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Pembrolizumab with Trastuzumab and Chemotherapy for Esophagogastric Cancer

This study is looking at whether adding two drugs, pembrolizumab and trastuzumab, to standard chemotherapy is an effective treatment for a type of stomach or esophageal cancer called HER2+ esophagogastric cancer. You might be able to join if you are 18 or older, have HER2+ esophagogastric cancer that can be surgically removed, and meet other health requirements. Researchers will measure how long people live without their cancer returning or getting worse (event-free survival) over two years to see if the treatment is successful. The current status of this study is unclear.

Study design
This is an interventional study with a planned enrollment of 49 participants. It involves receiving specific drug treatments.
What's involved
Eligible patients will receive 8 cycles of pembrolizumab, trastuzumab, and chemotherapy, followed by maintenance therapy to complete one year of treatment.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, event-free survival, will be measured at 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06123338

A Study of Pembrolizumab With Trastuzumab and Chemotherapy in People With Esophagogastric Cancer

Recruiting
PHASE2Ages 18+InterventionalTreatment
Memorial Sloan Kettering Cancer Center
~49 participants
Updated 2026-07-07 on ClinicalTrials.gov
What's tested:PembrolizumabTrastuzumabOxaliplatinCapecitabine5-FluorouracilDocetaxel

At a glance

Recruiting sites
10 of 10 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Event-free survival (EFS)
Measured over 2 years

Conditions

Esophageal Cancer
Gastric Adenocarcinoma
HER2 Gene Mutation

Explore related trials

Esophageal CarcinomaEsophagogastric CancerGastric AdenocarcinomaERBB2 Gene

NCT06123338

Where you'd take part

This study runs at 10 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Massachusetts General Hospital (Data Collection Only)

    Boston, Massachusettsstudy coordinator listed

    Recruiting

  • MD Anderson Cancer Center (Data Collection Only)

    Houston, Texasstudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

    Basking Ridge, New Jerseystudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Bergen (Limited Protocol Activities)

    Montvale, New Jerseystudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)

    New York, New Yorkstudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

    Middletown, New Jerseystudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Nassau (Limited Protocol Activities)

    Uniondale, New Yorkstudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)

    Commack, New Yorkstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Yelena Janjigian, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center

Who to contact

Yelena Janjigian, MD
[email protected]
646-888-4186
Email the study team

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Eligibility criteria

Inclusion

Age 18 years or older at time of signing informed consent.
ECOG performance status 0-1.
HER2+ esophageal, GEJ, or gastric adenocarcinoma biopsy or resection specimen as defined by local HER2 IHC3+ or IHC 2+/FISH\>2.0 expression.
Complete surgical resection of the primary tumor must be achievable
Demonstrate adequate organ function as defined in Table 1.
Absolute neutrophil count (ANC): ≥1,500 /mcL
Platelets: ≥100,000 / mcL
Hemoglobin: ≥8 g/dL Renal
Creatinine clearance: ≥ 50 mL/minute Hepatic
Serum total bilirubin: ≤ 1.5 X ULN OR Direct bilirubin ≤ ULN for subjects with total bilirubin levels \> 1.5 ULN. Except patients with Gilbert's disease (≤3x ULN)
AST and ALT: ≤ 2.5 X ULN
Albumin: \>3 mg/dL Coagulation
International normalized ratio (INR) OR prothrombin time (PT) Activated partial thromboplastin time (aPTT): \<1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants
Male participants: A male participant must agree to use contraception as detailed in Section 15.3 of this protocol during the treatment period and for at least 230 days (5 terminal half-lives of trastuzumab \[140\] plus an additional 90 days \[spermatogenesis cycle\]) after the last dose of study treatment and refrain from donating sperm during this period.
Female participants: A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:

Exclusion

Presence of metastatic or recurrent disease.
Has received prior treatment for esophagogastric cancer
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-CTLA-4 agent.
Has received prior therapy with an anti-HER2 agent
Left ventricular ejection fraction \<50% within 1 month of screening by MUGA or echocardiogram. Patients with an ejection fraction 45-49% may be permissible in the absence of any cardiac symptoms, if cleared by a cardiologist, and per the investigator's discresion.
Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
Patients who have received acute, low dose, systemic immunosuppressant medications (e.g., dexamethasone containing antiemetic regimen or steroids as CT scan contrast premedication) may be enrolled.
The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed.
Has a known history of active TB (Bacillus tuberculosis)
Hypersensitivity to pembrolizumab or any of its excipients
Has been diagnosed or treated for another malignancy in the past 3 years (not including non-melanoma skin cancer)
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
Has known history of, or any evidence of active, non-infectious pneumonitis.
Has an active infection requiring systemic therapy.
Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
A WOCBP who has a positive urine pregnancy test within 72 hours prior to allocation. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
Has had an allogeneic tissue or solid organ transplant
Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease; systemic lupus erythematosus; Wegener syndrome \[granulomatosis with polyangiitis\]; myasthenia gravis; Graves' disease; rheumatoid arthritis, hypophysitis, uveitis) within the past 3 years prior to the start of treatment. The following are exceptions to this criterion:
Subjects with vitiligo or alopecia
Subjects with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement or psoriasis not requiring systemic treatment.
Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA \[qualitative\] is detected).
Has received a live vaccine within 30 days of planned start of study therapy. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.
Is unwilling to give written informed consent, unwilling to participate, or unable to comply with the protocol for the duration of the study.

What this trial measures

  • Event-free survival (EFS)2 years

    EFS is defined as the time from start of treatment to time of disease progression, recurrence, or death, whichever occurs first.