NCT06123338 · Memorial Sloan Kettering Cancer Center
A Study of Pembrolizumab With Trastuzumab and Chemotherapy in People With Esophagogastric Cancer
What this study is about
The purpose of this study to find out whether adding trastuzumab and pembrolizumab to standard chemotherapy is an effective treatment for resectable HER2+ esophagogastric cancer.
View original scientific description
The purpose of this study to find out whether adding trastuzumab and pembrolizumab to standard chemotherapy is an effective treatment for resectable HER2+ esophagogastric cancer.
Interventions
DRUG
Pembrolizumab
Pembrolizumab will be administered on an every 3-week dosing schedule
DRUG
Trastuzumab
Trastuzumab will be administered on an every 3-week dosing schedule
DRUG
Oxaliplatin
Oxaliplatin every 3 weeks, +/-7 days
DRUG
Capecitabine
Capecitabine twice daily on days 1 to 14 every 3 weeks or 5-FU on days 1 to 5 every 3 weeks
DRUG
5-Fluorouracil
5-Fluorouracil administered as a 24 hour IV continuous infusion once every 2 weeks
DRUG
Docetaxel
Docetaxel administered intravenously once every 2 weeks.
OTHER
Nutrition questionnaires (optional)
will be collected (optionally)
OTHER
stool and saliva samples (optional)
will be collected (optionally)
Primary outcome measures
Event-free survival (EFS)
Time frame: 2 years
EFS is defined as the time from start of treatment to time of disease progression, recurrence, or death, whichever occurs first.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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. Table 1 - Organ Function Requirements for Eligibility Hematological
- 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
Where
- Boston, Massachusetts
- Basking Ridge, New Jersey
- Middletown, New Jersey
- Montvale, New Jersey
- Commack, New York
- Harrison, New York
- New York, New York
- Uniondale, New York
- Philadelphia, Pennsylvania
- Houston, Texas
Collaborators
Genentech, Inc., Merck Sharp & Dohme LLC
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 7, 2026 · Source of record for eligibility and locations