<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/NCT02998268</url>
  </required_header>
  <id_info>
    <org_study_id>1602016966</org_study_id>
    <nct_id>NCT02998268</nct_id>
  </id_info>
  <brief_title>Study of Pembrolizumab in Locally Advanced Esophageal Adenocarcinoma</brief_title>
  <official_title>Randomized, Multicenter Phase II Study of Pembrolizumab in Combination With Chemotherapy and Chemoradiation in Locally Advanced Esophageal Adenocarcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Weill Medical College of Cornell University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Merck Sharp &amp; Dohme LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Weill Medical College of Cornell University</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 is a randomized, multicenter phase II study of pembrolizumab in combination with&#xD;
      chemotherapy and chemoradiation in locally advanced esophageal adenocarcinoma to examine the&#xD;
      safety and efficacy of the combination of pembrolizumab with chemotherapy and chemoradiation&#xD;
      in locally advanced esophageal adenocarcinoma as assessed by 1 year disease free survival&#xD;
      rate.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized, multicenter phase II study of pembrolizumab in combination with&#xD;
      chemotherapy and chemoradiation in locally advanced esophageal adenocarcinoma to examine the&#xD;
      safety and efficacy of the combination of pembrolizumab with chemotherapy and chemoradiation&#xD;
      in locally advanced esophageal adenocarcinoma as assessed by 1 year disease free survival&#xD;
      rate. The investigators primary aim is to examine the safety and efficacy of pembrolizumab in&#xD;
      both pre-operative treatment paradigms for esophageal/GEJ carcinoma. The specific rationale&#xD;
      for the investigators study design is rooted in three unanswered questions:&#xD;
&#xD;
        1. does the addition of an immune check-point inhibitor (pembrolizumab) enhance the&#xD;
           efficacy of cytotoxic therapy (chemotherapy with chemoradiation) as determined by&#xD;
           response rates, nodal down-staging and 1 year disease free survival in comparison to&#xD;
           historical controls,&#xD;
&#xD;
        2. what are the pathological effects of combining pembrolizumab with chemotherapy alone,&#xD;
           and&#xD;
&#xD;
        3. what are the molecular (PD-L1 expression), immunological (TILs extent) and&#xD;
           gene-expression signatures associated with the efficacy of pembrolizumab in the&#xD;
           neoadjuvant setting.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">March 7, 2017</start_date>
  <completion_date type="Anticipated">April 2025</completion_date>
  <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Disease free survival rate</measure>
    <time_frame>1 year</time_frame>
    <description>To examine the safety and efficacy of the combination of pembrolizumab with chemotherapy and chemoradiation in locally advanced esophageal adenocarcinoma as assessed by 1 year disease free survival rate</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pathologic complete response rate</measure>
    <time_frame>1 year</time_frame>
    <description>To examine the efficacy of the combination of pembrolizumab with chemotherapy and chemoradiation as assessed by pathologic complete response rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>R0 resection rate.</measure>
    <time_frame>1 year</time_frame>
    <description>To examine the efficacy of the combination of pembrolizumab with chemotherapy and chemoradiation as assessed by R0 resection rate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median survival rates.</measure>
    <time_frame>1 year</time_frame>
    <description>To examine the efficacy of the combination of pembrolizumab with chemotherapy and chemoradiation as assessed by median survival rates.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>1 year overall survival rates.</measure>
    <time_frame>1 year</time_frame>
    <description>To examine the efficacy of the combination of pembrolizumab with chemotherapy and chemoradiation as assessed by 1 year overall survival rates</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reduction of local immune infiltration.</measure>
    <time_frame>Up to 1 year post-surgery</time_frame>
    <description>To explore the effect of the combination of pembrolizumab with chemotherapy as assessed by the local immune infiltration in each treatment group.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Prediction of tumor response.</measure>
    <time_frame>Up to 1 year post-surgery</time_frame>
    <description>To examine whether anti PD1 therapy is associated with a transcriptomic signature of intra-tumoral immune activation predictive of response.</description>
  </other_outcome>
  <other_outcome>
    <measure>Improved 1 year survival</measure>
    <time_frame>1 year</time_frame>
    <description>To examine whether anti PD1 therapy is associated with a transcriptomic signature of intra-tumoral immune activation predictive of improved 1 year survival.</description>
  </other_outcome>
  <other_outcome>
