<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/NCT04473027</url>
  </required_header>
  <id_info>
    <org_study_id>BC-5765</org_study_id>
    <nct_id>NCT04473027</nct_id>
  </id_info>
  <brief_title>BLood Groups as Biomarker to Optimize Odds of Response to Anti-PD-1 Drugs</brief_title>
  <acronym>BLOOD</acronym>
  <official_title>BLood Groups as Biomarker to Optimize Odds of Response to Anti-PD-1 Drugs (BLOOD Trial)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Ghent</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Jessa Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital, Antwerp</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Algemeen Ziekenhuis Maria Middelares</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>GZA Ziekenhuizen Campus Sint-Augustinus</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>AZ Sint-Jan AV</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>AZ Nikolaas</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>AZ Sint-Lucas Gent</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>AZ Sint-Lucas Brugge</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>General Hospital Groeninge</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>OLV van Lourdes Hospital Waregem</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>AZ Damiaan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>AZ Delta</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>ASZ Aalst</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Belgian Red Cross</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Ghent</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      BLOOD is an investigator-initiated, multicenter, prospective biomarker study in patients with&#xD;
      advanced melanoma treated with anti-PD-1 monotherapy in the first-line setting. The &quot;studied&#xD;
      products&quot; will be administered and managed within routine medical care in Belgium. The&#xD;
      overall goal is (i) to investigate biomarkers for anti-PD-1 monotherapy and (ii) to gather&#xD;
      evidence on real-life use of anti-PD-1 monotherapy in melanoma.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Low patient inclusion&#xD;
  </why_stopped>
  <start_date type="Actual">September 1, 2020</start_date>
  <completion_date type="Actual">April 22, 2021</completion_date>
  <primary_completion_date type="Actual">April 22, 2021</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>12 Months</target_duration>
  <primary_outcome>
    <measure>The association between ABO blood groups (specifically O vs A/B/AB) and anti-PD-1 monotherapy efficacy.</measure>
    <time_frame>25 weeks</time_frame>
    <description>In terms of objective response rate (ORR) according to RECIST v1.1</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Descriptive data on real-life use of anti-PD-1 therapy.</measure>
    <time_frame>3, 6, 12 months</time_frame>
    <description>Based on demographics (age, ethnicity, sex, height, weight (and Body Mass Index), smoking status, and gravida/para/abortus (if female)), melanoma history, clinical profile of participant at time of anti-PD-1 initiation, prior and/or concomitant intervention(s), duration of treatment exposure during the study, and effectiveness and safety of anti-PD-1 therapy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The association between ABO blood groups and anti-PD-1 monotherapy efficacy.</measure>
    <time_frame>12, 25 weeks</time_frame>
    <description>In terms of Overall Response Rate (ORR) / Disease Control Rate (DCR) / Best Overall Response (BOR) (RECIST v1.1)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The association between ABO blood groups and anti-PD-1 monotherapy efficacy.</measure>
    <time_frame>3, 6, 12 months</time_frame>
    <description>in terms of Progression-Free Survival (PFS) / Overall Survival (OS) (RECIST v1.1)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The association between Kell, Kidd, Duffy, MNS, Rhesus, and Dombrock blood group antigens and anti-PD-1 monotherapy efficacy.</measure>
    <time_frame>12, 25 weeks</time_frame>
    <description>In terms of ORR/DCR/BOR (RECIST v1.1)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The association between Kell, Kidd, Duffy, MNS, Rhesus, and Dombrock blood group antigens and anti-PD-1 monotherapy efficacy.</measure>
    <time_frame>3, 6, 12 months</time_frame>
    <description>In terms of PFS/OS (RECIST v1.1)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The association between irregular antibodies and anti-PD-1 monotherapy efficacy.</measure>
