<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/NCT03794128</url>
  </required_header>
  <id_info>
    <org_study_id>GO-003</org_study_id>
    <nct_id>NCT03794128</nct_id>
  </id_info>
  <brief_title>A Study of Personalized Neoantigen Cancer Vaccines</brief_title>
  <official_title>An Observational Feasibility Study for the Production of a Patient-Specific Neoantigen Cancer Vaccine and Screening Study for a Shared Neoantigen Cancer Vaccine in Patients With Advanced Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gritstone bio, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Gritstone bio, Inc.</source>
  <oversight_info>
    <has_dmc>No</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>
      The purpose of this study is 1) to evaluate the feasibility of manufacturing a&#xD;
      patient-specific neoantigen cancer vaccine, which involves predicting the patient's&#xD;
      neoantigens and generating a vaccine that encodes the predicted neoantigens; and, 2) to&#xD;
      identify and select patients who may be eligible for a shared neoantigen cancer vaccine where&#xD;
      their tumor contains a specific shared mutation and who have the correct HLA allele capable&#xD;
      of presenting the neoantigen derived from the tumor-specific mutation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Gritstone is developing two neoantigen-based cancer vaccines: the first is a patient-specific&#xD;
      cancer vaccine that requires a manufacturing period for each patient and the second is an&#xD;
      off-the-shelf cancer vaccine that targets shared neoantigens.&#xD;
&#xD;
      The process of generating a patient-specific neoantigen cancer vaccine involves multiple&#xD;
      steps, including collection of patient tumor and blood specimens, performing next-generation&#xD;
      sequencing (NGS), predicting the neoantigens to be included in the patient-specific vaccine,&#xD;
      and the manufacture and release of the patient-specific vaccine. Gaining experience in&#xD;
      managing the manufacturing process will provide important insights and experience regarding&#xD;
      this process to be used in operationalizing future clinical trials.&#xD;
&#xD;
      Selecting patients who may be eligible to receive a shared neoantigen vaccine requires first&#xD;
      identifying patients whose tumor possesses a neoantigen derived from an oncogenic mutation&#xD;
      that is encoded by the vaccine, and then determining whether the patient expresses a matching&#xD;
      HLA allele for antigen presentation.&#xD;
&#xD;
      Study participants will not receive any investigational treatment as part of this trial.&#xD;
      Patients screened in this study may be able to enroll in a separate investigational treatment&#xD;
      study sponsored by Gritstone Oncology, provided that the patient meets the specified&#xD;
      eligibility criteria for that treatment study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 25, 2018</start_date>
  <completion_date type="Actual">May 26, 2020</completion_date>
  <primary_completion_date type="Actual">January 17, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Group 1 only: Presence of neoantigens sufficient to warrant patient-specific vaccine manufacture</measure>
    <time_frame>At study enrollment</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Group 1 only: Percentage of patients for whom patient-specific vaccine is successfully manufactured (defined as meeting release criteria)</measure>
    <time_frame>Up to approximately 20 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Group 2 only: Percentage of patients with at least one of the twenty specified shared mutations contained in the expression cassette and a matching HLA allele for neoantigen presentation</measure>
    <time_frame>Up to approximately 2 weeks</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">93</enrollment>
  <condition>Non Small Cell Lung Cancer</condition>
  <condition>Colorectal Cancer</condition>
  <condition>Gastroesophageal Adenocarcinoma</condition>
  <condition>Urothelial Carcinoma</condition>
  <condition>Pancreatic Ductal Adenocarcinoma</condition>
  <arm_group>
    <arm_group_label>1 - patient-specific neoantigen cancer vaccine production</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>2 - shared neoantigen cancer vaccine screening</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Blood collection for research (next-generation sequencing [NGS])</intervention_name>
    <description>Participants will have whole blood collected for next-generation sequencing (NGS).</description>
    <arm_group_label>1 - patient-specific neoantigen cancer vaccine production</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Blood collection for research (HLA typing)</intervention_name>
    <description>Participants will have whole blood collected for HLA typing.</description>
    <arm_group_label>1 - patient-specific neoantigen cancer vaccine production</arm_group_label>
    <arm_group_label>2 - shared neoantigen cancer vaccine screening</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      -  whole blood specimen, for HLA typing (all participants)&#xD;
&#xD;
        -  FFPE tumor material from a biopsy or resection, for sequencing to identify&#xD;
           tumor-specific mutations (Group 1 participants only)&#xD;
&#xD;
        -  whole blood specimen, for sequencing of normal genome (Group 1 participants only)&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Oncology&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Group 1 Inclusion Criteria:&#xD;
