xml: <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/NCT06031233</url>
    </required_header>
    <id_info>
      <org_study_id>NL83071.075.22 / 20221102</org_study_id>
      <nct_id>NCT06031233</nct_id>
    </id_info>
    <brief_title>Evaluating the Safety of Shortened Infusion Times for dIfferent Oncological Immunotherapie</brief_title>
    <acronym>MINUTE</acronym>
    <official_title>Evaluating the Safety of Shortened Infusion Times for dIfferent Oncological Immunotherapies; An Observational Prospective Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Isala</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Isala</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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study is an observational, explorative, prospective study to show whether shortening of&#xD;
        infusion times for patients using nivolumab, pembrolizumab, ipilimumab, trastuzumab,&#xD;
        bevacizumab, durvalumab or atezolizumab continues to be associated with an acceptable safety&#xD;
        profile.&#xD;
  &#xD;
        Infusion times will be gradually shortened if tolerability allowes.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        After two cycles with normal infusion times, infusion time will be shortened to 15 mintues en&#xD;
        10 minutes subsequently if no infusion reaction occurs.&#xD;
  &#xD;
        Patient satisfaction will be evaluated.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">December 2024</completion_date>
    <primary_completion_date type="Anticipated">July 2024</primary_completion_date>
    <phase>Phase 4</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Incidence of infusion related reactions</measure>
      <time_frame>During or within 30 minutes after the end of the infusion</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Plasma levels of the administered mAb</measure>
      <time_frame>Within 15 minutes before start of the infusion</time_frame>
    </secondary_outcome>
    <other_outcome>
      <measure>Satisfaction with shortened infusion time assessed by the VAS</measure>
      <time_frame>Directly after infusion in fourth cycle (cycle length ranges from 21-42 days, depending on the specific antibody)</time_frame>
      <description>Scale 1-10, 1: not satisfied at all, 10: most satisfied</description>
    </other_outcome>
    <number_of_arms>7</number_of_arms>
    <enrollment type="Anticipated">679</enrollment>
    <condition>Oncology</condition>
    <condition>Infusion Reaction</condition>
    <arm_group>
      <arm_group_label>Nivolumab</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>If no infusion reaction has occurred after 2 cyclues, infusion time will stepwise be shortened to 10 minutes in the following cycles.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Pembrolizumab</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>If no infusion reaction has occurred after 2 cyclues, infusion time will stepwise be shortened to 10 minutes in the following cycles.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>ipilimumab</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>If no infusion reaction has occurred after 2 cyclues, infusion time will stepwise be shortened to 10 minutes in the following cycles.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Durvalumab</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>If no infusion reaction has occurred after 2 cyclues, infusion time will stepwise be shortened to 10 minutes in the following cycles.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Atezolizumab</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>If no infusion reaction has occurred after 2 cyclues, infusion time will stepwise be shortened to 10 minutes in the following cycles.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>bevacizumab</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>If no infusion reaction has occurred after 2 cyclues, infusion time will stepwise be shortened to 10 minutes in the following cycles.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Trastuzumab</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>If no infusion reaction has occurred after 2 cyclues, infusion time will stepwise be shortened to 10 minutes in the following cycles.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Nivolumab</intervention_name>
      <description>Gradual shortening of infusion times</description>
      <arm_group_label>Nivolumab</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Pembrolizumab</intervention_name>
      <description>Gradual shortening of infusion times</description>
      <arm_group_label>Pembrolizumab</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Ipilimumab</intervention_name>
      <description>Gradual shortening of infusion times</description>
      <arm_group_label>ipilimumab</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Durvalumab</intervention_name>
      <description>Gradual shortening of infusion times</description>
      <arm_group_label>Durvalumab</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Atezolizumab</intervention_name>
      <description>Gradual shortening of infusion times</description>
      <arm_group_label>Atezolizumab</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Bevacizumab</intervention_name>
      <description>Gradual shortening of infusion times</description>
      <arm_group_label>bevacizumab</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Trastuzumab</intervention_name>
      <description>Gradual shortening of infusion times</description>
      <arm_group_label>Trastuzumab</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Starting treatment with monoclonal antibodies: nivolumab, pembrolizumab ipilimumab,&#xD;
               bevacizumab, trastuzumab, durvalumab or atezolizumab.&#xD;
  &#xD;
            -  18 years and older.&#xD;
  &#xD;
            -  No known history of increased susceptibility to immunological reactions.&#xD;
  &#xD;
            -  Subject is able and willing to sign the Informed Consent Form prior to screening&#xD;
               evaluations.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Other research medication within 4 weeks of the start of the study.&#xD;
  &#xD;
            -  Inclusion in medical research in which the administration of medication should follow&#xD;
               its stated times and dosages of infusions&#xD;
  &#xD;
            -  Dosage deviates from standard protocol&#xD;
  &#xD;
            -  Patients whom receive drugs through a central venous catheter (and for example&#xD;
               porth-a-cath).&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>April 24, 2023</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Isala</investigator_affiliation>
      <investigator_full_name>HB Fiebrich-Westra</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Neoplasms</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Bevacizumab</mesh_term>
      <mesh_term>Pembrolizumab</mesh_term>
      <mesh_term>Nivolumab</mesh_term>
      <mesh_term>Trastuzumab</mesh_term>
      <mesh_term>Ipilimumab</mesh_term>
      <mesh_term>Atezolizumab</mesh_term>
      <mesh_term>Durvalumab</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06031233
  org study id: NL83071.075.22 / 20221102
  nct id: NCT06031233
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  This study is an observational, explorative, prospective study to show whether shortening of
        infusion times for patients using nivolumab, pembrolizumab, ipilimumab, trastuzumab,
        bevacizumab, durvalumab or atezolizumab continues to be associated with an acceptable safety
        profile.
