<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03257163</url>
  </required_header>
  <id_info>
    <org_study_id>Pro20170000375</org_study_id>
    <secondary_id>NCI-2017-01429</secondary_id>
    <secondary_id>071702</secondary_id>
    <secondary_id>P30CA072720</secondary_id>
    <nct_id>NCT03257163</nct_id>
  </id_info>
  <brief_title>Pembrolizumab, Capecitabine, and Radiation Therapy in Treating Patients With Mismatch-Repair Deficient and Epstein-Barr Virus Positive Gastric Cancer</brief_title>
  <official_title>A Phase II Study of Preoperative Pembrolizumab for Mismatch-Repair Deficient and Epstein-Barr Virus Positive Gastric Cancer Followed by Chemotherapy and Chemoradiation With Pembrolizumab</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rutgers, The State University of New Jersey</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Rutgers, The State University of New Jersey</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This phase II trial studies how well pembrolizumab works with capecitabine and radiation&#xD;
      therapy in treating patients with mismatch repair deficient and Epstein-Barr virus positive&#xD;
      gastric cancer. Monoclonal antibodies, such as pembrolizumab may interfere with the ability&#xD;
      of tumor cells to grow and spread. Drugs used in chemotherapy, such as capecitabine, work in&#xD;
      different ways to stop the growth of tumor cells, either by killing the cells, by stopping&#xD;
      them from dividing, or by stopping them from spreading. Radiation therapy uses high energy&#xD;
      x-rays to kill tumor cells and shrink tumors. Giving pembrolizumab, capecitabine and&#xD;
      radiation therapy may work better at treating gastric cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To assess efficacy (disease-free survival) of operable gastric cancer treated with PD-1&#xD;
      blockade using pembrolizumab.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To characterize the safety and tolerability of pembrolizumab in the preoperative setting&#xD;
      and postoperative setting with chemoradiation.&#xD;
&#xD;
      II. To evaluate response rates, recurrence rates, and patterns of recurrence/metastasis.&#xD;
&#xD;
      III. To characterize adverse events (AE) of pembrolizumab in combination with radiation&#xD;
      therapy and capecitabine.&#xD;
&#xD;
      IV. To evaluate overall survival rates.&#xD;
&#xD;
      TERTIARY OBJECTIVES:&#xD;
&#xD;
      I. To assess T cell responses and pathological responses in the tumor specimen. II. To&#xD;
      correlate PD-L1 expression in tumor tissue and stroma with tumor tissue response.&#xD;
&#xD;
      III. To evaluate ribonucleic acid (RNA) expression via Nanostring technology with tumor&#xD;
      tissue response.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Treatment repeats&#xD;
      every 21 days for up to 2 courses in the absence of disease progression or unacceptable&#xD;
      toxicity. Within 2-6 weeks, patients undergo surgery. Beginning up to 56 days after surgery,&#xD;
      patients receive pembrolizumab IV over 30 minutes on day 1 and capecitabine orally (PO) twice&#xD;
      daily (BID) on days 1-14. Treatment repeats every 21 days for up to 5 courses in the absence&#xD;
      of disease progression or unacceptable toxicity. Within 2-6 weeks of resting, patients&#xD;
      continue to receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21&#xD;
      days for up to 11 courses in the absence of disease progression or unacceptable toxicity.&#xD;
      Beginning course 4, patients undergo radiation therapy over 15-30 minutes on days 1-5 for up&#xD;
      to 5 weeks.&#xD;
&#xD;
      After completion of study treatment, patients are followed up every 12 weeks for 1 year,&#xD;
      every 16 weeks for 2 years, every 4 months for year 2, and every 6 months for 2 years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 29, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2025</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Recurrence-free survival (RFS) rate</measure>
    <time_frame>3 years</time_frame>
    <description>At the time of analysis (after 18 months of accrual and 18 additional months of follow-up), will compute a Kaplan-Meier survival curve and will compare the observed survival rate at three years to the historical level of 0.45.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Epstein-Barr Virus Positive</condition>
  <condition>Gastric Adenocarcinoma</condition>