&#xD;
          -  Provide a signed and dated informed consent form prior to initiation of study-specific&#xD;
             procedures&#xD;
&#xD;
          -  Patients with the indicated advanced or metastatic solid tumor as follows:&#xD;
&#xD;
               1. NSCLC who have received ≤ 1 cycle of systemic treatment with cytotoxic,&#xD;
                  platinum-based chemotherapy (Note: patients with NSCLC who are receiving&#xD;
                  pembrolizumab monotherapy as first line systemic monotherapy are eligible)&#xD;
&#xD;
               2. GEA who have received ≤ 1 cycle of systemic treatment with cytotoxic,&#xD;
                  platinum-based chemotherapy&#xD;
&#xD;
               3. mUC who have received ≤ 1 cycle of systemic treatment with cytotoxic,&#xD;
                  platinum-based chemotherapy&#xD;
&#xD;
               4. CRC-microsatellite stable (MSS) who have received ≤ 1 cycle of second line&#xD;
                  systemic therapy including a fluoropyrimidine and oxaliplatin or irinotecan&#xD;
                  (Note: patients receiving first-line systemic therapy are eligible)&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
          -  ECOG Performance Status 0 or 1&#xD;
&#xD;
          -  Available FFPE tumor specimen for sequencing and neoantigen selection&#xD;
&#xD;
          -  Measurable disease according to RECIST v1.1 Have adequate organ function, as measured&#xD;
             by laboratory values (criteria listed in protocol)&#xD;
&#xD;
        Group 1 Exclusion Criteria:&#xD;
&#xD;
          -  Tumors with genetic characteristics as follows:&#xD;
&#xD;
               1. For NSCLC, patients with a known driver genomic alteration in EGFR, ALK, ROS1,&#xD;
                  RET, or TRK&#xD;
&#xD;
               2. For CRC or GEA, patients with MSI disease&#xD;
&#xD;
               3. For CRC, patients with a known BRAF mutation or patients with peritoneal&#xD;
                  carcinomatosis&#xD;
&#xD;
        Group 2 Inclusion Criteria:&#xD;
&#xD;
          -  Provide a signed and dated informed consent form prior to initiation of study-specific&#xD;
             procedures&#xD;
&#xD;
          -  Patient's tumor possesses one of the mutations listed in the clinical study protocol,&#xD;
             as determined per local institutional standard&#xD;
&#xD;
          -  Patients with an advanced or metastatic solid tumor as follows:&#xD;
&#xD;
               1. MSS-CRC who are currently receiving systemic treatment with a fluoropyrimidine&#xD;
                  and oxaliplatin or irinotecan that may include a VEGF or EGFR targeting therapy&#xD;
                  as their first-line or second-line therapy for metastatic disease&#xD;
&#xD;
               2. NSCLC who are currently receiving systemic treatment with cytotoxic,&#xD;
                  platinum-based chemotherapy in combination with an anti-PD-(L)1 antibody&#xD;
&#xD;
               3. PDA who are currently receiving systemic cytotoxic chemotherapy as their&#xD;
                  first-line therapy for metastatic disease&#xD;
&#xD;
        Group 2 Exclusion Criteria&#xD;
&#xD;
          -  Patients with MSI disease&#xD;
&#xD;
          -  Patients with NSCLC with a known driver genomic alteration in EGFR, ALK, ROS1, RET, or&#xD;
             TRK&#xD;
&#xD;
        Complete inclusion and exclusion criteria are listed in the clinical study 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>
  <location>
    <facility>
      <name>University of Chicago Medicine Comprehensive Cancer Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbia University Medical Center, Herbert Irving Comprehensive Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Ohio State University Comprehensive Cancer Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tennessee Oncology</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Cancer Specialists</name>
      <address>
        <city>Fairfax</city>
        <state>Virginia</state>
        <zip>22031</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>December 18, 2018</study_first_submitted>
  <study_first_submitted_qc>January 2, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 4, 2019</study_first_posted>
  <last_update_submitted>September 10, 2020</last_update_submitted>
  <last_update_submitted_qc>September 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>neoantigen cancer vaccine</keyword>
  <keyword>personalized neoantigen cancer vaccine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenocarcinoma</mesh_term>
  </condition_browse>
  <!-- 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/NCT03794128
org study id: GO-003
nct id: NCT03794128
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is 1) to evaluate the feasibility of manufacturing a
      patient-specific neoantigen cancer vaccine, which involves predicting the patient's
      neoantigens and generating a vaccine that encodes the predicted neoantigens; and, 2) to
      identify and select patients who may be eligible for a shared neoantigen cancer vaccine where
      their tumor contains a specific shared mutation and who have the correct HLA allele capable
      of presenting the neoantigen derived from the tumor-specific mutation.
Gritstone is developing two neoantigen-based cancer vaccines: the first is a patient-specific
      cancer vaccine that requires a manufacturing period for each patient and the second is an
      off-the-shelf cancer vaccine that targets shared neoantigens.

