<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/NCT03786419</url>
  </required_header>
  <id_info>
    <org_study_id>JCJ-768883</org_study_id>
    <nct_id>NCT03786419</nct_id>
  </id_info>
  <brief_title>A Study of Atezolizumab in Unresectable or Advaced Malignant Pleural Mesothelioma</brief_title>
  <official_title>Phase II Study to Evaluate the Efficacy and Safety of Atezolizumab in Subjects With Unresectable or Advanced Malignant Pleural Mesothelioma Who Experienced Progression on Platinum-Based Chemotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Health Pharma Professional Research</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Health Pharma Professional Research</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a national, single arm, phase II trial in patients with diagnosis of unresectable or&#xD;
      advanced malignant pleural mesothelioma who experienced progression after platinum-based&#xD;
      chemotherapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study includes a screening period a treatment period, a termination treatment visit ≤30&#xD;
      days following the last dose of the study drug, and a follow-up period. Day 1 is defined as&#xD;
      the first day in which patients receive atezolizumab. The study is expected to enroll 36&#xD;
      patients.&#xD;
&#xD;
      Enrolled patients will receive a fixed dose of atezolizumab 1200 mg administered&#xD;
      intravenously the first day of each cycle. A treatment cycle will last 21 days (± 3 days).&#xD;
      Treatment with atezolizumab will continue until investigator-assessed loss of clinical&#xD;
      benefit, unacceptable toxicity, investigator or participant's decision to withdraw from&#xD;
      therapy, or death (whichever occurs first).&#xD;
&#xD;
      Treatment with atezolizumab may continue while patients experience clinical benefit based on&#xD;
      the investigator's assessment (absence of unacceptable toxicity or symptomatic deterioration&#xD;
      attributable to disease progression, at the discretion of the investigator after evaluating&#xD;
      radiographic data, biopsy results [if available], and clinical status), or until unacceptable&#xD;
      toxicity or death.&#xD;
&#xD;
      During treatment, patients treated with atezolizumab, who demonstrate evidence of clinical&#xD;
      benefit may continue treatment with atezolizumab after meeting disease progression criteria,&#xD;
      based on the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. The following need&#xD;
      to be met, as specified by the protocol.&#xD;
&#xD;
      All patients must undergo tumor assessments at baseline and every 9 weeks (± 7 days)&#xD;
      following cycle 1, day 1, regardless of treatment delays, until radiographic disease&#xD;
      progression, as per RECIST v1.1 modified for mesothelioma, or loss of clinical benefit in&#xD;
      patients treated with atezolizumab, who continue treatment beyond disease progression, as per&#xD;
      RECIST v1.1, withdrawal of consent, death or study termination by principal investigator,&#xD;
      whichever occurs first.&#xD;
&#xD;
      The study will end if all enrolled patients die, withdraw their consent, become lost to&#xD;
      follow-up, or have been monitored during 12 months from the enrollment of the last patient,&#xD;
      whichever occurs first.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Publication of study results of ICI use in MPM as first line therapy&#xD;
  </why_stopped>
  <start_date type="Anticipated">August 2020</start_date>
  <completion_date type="Anticipated">August 2020</completion_date>
  <primary_completion_date type="Anticipated">August 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>Objective Response Rate</measure>
    <time_frame>From the time of initial response until documented tumor progression or death, whichever occurs first (up to approximately 4 years)</time_frame>
    <description>The number of subjects whose best confirmed objective response is a CR or PR, divided by the number of treated subjects</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival</measure>
    <time_frame>Baseline up to disease progression or death, whichever occurs first (up to approximately 4 years)</time_frame>
    <description>The time from the date of the start of treatment to the date of the first documented tumor progression as determined by RECIST v 1.1, or death, whichever occurs first</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of response</measure>
    <time_frame>Baseline up to disease progression or death, whichever occurs first (up to approximately 4 years)</time_frame>