  <condition>Mismatch Repair Protein Deficiency</condition>
  <condition>Stage IB Gastric Cancer AJCC v7</condition>
  <condition>Stage II Gastric Cancer AJCC v7</condition>
  <condition>Stage IIA Gastric Cancer AJCC v7</condition>
  <condition>Stage IIB Gastric Cancer AJCC v7</condition>
  <condition>Stage III Gastric Cancer AJCC v7</condition>
  <condition>Stage IIIA Gastric Cancer AJCC v7</condition>
  <condition>Stage IIIB Gastric Cancer AJCC v7</condition>
  <condition>Stage IIIC Gastric Cancer AJCC v7</condition>
  <arm_group>
    <arm_group_label>Treatment (pembrolizumab, capecitabine, radiation therapy)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 2 courses in the absence of disease progression or unacceptable toxicity. Within 2-6 weeks, patients undergo surgery. Beginning up to 56 days after surgery, patients receive pembrolizumab IV over 30 minutes on day 1 and capecitabine PO BID on days 1-14. Treatment repeats every 21 days for up to 5 courses in the absence of disease progression or unacceptable toxicity. Within 2-6 weeks of resting, patients continue to receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 11 courses in the absence of disease progression or unacceptable toxicity. Beginning course 4, patients undergo radiation therapy over 15-30 minutes on days 1-5 for up to 5 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Capecitabine</intervention_name>
    <description>Given PO</description>
    <arm_group_label>Treatment (pembrolizumab, capecitabine, radiation therapy)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Laboratory Biomarker Analysis</intervention_name>
    <description>Correlative studies</description>
    <arm_group_label>Treatment (pembrolizumab, capecitabine, radiation therapy)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Pembrolizumab</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Treatment (pembrolizumab, capecitabine, radiation therapy)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Radiation Therapy</intervention_name>
    <description>Undergo radiation therapy</description>
    <arm_group_label>Treatment (pembrolizumab, capecitabine, radiation therapy)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Written informed consent for the trial&#xD;
&#xD;
          -  Must have operable gastric adenocarcinoma, T2-T4a, N0-N3, M0&#xD;
&#xD;
          -  Staging evaluation within 42 days of enrollment consisting of staging laparoscopy,&#xD;
             computed tomography (CT) scan of the abdomen and pelvis, and positron emission&#xD;
             tomography (PET) scan will be acquired; also endoscopic ultrasound (EUS) tumor and&#xD;
             nodal staging will be required&#xD;
&#xD;
          -  Mismatch repair deficiency as identified by immunohistochemistry or other&#xD;
             institutional standard, or Epstein-Barr virus positivity as determined by in situ&#xD;
             hybridization or other institutional standard&#xD;
&#xD;
          -  Be willing to provide tissue from a newly obtained core or excisional biopsy of a&#xD;
             tumor lesion; newly-obtained is defined as a specimen obtained up to 10 weeks (70&#xD;
             days) prior to initiation of treatment on day 1; subjects for whom newly-obtained&#xD;
             samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an&#xD;
             archived specimen (if available from prior biopsy) only upon agreement from the&#xD;
             sponsor&#xD;
&#xD;
          -  Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG)&#xD;
             performance scale&#xD;
&#xD;
          -  Absolute neutrophil count (ANC) &gt;= 1,500 /mcL&#xD;
&#xD;
          -  Platelets &gt;= 100,000 / mcL&#xD;
&#xD;
          -  Hemoglobin &gt;= 7 g/dL or &gt;= 5.6 mmol/L with transfusion or erythropoietin (EPO)&#xD;
             dependency&#xD;
&#xD;
          -  Serum creatinine =&lt; 1.5 X upper limit of normal (ULN) OR measured or calculated&#xD;
             creatinine clearance (glomerular filtration rate [GFR] can also be used in place of&#xD;
             creatinine or creatinine clearance [CrCl]) &gt;= 60 mL/min for subject with creatinine&#xD;
             levels &gt; 1.5 X institutional ULN&#xD;
&#xD;
          -  Serum total bilirubin =&lt; 1.5 X ULN OR direct bilirubin =&lt; ULN for subjects with total&#xD;
             bilirubin levels &gt; 1.5 ULN&#xD;
&#xD;
          -  Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) and&#xD;
             alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =&lt; 2.5 X&#xD;
             ULN&#xD;
&#xD;
          -  Albumin &gt;= 2.5 mg/dL&#xD;
&#xD;
          -  International normalized ratio (INR) or prothrombin time (PT) =&lt; 1.5 X ULN unless&#xD;
             subject is receiving anticoagulant therapy as long as PT or partial thromboplastin&#xD;
             time (PTT) is within therapeutic range of intended use of anticoagulants&#xD;
&#xD;
          -  Activated partial thromboplastin time (aPTT) =&lt; 1.5 X ULN unless subject is receiving&#xD;
             anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use&#xD;
             of anticoagulants&#xD;
&#xD;
          -  Female subject of childbearing potential should have a negative urine or serum&#xD;
             pregnancy within 7 days of enrollment; if the urine test is positive or cannot be&#xD;
             confirmed as negative, a serum pregnancy test will be required&#xD;
&#xD;
          -  Female subjects of childbearing potential must be willing to use an adequate method of&#xD;
             contraception for the course of the study through 120 days after the last dose of&#xD;
             study medication; Note: abstinence is acceptable if this is the usual lifestyle and&#xD;
             preferred contraception for the subject&#xD;
&#xD;
          -  Male subjects of childbearing potential must agree to use an adequate method of&#xD;
             contraception starting with the first dose of study therapy through 120 days after the&#xD;
             last dose of study therapy; Note: abstinence is acceptable if this is the usual&#xD;
             lifestyle and preferred contraception for the subject&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of metastatic disease is not allowed; subjects must be evaluated with imaging&#xD;
             consisting of CT scan and PET scan prior to enrollment for protocol therapy to exclude&#xD;
             metastatic disease&#xD;
&#xD;
          -  Prior chemotherapy, adjuvant therapy, or radiotherapy for gastric cancer&#xD;
&#xD;
          -  Prior radiotherapy that overlaps with planned radiotherapy portal&#xD;
&#xD;
          -  Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any&#xD;
             other form of immunosuppressive therapy within 7 days prior to the first dose of trial&#xD;
             treatment&#xD;
&#xD;
          -  Has a known history of active TB (Bacillus tuberculosis)&#xD;
&#xD;
          -  Hypersensitivity to pembrolizumab or any of its excipients&#xD;
&#xD;
          -  Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study&#xD;
             day 1 or who has not recovered (i.e., =&lt; grade 1 or at baseline) from adverse events&#xD;
             due to agents administered more than 4 weeks earlier&#xD;
&#xD;
          -  Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy&#xD;
             within 2 weeks prior to study day 1 or who has not recovered (i.e., =&lt; grade 1 or at&#xD;
             baseline) from adverse events due to a previously administered agent&#xD;
&#xD;
               -  Note: subjects with =&lt; grade 2 neuropathy are an exception to this criterion and&#xD;
                  may qualify for the study&#xD;
&#xD;
               -  Note: if subject received major surgery, they must have recovered adequately from&#xD;
                  the toxicity and/or complications from the intervention prior to starting therapy&#xD;
&#xD;
          -  Has a known additional malignancy that is progressing or requires active treatment;&#xD;
             exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the&#xD;
             skin that has undergone potentially curative therapy or in situ cervical cancer&#xD;
&#xD;
          -  Has active autoimmune disease that has required systemic treatment in the past 2 years&#xD;
             (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive&#xD;
             drugs); replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid&#xD;
             replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a&#xD;
             form of systemic treatment&#xD;
&#xD;
          -  Has a history of (non-infectious) pneumonitis that required steroids or current&#xD;
             pneumonitis&#xD;
&#xD;
          -  Evidence of interstitial lung disease&#xD;
&#xD;
          -  Has an active infection requiring systemic therapy&#xD;
&#xD;
          -  Has a history or current evidence of any condition, therapy, or laboratory abnormality&#xD;
