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
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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Able to provide written informed consent and can understand and comply with the requirements of the study.
2. Histopathologically-confirmed diagnosis of locally advanced unresectable or metastatic G/GEJ adenocarcinoma.
3. No prior systemic therapy for locally advanced unresectable or metastatic G/GEJ adenocarcinoma. NOTE: For participants who have received prior neoadjuvant/adjuvant therapy for curative intent, the time between disease progression and last treatment should be at least 6 months.
4. ECOG PS of 0 or 1 within 3 days prior to randomization.
5. Age ≥ 18 years at the time of voluntarily signing informed consent.
6. Evaluable PD-L1 expression results.
7. Participants must have at least one measurable lesion per RECIST v1.1 as assessed by investigator assessment. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
8. Adequate organ function as indicated by the following laboratory values. Specimens must be collected within 7 days prior to the first dose of study treatment.
9. Life expectancy ≥3 months.
10. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 7 days prior to the first dose and agree to use effective contraception during treatment, and for at least 150 days after the last dose of cadonilimab/nivolumab, 270 days after the last dose of oxaliplatin, and 180 days after the last dose of capecitabine.
11. Non-sterile males must agree to use effective contraception during treatment and for at least 120 days following the last dose of cadonilimab/nivolumab/capecitabine and 180 days after the last dose of oxaliplatin.
Exclusion Criteria:
1. Histopathologically confirmed other pathological types, such as squamous cell carcinoma, sarcoma or undifferentiated carcinoma.
2. Known HER2 positive. Be HER2-positive defined as either IHC 3+ or IHC 2+ in combination with ISH+ (or FISH).
3. Participants with active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable (i.e., without evidence of progression) for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention.
4. Presence of clinically symptomatic pleural effusion, pericardial effusion, or ascites requiring frequent drainage (≥ 1 time/month).
5. Clinically significant bleeding symptoms within 28 days before the first dose or a definite tendency to bleed.
6. Have a history of ≥ Grade 2 gastrointestinal perforation and/or fistulae (including prior gastric fistula operation) within 6 months prior to randomization.
7. Participants who, in the opinion of the investigator, have symptoms or signs suggestive of clinically unacceptable deterioration of the primary disease at the time of screening.
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
UCLA Health
Los Angeles
California
Rocky Mountain Cancer Centers
Denver
Colorado
Yale School of Medicine
New Haven
Connecticut
Dana Farber Cancer Institute
Boston
Massachusetts
Henry Ford Health
Detroit
Michigan
Mount Sinai
New York
New York
Memorial Sloan Kettering Cancer Center
New York
New York
Oregon Health and Science University
Portland
Oregon
Sarah Cannon Research Institute (SCRI) - Oncology Partners
Nashville
Tennessee
Baylor Scott & White Health
Dallas
Texas
MD Anderson Cancer Center
Houston
Texas
University of Wisconsin Carbone Cancer Center
Madison
Wisconsin
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
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
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.
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