    <description>The time from documentation of tumor response to disease progression as determined by RECIST v1.1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>Baseline up to 1 year after treatment discontinuation</time_frame>
    <description>The time from the date of the start of treatment until death from any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety of atezolizumab</measure>
    <time_frame>Baseline up to 60 days after the last dose of the study drug or until another oncologic treatment is initiated, whichever occurs first</time_frame>
    <description>The incidence of treatment-related adverse events assessed by CTCAE v4.03</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health Related Quality of Life (HRQoL) Scores</measure>
    <time_frame>Baseline until 1 year after treatment discontinuation or death, whichever occurs first</time_frame>
    <description>Change from Baseline in Health Related Quality of Life (HRQoL) Scores as Measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - C30 (EORTC QLQ-C30)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Functioning and Symptoms Score</measure>
    <time_frame>Baseline until 1 year after treatment discontinuation or death, whichever occurs first</time_frame>
    <description>Change from Baseline in Patient Functioning and Symptoms Score as Measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module LC-13 (QLQ-LC13)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Malignant Pleural Mesothelioma, Advanced</condition>
  <condition>Malignant Pleural Mesothelioma, Unresectable</condition>
  <arm_group>
    <arm_group_label>Atezolizumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with unresectable or advanced malignant pleural mesothelioma who have progressed after platinum-based chemotherapy will receive atezolizumab 1200 mg every 21 days, until Investigator-assessed loss of clinical benefit, unacceptable toxicity, investigator or participant's decision to withdraw from therapy, or death (whichever occurs first).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Atezolizumab</intervention_name>
    <description>Participants will be given 1200 mg of Atezolizumab as single agent by IV infusion every 21 days. First infusion will be over 60 min. Subsequent Atezolizumab cycles may be administered for 30 minutes, if there were no perfusion-related toxicity</description>
    <arm_group_label>Atezolizumab</arm_group_label>
    <other_name>Tecentriq</other_name>
    <other_name>RO5541267</other_name>
    <other_name>MPDL3280A</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Signed informed consent form.&#xD;
&#xD;
          -  Patients have ≥18 years of age.&#xD;
&#xD;
          -  Diagnosis of malignant pleural mesothelioma histologically confirmed by certified&#xD;
             pathologist.&#xD;
&#xD;
          -  Unresectable and/or advanced disease, based on the Seventh Edition American Joint&#xD;
             Committee on Cancer (AJCC) Cancer Staging Manual. Patients with MPM diagnosed with&#xD;
             early disease and whose comorbidities make them ineligible for surgical procedures or&#xD;
             who do not accept surgery treatment.&#xD;
&#xD;
          -  Patients should have received at least one platinum-based treatment and should have&#xD;
             reported progression after at least two treatment cycles.&#xD;
&#xD;
          -  Disease measurable as per the Response Evaluation Criteria in Solid Tumors (RECIST)&#xD;
             modified for mesothelioma.&#xD;
&#xD;
          -  ECOG performance status ≤2.&#xD;
&#xD;
          -  &gt;12-week life expectancy.&#xD;
&#xD;
          -  Patients with adequate organ function&#xD;
&#xD;
          -  Patients should have recovered to grade ≤1 in all adverse events associated with&#xD;
             previous antineoplastic therapies, excluding alopecia.&#xD;
&#xD;
          -  Patients should be able to comply with protocol procedures, at the discretion of the&#xD;
             investigator&#xD;
&#xD;
          -  Patients of both genders who are potentially fertile should use effective&#xD;
             contraceptive methods (barrier methods plus other contraceptive methods) before study&#xD;
             entry and during their participation in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients diagnosed with another tumor, except for treated cervical carcinoma in situ,&#xD;
             epidermoid carcinoma, or superficial bladder cancer (Ta and Tis), or other malignancy&#xD;
             for which healing therapy was administered within 5 years before study enrollment.&#xD;
&#xD;
