<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/NCT04478695</url>
  </required_header>
  <id_info>
    <org_study_id>20170646</org_study_id>
    <secondary_id>KEYNOTE-613</secondary_id>
    <nct_id>NCT04478695</nct_id>
  </id_info>
  <brief_title>Study of AMG 330 in Combination With Pembrolizumab in Adult With Relapsed or Refractory Acute Myeloid Leukemia</brief_title>
  <official_title>A Phase 1b Study Assessing Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of AMG 330 cIV in Combination With Pembrolizumab in Adult Subjects With Relapsed or Refractory Acute Myeloid Leukemia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Amgen</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Merck Sharp &amp; Dohme LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Amgen</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this study is to evaluate the safety and tolerability of AMG 330,&#xD;
      administered in combination with pembrolizumab, in participants with relapsed or refractory&#xD;
      acute myeloid leukemia (R/R AML).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will assess the safety and tolerability of AMG 330 in combination with&#xD;
      pembrolizumab and whether pembrolizumab will enhance the anti-AML activity of AMG 330. Both&#xD;
      cohort 1 and 2 will include AMG 330 and pembrolizumab with the difference being the&#xD;
      initiation date for pembrolizumab treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Amgen Decision&#xD;
  </why_stopped>
  <start_date type="Actual">September 29, 2020</start_date>
  <completion_date type="Actual">October 17, 2020</completion_date>
  <primary_completion_date type="Actual">October 17, 2020</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants who Experience Dose-Limiting Toxicities (DLTs)</measure>
    <time_frame>Up to 1 year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants who Experience Treatment-Emergent Adverse Events (TEAE)</measure>
    <time_frame>Up to 1 year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants who Experience Treatment-Related Adverse Events (TRAE)</measure>
    <time_frame>Up to 1 year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants who Experience a Clinically Significant Change in Vital Sign Measurements</measure>
    <time_frame>Up to 1 year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants who Experience a Clinically Significant Change in Electrocardiograms (ECGs) Results</measure>
    <time_frame>Up to 1 year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants who Experience a Clinically Significant Change in Clinical Laboratory Tests</measure>
    <time_frame>Up to 1 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants who Experience a Response to Treatment</measure>
    <time_frame>Up to 1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Response</measure>
    <time_frame>Up to 1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum Concentration of AMG 330</measure>
    <time_frame>Up to 1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with Anti-AMG 330 Antibody Formation</measure>
    <time_frame>Up to 1 year</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1</enrollment>
  <condition>Relapsed or Refractory Acute Myeloid Leukemia</condition>
  <arm_group>
    <arm_group_label>Cohort 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AMG 330</intervention_name>
    <description>Continuous intravenous (IV) infusion.</description>
    <arm_group_label>Cohort 1</arm_group_label>
    <arm_group_label>Cohort 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pembrolizumab</intervention_name>
    <description>Intravenous (IV) infusion.</description>
    <arm_group_label>Cohort 1</arm_group_label>
    <arm_group_label>Cohort 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion criteria&#xD;
&#xD;
          -  AML as defined by the WHO Classification persisting or recurring following one or more&#xD;
             treatment courses. Except APL&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) ≤1&#xD;
&#xD;
        Key Exclusion criteria&#xD;
&#xD;
          -  Active extramedullary AML in the central nervous system.&#xD;
&#xD;
          -  Known hypersensitivity to immunoglobulins.&#xD;
&#xD;
          -  Non-manageable graft versus host disease.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>120 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>MD</last_name>
    <role>Study Director</role>
    <affiliation>Amgen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>City of Hope National Medical Center</name>
      <address>
        <city>Duarte</city>
        <state>California</state>
        <zip>91010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas MD Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.amgentrials.com</url>
    <description>AmgenTrials clinical trials website</description>
  </link>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>July 16, 2020</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>November 18, 2022</last_update_submitted>
  <last_update_submitted_qc>November 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 22, 2022</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>Leukemia</mesh_term>
    <mesh_term>Leukemia, Myeloid</mesh_term>
    <mesh_term>Leukemia, Myeloid, Acute</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>Yes</sharing_ipd>
    <ipd_description>De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.</ipd_time_frame>
    <ipd_access_criteria>Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.</ipd_access_criteria>
    <ipd_url>https://www.amgen.com/datasharing</ipd_url>
  </patient_data>
  <pending_results>
    <submitted>August 11, 2023</submitted>
  </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/NCT04478695
org study id: 20170646
secondary id: KEYNOTE-613
nct id: NCT04478695
lead sponsor: 
collaborator: 
is fda regulated drug: Yes
is fda regulated device: No
The primary objective of this study is to evaluate the safety and tolerability of AMG 330,
      administered in combination with pembrolizumab, in participants with relapsed or refractory
      acute myeloid leukemia (R/R AML).
This study will assess the safety and tolerability of AMG 330 in combination with
      pembrolizumab and whether pembrolizumab will enhance the anti-AML activity of AMG 330. Both
      cohort 1 and 2 will include AMG 330 and pembrolizumab with the difference being the
      initiation date for pembrolizumab treatment.
allocation: Non-Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants who Experience Dose-Limiting Toxicities (DLTs)
time frame: Up to 1 year
measure: Number of Participants who Experience Treatment-Emergent Adverse Events (TEAE)
time frame: Up to 1 year
measure: Number of Participants who Experience Treatment-Related Adverse Events (TRAE)
time frame: Up to 1 year
measure: Number of Participants who Experience a Clinically Significant Change in Vital Sign Measurements
time frame: Up to 1 year
measure: Number of Participants who Experience a Clinically Significant Change in Electrocardiograms (ECGs) Results
time frame: Up to 1 year
measure: Number of Participants who Experience a Clinically Significant Change in Clinical Laboratory Tests
time frame: Up to 1 year
measure: Number of Participants who Experience a Response to Treatment
time frame: Up to 1 year
measure: Duration of Response
time frame: Up to 1 year
measure: Serum Concentration of AMG 330
time frame: Up to 1 year
measure: Number of Participants with Anti-AMG 330 Antibody Formation
time frame: Up to 1 year
arm group label: Cohort 1
arm group type: Experimental
arm group label: Cohort 2
arm group type: Experimental
intervention type: Drug
intervention name: AMG 330
description: Continuous intravenous (IV) infusion.
arm group label: Cohort 1
arm group label: Cohort 2
intervention type: Drug
intervention name: Pembrolizumab
description: Intravenous (IV) infusion.
arm group label: Cohort 1
arm group label: Cohort 2
criteria: 
gender: All
minimum age: 18 Years
maximum age: 120 Years
healthy volunteers: No
last name: MD
role: Study Director
affiliation: Amgen
facility: 
facility: 
country: United States
url: http://www.amgentrials.com
description: AmgenTrials clinical trials website
responsible party type: Sponsor
mesh term: Leukemia
mesh term: Leukemia, Myeloid
mesh term: Leukemia, Myeloid, Acute
mesh term: Pembrolizumab
sharing ipd: Yes
ipd description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
ipd access criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
ipd url: https://www.amgen.com/datasharing
submitted: August 11, 2023