πŸ›οΈ Verified NIH Record β€’ Updated 2026-07-08

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 (NCT07700979)

A 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

🟑 Not Yet Recruiting Phase3 πŸ’Š Investigational Drug / Biologic Sponsor: Akeso

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Mayo Clinic β€” Phoenix, Arizona

Age range: 18 Years

πŸ“‹ "Do I Qualify?" β€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria β†—

πŸ“ All Participating Trial Locations (25 Sites)

  • Mayo Clinic β€” Phoenix, Arizona
  • UCLA Health β€” Los Angeles, California
  • Rocky Mountain Cancer Centers β€” Denver, Colorado
  • Yale School of Medicine β€” New Haven, Connecticut
  • Dana Farber Cancer Institute β€” Boston, Massachusetts
  • Henry Ford Health β€” Detroit, Michigan
  • Mount Sinai β€” New York, New York
  • Memorial Sloan Kettering Cancer Center β€” New York, New York
  • Oregon Health and Science University β€” Portland, Oregon
  • Sarah Cannon Research Institute (SCRI) - Oncology Partners β€” Nashville, Tennessee
  • Baylor Scott & White Health β€” Dallas, Texas
  • MD Anderson Cancer Center β€” Houston, Texas
  • University of Wisconsin Carbone Cancer Center β€” Madison, Wisconsin
  • Beijing Friendship Hospital, Capital Medical University β€” Beijing,
  • Peking University Cancer Hospital, Gastrointestinal Cancer Center I β€” Beijing,
  • Peking University Cancer Hospital, Gastrointestinal Oncology β€” Beijing,
  • Guangdong Provincial People's Hospital β€” Guangzhou,
  • Zhongshan Hospital Fudan University β€” Shanghai,
  • Universitaetsklinikum Essen β€” Essen, North Rhine-Westphalia
  • University Cancer Center Frankfurt β€” Frankfurt,
  • UniversitΓ€tsmedizin der Johannes Gutenberg-UniversitΓ€t β€” Mainz,
  • Univerity Marburg β€” Marburg,
  • Pratia MCM KrakΓ³w β€” Krakow,
  • Pratia PoznaΕ„ β€” Poznan,
  • Narodowy Instytut Onkologii-im. Marii Sklodowskiej Curie Panstwowy Instytut Badawczy - w Warszawie β€” Warsaw,

πŸ“ž Contact the Study Coordinator

Phone: 86-0760-89873999

Email: clinicaltrials@akesobio.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

πŸ’° Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA Β§ 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

πŸ’‘ How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
πŸ›οΈ View Official NIH Record β†—