      The process of generating a patient-specific neoantigen cancer vaccine involves multiple
      steps, including collection of patient tumor and blood specimens, performing next-generation
      sequencing (NGS), predicting the neoantigens to be included in the patient-specific vaccine,
      and the manufacture and release of the patient-specific vaccine. Gaining experience in
      managing the manufacturing process will provide important insights and experience regarding
      this process to be used in operationalizing future clinical trials.

      Selecting patients who may be eligible to receive a shared neoantigen vaccine requires first
      identifying patients whose tumor possesses a neoantigen derived from an oncogenic mutation
      that is encoded by the vaccine, and then determining whether the patient expresses a matching
      HLA allele for antigen presentation.

      Study participants will not receive any investigational treatment as part of this trial.
      Patients screened in this study may be able to enroll in a separate investigational treatment
      study sponsored by Gritstone Oncology, provided that the patient meets the specified
      eligibility criteria for that treatment study.
observational model: Case-Only
time perspective: Prospective
measure: Group 1 only: Presence of neoantigens sufficient to warrant patient-specific vaccine manufacture
time frame: At study enrollment
measure: Group 1 only: Percentage of patients for whom patient-specific vaccine is successfully manufactured (defined as meeting release criteria)
time frame: Up to approximately 20 weeks
measure: Group 2 only: Percentage of patients with at least one of the twenty specified shared mutations contained in the expression cassette and a matching HLA allele for neoantigen presentation
time frame: Up to approximately 2 weeks
arm group label: 1 - patient-specific neoantigen cancer vaccine production
arm group label: 2 - shared neoantigen cancer vaccine screening
intervention type: Procedure
intervention name: Blood collection for research (next-generation sequencing [NGS])
description: Participants will have whole blood collected for next-generation sequencing (NGS).
arm group label: 1 - patient-specific neoantigen cancer vaccine production
intervention type: Procedure
intervention name: Blood collection for research (HLA typing)
description: Participants will have whole blood collected for HLA typing.
arm group label: 1 - patient-specific neoantigen cancer vaccine production
arm group label: 2 - shared neoantigen cancer vaccine screening
-  whole blood specimen, for HLA typing (all participants)

        -  FFPE tumor material from a biopsy or resection, for sequencing to identify
           tumor-specific mutations (Group 1 participants only)

        -  whole blood specimen, for sequencing of normal genome (Group 1 participants only)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Adenocarcinoma