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/NCT05968326</url>
    </required_header>
    <id_info>
      <org_study_id>GO44479</org_study_id>
      <secondary_id>2022-502404-73-00</secondary_id>
      <nct_id>NCT05968326</nct_id>
    </id_info>
    <brief_title>A Study of the Efficacy and Safety of Adjuvant Autogene Cevumeran Plus Atezolizumab and mFOLFIRINOX Versus mFOLFIRINOX Alone in Participants With Resected Pancreatic Ductal Adenocarcinoma</brief_title>
    <acronym>IMCODE003</acronym>
    <official_title>A Phase II, Open-Label, Multicenter, Randomized Study of the Efficacy and Safety of Adjuvant Autogene Cevumeran Plus Atezolizumab and mFOLFIRINOX Versus mFOLFIRINOX Alone in Patients With Resected Pancreatic Ductal Adenocarcinoma</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Genentech, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>BioNTech SE</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Genentech, Inc.</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this study is to evaluate the efficacy and safety of adjuvant autogene&#xD;
        cevumeran plus atezolizumab and modified leucovorin, 5-fluorouracil (5-FU), irinotecan, and&#xD;
        oxaliplatin (mFOLFIRINOX) versus mFOLFIRINOX alone in participants with resected pancreatic&#xD;
        ductal adenocarcinoma (PDAC) who have not received prior systemic anti-cancer treatment for&#xD;
        PDAC and have no evidence of disease after surgery.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">October 5, 2023</start_date>
    <completion_date type="Anticipated">May 22, 2029</completion_date>
    <primary_completion_date type="Anticipated">May 22, 2029</primary_completion_date>
    <phase>Phase 2</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Disease Free Survival (DFS)</measure>
      <time_frame>From randomization to first recurrence of PDAC or first occurrence of new cancer, as determined by the investigator, or death from any cause (whichever occurs first), up to approximately 6 years</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>DFS Rates at 12, 24, and 36 Months</measure>
      <time_frame>Months 12, 24, 36</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall Survival (OS)</measure>
      <time_frame>From randomization to death from any cause (up to approximately 6 years)</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>OS Rates at 3 and 5 Years</measure>
      <time_frame>Years 3 and 5</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of Participants With Adverse Events (AEs)</measure>
      <time_frame>Up to approximately 6 years</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">260</enrollment>
    <condition>Adenocarcinoma, Pancreatic Ductal</condition>
    <arm_group>
      <arm_group_label>Arm 1: Autogene Cevumeran + Atezolizumab + mFOLFIRINOX</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive autogene cevumeran, atezolizumab and mFOLFIRINOX.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Arm 2: mFOLFIRINOX</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participants will receive mFOLFIRINOX.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Autogene cevumeran</intervention_name>
      <description>Autogene cevumeran will be administered intravenously (IV) at a recommended dose at specified timepoints.</description>
      <arm_group_label>Arm 1: Autogene Cevumeran + Atezolizumab + mFOLFIRINOX</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Atezolizumab</intervention_name>
      <description>Atezolizumab will be administered IV at a dose of 1680 milligrams (mg) at specified timepoints.</description>
      <arm_group_label>Arm 1: Autogene Cevumeran + Atezolizumab + mFOLFIRINOX</arm_group_label>
      <other_name>Tecentriq</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>mFOLFIRINOX</intervention_name>
      <description>mFOLFIRINOX (oxaliplatin, leucovorin, irinotecan, 5-FU) will be administered IV at specified timepoints.</description>
      <arm_group_label>Arm 1: Autogene Cevumeran + Atezolizumab + mFOLFIRINOX</arm_group_label>
      <arm_group_label>Arm 2: mFOLFIRINOX</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Histologically confirmed diagnosis of PDAC&#xD;
  &#xD;
            -  Pancreatic cancer tumor, lymph node, metastasis (TNM) pathological staging values of&#xD;
               T1-T3, N0-N2, and M0 per the American Joint Committee on Cancer (AJCC) Cancer Staging&#xD;
               Manual&#xD;
  &#xD;
            -  Macroscopically complete (R0 or R1) resection of PDAC&#xD;
  &#xD;
            -  Unequivocal absence of disease after surgery as assessed by the investigator within 28&#xD;
               days prior to randomization&#xD;
  &#xD;
            -  CA19-9 level measured within 14 days prior to randomization&#xD;
  &#xD;
            -  Interval of between 6 and 12 weeks since resection of PDAC&#xD;
  &#xD;
            -  Full recovery from surgery and ability to receive atezolizumab, autogene cevumeran,&#xD;
               and mFOLFIRINOX in the investigator's judgment&#xD;
  &#xD;
            -  Adequate hematologic and end-organ function&#xD;
  &#xD;
            -  Female participants of childbearing potential must be willing to avoid pregnancy&#xD;
               during the treatment period and for 90 days after the final dose of autogene&#xD;
               cevumeran, for 6 months after the last dose of chemotherapy, and for 5 months after&#xD;
               the final dose of atezolizumab.&#xD;
  &#xD;
            -  Male participants with a female partner of childbearing potential or pregnant female&#xD;
               partner must remain abstinent or use specified contraceptive methods during the&#xD;
               treatment period and for 28 days after the final dose of autogene cevumeran and for 6&#xD;
