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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
900
Anti-PD-1/ CTLA-4 tetrameric bispecific antibody
A combination treatment contains oxaliplatin and capecitabine
Anti-PD-1 monoclonal antibody
Placebo
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
...and 15 more locations
Overall survival (OS)
Time from randomization to death from any cause
Time frame: Approximately up to 14months
Progression-free survival(PFS)
Time from the date of randomization to the date of progressive disease or death from any cause, whichever occurs first.
Time frame: Approximately up to 8 months
Objective response rate (ORR)
Time frame: Approximately up to 8 months
Disease control rate (DCR)
Time frame: Approximately up to 8 months
Duration of response (DoR)
Time frame: Approximately up to 8 months
Safety assessment
Incidence and severity of adverse events (AEs) and clinically significant abnormal laboratory test results
Time frame: Approximately up to 18 months
Yelena Janjigian, MD
CONTACT
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.