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
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Study 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
Primary outcome measure(s)
- Overall survival (OS) — Approximately up to 14months
Time from randomization to death from any cause
Trial sites (25)
| Facility | City | Region | Status |
|---|---|---|---|
| Mayo Clinic | Phoenix | Arizona | Not Yet Recruiting |
| UCLA Health | Los Angeles | California | Not Yet Recruiting |
| Rocky Mountain Cancer Centers | Denver | Colorado | Not Yet Recruiting |
| Yale School of Medicine | New Haven | Connecticut | Not Yet Recruiting |
| Dana Farber Cancer Institute | Boston | Massachusetts | Not Yet Recruiting |
| Henry Ford Health | Detroit | Michigan | Not Yet Recruiting |
| Mount Sinai | New York | New York | Not Yet Recruiting |
| Memorial Sloan Kettering Cancer Center | New York | New York | Not Yet Recruiting |
| Oregon Health and Science University | Portland | Oregon | Not Yet Recruiting |
| Sarah Cannon Research Institute (SCRI) - Oncology Partners | Nashville | Tennessee | Not Yet Recruiting |
| Baylor Scott & White Health | Dallas | Texas | Not Yet Recruiting |
| MD Anderson Cancer Center | Houston | Texas | Not Yet Recruiting |
| University of Wisconsin Carbone Cancer Center | Madison | Wisconsin | Not Yet Recruiting |
| Beijing Friendship Hospital, Capital Medical University | Beijing | China | Not Yet Recruiting |
| Peking University Cancer Hospital, Gastrointestinal Cancer Center I | Beijing | China | Recruiting |
| Peking University Cancer Hospital, Gastrointestinal Oncology | Beijing | China | Not Yet Recruiting |
| Guangdong Provincial People's Hospital | Guangzhou | China | Not Yet Recruiting |
| Zhongshan Hospital Fudan University | Shanghai | China | Not Yet Recruiting |
| Universitaetsklinikum Essen | Essen | North Rhine-Westphalia | Not Yet Recruiting |
| University Cancer Center Frankfurt | Frankfurt | Germany | Not Yet Recruiting |
| Universitätsmedizin der Johannes Gutenberg-Universität | Mainz | Germany | Not Yet Recruiting |
| Univerity Marburg | Marburg | Germany | Not Yet Recruiting |
| Pratia MCM Kraków | Krakow | Poland | Not Yet Recruiting |
| Pratia Poznań | Poznan | Poland | Not Yet Recruiting |
| Narodowy Instytut Onkologii-im. Marii Sklodowskiej Curie Panstwowy Instytut Badawczy - w Warszawie | Warsaw | Poland | Not Yet Recruiting |
On this site
📄 Opdivo (nivolumab) drug profile →More Akeso trials in the USA
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07700979 on ClinicalTrials.gov ↗ ← All trials in the USA