<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/NCT04436406</url>
  </required_header>
  <id_info>
    <org_study_id>IRAS 256684</org_study_id>
    <nct_id>NCT04436406</nct_id>
  </id_info>
  <brief_title>PD-L1 Expression in Cancer (PECan Study).</brief_title>
  <acronym>PECan</acronym>
  <official_title>Measurement of PD-L1 Expression in Cancer to Monitor Treatment Response.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Guy's and St Thomas' NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>NanoMab Technology (UK) Limited</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Guy's and St Thomas' NHS Foundation Trust</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>
      Measurement of PD-L1 expression in cancer to monitor treatment response.&#xD;
&#xD;
      A prospective non-blinded, single centre, single interventional arm diagnostic imaging study.&#xD;
&#xD;
      To determine the baseline level and variability within and between patients and tumour types&#xD;
      of PD-L1 expression in melanoma and non-small cell lung cancer in immunotherapy naïve&#xD;
      patients using [99mTc]-anti-PD-L1 SPECT/CT and immunohistochemistry.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Using [99mTc]-labeled anti-PD-L1 single-domain antibody, this study aims to prospectively&#xD;
      measure changes in PD-L1 expression determined with SPECT/CT imaging and correlate these&#xD;
      changes with response to anti-PD(L)1 immunotherapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 11, 2020</start_date>
  <completion_date type="Anticipated">January 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">October 31, 2023</primary_completion_date>
  <phase>N/A</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage change in PD-L1 expression (using [99mTc] SPECT) in NSCLC.</measure>
    <time_frame>Up to 18 weeks</time_frame>
    <description>PD-L1 expression reported by measurement of tumour:blood pool ratio and/or SUV of [99mTc]-anti-PD-L1-sdAb uptake on SPECT. Measurement at baseline and 9 weeks will be compared to determine % change.&#xD;
Standard clinical imaging assessment at 9 and 18 weeks used as comparators.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage change in PD-L1 expression (using [99mTc] SPECT) in melanoma lesions.</measure>
    <time_frame>Up to 24 weeks</time_frame>
    <description>PD-L1 expression reported by measurement of tumour:blood pool ratio and/or SUV of [99mTc]-anti-PD-L1-sdAb uptake on SPECT. Measurement at baseline and 12 weeks will be compared to determine % change.&#xD;
Standard clinical imaging assessment at 12 and 24 weeks used as comparators.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Report PD-L1 tumour expression (using [99mTc] SPECT) of immunotherapy naive participants compared to PD-L1 expression determine by standard immunohistochemistry.</measure>
    <time_frame>Baseline</time_frame>
    <description>Correlation between PD-L1 expression reported by measurement of tumour:blood pool ratio and/or SUV of [99mTc]-anti-PD-L1-sdAb uptake on SPECT and PD-L1 expression determined by standard of care immunohistochemistry.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Non-small Cell Lung Cancer</condition>
  <condition>Melanoma</condition>
  <arm_group>
    <arm_group_label>Advanced malignant disease (non-small cell lung cancer or malignant melanoma)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group 1: Participants with non-small cell lung cancer (NSCLC) as per inclusion/exclusion criteria undergo baseline PD-L1 expression testing by immunohistochemistry and [99m-Tc]-anti-PD-L1 single-domain antibody SPECT/CT imaging at 0 and 9 weeks.&#xD;
FDG-PET/CT is also performed at baseline (0) and first follow-up (9) weeks scans, in addition to standard CT clinical imaging at 0, 9 and 18 weeks.&#xD;
Group 2: Participants with malignant melanoma (MM) as per inclusion/exclusion criteria undergo baseline PD-L1 expression testing by immunohistochemistry and [99m-Tc]-anti-PD-L1 single-domain antibody SPECT/CT imaging at 0 and 12 weeks.&#xD;
FDG-PET/CT is also performed as standard clinical imaging at baseline (0), first follow-up (12) weeks and 24 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>[99mTc]-NM-01 SPECT/CT</intervention_name>
    <description>Technetium labelled anti-PD-L1 single-domain antibody (NM-01) single-photon emission computed tomography (SPECT)/CT</description>
    <arm_group_label>Advanced malignant disease (non-small cell lung cancer or malignant melanoma)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 18 or above&#xD;
&#xD;
          -  Patients with histologically confirmed NSCLC or melanoma scheduled for PD1/PDL1&#xD;
             immunotherapy alone or in combination with other systemic anti-cancer therapy.&#xD;
&#xD;
          -  Willingness and ability to comply with scheduled study visits and tests.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or lactating women&#xD;
&#xD;
          -  Concomitant uncontrolled medical conditions&#xD;
&#xD;
          -  Patients likely to require palliative radiotherapy within the first 12 weeks of&#xD;
             treatment or radiotherapy to target lesion(s) received within preceding 42 days&#xD;
&#xD;
          -  More than 3 months between IHC PDL1 and study recruitment&#xD;
&#xD;
          -  Patients who have received other systemic anti-cancer therapy within preceding 14 days&#xD;
&#xD;
          -  Prognosis less than 3 months&#xD;
