<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/NCT03760952</url>
  </required_header>
  <id_info>
    <org_study_id>IMA-SCREENING</org_study_id>
    <nct_id>NCT03760952</nct_id>
  </id_info>
  <brief_title>Human Leukocyte Antigen Typing and Tumor Antigen Expression Profiling</brief_title>
  <official_title>Human Leukocyte Antigen Typing and Tumor Antigen Expression Profiling</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Immatics US, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Immatics US, 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>
      This screening study will identify HLA molecular subtype positive and tumor antigen target(s)&#xD;
      positive patients who may be eligible for enrollment into Immatics clinical studies. This&#xD;
      screening study is intended for patients with advanced and/or metastatic solid cancers. No&#xD;
      treatment intervention will occur as part of this screening study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this screening study is to identify human leukocyte antigen (HLA) molecular&#xD;
      subtype positive and tumor antigen target(s) positive patients. No treatment intervention&#xD;
      will occur as part of this screening study.&#xD;
&#xD;
      After diagnosis of advanced and/or solid metastatic cancers, patients will be tested for HLA&#xD;
      molecular subtype positivity. Patients that are HLA molecular subtype positive are then&#xD;
      assessed to determine if their tumor antigen target(s) is positive (biopsy screening). Fresh&#xD;
      tumor tissue obtained by a biopsy for this screening study will be required. If the patient&#xD;
      is undergoing a surgical procedure directed towards tumor or palliative treatment (e.g., a&#xD;
      resection, debulking surgery, etc.) and has consented to the study, then fresh tissue may be&#xD;
      collected during the procedure to avoid the patient being subjected to another biopsy.&#xD;
&#xD;
      Tumor antigen targets in fresh tumor samples will be determined by an in vitro diagnostic&#xD;
      (IVD) assay. Therefore, any remaining tumor specimens may be used for exploratory biomarker&#xD;
      analyses and validation studies for regulatory approval.&#xD;
&#xD;
      Immatics is conducting clinical studies which target patients with advanced and/or metastatic&#xD;
      solid cancers. Patients who are HLA subtype phenotype positive and whose tumors express one&#xD;
      or more of the tumor antigen targets of interest may be eligible for ongoing clinical studies&#xD;
      of adoptive cell therapy (ACT).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 26, 2019</start_date>
  <completion_date type="Actual">November 15, 2022</completion_date>
  <primary_completion_date type="Actual">November 15, 2022</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>Frequency of patients with protocol-specified HLA subtype</measure>
    <time_frame>3 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Frequency of patients with expression of analyzed tumor antigen targets</measure>
    <time_frame>3 years</time_frame>
  </primary_outcome>
  <other_outcome>
    <measure>Incidence of antigen target expression in solid tumors</measure>
    <time_frame>3 years</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Comparison of antigen target expression in fresh and FFPE tumor samples</measure>
    <time_frame>3 years</time_frame>
  </other_outcome>
  <enrollment type="Actual">242</enrollment>
  <condition>Refractory Cancer</condition>
  <condition>Recurrent Cancer</condition>
  <condition>Adult Solid Tumor</condition>
  <condition>Neoplasms</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Tumor Biopsy&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with confirmed advanced and/or metastatic solid tumors&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Signed an Informed Consent Form (ICF)&#xD;
&#xD;
          2. Patients ≥ 18 years of age&#xD;
&#xD;
          3. Patients with confirmed advanced and/or metastatic solid tumors.&#xD;
&#xD;
          4. For liver cancer patients, the diagnosis must be confirmed&#xD;
&#xD;
               -  Pathological diagnosis of liver cancer based on biopsy/resection is required&#xD;
&#xD;
               -  For patients without pathological diagnosis, an imaging technique obtained by&#xD;
                  computed tomography (CT) scan or magnetic resonance imaging (MRI) is needed.&#xD;
&#xD;
          5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 0-1&#xD;
&#xD;
          6. Life expectancy &gt; 6 months&#xD;
&#xD;
          7. There is no limitation for prior anti-cancer treatments&#xD;
&#xD;
          8. HLA molecular phenotype positive.&#xD;
&#xD;
          9. Measurable disease according to Response Evaluation Criteria in Solid Tumors&#xD;
             (RECIST)1.1&#xD;
&#xD;
         10. At least one lesion considered accessible for biopsy unless fresh tumor tissue is&#xD;
             being collected during a surgical procedure directed towards tumor treatment or&#xD;
             palliative therapy or the patient has uterine cancer (including endometrial cancer or&#xD;
             uterine carcinosarcoma) or melanoma&#xD;
&#xD;
         11. Patient has adequate pulmonary function&#xD;
&#xD;
         12. Acceptable organ and marrow function&#xD;
&#xD;
         13. Acceptable coagulation status&#xD;
&#xD;
         14. Adequate hepatic function&#xD;
&#xD;
         15. Acceptable levels of serum creatinine&#xD;
&#xD;
         16. For liver cancer patients only, Child-Pugh score of &lt; 6&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of other malignancies (except for adequately treated basal or squamous cell&#xD;
