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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Akeso
Study ID
NCT07700979
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Gastric / Gastroesophageal Junction Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cadonilimab — DRUG
    Anti-PD-1/ CTLA-4 tetrameric bispecific antibody
  • CAPOX regimen — DRUG
    A combination treatment contains oxaliplatin and capecitabine
  • Nivolumab — DRUG
    Anti-PD-1 monoclonal antibody
  • Placebo — DRUG
    Placebo

Study Details

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.

Key Dates

First listed
Jul 14, 2026
Start date
Aug 20, 2026
Status verified
Jun 2026
Primary completion
Aug 18, 2029
Completion
Aug 18, 2030

Study Design

Enrollment
900 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cadonilimab/placebo+CAPOX
    Cadonilimab/placebo in combination with oxaliplatin and capecitabine (CAPOX)
  • Active Comparator: CAPOX±nivolumab/placebo
    Oxaliplatin and capecitabine with or without nivolumab (CAPOX)

Primary Outcome Measure

Overall survival (OS) [ Time Frame: Approximately up to 14months ]

Central Contacts

Locations (13)

FacilityCityStateZIPSite coordinators
Mayo ClinicPhoenixArizona85054
Ashish Chintakuntlawar,
UCLA HealthLos AngelesCalifornia90095
Randy Hecht, MD
Rocky Mountain Cancer CentersDenverColorado80218
Allen L Cohn, MD
Yale School of MedicineNew HavenConnecticut06510
Raghav Sundar, MD
Dana Farber Cancer InstituteBostonMassachusetts02215-
Henry Ford HealthDetroitMichigan48202
Zaid AI-Saheli, MD
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Mount SinaiNew YorkNew York10029
Deirdre Cohen, MD
Oregon Health and Science UniversityPortlandOregon97239
Emerson Chen, MD
Sarah Cannon Research Institute (SCRI) - Oncology PartnersNashvilleTennessee37203
David R Spigel, MD
Baylor Scott & White HealthDallasTexas75246-
MD Anderson Cancer CenterHoustonTexas77030
Jaffer A. Ajani,, MD
University of Wisconsin Carbone Cancer CenterMadisonWisconsin53792
Nataliya Uboha, MD

Find similar trials in Phoenix, AZ

By research site
Mayo Clinic· Phoenix, AZUCLA Health· Los Angeles, CARocky Mountain Cancer Centers· Denver, COYale School of Medicine· New Haven, CTDana Farber Cancer Institute· Boston, MAHenry Ford Health· Detroit, MI

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