               months after the last dose of chemotherapy. Men must refrain from donating sperm&#xD;
               during this same period.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Prior adjuvant, neoadjuvant, or induction treatment for pancreatic cancer&#xD;
  &#xD;
            -  Absence of spleen; distal pancreatectomy with splenectomy is exclusionary&#xD;
  &#xD;
            -  Pregnancy or breastfeeding&#xD;
  &#xD;
            -  Active or history of autoimmune disease or immune deficiency&#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>Clinical Trials</last_name>
      <role>Study Director</role>
      <affiliation>Hoffmann-La Roche</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Reference Study ID Number: GO44479 https://forpatients.roche.com/</last_name>
      <phone>888-662-6728 (U.S. Only)</phone>
      <email>global-roche-genentech-trials@gene.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Memorial Sloan Kettering Cancer Center Basking Ridge</name>
        <address>
          <city>Basking Ridge</city>
          <state>New Jersey</state>
          <zip>07920</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Memorial Sloan Kettering Cancer Center; MSK Monmouth</name>
        <address>
          <city>Middletown</city>
          <state>New Jersey</state>
          <zip>07748</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Memorial Sloan Kettering Cancer Center at Bergen</name>
        <address>
          <city>Montvale</city>
          <state>New Jersey</state>
          <zip>07645</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Memorial Sloan Kettering Cancer Center - Commack</name>
        <address>
          <city>Commack</city>
          <state>New York</state>
          <zip>11725</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Memorial Sloan Kettering Cancer Center at Westchester</name>
        <address>
          <city>Harrison</city>
          <state>New York</state>
          <zip>10604</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Memorial Sloan Kettering Cancer Center</name>
        <address>
          <city>New York</city>
          <state>New York</state>
          <zip>11101</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Memorial Sloan Kettering Cancer Center at Nassau</name>
        <address>
          <city>Uniondale</city>
          <state>New York</state>
          <zip>11553</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 21, 2023</study_first_submitted>
    <study_first_submitted_qc>July 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</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>Adenocarcinoma</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>Yes</sharing_ipd>
      <ipd_description>Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).</ipd_description>
    </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/NCT05968326
  org study id: GO44479
  secondary id: 2022-502404-73-00
  nct id: NCT05968326
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  The purpose of this study is to evaluate the efficacy and safety of adjuvant autogene
        cevumeran plus atezolizumab and modified leucovorin, 5-fluorouracil (5-FU), irinotecan, and
        oxaliplatin (mFOLFIRINOX) versus mFOLFIRINOX alone in participants with resected pancreatic
        ductal adenocarcinoma (PDAC) who have not received prior systemic anti-cancer treatment for
        PDAC and have no evidence of disease after surgery.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Disease Free Survival (DFS)
  time frame: From randomization to first recurrence of PDAC or first occurrence of new cancer, as determined by the investigator, or death from any cause (whichever occurs first), up to approximately 6 years
  measure: DFS Rates at 12, 24, and 36 Months
  time frame: Months 12, 24, 36
  measure: Overall Survival (OS)
  time frame: From randomization to death from any cause (up to approximately 6 years)
  measure: OS Rates at 3 and 5 Years
  time frame: Years 3 and 5
  measure: Percentage of Participants With Adverse Events (AEs)
  time frame: Up to approximately 6 years
  arm group label: Arm 1: Autogene Cevumeran + Atezolizumab + mFOLFIRINOX
  arm group type: Experimental
  description: Participants will receive autogene cevumeran, atezolizumab and mFOLFIRINOX.
  arm group label: Arm 2: mFOLFIRINOX
  arm group type: Active Comparator
  description: Participants will receive mFOLFIRINOX.
  intervention type: Drug
  intervention name: Autogene cevumeran
  description: Autogene cevumeran will be administered intravenously (IV) at a recommended dose at specified timepoints.
  arm group label: Arm 1: Autogene Cevumeran + Atezolizumab + mFOLFIRINOX
  intervention type: Drug
  intervention name: Atezolizumab
  description: Atezolizumab will be administered IV at a dose of 1680 milligrams (mg) at specified timepoints.
  arm group label: Arm 1: Autogene Cevumeran + Atezolizumab + mFOLFIRINOX
  other name: Tecentriq
  intervention type: Drug
  intervention name: mFOLFIRINOX
  description: mFOLFIRINOX (oxaliplatin, leucovorin, irinotecan, 5-FU) will be administered IV at specified timepoints.
  arm group label: Arm 1: Autogene Cevumeran + Atezolizumab + mFOLFIRINOX
  arm group label: Arm 2: mFOLFIRINOX
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Clinical Trials
  role: Study Director
  affiliation: Hoffmann-La Roche
  last name: Reference Study ID Number: GO44479 https://forpatients.roche.com/
  phone: 888-662-6728 (U.S. Only)
  email: global-roche-genentech-trials@gene.com
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  country: United States
  responsible party type: Sponsor
  mesh term: Adenocarcinoma
  mesh term: Atezolizumab
  sharing ipd: Yes
  ipd description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).