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NOT YET RECRUITING
NCT07700979
PHASE3

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

View on ClinicalTrials.gov

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

DRUG

Cadonilimab

Anti-PD-1/ CTLA-4 tetrameric bispecific antibody

DRUG

CAPOX regimen

A combination treatment contains oxaliplatin and capecitabine

DRUG

Nivolumab

Anti-PD-1 monoclonal antibody

DRUG

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