             that might confound the results of the trial, interfere with the subject?s&#xD;
             participation for the full duration of the trial, or is not in the best interest of&#xD;
             the subject to participate, in the opinion of the treating investigator&#xD;
&#xD;
          -  Has known psychiatric or substance abuse disorders that would interfere with&#xD;
             cooperation with the requirements of the trial&#xD;
&#xD;
          -  Is pregnant or breastfeeding, or expecting to conceive or father children within the&#xD;
             projected duration of the trial, starting with the pre-screening or screening visit&#xD;
             through 120 days after the last dose of trial treatment&#xD;
&#xD;
          -  Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent&#xD;
&#xD;
          -  Has a known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies)&#xD;
&#xD;
          -  Has known active hepatitis B (e.g., hepatitis B surface antigen [HBsAg] reactive) or&#xD;
             hepatitis C (e.g., hepatitis C virus (HCV) RNA [qualitative] is detected)&#xD;
&#xD;
          -  Has received a live vaccine within 30 days of planned start of study therapy; Note:&#xD;
             seasonal influenza vaccines for injection are generally inactivated flu vaccines and&#xD;
             are allowed; however intranasal influenza vaccines (e.g., Flu-Mist) are live&#xD;
             attenuated vaccines, and are not allowed&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Salma Jabbour</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rutgers Cancer Institute of New Jersey</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Emory University</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30308</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Salma Jabbour, MD</last_name>
      <phone>732-235-2465</phone>
      <email>jabbousk@cinj.rutgers.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Rutgers Cancer Institute of New Jersey</name>
      <address>
        <city>New Brunswick</city>
        <state>New Jersey</state>
        <zip>08903</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Salma K. Jabbour</last_name>
      <phone>732-235-3961</phone>
      <email>jabbousk@cinj.rutgers.edu</email>
    </contact>
    <investigator>
      <last_name>Salma K. Jabbour</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Montefiore Medical Center</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10467</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Salma Jabbour, MD</last_name>
      <phone>732-235-3961</phone>
      <email>jabbousk@cinj.rutgers.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>August 17, 2017</study_first_submitted>
  <study_first_submitted_qc>August 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 22, 2017</study_first_posted>
  <last_update_submitted>July 11, 2023</last_update_submitted>
  <last_update_submitted_qc>July 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rutgers Cancer Institute of New Jersey</investigator_affiliation>
    <investigator_full_name>Salma Jabbour, MD</investigator_full_name>
    <investigator_title>Professor Department of Radiation Oncology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Epstein-Barr Virus Infections</mesh_term>
    <mesh_term>Stomach Neoplasms</mesh_term>
    <mesh_term>Protein Deficiency</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pembrolizumab</mesh_term>
    <mesh_term>Capecitabine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03257163
org study id: Pro20170000375
secondary id: NCI-2017-01429
secondary id: 071702
secondary id: P30CA072720
nct id: NCT03257163
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This phase II trial studies how well pembrolizumab works with capecitabine and radiation
      therapy in treating patients with mismatch repair deficient and Epstein-Barr virus positive
      gastric cancer. Monoclonal antibodies, such as pembrolizumab may interfere with the ability
      of tumor cells to grow and spread. Drugs used in chemotherapy, such as capecitabine, work in
      different ways to stop the growth of tumor cells, either by killing the cells, by stopping
      them from dividing, or by stopping them from spreading. Radiation therapy uses high energy
      x-rays to kill tumor cells and shrink tumors. Giving pembrolizumab, capecitabine and
      radiation therapy may work better at treating gastric cancer.
PRIMARY OBJECTIVES:

