NCT06123338

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for phase_2

Timeline
19mo left

Started Feb 2024

Typical duration for phase_2

Geographic Reach
1 country

10 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress59%
Feb 2024Nov 2027

First Submitted

Initial submission to the registry

November 3, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 8, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2024

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2027

Last Updated

January 29, 2026

Status Verified

January 1, 2026

Enrollment Period

3.8 years

First QC Date

November 3, 2023

Last Update Submit

January 27, 2026

Conditions

Esophageal CancerGastric AdenocarcinomaHER2 Gene Mutation

Keywords

HER2+ Esophageal cancerEsophageal CancerGastric AdenocarcinomaHER2+ GEJ cancerHER2 IHC3+ expressionIHC 2+/FISH>2.0 expressionEsophagogastric cancerMemorial Sloan Kettering Cancer Center23-124

Outcome Measures

Primary Outcomes (1)

  • Event-free survival (EFS)

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

    2 years

Study Arms (1)

Esophagogastric Cancer

EXPERIMENTAL

Participants will have a diagnosis of resectable HER2+ (IHC 3+ or IHC 2+/FISH ratio \>2.0) esophageal, GEJ or gastric cancer.

Drug: PembrolizumabDrug: TrastuzumabDrug: OxaliplatinDrug: CapecitabineDrug: 5-FluorouracilDrug: Docetaxel

Interventions

PembrolizumabDRUG

Pembrolizumab will be administered on an every 3-week dosing schedule

Esophagogastric Cancer
TrastuzumabDRUG

Trastuzumab will be administered on an every 3-week dosing schedule

Esophagogastric Cancer
OxaliplatinDRUG

Oxaliplatin every 3 weeks, +/-7 days

Esophagogastric Cancer
CapecitabineDRUG

Capecitabine twice daily on days 1 to 14 every 3 weeks or 5-FU on days 1 to 5 every 3 weeks

Esophagogastric Cancer
5-FluorouracilDRUG

5-Fluorouracil administered as a 24 hour IV continuous infusion once every 2 weeks

Esophagogastric Cancer
DocetaxelDRUG

Docetaxel administered intravenously once every 2 weeks.

Esophagogastric Cancer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 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.
  • +3 more criteria

You may not qualify if:

  • 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.
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Massachusetts General Hospital (Data Collection Only)

Boston, Massachusetts, 02114, United States

RECRUITING

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, 07920, United States

RECRUITING

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, 07748, United States

RECRUITING

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645, United States

RECRUITING

Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)

Commack, New York, 11725, United States

RECRUITING

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, 10604, United States

RECRUITING

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065, United States

RECRUITING

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, 11553, United States

RECRUITING

University of Pennsylvania (Data Collection Only)

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MD Anderson Cancer Center (Data Collection Only)

Houston, Texas, 77030, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

pembrolizumabTrastuzumabOxaliplatinCapecitabineFluorouracilDocetaxel

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsCoordination ComplexesOrganic ChemicalsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsDiterpenesTerpenes

Study Officials

  • Yelena Janjigian, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yelena Janjigian, MD

CONTACT

646-888-4186janjigiy@mskcc.org

Samuel Cytryn, MD

CONTACT

cytryns@mskcc.org

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: This is a single-arm phase 2 study in which patients with resectable HER2-positive EGC will receive peri-operative trastuzumab and pembrolizumab in combination with chemotherapy.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2023

First Posted

November 8, 2023

Study Start

February 1, 2024

Primary Completion (Estimated)

November 30, 2027

Study Completion (Estimated)

November 30, 2027

Last Updated

January 29, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

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 beginning 12 months after publication and for up to 36 months post publication. 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.

Locations

US(10)