A Study of Cadonilimab Combined With Chemotherapy in People With Gastric or Gastroesophageal Junction Cancer

June 1, 2026 updated by: Memorial Sloan Kettering Cancer Center

A Phase 2, Single-arm Study of Cadonilimab and FLOT Chemotherapy in Patients With Locally Advanced, Resectable Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

The purpose of this study is to find out whether adding cadonilimab to the usual chemotherapy approach is an effective and safe treatment for participants with locally advanced/resectable gastric cancer or gastroesophageal junction (GEJ) cancer

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

37

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Recruiting
        • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
        • Contact:
          • Yelena Janjigian, MD
          • Phone Number: 646-888-4286
      • Middletown, New Jersey, United States, 07748
        • Recruiting
        • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
        • Contact:
          • Yelena Janjigian, MD
          • Phone Number: 646-888-4286
      • Montvale, New Jersey, United States, 07645
        • Recruiting
        • Memorial Sloan Kettering Bergen (Limited Protocol Activities)
        • Contact:
          • Yelena Janjigian, MD
          • Phone Number: 646-888-4286
    • New York
      • Commack, New York, United States, 11725
        • Recruiting
        • Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)
        • Contact:
          • Yelena Janjigian, MD
          • Phone Number: 646-888-4286
      • Harrison, New York, United States, 10604
        • Recruiting
        • Memorial Sloan Kettering Westchester (Limited Protocol Activities)
        • Contact:
          • Yelena Janjigian, MD
          • Phone Number: 646-888-4286
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center (All Protocol Activities)
        • Contact:
          • Yelena Y Janjigian, MD
          • Phone Number: 646-888-4286
      • Uniondale, New York, United States, 11553
        • Recruiting
        • Memorial Sloan Kettering Nassau (Limited Protocol Activities)
        • Contact:
          • Yelena Janjigian, MD
          • Phone Number: 646-888-4286

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Capable of providing signed informed consent.
  • Age ≥18 years at time of informed consent.
  • ECOG performance status (PS) of 0 or 1 at enrollment.
  • Pathologically confirmed gastric or GEJ adenocarcinoma with T1 N+ M0 or T2-4 N0-3 M0 (per AJCC 8th edition) resectable disease deemed eligible for radical surgery. A diagnostic laparoscopy is strongly recommended to confirm M0 status.
  • HER2-negative tumor (IHC 0, 1+, or IHC 2+ and FISH non-amplified).

  • Adequate organ and marrow function as defined below:

    1. Hemoglobin ≥9.0 g/dL
    2. Absolute neutrophil count ≥1.5 x 109/L
    3. Platelet count ≥100 x 109/L
    4. Serum bilirubin ≤1.5 x upper limit of normal (ULN). Patients with known Gilbert's disease who have bilirubin level ≤ 3 x ULN may be enrolled.
    5. ALT and AST ≤2.5 x ULN
    6. Albumin ≥2.8g/dL (albumin infusion is not allowed within 14 days before the start of treatment)

    7. Measured creatinine clearance >50 mL/min as determined by Cockcroft-Gault using actual body weight 7. Willing and able to undergo pre-treatment (during screening) and on-treatment tumor biopsies.

      8. Women of childbearing potential (as defined in Section 13.3) must have a negative serum pregnancy test within 72 hours prior to the first dose and agree to take effective contraception measures during the study drug administration and within 9 months after the last dose.

      9. Male patients with female partners of childbearing potential (as defined in Section 13.3) must agree to take effective contraception measures during the study drug administration and within 6 months after the last dose.

      Exclusion Criteria:

  • Histologies other than adenocarcinoma, including squamous/adenosquamous cell carcinoma, neuroendocrine, or GI stromal tumor.
  • HER2-positive tumor (IHC 2+ and FISH-amplified, or IHC 3+).
  • Prior anticancer treatment for the disease under study (chemotherapy, radiation therapy, chemoradiation, approved or investigational therapy) prior to initiation of study treatment.
  • Prior receipt of an anti-PD1 or anti-CTLA4 monoclonal antibody, including for prior non-gastric malignancy.

  • Underlying medical conditions that, in the Investigator's opinion, make the administration of cadonilimab hazardous, including but not limited to:

    1. Interstitial lung disease (ILD), including history of ILD or non-infectious pneumonitis.
    2. Active viral, bacterial, or fungal infections requiring parenteral treatment within 14 days of initiation of cadonilimab with the exception of prophylactic antibiotic treatment.
    3. Clinically significant cardiovascular disease, such as New York Heart Association Class II or greater cardiac disease or cerebrovascular accident within 3 months prior to initiation of study treatment, myocardial infarction within 6 months prior to initiation of study treatment, or unstable arrhythmia.
    4. A condition or unresolved AE from a prior investigational drug that may obscure interpretation of toxicity determination or AEs.
    5. History of prior solid-organ transplant, including allogeneic bone marrow transplant.
  • Concurrent chronic medical condition requiring the use of supraphysiologic doses of corticosteroids (>10 mg/day of oral prednisone or equivalent) or immunosuppressive medications (absorbable topical corticosteroids not excluded).

  • Any active autoimmune disease or documented history of autoimmune disease or syndrome that required systemic treatment in the past 2 years (i.e. with the use of disease-modifying agents, corticosteroids, or immunosuppressive drugs), except for vitiligo or resolved childhood asthma or atopy.

    1. Replacement therapy (e.g. insulin, levothyroxine) is not considered a form of systemic treatment.
    2. Participants with asthma who require intermittent use of bronchodilators, inhaled steroids, or local steroid injections not excluded.
    3. Participants with hypothyroidism stable on hormone replacement or Sjogren's syndrome not excluded.
  • Known hypersensitivity to any excipient contained in the formulations of study interventions.
  • Prior active malignancy active within the previous 2 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer(s), superficial bladder cancer, or carcinoma in-situ of the cervix, breast, or prostate cancer. Other cases of prior malignanices may be allowed after discussion with the Principal Investigator.
  • Known HIV infection with detectable viral load. Patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
  • Known acute hepatitis B or chronic hepatitis B infection with active untreated disease. For patients with evidence of chronic infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
  • Known hepatitis C infection with detectable viral RNA. Patients with HCV infection who are currently on treatment are eligible if they have an undetectable HCV viral load.
  • Receipt of a live attenuated vaccine within 30 days of study treatment initiation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Participants with HER2-negative gastric or GEJ adenocarcinoma
Participants will have locally advanced, resectable, HER2-negative gastric or GEJ adenocarcinoma
Drug: Cadonilimab
Perioperative cadonilimab plus neoadjuvant chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Event-free survival (EFS) rata
Time Frame: 18 months
To determine the 18-month event-free survival (EFS) rate in patients with locally advanced, resectable, HER2-negative gastric or GEJ adenocarcinoma treated with perioperative cadonilimab and FLOT chemotherapy
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Yelena Janjigian, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 27, 2026

Primary Completion (Estimated)

May 27, 2029

Study Completion (Estimated)

May 27, 2029

Study Registration Dates

First Submitted

June 1, 2026

First Submitted That Met QC Criteria

June 1, 2026

First Posted (Actual)

June 5, 2026

Study Record Updates

Last Update Posted (Actual)

June 5, 2026

Last Update Submitted That Met QC Criteria

June 1, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 26-102

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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