Gastric CancerPhase 2NCT07631000
A Study of Cadonilimab Combined With Chemotherapy in People With Gastric or Gastroesophageal Junction Cancer
A Phase 2 study testing Cadonilimab in people with Gastric Cancer and Gastroesophageal-junction Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer, Gastroesophageal-junction Cancer
- What is being tested?
- Cadonilimab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 7 sitesUnited States
- Study dates
- 27 May 2026to 27 May 2029
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- Hemoglobin ≥9.0 g/dL
- Absolute neutrophil count ≥1.5 x 109/L
- Platelet count ≥100 x 109/L
- 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.
- ALT and AST ≤2.5 x ULN
- Albumin ≥2.8g/dL (albumin infusion is not allowed within 14 days before the start of treatment)
- 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.
Who cannot join
- 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:
- Interstitial lung disease (ILD), including history of ILD or non-infectious pneumonitis.
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- Active viral, bacterial, or fungal infections requiring parenteral treatment within 14 days of initiation of cadonilimab with the exception of prophylactic antibiotic treatment.
- 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.
- A condition or unresolved AE from a prior investigational drug that may obscure interpretation of toxicity determination or AEs.
- 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.
- Replacement therapy (e.g. insulin, levothyroxine) is not considered a form of systemic treatment.
- Participants with asthma who require intermittent use of bronchodilators, inhaled steroids, or local steroid injections not excluded.
- 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.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920
Yelena Janjigian, MD, 646-888-4286
- Recruiting
Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)
Commack, New York, 11725
Yelena Janjigian, MD, 646-888-4286
- Recruiting
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604
Yelena Janjigian, MD, 646-888-4286
- Recruiting
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748
Yelena Janjigian, MD, 646-888-4286
- Recruiting
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645
Yelena Janjigian, MD, 646-888-4286
- Recruiting
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
Yelena Y Janjigian, MD, 646-888-4286
- Recruiting
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, 11553
Yelena Janjigian, MD, 646-888-4286
About this study
Official title: 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
- Conditions
- Gastric Cancer, Gastroesophageal-junction Cancer
- Being tested
- Cadonilimab
- Keywords
- Gastroesophageal-junction Cancer, Gastric Cancer, Memorial Sloan Kettering Cancer Center, 26-102
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CadonilimabDrug
Perioperative cadonilimab plus neoadjuvant chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Participants with HER2-negative gastric or GEJ adenocarcinoma | Experimental | Participants will have locally advanced, resectable, HER2-negative gastric or GEJ adenocarcinoma Receives: Drug: Cadonilimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-free survival (EFS) rata
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
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start27 May 2026
- Primary completion27 May 2029 (estimated)
- Study completion27 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yelena Janjigian, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07631000
- Sponsor's protocol ID
- 26-102
- Status last verified
- Sep 2026
- First submitted
- 1 Jun 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.