          -  Simultaneous participation in another study on a study drug, or if the patient&#xD;
             participated in a study within 28 days before study treatment initiation.&#xD;
&#xD;
          -  Medical history of interstitial lung disease (ILD), drug-induced interstitial disease,&#xD;
             radiation pneumonitis that required treatment with steroids, or any sign of clinically&#xD;
             active interstitial lung disease.&#xD;
&#xD;
          -  Use of systemic immunosuppressive therapy (use of steroids with a dose &gt;10 mg of&#xD;
             prednisone or other immunosuppressive therapy).&#xD;
&#xD;
          -  Presence of active autoimmune disease.&#xD;
&#xD;
          -  Suspicion or certainty of symptomatic brain metastasis or spinal cord compression.&#xD;
             Patients with asymptomatic and stable brain metastasis are eligible for the study.&#xD;
&#xD;
          -  Pregnant or breastfeeding women. Women of childbearing potential must have a negative&#xD;
             pregnancy test carried out within 7 days prior to treatment initiation.&#xD;
&#xD;
          -  Patient previously treated with immunotherapy (PD-1/PD-L1 inhibitors).&#xD;
&#xD;
          -  Major surgery within 4 weeks prior to study treatment initiation or expected major&#xD;
             surgery during the course of the study for non-diagnostic purposes.&#xD;
&#xD;
          -  Known seropositivity for human immunodeficiency virus (HIV). tory or symptoms of HIV&#xD;
             may enter the study only if there is negative serology.&#xD;
&#xD;
          -  Active tuberculosis.&#xD;
&#xD;
          -  Administration of a live attenuated vaccine within 4 weeks prior to study treatment&#xD;
             initiation or at any moment during the course of the study.&#xD;
&#xD;
          -  Last chemotherapy cycle within 30 days prior to first treatment administration.&#xD;
&#xD;
          -  Any unstable disease or condition that may threaten the patient's safety and/or the&#xD;
             patient's study compliance.&#xD;
&#xD;
          -  Drug addiction or clinical, psychological, or social disorders that may undermine the&#xD;
             informed consent validity or affect compliance with protocol.&#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>Jorge Arturo Alatorre Alexander, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Health Pharma Professional Research</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Health Pharma Professional Research</name>
      <address>
        <city>Mexico City</city>
        <zip>03810</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>December 18, 2018</study_first_submitted>
  <study_first_submitted_qc>December 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 26, 2018</study_first_posted>
  <last_update_submitted>May 11, 2021</last_update_submitted>
  <last_update_submitted_qc>May 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 13, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Health Pharma Professional Research</investigator_affiliation>
    <investigator_full_name>Jorge Arturo Alatorre Alexander</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Malignant Pleural Mesothelioma</keyword>
  <keyword>Atezolizumab</keyword>
  <keyword>Thoracic neoplasms</keyword>
  <keyword>Antibodies, monoclonal</keyword>
  <keyword>Antineoplasic, agents</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mesothelioma</mesh_term>
    <mesh_term>Mesothelioma, Malignant</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atezolizumab</mesh_term>
  </intervention_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/NCT03786419
org study id: JCJ-768883
nct id: NCT03786419
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This is a national, single arm, phase II trial in patients with diagnosis of unresectable or
      advanced malignant pleural mesothelioma who experienced progression after platinum-based
      chemotherapy.
The study includes a screening period a treatment period, a termination treatment visit ≤30
      days following the last dose of the study drug, and a follow-up period. Day 1 is defined as
      the first day in which patients receive atezolizumab. The study is expected to enroll 36
      patients.

      Enrolled patients will receive a fixed dose of atezolizumab 1200 mg administered
      intravenously the first day of each cycle. A treatment cycle will last 21 days (± 3 days).
      Treatment with atezolizumab will continue until investigator-assessed loss of clinical
      benefit, unacceptable toxicity, investigator or participant's decision to withdraw from
      therapy, or death (whichever occurs first).

