Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Esophageal Neoplasms

Adenocarcinoma

Stomach Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Head and Neck Neoplasms

Esophageal Diseases

Esophageal Cancer

Stomach Cancer

Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

Trastuzumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Trastuzumab will be administered on an every 3 week dosing schedule, with initial loading dose of 8 mg/kg as a 90 minute infusion, followed by trastuzumab 6 mg/kg every 3 weeks.

The planned dose of pembrolizumab for this study is 200 mg every 3 weeks.

Trastuzumab (8mg/kg loading dose; 6mg/kg maintenance) will be administered on day 1 of each 3-week dosing cycle (21 days).

Pembrolizumab 200 mg IV will be administered on day 1 of each 3-week dosing cycle (21 days).

Yelena Y Janjigian, MD

The purpose of this study is to find out whether treatment with trastuzumab combined with pembrolizumab will improve the clearance of tumor DNA from participants' bodies after surgery.

This is a single arm pilot study of adjuvant pembrolizumab + trastuzumab.

A Single-Arm Pilot Study of Adjuvant Pembrolizumab Plus Trastuzumab in HER2+ Esophagogastric Tumors With Persistent Circulating Tumor DNA Following Curative Resection

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.

The primary endpoint of the study is the proportion of patients with ctDNA clearance at 6 months with trastuzumab/pembrolizumab or trastuzumab/placebo in patients with HER2+ esophagogastric cancer with persistent ctDNA despite curative surgery and standard perioperative/adjuvant therapy.

CtDNA clearance is the conversion of detectable to undetectable ctDNA

Memorial Sloan Kettering Cancer Center

Trastuzumab will be administered on an every 3 week dosing schedule, with initial loading dose of 8 mg/kg as a 90 minute infusion, followed by trastuzumab 6 mg/kg every 3 weeks.

The planned dose of pembrolizumab for this study is 200 mg every 3 weeks.

Trastuzumab: Trastuzumab (8mg/kg loading dose; 6mg/kg maintenance) will be administered on day 1 of each 3-week dosing cycle (21 days).

Pembrolizumab: Pembrolizumab 200 mg IV will be administered on day 1 of each 3-week dosing cycle (21 days).

Trastuzumab and Pembrolizumab

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Yelena Janjigian,MD

N/A - data were not collected because the one participant accrued to the study died prematurely due to a treatment unrelated infection

Rate of ctDNA Clearance at 6 Months

Overall Study

Thoracic Neoplasms

Patients with histologically proven esophageal cancer to be treated with radiation therapy with concurrent chemotherapy to a final dose of \>/=40 Gy included in this study at UT MD Anderson Cancer Center in Houston, Texas.

Blood (about 1 teaspoon) drawn to measure cardiac biomarkers at the following time points: within 12-24 hours of the start of radiation, one (1) time during the third week of radiation, within 48 hours after completion of radiation, and about 1 to 2 months after completion of radiation therapy.

Cardiac Biomarker Blood Draws

Steven H. Lin, MD,PHD

The goal of this clinical research study is to learn if the radiation that you will receive for esophageal cancer may cause the heart to create more proteins called cardiac biomarkers.

When cardiac biomarkers are above normal levels, there may be heart damage. The relationship between cardiac biomarkers and radiation therapy has not been well studied. Learning more about this relationship may lead to better ways to check the heart during radiation therapy and predict heart problems.

If you are found to be eligible and you agree to take part in this study, you will have baseline tests. The following tests and procedures will be performed within 1-2 weeks from the start of radiation:

* You will be asked about any other health problems you may have.
* Your performance status will be recorded.
* Blood (about 2 teaspoons) will be drawn for routine tests.
* Blood (about 1 teaspoon) will be drawn to measure cardiac biomarkers.
* You will have an electrocardiogram (ECG) to check your heart function.
* If the study doctor thinks it is needed, you will have an exam by a cardiologist (a doctor who diagnoses and treats heart problems) who will check the results of your ECG.

Study Visits:

Blood (about 1 teaspoon) will be drawn to measure cardiac biomarkers at the following time points:

* Within 12-24 hours of the start of radiation
* One (1) time during the third week of radiation
* Within 48 hours after completion of radiation

Follow-Up:

About 1 to 2 months after you complete radiation therapy, depending on when you and your doctor decide, you will return to the clinic. The following tests and procedures will be performed:

* Blood (about 1 teaspoon) will be drawn to measure cardiac biomarkers.
* You will have an ECG.

Length of Study Participation:

You will be off study after your follow-up visit.

You will no longer be able to take part in the study if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

This is an investigational study. Using cardiac biomarkers to check the heart during radiation therapy to predict future heart problems is considered investigational.

Up to 100 patients will be enrolled in this study. All will be enrolled at MD Anderson.

Blood draws include troponin I, NT-proBNP, and BNP.

Cardiac Biomarker Study in Esophageal Cancer Patients Treated With Chemotherapy and Radiation

Descriptive statistics used to summarize change from baseline in enzyme levels at each time point (beyond baseline). Each enzyme examined separately. Pearson or Spearman correlation coefficient used to examine correlation between changes in cardiac biomarkers from baseline in enzyme level at each time point and mean radiotherapy dose or cumulative dose to heart. Linear mixed effects regression model used to model longitudinal change in cardiac biomarker from baseline as a function of cumulative radiation to the heart, radiation modality (Protons vs Photons), and time.

Incidence of adverse cardiac outcomes tabulated including myocardial infarction, heart failure, arrhythmias, all-cause and cardiac-specific mortality at same time points used to analyze cardiac biomarker levels.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Single-Arm Pilot Study of Adjuvant Pembrolizumab Plus Trastuzumab in HER2+ Esophagogastric Tumors With Persistent Circulating Tumor DNA Following Curative Resection	NCT04510285	Esophagogastric... Gastric Cancer Gastric Tumor Esophageal Canc... Esophageal Neop... Esophageal Tumo... GastroEsophagea... Gastroesophagea... Gastroesophagea... Gastroesophagea...	Trastuzumab Pembrolizumab	18 Years -	Memorial Sloan Kettering Cancer Center
Cardiac Biomarker Study in Esophageal Cancer Patients Treated With Chemotherapy and Radiation	NCT01627080	Esophageal Canc...	Cardiac Biomark...	18 Years -	M.D. Anderson Cancer Center
A Single-Arm Pilot Study of Adjuvant Pembrolizumab Plus Trastuzumab in HER2+ Esophagogastric Tumors With Persistent Circulating Tumor DNA Following Curative Resection	NCT04510285	Esophagogastric... Gastric Cancer Gastric Tumor Esophageal Canc... Esophageal Neop... Esophageal Tumo... GastroEsophagea... Gastroesophagea... Gastroesophagea... Gastroesophagea...	Trastuzumab Pembrolizumab	18 Years -	Memorial Sloan Kettering Cancer Center

Spots Global Cancer Trial Database for gastroesophageal junction tumor