    <measure>Induction of PD-L1 expression or induction of an inflammatory signature in tumors.</measure>
    <time_frame>Up to 1 year post-surgery.</time_frame>
    <description>To examine whether chemotherapy is associated with induction of PD-L1 expression or induction of an inflammatory signature in tumors</description>
  </other_outcome>
  <other_outcome>
    <measure>Association of anti-PD1 therapy with increased intra-tumoral immune cell infiltration.</measure>
    <time_frame>Up to 1 year post-surgery.</time_frame>
    <description>To examine whether anti PD1 therapy is associated with increased intra-tumoral immune cell infiltration.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">39</enrollment>
  <condition>Esophageal Adenocarcinoma</condition>
  <arm_group>
    <arm_group_label>Cohort 1</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Subjects in Cohort 1 receive conventional induction chemotherapy with taxol/ carboplatin followed by weekly chemoradiation (taxol/ carboplatin) with pembrolizumab. Following surgery, pembrolizumab is administered every 3 weeks for 1 year.&#xD;
Pembrolizumab dosing is 200 mg administered as a 30 minute IV infusion.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects in Cohort 2 receive pembrolizumab along with induction chemotherapy with taxol/ carboplatin followed by weekly chemoradiation (taxol/ carboplatin) with pembrolizumab. Following surgery, pembrolizumab is administered every 3 weeks for 1 year.&#xD;
Pembrolizumab dosing is 200 mg administered as a 30 minute IV infusion.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pembrolizumab</intervention_name>
    <description>Pembrolizumab is a potent and highly selective humanized monoclonal antibody (mAb) of the IgG4/kappa isotype designed to directly block the interaction between PD-1 and its ligands, PD-L1 and PD-L2.</description>
    <arm_group_label>Cohort 1</arm_group_label>
    <arm_group_label>Cohort 2</arm_group_label>
    <other_name>Keytruda</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Taxol</intervention_name>
    <description>Taxol is a novel antimicrotubule agent that promotes the assembly of microtubules from tubulin dimers and stabilizes microtubules by preventing depolymerization. This stability results in the inhibition of the normal dynamic reorganization of the microtubule network that is essential for vital interphase and mitotic cellular functions.</description>
    <arm_group_label>Cohort 1</arm_group_label>
    <arm_group_label>Cohort 2</arm_group_label>
    <other_name>Paclitaxel</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Carboplatin</intervention_name>
    <description>Carboplatin is a platinum coordination compound that is used as a cancer chemotherapeutic agent. Carboplatin produces predominantly interstrand DNA cross-links rather than DNA -protein cross-links.</description>
    <arm_group_label>Cohort 1</arm_group_label>
    <arm_group_label>Cohort 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients must have histologically or cytologically confirmed esophageal or GEJ&#xD;
             adenocarcinoma&#xD;
&#xD;
          2. Clinical tumor stage should be T2 Npositive M0 or T3--T4, Nany, M0&#xD;
&#xD;
          3. Be willing and able to provide written informed consent/assent for the trial&#xD;
&#xD;
          4. Be 18 years of age or older on day of signing informed consent.&#xD;
&#xD;
          5. Be a candidate for surgical resection.&#xD;
&#xD;
          6. Be willing to provide tissue during endoscopic assessment of their tumor.&#xD;
&#xD;
          7. Have a performance status of 0 or 1 on the ECOG Performance Scale.&#xD;
&#xD;
          8. Demonstrate adequate organ function as defined below, all screening labs should be&#xD;
             performed within 14 days of treatment initiation.&#xD;
&#xD;
               -  Absolute neutrophil count (ANC) ≥1,500 /mcL&#xD;
&#xD;
               -  Platelets≥100,000 / mcL&#xD;
&#xD;
               -  Hemoglobin ≥9 g/dL or ≥5.6 mmol/L without transfusion within 7 days of assessment&#xD;
&#xD;
               -  Serum creatinine OR Measured or calculated creatinine clearance ≤1.5 X upper&#xD;
                  limit of normal (ULN) OR&#xD;
&#xD;
               -  ≥60 mL/min for subject with creatinine levels &gt; 1.5 X institutional ULN&#xD;
                  (Creatinine clearance should be calculated per institutional standard) (GFR can&#xD;
                  also be used in place of creatinine or CrCl)&#xD;
&#xD;
               -  Serum total bilirubin ≤ 1.5 X ULN OR&#xD;
&#xD;
               -  Direct bilirubin ≤ ULN for subjects with total bilirubin levels &gt; 1.5 ULN&#xD;
&#xD;
               -  AST (SGOT) and ALT (SGPT) ≤ 2.5 X ULN&#xD;
&#xD;
               -  Albumin &gt;2.5 mg/dL&#xD;
&#xD;
               -  International Normalized Ratio (INR) OR Prothrombin Time (PT) ≤1.5 X ULN unless&#xD;
                  subject is receiving anticoagulant therapy as long as PT or PTT is within&#xD;
                  therapeutic range of intended use of anticoagulants&#xD;
&#xD;
               -  Activated Partial Thromboplastin Time (aPTT) ≤1.5 X ULN unless subject is&#xD;
                  receiving anticoagulant therapy as long as PT or PTT is within therapeutic range&#xD;