&#xD;
          -  Previous anticancer treatment with any checkpoint inhibitor or other immunotherapy,&#xD;
             i.e. only immunotherapy naïve patients&#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>Gary JR Cook</last_name>
    <role>Principal Investigator</role>
    <affiliation>King's College London, London, UK</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Daniel J Hughes, MBBS MRCP</last_name>
    <phone>020 7188 7188</phone>
    <phone_ext>88378</phone_ext>
    <email>daniel.hughes@kcl.ac.uk</email>
  </overall_contact>
  <location>
    <facility>
      <name>Guy's and St Thomas' NHS Foundation Trust</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Daniel J Hughes, MBBS MRCP</last_name>
      <phone>(0044)20 7188 7188</phone>
      <phone_ext>88378</phone_ext>
      <email>daniel.hughes@kcl.ac.uk</email>
    </contact>
    <contact_backup>
      <last_name>Gary JR Cook</last_name>
      <phone>(0044)20 7188 7188</phone>
      <phone_ext>88378</phone_ext>
      <email>gary.cook@kcl.ac.uk</email>
    </contact_backup>
    <investigator>
      <last_name>Gary JR Cook</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Daniel J Hughes</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>March 9, 2020</study_first_submitted>
  <study_first_submitted_qc>June 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>December 13, 2022</last_update_submitted>
  <last_update_submitted_qc>December 13, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 15, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>immunotherapy</keyword>
  <keyword>checkpoint inhibitors</keyword>
  <keyword>molecular imaging</keyword>
  <keyword>non-small cell lung cancer</keyword>
  <keyword>melanoma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term>
    <mesh_term>Melanoma</mesh_term>
  </condition_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/NCT04436406
org study id: IRAS 256684
nct id: NCT04436406
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Measurement of PD-L1 expression in cancer to monitor treatment response.

      A prospective non-blinded, single centre, single interventional arm diagnostic imaging study.

      To determine the baseline level and variability within and between patients and tumour types
      of PD-L1 expression in melanoma and non-small cell lung cancer in immunotherapy naïve
      patients using [99mTc]-anti-PD-L1 SPECT/CT and immunohistochemistry.
Using [99mTc]-labeled anti-PD-L1 single-domain antibody, this study aims to prospectively
      measure changes in PD-L1 expression determined with SPECT/CT imaging and correlate these
      changes with response to anti-PD(L)1 immunotherapy.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Percentage change in PD-L1 expression (using [99mTc] SPECT) in NSCLC.
time frame: Up to 18 weeks
description: PD-L1 expression reported by measurement of tumour:blood pool ratio and/or SUV of [99mTc]-anti-PD-L1-sdAb uptake on SPECT. Measurement at baseline and 9 weeks will be compared to determine % change.
Standard clinical imaging assessment at 9 and 18 weeks used as comparators.
measure: Percentage change in PD-L1 expression (using [99mTc] SPECT) in melanoma lesions.
time frame: Up to 24 weeks
description: PD-L1 expression reported by measurement of tumour:blood pool ratio and/or SUV of [99mTc]-anti-PD-L1-sdAb uptake on SPECT. Measurement at baseline and 12 weeks will be compared to determine % change.
Standard clinical imaging assessment at 12 and 24 weeks used as comparators.
measure: Report PD-L1 tumour expression (using [99mTc] SPECT) of immunotherapy naive participants compared to PD-L1 expression determine by standard immunohistochemistry.
time frame: Baseline
description: Correlation between PD-L1 expression reported by measurement of tumour:blood pool ratio and/or SUV of [99mTc]-anti-PD-L1-sdAb uptake on SPECT and PD-L1 expression determined by standard of care immunohistochemistry.
arm group label: Advanced malignant disease (non-small cell lung cancer or malignant melanoma)
arm group type: Experimental
description: Group 1: Participants with non-small cell lung cancer (NSCLC) as per inclusion/exclusion criteria undergo baseline PD-L1 expression testing by immunohistochemistry and [99m-Tc]-anti-PD-L1 single-domain antibody SPECT/CT imaging at 0 and 9 weeks.
FDG-PET/CT is also performed at baseline (0) and first follow-up (9) weeks scans, in addition to standard CT clinical imaging at 0, 9 and 18 weeks.
Group 2: Participants with malignant melanoma (MM) as per inclusion/exclusion criteria undergo baseline PD-L1 expression testing by immunohistochemistry and [99m-Tc]-anti-PD-L1 single-domain antibody SPECT/CT imaging at 0 and 12 weeks.
FDG-PET/CT is also performed as standard clinical imaging at baseline (0), first follow-up (12) weeks and 24 weeks.
intervention type: Diagnostic Test
intervention name: [99mTc]-NM-01 SPECT/CT
description: Technetium labelled anti-PD-L1 single-domain antibody (NM-01) single-photon emission computed tomography (SPECT)/CT
arm group label: Advanced malignant disease (non-small cell lung cancer or malignant melanoma)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gary JR Cook
role: Principal Investigator
affiliation: King's College London, London, UK
last name: Daniel J Hughes, MBBS MRCP
phone: 020 7188 7188
phone ext: 88378
email: daniel.hughes@kcl.ac.uk
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Melanoma
sharing ipd: No