<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/NCT03253068</url>
  </required_header>
  <id_info>
    <org_study_id>MK-3475-IIT-55441</org_study_id>
    <nct_id>NCT03253068</nct_id>
  </id_info>
  <brief_title>Pembrolizumab Plus Amurubicin in Patients With Refractory Small-cell Lung Cancer</brief_title>
  <official_title>A Phase II Study of Pembrolizumab Plus Amurubicin in Patients With Refractory Small-cell Lung Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wakayama Medical 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>Wakayama Medical University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To explore the overall response rate (ORR) per RECIST 1.1 as assessed by investigators in&#xD;
      subjects with refractory small cell lung cancer treated with pembrolizumab (Pembro) plus&#xD;
      amurubicin (AMR).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Open, uncontrolled, multi-center, phase II study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 28, 2020</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>Overall response rate</measure>
    <time_frame>Imaging will be performed every 6 weeks through study completion, an average of 6 months</time_frame>
    <description>Overall response rate will be assessed using RECIST ver1.1 by investigators</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">25</enrollment>
  <condition>Small Cell Lung Cancer Extensive Stage</condition>
  <arm_group>
    <arm_group_label>Pembrolizumab plus amurubicin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pembrolizumab 200mg/body plus amurubicin 40mg/m2, intravenous, every 3 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pembrolizumab plus amurubicin</intervention_name>
    <description>Pembrolizumab 200mg/body plus amurubicin 40mg/m2, intravenous, every 3 weeks</description>
    <arm_group_label>Pembrolizumab plus amurubicin</arm_group_label>
    <other_name>Keytruda, calsed</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Have a histologically or cytologically confirmed diagnosis of SCLC.&#xD;
&#xD;
          2. Confirmed radiological relapse within 90 days from the last day of first-line&#xD;
             chemotherapy.&#xD;
&#xD;
          3. Have adequate tumor tissue sample to test PD-L1 immunohistochemistry.&#xD;
&#xD;
          4. Have measurable disease based on RECIST 1.1 as determined by the site.&#xD;
&#xD;
          5. Be ≥20 years of age on day of signing informed consent.&#xD;
&#xD;
          6. Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group&#xD;
&#xD;
          7. Have adequate organ function as indicated by the following laboratory values&#xD;
&#xD;
          8. Is expected to live more than 90 days.&#xD;
&#xD;
          9. Be willing and able to provide written informed consent/assent for the trial.&#xD;
&#xD;
         10. Female subject of childbearing potential should have a negative urine or serum&#xD;
             pregnancy within 72 hours from registration.&#xD;
&#xD;
         11. Female subjects of childbearing potential must be willing to use an adequate method of&#xD;
             contraception as outlined in Section 5.7.2 - Contraception, for the course of the&#xD;
             study through 120 days (or longer as specified by local institutional guidelines)&#xD;
             after the last dose of study medication.&#xD;
&#xD;
         12. Male subjects of childbearing potential must agree to use an adequate method of&#xD;
             contraception as outlined in Section 5.7.2- Contraception, starting with the first&#xD;
             dose of study therapy through 120 days (or longer as specified by local institutional&#xD;
             guidelines) 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 investigation device&#xD;
             within 30 days from registration.&#xD;
&#xD;
          2. Is receiving systemic steroid therapy ≤ 3 days from registration or receiving any&#xD;
             other form of immunosuppressive medication.&#xD;
&#xD;
          3. Has received prior systemic cytotoxic chemotherapy, biological therapy, OR major&#xD;
             surgery within 3 weeks of the first dose of trial treatment; received thoracic&#xD;
             radiation therapy of &gt; 30 Gy within 6 months from registration.&#xD;
&#xD;
          4. Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or&#xD;
             anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody.&#xD;
&#xD;
          5. Has symptomatic central nervous system (CNS) metastases and/or carcinomatous&#xD;
             meningitis.&#xD;
&#xD;
          6. Active autoimmune disease that has required systemic treatment in past 2 years (i.e.&#xD;
             with use of disease modifying agents, corticosteroids or immunosuppressive drugs).&#xD;
&#xD;
          7. Has had an allogeneic tissue/solid organ transplant.&#xD;
&#xD;
          8. History of noninfectious pneumonitis that required steroids or current active&#xD;
