Actively Recruiting
A Phase 2 Study of Neoadjuvant Pembrolizumab with Trastuzumab and Chemotherapy in Resectable HER2-Positive Esophagogastric Cancer
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-05-28
49
Participants Needed
10
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Memorial Sloan Kettering Cancer Center
Lead Sponsor
G
Genentech, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether adding pembrolizumab and trastuzumab to standard chemotherapy can improve treatment for patients with resectable HER2-positive esophagogastric cancer, including esophageal, gastroesophageal junction, or gastric adenocarcinoma. This phase 2 study focuses on patients whose tumors express HER2 at specific levels and aims to assess the effectiveness of this combination therapy. Participants will receive eight cycles of pembrolizumab and trastuzumab combined with chemotherapy before and after surgery. Chemotherapy involves fluoropyrimidine and oxaliplatin initially, later transitioning to a regimen called FLOT, which includes 5-fluorouracil, oxaliplatin, and docetaxel. Pembrolizumab and trastuzumab maintenance therapy will continue to complete one year of total treatment. Pembrolizumab and trastuzumab are administered every three weeks, and chemotherapy drugs have varying schedules as described. During the study, participants will undergo evaluations to monitor their health, including assessments of organ function to ensure safety. Optional collections of nutrition questionnaires, stool, and saliva samples may occur. The primary outcome measured is event-free survival at two years. The study is sponsored by Memorial Sloan Kettering Cancer Center and will last until late 2027, with no masking or placebo control involved.
CONDITIONS
Brief Title
A Study of Pembrolizumab With Trastuzumab and Chemotherapy in People With Esophagogastric Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at time of informed consent
- ECOG performance status of 0 or 1
- HER2-positive esophageal, gastroesophageal junction, or gastric adenocarcinoma confirmed by biopsy or resection specimen
- Primary tumor must be resectable by surgery
- Adequate organ function including neutrophil count ≥1,500/mcL, platelets ≥100,000/mcL, hemoglobin ≥8 g/dL
- Creatinine clearance ≥50 mL/min
- Serum total bilirubin ≤1.5 times upper limit of normal or direct bilirubin ≤ upper limit of normal (exceptions apply)
- AST and ALT ≤2.5 times upper limit of normal
- Albumin >3 mg/dL
- INR or PT and aPTT within acceptable ranges unless on anticoagulant therapy
- Male participants agree to use contraception during treatment and for at least 230 days after last dose
- Female participants not pregnant or breastfeeding and agree to contraception if of childbearing potential during treatment and for at least 170 days after last dose
You will not qualify if you...
- Presence of metastatic or recurrent esophagogastric cancer
- Prior treatment for esophagogastric cancer
- Previous therapy with anti-PD-1, anti-PD-L1, anti-CTLA-4, or anti-HER2 agents
- Left ventricular ejection fraction below 50% within one month before screening (exceptions apply with cardiologist clearance)
- Participation in another investigational study within 4 weeks before treatment
- Diagnosis of immunodeficiency or recent systemic immunosuppressive therapy within 7 days before treatment
- Known active tuberculosis infection
- Allergy or hypersensitivity to pembrolizumab or its components
- Diagnosis or treatment of another cancer in past 3 years (excluding non-melanoma skin cancer)
- Active central nervous system metastases or carcinomatous meningitis
- Active non-infectious pneumonitis
- Active infection requiring systemic therapy
- Psychiatric or substance abuse disorders interfering with study participation
- Pregnancy, breastfeeding, or plans to conceive/father children during study and 120 days after last dose
- Positive pregnancy test for women of childbearing potential
- History of allogeneic tissue or solid organ transplant
- Active or recent autoimmune or inflammatory disorders within past 3 years (exceptions apply)
- Known HIV infection
- Active hepatitis B or C infection
- Receipt of live vaccine within 30 days before study treatment
- Unable or unwilling to provide informed consent or comply with study protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 year
Participants receive 8 peri-operative cycles of pembrolizumab, trastuzumab, and chemotherapy, followed by pembrolizumab and trastuzumab maintenance to complete 1 total year of therapy.
Every 3 weeks dosing visits during peri-operative cycles and maintenance
Trial Site Locations
Total: 10 locations
1
Massachusetts General Hospital (Data Collection Only)
Boston, Massachusetts, United States, 02114
Actively Recruiting
2
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
3
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
4
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
5
Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)
Commack, New York, United States, 11725
Actively Recruiting
6
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
7
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065
Actively Recruiting
8
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, United States, 11553
Actively Recruiting
9
University of Pennsylvania (Data Collection Only)
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
10
MD Anderson Cancer Center (Data Collection Only)
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
Y
Yelena Janjigian, MD
S
Samuel Cytryn, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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