                  of intended use of anticoagulants&#xD;
&#xD;
          9. Female subject of childbearing potential should have a negative urine or serum&#xD;
             pregnancy within 7 days prior to receiving the first dose of study medication. If the&#xD;
             urine test is positive or cannot be confirmed as negative, a serum pregnancy test will&#xD;
             be required.&#xD;
&#xD;
         10. Female subjects of childbearing potential should be willing to use 2 methods of birth&#xD;
             control or be surgically sterile, or abstain from heterosexual activity for the course&#xD;
             of the study through 120 days after the last dose of study medication (Reference&#xD;
             Section 5.7.2). Subjects of childbearing potential are those who have not been&#xD;
             surgically sterilized or have not been free from menses for &gt; 1 year.&#xD;
&#xD;
         11. Male subjects should agree to use an adequate method of contraception starting with&#xD;
             the first dose of study therapy through 120 days after the last dose of study therapy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Is currently participating and receiving study therapy or has participated in a study&#xD;
             of an investigational agent and received study therapy or used an investigational&#xD;
             device within 4 weeks of the first dose of treatment.&#xD;
&#xD;
          2. Evidence of metastatic disease.&#xD;
&#xD;
          3. 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;
          4. Has active TB or a history of active TB within 10 years of registration (Bacillus&#xD;
             Tuberculosis)&#xD;
&#xD;
          5. Hypersensitivity to pembrolizumab or any of its excipients.&#xD;
&#xD;
          6. Has had a prior anti-cancer treatment, including chemotherapy, radiation, or&#xD;
             monoclonal antibody (mAb) for their current diagnosis of esophageal adenocarcinoma.&#xD;
&#xD;
          7. Has a known additional malignancy that is active. Exceptions include basal cell&#xD;
             carcinoma of the skin or squamous cell carcinoma of the skin that has undergone&#xD;
             potentially curative therapy or in situ cervical cancer.&#xD;
&#xD;
          8. Has a previous invasive malignancy treated with curative intent less than 3 years from&#xD;
             time of registration. Exceptions include prostate cancer, basal cell squamous skin&#xD;
             cancer, and cervical cancer.&#xD;
&#xD;
          9. 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;
         10. Has known history of, or any evidence of active, non-infectious pneumonitis.&#xD;
&#xD;
         11. Has an active infection requiring systemic therapy.&#xD;
&#xD;
         12. 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;
         13. Has known psychiatric or substance abuse disorders that would interfere with&#xD;
             cooperation with the requirements of the trial.&#xD;
&#xD;
         14. 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;
         15. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.&#xD;
&#xD;
         16. Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).&#xD;
&#xD;
         17. Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA&#xD;
             [qualitative] is detected).&#xD;
&#xD;
         18. 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>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Manish Shah, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Weill Medical College of Cornell University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>USC Keck School of Medicine, Norris Cancer Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109-5848</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Weill Cornell Medicine</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10068</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rhode Island Hospital</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02903</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>November 29, 2016</study_first_submitted>
  <study_first_submitted_qc>December 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 20, 2016</study_first_posted>
  <last_update_submitted>May 30, 2023</last_update_submitted>
  <last_update_submitted_qc>May 30, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 31, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenocarcinoma</mesh_term>
    <mesh_term>Esophageal Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paclitaxel</mesh_term>
    <mesh_term>Carboplatin</mesh_term>
    <mesh_term>Pembrolizumab</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/NCT02998268
org study id: 1602016966
nct id: NCT02998268
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This is a randomized, multicenter phase II study of pembrolizumab in combination with
      chemotherapy and chemoradiation in locally advanced esophageal adenocarcinoma to examine the
      safety and efficacy of the combination of pembrolizumab with chemotherapy and chemoradiation
      in locally advanced esophageal adenocarcinoma as assessed by 1 year disease free survival
      rate.