      Treatment with atezolizumab may continue while patients experience clinical benefit based on
      the investigator's assessment (absence of unacceptable toxicity or symptomatic deterioration
      attributable to disease progression, at the discretion of the investigator after evaluating
      radiographic data, biopsy results [if available], and clinical status), or until unacceptable
      toxicity or death.

      During treatment, patients treated with atezolizumab, who demonstrate evidence of clinical
      benefit may continue treatment with atezolizumab after meeting disease progression criteria,
      based on the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. The following need
      to be met, as specified by the protocol.

      All patients must undergo tumor assessments at baseline and every 9 weeks (± 7 days)
      following cycle 1, day 1, regardless of treatment delays, until radiographic disease
      progression, as per RECIST v1.1 modified for mesothelioma, or loss of clinical benefit in
      patients treated with atezolizumab, who continue treatment beyond disease progression, as per
      RECIST v1.1, withdrawal of consent, death or study termination by principal investigator,
      whichever occurs first.

      The study will end if all enrolled patients die, withdraw their consent, become lost to
      follow-up, or have been monitored during 12 months from the enrollment of the last patient,
      whichever occurs first.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Objective Response Rate
time frame: From the time of initial response until documented tumor progression or death, whichever occurs first (up to approximately 4 years)
description: The number of subjects whose best confirmed objective response is a CR or PR, divided by the number of treated subjects
measure: Progression-free survival
time frame: Baseline up to disease progression or death, whichever occurs first (up to approximately 4 years)
description: The time from the date of the start of treatment to the date of the first documented tumor progression as determined by RECIST v 1.1, or death, whichever occurs first
measure: Duration of response
time frame: Baseline up to disease progression or death, whichever occurs first (up to approximately 4 years)
description: The time from documentation of tumor response to disease progression as determined by RECIST v1.1
measure: Overall survival
time frame: Baseline up to 1 year after treatment discontinuation
description: The time from the date of the start of treatment until death from any cause
measure: Safety of atezolizumab
time frame: Baseline up to 60 days after the last dose of the study drug or until another oncologic treatment is initiated, whichever occurs first
description: The incidence of treatment-related adverse events assessed by CTCAE v4.03
measure: Health Related Quality of Life (HRQoL) Scores
time frame: Baseline until 1 year after treatment discontinuation or death, whichever occurs first
description: Change from Baseline in Health Related Quality of Life (HRQoL) Scores as Measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - C30 (EORTC QLQ-C30)
measure: Patient Functioning and Symptoms Score
time frame: Baseline until 1 year after treatment discontinuation or death, whichever occurs first
description: Change from Baseline in Patient Functioning and Symptoms Score as Measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module LC-13 (QLQ-LC13)
arm group label: Atezolizumab
arm group type: Experimental
description: Participants with unresectable or advanced malignant pleural mesothelioma who have progressed after platinum-based chemotherapy will receive atezolizumab 1200 mg every 21 days, until Investigator-assessed loss of clinical benefit, unacceptable toxicity, investigator or participant's decision to withdraw from therapy, or death (whichever occurs first).
intervention type: Drug
intervention name: Atezolizumab
description: Participants will be given 1200 mg of Atezolizumab as single agent by IV infusion every 21 days. First infusion will be over 60 min. Subsequent Atezolizumab cycles may be administered for 30 minutes, if there were no perfusion-related toxicity
arm group label: Atezolizumab
other name: Tecentriq
other name: RO5541267
other name: MPDL3280A
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jorge Arturo Alatorre Alexander, MD
role: Principal Investigator
affiliation: Health Pharma Professional Research
facility: 
country: Mexico
responsible party type: Principal Investigator
investigator affiliation: Health Pharma Professional Research
investigator full name: Jorge Arturo Alatorre Alexander
investigator title: Principal Investigator
mesh term: Mesothelioma
mesh term: Mesothelioma, Malignant
mesh term: Atezolizumab
sharing ipd: No