  
        Infusion times will be gradually shortened if tolerability allowes.
  After two cycles with normal infusion times, infusion time will be shortened to 15 mintues en
        10 minutes subsequently if no infusion reaction occurs.
  
        Patient satisfaction will be evaluated.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Incidence of infusion related reactions
  time frame: During or within 30 minutes after the end of the infusion
  measure: Plasma levels of the administered mAb
  time frame: Within 15 minutes before start of the infusion
  measure: Satisfaction with shortened infusion time assessed by the VAS
  time frame: Directly after infusion in fourth cycle (cycle length ranges from 21-42 days, depending on the specific antibody)
  description: Scale 1-10, 1: not satisfied at all, 10: most satisfied
  arm group label: Nivolumab
  arm group type: Experimental
  description: If no infusion reaction has occurred after 2 cyclues, infusion time will stepwise be shortened to 10 minutes in the following cycles.
  arm group label: Pembrolizumab
  arm group type: Experimental
  description: If no infusion reaction has occurred after 2 cyclues, infusion time will stepwise be shortened to 10 minutes in the following cycles.
  arm group label: ipilimumab
  arm group type: Experimental
  description: If no infusion reaction has occurred after 2 cyclues, infusion time will stepwise be shortened to 10 minutes in the following cycles.
  arm group label: Durvalumab
  arm group type: Experimental
  description: If no infusion reaction has occurred after 2 cyclues, infusion time will stepwise be shortened to 10 minutes in the following cycles.
  arm group label: Atezolizumab
  arm group type: Experimental
  description: If no infusion reaction has occurred after 2 cyclues, infusion time will stepwise be shortened to 10 minutes in the following cycles.
  arm group label: bevacizumab
  arm group type: Experimental
  description: If no infusion reaction has occurred after 2 cyclues, infusion time will stepwise be shortened to 10 minutes in the following cycles.
  arm group label: Trastuzumab
  arm group type: Experimental
  description: If no infusion reaction has occurred after 2 cyclues, infusion time will stepwise be shortened to 10 minutes in the following cycles.
  intervention type: Drug
  intervention name: Nivolumab
  description: Gradual shortening of infusion times
  arm group label: Nivolumab
  intervention type: Drug
  intervention name: Pembrolizumab
  description: Gradual shortening of infusion times
  arm group label: Pembrolizumab
  intervention type: Drug
  intervention name: Ipilimumab
  description: Gradual shortening of infusion times
  arm group label: ipilimumab
  intervention type: Drug
  intervention name: Durvalumab
  description: Gradual shortening of infusion times
  arm group label: Durvalumab
  intervention type: Drug
  intervention name: Atezolizumab
  description: Gradual shortening of infusion times
  arm group label: Atezolizumab
  intervention type: Drug
  intervention name: Bevacizumab
  description: Gradual shortening of infusion times
  arm group label: bevacizumab
  intervention type: Drug
  intervention name: Trastuzumab
  description: Gradual shortening of infusion times
  arm group label: Trastuzumab
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  responsible party type: Principal Investigator
  investigator affiliation: Isala
  investigator full name: HB Fiebrich-Westra
  investigator title: Principal Investigator
  mesh term: Neoplasms
  mesh term: Bevacizumab
  mesh term: Pembrolizumab
  mesh term: Nivolumab
  mesh term: Trastuzumab
  mesh term: Ipilimumab
  mesh term: Atezolizumab
  mesh term: Durvalumab
  sharing ipd: No