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

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.

Trial Details

NCT ID
NCT07700979
Phase
PHASE3
Sponsor
Akeso
Status
RECRUITING
Cancer Type
Gastric Cancer
Interventions
  • Cadonilimab
  • CAPOX regimen
  • Nivolumab
  • Placebo
Locations (sample)
  • Phoenix, Arizona, United States|33.44838,-112.07404
  • Los Angeles, California, United States|34.05223,-118.24368
  • Denver, Colorado, United States|39.73915,-104.9847
  • New Haven, Connecticut, United States|41.30815,-72.92816
  • Boston, Massachusetts, United States|42.35843,-71.05977

Key Eligibility Criteria

  • Able to provide written informed consent and can understand and comply with the requirements of the study.
  • Histopathologically-confirmed diagnosis of locally advanced unresectable or metastatic G/GEJ adenocarcinoma.
  • No prior systemic therapy for locally advanced unresectable or metastatic G/GEJ adenocarcinoma. NOTE: For participants who have received prior neoa…
  • ECOG PS of 0 or 1 within 3 days prior to randomization.

For full eligibility, visit ClinicalTrials.gov.

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