    <time_frame>12, 25 weeks</time_frame>
    <description>In terms of ORR/DCR/BOR (RECIST v1.1)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The association between irregular antibodies and anti-PD-1 monotherapy efficacy.</measure>
    <time_frame>3, 6, 12 months</time_frame>
    <description>In terms of PFS/OS (RECIST v1.1)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To evaluate the association between overall survival and other endpoints as defined in the primary endpoints.</measure>
    <time_frame>12 months</time_frame>
    <description>(i.e., ORR, DCR, BOR, and PFS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The association between steroid administration and anti-PD-1 monotherapy efficacy.</measure>
    <time_frame>12, 25 weeks</time_frame>
    <description>In terms of ORR/DCR/BOR (RECIST v1.1)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The association between steroid administration and anti-PD-1 monotherapy efficacy.</measure>
    <time_frame>3, 6, 12 months</time_frame>
    <description>In terms of PFS/OS (RECIST v1.1)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The association between immunosuppressant administration and anti-PD-1 monotherapy efficacy.</measure>
    <time_frame>12, 25 weeks</time_frame>
    <description>In terms of ORR/DCR/BOR (RECIST v1.1)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The association between immunosuppressant administration and anti-PD-1 monotherapy efficacy.</measure>
    <time_frame>3, 6, 12 months</time_frame>
    <description>In terms of PFS/OS (RECIST v1.1)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The association between antibiotics administration and anti-PD-1 monotherapy efficacy.</measure>
    <time_frame>12, 25 weeks</time_frame>
    <description>In terms of ORR/DCR/BOR (RECIST v1.1)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The association between antibiotics administration and anti-PD-1 monotherapy efficacy.</measure>
    <time_frame>3, 6, 12 months</time_frame>
    <description>In terms of PFS/OS (RECIST v1.1)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The association between selected baseline and intermediate data (as listed in Outcome 2) and anti-PD-1 monotherapy efficacy.</measure>
    <time_frame>12, 25 weeks</time_frame>
    <description>In terms of ORR/DCR/BOR (RECIST v1.1)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The association between selected baseline and intermediate data (as listed in Outcome 2) and anti-PD-1 monotherapy efficacy.</measure>
    <time_frame>3, 6, 12 months</time_frame>
    <description>In terms of PFS/OS (RECIST v1.1)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>The relationship between anti-PD-1 monotherapy efficacy and red blood cell transfusions.</measure>
    <time_frame>12, 25 weeks and 3, 6, 12 months</time_frame>
    <description>In terms of ORR/DCR/BOR/PFS/OS (RECIST v1.1)</description>
  </other_outcome>
  <other_outcome>
    <measure>The relationship between anti-PD-1 monotherapy efficacy and vaccinations.</measure>
    <time_frame>12, 25 weeks and 3, 6, 12 months</time_frame>
    <description>In terms of ORR/DCR/BOR/PFS/OS (RECIST v1.1)</description>
  </other_outcome>
  <other_outcome>
    <measure>The relationship between anti-PD-1 monotherapy efficacy and previous pregnancies.</measure>
    <time_frame>12, 25 weeks and 3, 6, 12 months</time_frame>
    <description>In terms of ORR/DCR/BOR/PFS/OS (RECIST v1.1)</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">3</enrollment>
  <condition>Melanoma</condition>
  <condition>Cancer</condition>
  <arm_group>
    <arm_group_label>Patients with advanced melanoma</arm_group_label>
    <description>Patients receiving anti-PD-1 monotherapy (Nivolumab or Pembrolizumab) in the first-line setting</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Blood sample collection</intervention_name>
    <description>Whole venous blood of participants will be collected in EDTA tubes (max. 10 mL) at baseline, before start of first immunotherapy round. The Belgian Red Cross will perform serological blood group diagnostics, and molecular RBC typing.</description>
    <arm_group_label>Patients with advanced melanoma</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      EDTA blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with advanced melanoma&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically proven advanced melanoma.&#xD;
&#xD;
          -  Anti-PD-1 monotherapy of advanced (unresectable or metastatic) melanoma (prescribed&#xD;
             within its approved indication as per usual practice according to RIZIV/INAMI&#xD;
             regulations) in the first-line setting.&#xD;
&#xD;
          -  No prior systemic therapy for advanced melanoma.&#xD;
&#xD;
          -  Have measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST)&#xD;
             version 1.1.&#xD;
&#xD;
          -  At least 18 years of age.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior treatment with any drug specifically targeting T-cell co-stimulation or immune&#xD;
             checkpoints (e.g., antibodies targeting PD-(L)1 or CTLA-4, chimeric antigen receptor T&#xD;
             (CAR-T) cell therapy).&#xD;
&#xD;
          -  Metastasis-directed therapy (surgery or radiotherapy) with definitive intent (local&#xD;
             therapy to address symptomatic sites of disease is permitted).&#xD;
&#xD;
          -  Previous systemic treatment for advanced melanoma.&#xD;
&#xD;
          -  Active central nervous system (CNS) metastases (previously treated brain metastases&#xD;
             are permitted if stable) or carcinomatous meningitis.&#xD;
&#xD;
          -  Diagnosis of any other malignancy within 5 years prior to study inclusion, except for&#xD;
             adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the&#xD;
             breast or of the cervix, low-risk prostate cancer on surveillance without any plans&#xD;
             for treatment intervention, or prostate cancer that has been adequately treated with&#xD;
             prostatectomy or radiotherapy and currently with no evidence of disease and symptoms.&#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>Hannelore Denys, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical Oncologist</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Emiel De Jaeghere, MD</last_name>
    <role>Study Chair</role>
    <affiliation>PhD Fellow</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Gent</name>
      <address>
        <city>Gent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 16, 2020</study_first_posted>
  <last_update_submitted>May 6, 2021</last_update_submitted>
  <last_update_submitted_qc>May 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 10, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Immunotherapy</keyword>
  <keyword>Anti-PD-1</keyword>
  <keyword>Nivolumab</keyword>
  <keyword>Pembrolizumab</keyword>
  <keyword>Biomarker</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT04473027
org study id: BC-5765
nct id: NCT04473027
lead sponsor: 
collaborator: 
collaborator: 
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collaborator: 
collaborator: 
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is fda regulated drug: No
is fda regulated device: No
is us export: No
BLOOD is an investigator-initiated, multicenter, prospective biomarker study in patients with
      advanced melanoma treated with anti-PD-1 monotherapy in the first-line setting. The "studied
      products" will be administered and managed within routine medical care in Belgium. The
      overall goal is (i) to investigate biomarkers for anti-PD-1 monotherapy and (ii) to gather
      evidence on real-life use of anti-PD-1 monotherapy in melanoma.
observational model: Cohort
time perspective: Prospective
measure: The association between ABO blood groups (specifically O vs A/B/AB) and anti-PD-1 monotherapy efficacy.
time frame: 25 weeks
description: In terms of objective response rate (ORR) according to RECIST v1.1
measure: Descriptive data on real-life use of anti-PD-1 therapy.
time frame: 3, 6, 12 months
description: Based on demographics (age, ethnicity, sex, height, weight (and Body Mass Index), smoking status, and gravida/para/abortus (if female)), melanoma history, clinical profile of participant at time of anti-PD-1 initiation, prior and/or concomitant intervention(s), duration of treatment exposure during the study, and effectiveness and safety of anti-PD-1 therapy.
measure: The association between ABO blood groups and anti-PD-1 monotherapy efficacy.
time frame: 12, 25 weeks
description: In terms of Overall Response Rate (ORR) / Disease Control Rate (DCR) / Best Overall Response (BOR) (RECIST v1.1)
measure: The association between ABO blood groups and anti-PD-1 monotherapy efficacy.
time frame: 3, 6, 12 months
description: in terms of Progression-Free Survival (PFS) / Overall Survival (OS) (RECIST v1.1)
measure: The association between Kell, Kidd, Duffy, MNS, Rhesus, and Dombrock blood group antigens and anti-PD-1 monotherapy efficacy.
