Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

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 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

900

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

  • Navn: Yelena Janjigian, MD

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Cadonilimab/placebo+CAPOX
Cadonilimab/placebo in combination with oxaliplatin and capecitabine (CAPOX)
Legemiddel: Placebo
Placebo
Legemiddel: Cadonilimab
Anti-PD-1/ CTLA-4 tetramerisk bispesifikt antistoff
Legemiddel: CAPOX regimen
A combination treatment contains oxaliplatin and capecitabine
Aktiv komparator: CAPOX±nivolumab/placebo
Oxaliplatin and capecitabine with or without nivolumab (CAPOX)
Legemiddel: Placebo
Placebo
Legemiddel: CAPOX regimen
A combination treatment contains oxaliplatin and capecitabine
Legemiddel: Nivolumab
Anti-PD-1 monoclonal antibody

Hva måler studien?

Primære resultatmål

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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Akeso

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

20. august 2026

Primær fullføring (Antatt)

18. august 2029

Studiet fullført (Antatt)

18. august 2030

Datoer for studieregistrering

Først innsendt

8. juli 2026

Først innsendt som oppfylte QC-kriteriene

8. juli 2026

Først lagt ut (Faktiske)

14. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

14. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. juli 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • AK104-311

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere