland, Oregon, United States
Sarah Cannon Research Institute (SCRI) - Oncology Partners
Nashville, Tennessee, United States
Baylor Scott & White Health
Dallas, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 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