This is a randomized, multicenter phase II study of pembrolizumab in combination with
      chemotherapy and chemoradiation in locally advanced esophageal adenocarcinoma to examine the
      safety and efficacy of the combination of pembrolizumab with chemotherapy and chemoradiation
      in locally advanced esophageal adenocarcinoma as assessed by 1 year disease free survival
      rate. The investigators primary aim is to examine the safety and efficacy of pembrolizumab in
      both pre-operative treatment paradigms for esophageal/GEJ carcinoma. The specific rationale
      for the investigators study design is rooted in three unanswered questions:

        1. does the addition of an immune check-point inhibitor (pembrolizumab) enhance the
           efficacy of cytotoxic therapy (chemotherapy with chemoradiation) as determined by
           response rates, nodal down-staging and 1 year disease free survival in comparison to
           historical controls,

        2. what are the pathological effects of combining pembrolizumab with chemotherapy alone,
           and

        3. what are the molecular (PD-L1 expression), immunological (TILs extent) and
           gene-expression signatures associated with the efficacy of pembrolizumab in the
           neoadjuvant setting.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Disease free survival rate
time frame: 1 year
description: To examine the safety and efficacy of the combination of pembrolizumab with chemotherapy and chemoradiation in locally advanced esophageal adenocarcinoma as assessed by 1 year disease free survival rate
measure: Pathologic complete response rate
time frame: 1 year
description: To examine the efficacy of the combination of pembrolizumab with chemotherapy and chemoradiation as assessed by pathologic complete response rate
measure: R0 resection rate.
time frame: 1 year
description: To examine the efficacy of the combination of pembrolizumab with chemotherapy and chemoradiation as assessed by R0 resection rate.
measure: Median survival rates.
time frame: 1 year
description: To examine the efficacy of the combination of pembrolizumab with chemotherapy and chemoradiation as assessed by median survival rates.
measure: 1 year overall survival rates.
time frame: 1 year
description: To examine the efficacy of the combination of pembrolizumab with chemotherapy and chemoradiation as assessed by 1 year overall survival rates
measure: Reduction of local immune infiltration.
time frame: Up to 1 year post-surgery
description: To explore the effect of the combination of pembrolizumab with chemotherapy as assessed by the local immune infiltration in each treatment group.
measure: Prediction of tumor response.
time frame: Up to 1 year post-surgery
description: To examine whether anti PD1 therapy is associated with a transcriptomic signature of intra-tumoral immune activation predictive of response.
measure: Improved 1 year survival
time frame: 1 year
description: To examine whether anti PD1 therapy is associated with a transcriptomic signature of intra-tumoral immune activation predictive of improved 1 year survival.
measure: Induction of PD-L1 expression or induction of an inflammatory signature in tumors.
time frame: Up to 1 year post-surgery.
description: To examine whether chemotherapy is associated with induction of PD-L1 expression or induction of an inflammatory signature in tumors
measure: Association of anti-PD1 therapy with increased intra-tumoral immune cell infiltration.
time frame: Up to 1 year post-surgery.
description: To examine whether anti PD1 therapy is associated with increased intra-tumoral immune cell infiltration.
arm group label: Cohort 1
arm group type: Other
description: Subjects in Cohort 1 receive conventional induction chemotherapy with taxol/ carboplatin followed by weekly chemoradiation (taxol/ carboplatin) with pembrolizumab. Following surgery, pembrolizumab is administered every 3 weeks for 1 year.
Pembrolizumab dosing is 200 mg administered as a 30 minute IV infusion.
arm group label: Cohort 2
arm group type: Experimental
description: Subjects in Cohort 2 receive pembrolizumab along with induction chemotherapy with taxol/ carboplatin followed by weekly chemoradiation (taxol/ carboplatin) with pembrolizumab. Following surgery, pembrolizumab is administered every 3 weeks for 1 year.
Pembrolizumab dosing is 200 mg administered as a 30 minute IV infusion.
intervention type: Drug
intervention name: Pembrolizumab
description: Pembrolizumab is a potent and highly selective humanized monoclonal antibody (mAb) of the IgG4/kappa isotype designed to directly block the interaction between PD-1 and its ligands, PD-L1 and PD-L2.
arm group label: Cohort 1
arm group label: Cohort 2
other name: Keytruda
intervention type: Drug
intervention name: Taxol
description: Taxol is a novel antimicrotubule agent that promotes the assembly of microtubules from tubulin dimers and stabilizes microtubules by preventing depolymerization. This stability results in the inhibition of the normal dynamic reorganization of the microtubule network that is essential for vital interphase and mitotic cellular functions.
arm group label: Cohort 1
arm group label: Cohort 2
other name: Paclitaxel
intervention type: Drug
intervention name: Carboplatin
description: Carboplatin is a platinum coordination compound that is used as a cancer chemotherapeutic agent. Carboplatin produces predominantly interstrand DNA cross-links rather than DNA -protein cross-links.
arm group label: Cohort 1
arm group label: Cohort 2
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Manish Shah, MD
role: Principal Investigator
affiliation: Weill Medical College of Cornell University
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Adenocarcinoma
mesh term: Esophageal Neoplasms
mesh term: Paclitaxel
mesh term: Carboplatin
mesh term: Pembrolizumab
sharing ipd: No