             pneumonitis, or any evidence of interstitial lung disease by CT scan.&#xD;
&#xD;
          9. Has received or will receive a live vaccine within 30 days from registration.&#xD;
&#xD;
         10. Has an active infection requiring intravenous systemic therapy and oral&#xD;
             administration.&#xD;
&#xD;
         11. Has known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).&#xD;
&#xD;
         12. Has known active Hepatitis B, or Hepatitis C.&#xD;
&#xD;
         13. Has any history of prior malignancy, with the exception of basal cell carcinoma of the&#xD;
             skin, superficial bladder cancer, squamous cell carcinoma of the skin, in situ&#xD;
             cervical cancer, or has undergone potentially curative therapy with no evidence of&#xD;
             that disease recurrence for 5 years since initiation of that therapy.&#xD;
&#xD;
         14. Has Known history of serious allergy.&#xD;
&#xD;
         15. 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;
         16. Has known psychiatric or substance abuse disorders that would interfere with&#xD;
             cooperation with the requirements of the trial.&#xD;
&#xD;
         17. 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 (or longer as specified by local institutional guidelines) after the&#xD;
             last dose of trial treatment.&#xD;
&#xD;
         18. Hypersensitivity or allergy to pembrolizumab or any of its excipients, and/or to AMR&#xD;
             or any of its excipients.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hiroaki Akamatsu, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Third Department of Internal Medicine, Wakayama Medical University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Nobuyuki Katakami, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Division of Integrated Oncology, Institute of Biomedical Research and Innovation</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kazuhiko Nakagawa, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Medical Oncology, Kinki University, Faculty of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Wakayama Medical University</name>
      <address>
        <city>Wakayama</city>
        <zip>641-8509</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>August 12, 2017</study_first_submitted>
  <study_first_submitted_qc>August 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 17, 2017</study_first_posted>
  <last_update_submitted>May 18, 2020</last_update_submitted>
  <last_update_submitted_qc>May 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Wakayama Medical University</investigator_affiliation>
    <investigator_full_name>Hiroaki Akamatsu</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
    <mesh_term>Small Cell Lung Carcinoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pembrolizumab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>September 2, 2021</submitted>
    <returned>September 30, 2021</returned>
  </pending_results>
  <!-- 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/NCT03253068
org study id: MK-3475-IIT-55441
nct id: NCT03253068
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To explore the overall response rate (ORR) per RECIST 1.1 as assessed by investigators in
      subjects with refractory small cell lung cancer treated with pembrolizumab (Pembro) plus
      amurubicin (AMR).
Open, uncontrolled, multi-center, phase II study.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall response rate
time frame: Imaging will be performed every 6 weeks through study completion, an average of 6 months
description: Overall response rate will be assessed using RECIST ver1.1 by investigators
arm group label: Pembrolizumab plus amurubicin
arm group type: Experimental
description: Pembrolizumab 200mg/body plus amurubicin 40mg/m2, intravenous, every 3 weeks
intervention type: Drug
intervention name: Pembrolizumab plus amurubicin
description: Pembrolizumab 200mg/body plus amurubicin 40mg/m2, intravenous, every 3 weeks
arm group label: Pembrolizumab plus amurubicin
other name: Keytruda, calsed
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Hiroaki Akamatsu, M.D.
role: Principal Investigator
affiliation: Third Department of Internal Medicine, Wakayama Medical University
last name: Nobuyuki Katakami, M.D., Ph.D.
role: Principal Investigator
affiliation: Division of Integrated Oncology, Institute of Biomedical Research and Innovation
last name: Kazuhiko Nakagawa, M.D., Ph.D.
role: Principal Investigator
affiliation: Department of Medical Oncology, Kinki University, Faculty of Medicine
facility: 
country: Japan
responsible party type: Principal Investigator
investigator affiliation: Wakayama Medical University
investigator full name: Hiroaki Akamatsu
investigator title: Assistant Professor
mesh term: Lung Neoplasms
mesh term: Small Cell Lung Carcinoma
mesh term: Pembrolizumab
sharing ipd: No
submitted: September 2, 2021
returned: September 30, 2021