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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 (G/GEJ)

8. juli 2026 opdateret af: Akeso

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

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

900

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

  • Navn: Yelena Janjigian, MD

Studiesteder

  • Forenede Stater
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85054
        • Mayo Clinic
        • Kontakt:
          • Ashish Chintakuntlawar,
    • California
      • Los Angeles, California, Forenede Stater, 90095
        • UCLA Health
        • Kontakt:
          • Randy Hecht, MD
    • Colorado
      • Denver, Colorado, Forenede Stater, 80218
        • Rocky Mountain Cancer Centers
        • Kontakt:
          • Allen L Cohn, MD
    • Connecticut
      • New Haven, Connecticut, Forenede Stater, 06510
        • Yale School of Medicine
        • Kontakt:
          • Raghav Sundar, MD
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02215
        • Dana Farber Cancer Institute
    • Michigan
      • Detroit, Michigan, Forenede Stater, 48202
        • Henry Ford Health
        • Kontakt:
          • Zaid AI-Saheli, MD
    • New York
      • New York, New York, Forenede Stater, 10065
        • Memorial Sloan Kettering Cancer Center
      • New York, New York, Forenede Stater, 10029
        • Mount Sinai
        • Kontakt:
          • Deirdre Cohen, MD
    • Oregon
      • Portland, Oregon, Forenede Stater, 97239
        • Oregon Health and Science University
        • Kontakt:
          • Emerson Chen, MD
    • Tennessee
      • Nashville, Tennessee, Forenede Stater, 37203
        • Sarah Cannon Research Institute (SCRI) - Oncology Partners
        • Kontakt:
          • David R Spigel, MD
    • Texas
      • Dallas, Texas, Forenede Stater, 75246
        • Baylor Scott & White Health
      • Houston, Texas, Forenede Stater, 77030
        • MD Anderson Cancer Center
        • Kontakt:
          • Jaffer A. Ajani,, MD
    • Wisconsin
      • Madison, Wisconsin, Forenede Stater, 53792
        • University of Wisconsin Carbone Cancer Center
        • Kontakt:
          • Nataliya Uboha, MD
  • Kina
      • Beijing, Kina
        • Beijing Friendship Hospital, Capital Medical University
        • Kontakt:
          • Wei Deng, MD
      • Beijing, Kina
        • Peking University Cancer Hospital, Gastrointestinal Cancer Center I
        • Kontakt:
          • Jiafu Ji, MD
      • Beijing, Kina
        • Peking University Cancer Hospital, Gastrointestinal Oncology
        • Kontakt:
          • Lin Shen, MD
      • Guangzhou, Kina
        • Guangdong Provincial People's Hospital
        • Kontakt:
          • Jian Xiao, MD
      • Shanghai, Kina
        • Zhongshan Hospital Fudan University
        • Kontakt:
          • Xuefei Wang, MD
  • Polen
      • Krakow, Polen
        • Pratia MCM Krakow
      • Poznan, Polen
        • PRATIA Poznań
        • Kontakt:
          • Piotr Tomczak, MD
      • Warsaw, Polen
        • Narodowy Instytut Onkologii-im. Marii Sklodowskiej Curie Panstwowy Instytut Badawczy - w Warszawie
        • Kontakt:
          • Lucjan S Wyrwicz, MD
  • Tyskland
      • Frankfurt, Tyskland
        • University Cancer Center Frankfurt
        • Kontakt:
          • Thorsten O Goetze, MD
      • Mainz, Tyskland
        • Universitätsmedizin der Johannes Gutenberg-Universität
        • Kontakt:
          • Markus Mohler, MD
      • Marburg, Tyskland
        • Univerity Marburg
    • North Rhine-Westphalia
      • Essen, North Rhine-Westphalia, Tyskland
        • Universitaetsklinikum Essen
        • Kontakt:
          • Isabel Virchow, MD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Cadonilimab/placebo+CAPOX
Cadonilimab/placebo in combination with oxaliplatin and capecitabine (CAPOX)
Medicin: Placebo
Placebo
Medicin: Cadonilimab
Anti-PD-1/ CTLA-4 tetramerisk bispecifikt antistof
Medicin: CAPOX regimen
A combination treatment contains oxaliplatin and capecitabine
Aktiv komparator: CAPOX±nivolumab/placebo
Oxaliplatin and capecitabine with or without nivolumab (CAPOX)
Medicin: Placebo
Placebo
Medicin: CAPOX regimen
A combination treatment contains oxaliplatin and capecitabine
Medicin: Nivolumab
Anti-PD-1 monoclonal antibody

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overall survival (OS)
Tidsramme: Approximately up to 14months
Time from randomization to death from any cause
Approximately up to 14months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Progression-free survival(PFS)
Tidsramme: Approximately up to 8 months
Time from the date of randomization to the date of progressive disease or death from any cause, whichever occurs first.
Approximately up to 8 months
Objective response rate (ORR)
Tidsramme: Approximately up to 8 months
Approximately up to 8 months
Disease control rate (DCR)
Tidsramme: Approximately up to 8 months
Approximately up to 8 months
Duration of response (DoR)
Tidsramme: Approximately up to 8 months
Approximately up to 8 months
Safety assessment
Tidsramme: Approximately up to 18 months
Incidence and severity of adverse events (AEs) and clinically significant abnormal laboratory test results
Approximately up to 18 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Akeso

Efterforskere

  • Ledende efterforsker: Jiafu Ji, MD, Peking University Cancer Hospital, Beijing, Beijing 100142, China
  • Ledende efterforsker: Lin Shen, MD, Peking University Cancer Hospital, Beijing, Beijing 100142, China
  • Ledende efterforsker: Markus Mohler, MD, Johannes Gutenberg University Clinic, Germany

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

20. august 2026

Primær færdiggørelse (Anslået)

18. august 2029

Studieafslutning (Anslået)

18. august 2030

Datoer for studieregistrering

Først indsendt

8. juli 2026

Først indsendt, der opfyldte QC-kriterier

8. juli 2026

Først opslået (Faktiske)

14. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. juli 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • AK104-311

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Betingelser

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Sponsor / samarbejdspartnere

Placeringer

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