      I. To assess efficacy (disease-free survival) of operable gastric cancer treated with PD-1
      blockade using pembrolizumab.

      SECONDARY OBJECTIVES:

      I. To characterize the safety and tolerability of pembrolizumab in the preoperative setting
      and postoperative setting with chemoradiation.

      II. To evaluate response rates, recurrence rates, and patterns of recurrence/metastasis.

      III. To characterize adverse events (AE) of pembrolizumab in combination with radiation
      therapy and capecitabine.

      IV. To evaluate overall survival rates.

      TERTIARY OBJECTIVES:

      I. To assess T cell responses and pathological responses in the tumor specimen. II. To
      correlate PD-L1 expression in tumor tissue and stroma with tumor tissue response.

      III. To evaluate ribonucleic acid (RNA) expression via Nanostring technology with tumor
      tissue response.

      OUTLINE:

      Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Treatment repeats
      every 21 days for up to 2 courses in the absence of disease progression or unacceptable
      toxicity. Within 2-6 weeks, patients undergo surgery. Beginning up to 56 days after surgery,
      patients receive pembrolizumab IV over 30 minutes on day 1 and capecitabine orally (PO) twice
      daily (BID) on days 1-14. Treatment repeats every 21 days for up to 5 courses in the absence
      of disease progression or unacceptable toxicity. Within 2-6 weeks of resting, patients
      continue to receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21
      days for up to 11 courses in the absence of disease progression or unacceptable toxicity.
      Beginning course 4, patients undergo radiation therapy over 15-30 minutes on days 1-5 for up
      to 5 weeks.

      After completion of study treatment, patients are followed up every 12 weeks for 1 year,
      every 16 weeks for 2 years, every 4 months for year 2, and every 6 months for 2 years.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Recurrence-free survival (RFS) rate
time frame: 3 years
description: At the time of analysis (after 18 months of accrual and 18 additional months of follow-up), will compute a Kaplan-Meier survival curve and will compare the observed survival rate at three years to the historical level of 0.45.
arm group label: Treatment (pembrolizumab, capecitabine, radiation therapy)
arm group type: Experimental
description: Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 2 courses in the absence of disease progression or unacceptable toxicity. Within 2-6 weeks, patients undergo surgery. Beginning up to 56 days after surgery, patients receive pembrolizumab IV over 30 minutes on day 1 and capecitabine PO BID on days 1-14. Treatment repeats every 21 days for up to 5 courses in the absence of disease progression or unacceptable toxicity. Within 2-6 weeks of resting, patients continue to receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 11 courses in the absence of disease progression or unacceptable toxicity. Beginning course 4, patients undergo radiation therapy over 15-30 minutes on days 1-5 for up to 5 weeks.
intervention type: Drug
intervention name: Capecitabine
description: Given PO
arm group label: Treatment (pembrolizumab, capecitabine, radiation therapy)
intervention type: Other
intervention name: Laboratory Biomarker Analysis
description: Correlative studies
arm group label: Treatment (pembrolizumab, capecitabine, radiation therapy)
intervention type: Biological
intervention name: Pembrolizumab
description: Given IV
arm group label: Treatment (pembrolizumab, capecitabine, radiation therapy)
intervention type: Radiation
intervention name: Radiation Therapy
description: Undergo radiation therapy
arm group label: Treatment (pembrolizumab, capecitabine, radiation therapy)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Salma Jabbour
role: Principal Investigator
affiliation: Rutgers Cancer Institute of New Jersey
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Rutgers Cancer Institute of New Jersey
investigator full name: Salma Jabbour, MD
investigator title: Professor Department of Radiation Oncology
mesh term: Epstein-Barr Virus Infections
mesh term: Stomach Neoplasms
mesh term: Protein Deficiency
mesh term: Pembrolizumab
mesh term: Capecitabine
sharing ipd: No