time frame: 12, 25 weeks
description: In terms of ORR/DCR/BOR (RECIST v1.1)
measure: The association between Kell, Kidd, Duffy, MNS, Rhesus, and Dombrock blood group antigens and anti-PD-1 monotherapy efficacy.
time frame: 3, 6, 12 months
description: In terms of PFS/OS (RECIST v1.1)
measure: The association between irregular antibodies and anti-PD-1 monotherapy efficacy.
time frame: 12, 25 weeks
description: In terms of ORR/DCR/BOR (RECIST v1.1)
measure: The association between irregular antibodies and anti-PD-1 monotherapy efficacy.
time frame: 3, 6, 12 months
description: In terms of PFS/OS (RECIST v1.1)
measure: To evaluate the association between overall survival and other endpoints as defined in the primary endpoints.
time frame: 12 months
description: (i.e., ORR, DCR, BOR, and PFS)
measure: The association between steroid administration and anti-PD-1 monotherapy efficacy.
time frame: 12, 25 weeks
description: In terms of ORR/DCR/BOR (RECIST v1.1)
measure: The association between steroid administration and anti-PD-1 monotherapy efficacy.
time frame: 3, 6, 12 months
description: In terms of PFS/OS (RECIST v1.1)
measure: The association between immunosuppressant administration and anti-PD-1 monotherapy efficacy.
time frame: 12, 25 weeks
description: In terms of ORR/DCR/BOR (RECIST v1.1)
measure: The association between immunosuppressant administration and anti-PD-1 monotherapy efficacy.
time frame: 3, 6, 12 months
description: In terms of PFS/OS (RECIST v1.1)
measure: The association between antibiotics administration and anti-PD-1 monotherapy efficacy.
time frame: 12, 25 weeks
description: In terms of ORR/DCR/BOR (RECIST v1.1)
measure: The association between antibiotics administration and anti-PD-1 monotherapy efficacy.
time frame: 3, 6, 12 months
description: In terms of PFS/OS (RECIST v1.1)
measure: The association between selected baseline and intermediate data (as listed in Outcome 2) and anti-PD-1 monotherapy efficacy.
time frame: 12, 25 weeks
description: In terms of ORR/DCR/BOR (RECIST v1.1)
measure: The association between selected baseline and intermediate data (as listed in Outcome 2) and anti-PD-1 monotherapy efficacy.
time frame: 3, 6, 12 months
description: In terms of PFS/OS (RECIST v1.1)
measure: The relationship between anti-PD-1 monotherapy efficacy and red blood cell transfusions.
time frame: 12, 25 weeks and 3, 6, 12 months
description: In terms of ORR/DCR/BOR/PFS/OS (RECIST v1.1)
measure: The relationship between anti-PD-1 monotherapy efficacy and vaccinations.
time frame: 12, 25 weeks and 3, 6, 12 months
description: In terms of ORR/DCR/BOR/PFS/OS (RECIST v1.1)
measure: The relationship between anti-PD-1 monotherapy efficacy and previous pregnancies.
time frame: 12, 25 weeks and 3, 6, 12 months
description: In terms of ORR/DCR/BOR/PFS/OS (RECIST v1.1)
arm group label: Patients with advanced melanoma
description: Patients receiving anti-PD-1 monotherapy (Nivolumab or Pembrolizumab) in the first-line setting
intervention type: Diagnostic Test
intervention name: Blood sample collection
description: Whole venous blood of participants will be collected in EDTA tubes (max. 10 mL) at baseline, before start of first immunotherapy round. The Belgian Red Cross will perform serological blood group diagnostics, and molecular RBC typing.
arm group label: Patients with advanced melanoma
EDTA blood
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Hannelore Denys, MD, PhD
role: Principal Investigator
affiliation: Medical Oncologist
last name: Emiel De Jaeghere, MD
role: Study Chair
affiliation: PhD Fellow
facility: 
country: Belgium
responsible party type: Sponsor
mesh term: Melanoma
sharing ipd: No