             carcinoma or carcinoma in situ) within the last 3 years&#xD;
&#xD;
          2. Patients with primary central nervous system (CNS)/brain tumors&#xD;
&#xD;
          3. Patients whose tumors have very low expression of tumor antigen targets such as kidney&#xD;
             chromophobe, thyroid carcinoma, and prostate adenocarcinoma&#xD;
&#xD;
          4. Patients who are pregnant or are breastfeeding&#xD;
&#xD;
          5. Patients with serious autoimmune disease Note: At the discretion of the investigator,&#xD;
             these patients may be included if their disease is well controlled without the use of&#xD;
             immunosuppressive agents&#xD;
&#xD;
          6. Patients with prior stem cell transplantation or solid organ transplantation&#xD;
&#xD;
          7. Any condition contraindicating leukapheresis&#xD;
&#xD;
          8. Patients with any of the following cardiac conditions: uncontrolled hypertension&#xD;
             despite optimal therapy, uncontrolled angina, ventricular arrhythmias, congestive&#xD;
             heart failure, baseline left ventricular ejection fraction ≤ 50%, prior or current&#xD;
             cardiomyopathy, atrial fibrillation with heart rate &gt; 100 bpm, unstable ischemic heart&#xD;
             disease&#xD;
&#xD;
          9. Patients with active diverticulitis, intra-abdominal abscess, or GI obstruction&#xD;
&#xD;
         10. Patients with active pneumonitis&#xD;
&#xD;
         11. Patients with active (uncontrolled/untreated) brain metastases NOTE: Patients with a&#xD;
             history of brain metastases may be eligible, if an imaging scan with contrast&#xD;
             enhancement not older than 4 weeks is able to exclude the existence of currently&#xD;
             active brain metastasis.&#xD;
&#xD;
         12. History of hypersensitivity on fludarabine (FLU), cyclophosphamide (CY), or&#xD;
             interleukin (IL)-2&#xD;
&#xD;
         13. History of current immunodeficiency disease or prior treatment compromising immune&#xD;
             function at the discretion of the investigator.&#xD;
&#xD;
         14. Patients with Grade 3 or Grade 4 immune-related toxicities related to checkpoint&#xD;
             inhibitors or patients requiring corticosteroid treatment (≥ 10 mg/day prednisone or&#xD;
             equivalent dose).&#xD;
&#xD;
         15. Patients with bleeding diathesis or coagulopathy&#xD;
&#xD;
         16. Any serious and/or unstable pre-existing medical, psychiatric disorder or other&#xD;
             conditions that could interfere with patient's safety&#xD;
&#xD;
         17. HIV infection, active hepatitis B or C infection. History of treated hepatitis B or C&#xD;
             is permitted if the viral load is undetectable per qPCR and/or nucleic acid testing&#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>Cedrik Britten, M.D.</last_name>
    <role>Study Director</role>
    <affiliation>Immatics US</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Chicago</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</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pittsburgh Medical Center</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oncology Consultants</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>November 29, 2018</study_first_submitted>
  <study_first_submitted_qc>November 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 3, 2018</study_first_posted>
  <last_update_submitted>February 3, 2023</last_update_submitted>
  <last_update_submitted_qc>February 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>T-cell therapy</keyword>
  <keyword>Immunotherapy</keyword>
  <keyword>Screening</keyword>
  <keyword>Metastatic</keyword>
  <keyword>Previously Treated</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Recurrence</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/NCT03760952
org study id: IMA-SCREENING
nct id: NCT03760952
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This screening study will identify HLA molecular subtype positive and tumor antigen target(s)
      positive patients who may be eligible for enrollment into Immatics clinical studies. This
      screening study is intended for patients with advanced and/or metastatic solid cancers. No
      treatment intervention will occur as part of this screening study.
The purpose of this screening study is to identify human leukocyte antigen (HLA) molecular
      subtype positive and tumor antigen target(s) positive patients. No treatment intervention
      will occur as part of this screening study.

      After diagnosis of advanced and/or solid metastatic cancers, patients will be tested for HLA
      molecular subtype positivity. Patients that are HLA molecular subtype positive are then
      assessed to determine if their tumor antigen target(s) is positive (biopsy screening). Fresh
      tumor tissue obtained by a biopsy for this screening study will be required. If the patient
      is undergoing a surgical procedure directed towards tumor or palliative treatment (e.g., a
      resection, debulking surgery, etc.) and has consented to the study, then fresh tissue may be
      collected during the procedure to avoid the patient being subjected to another biopsy.

      Tumor antigen targets in fresh tumor samples will be determined by an in vitro diagnostic
      (IVD) assay. Therefore, any remaining tumor specimens may be used for exploratory biomarker
      analyses and validation studies for regulatory approval.

      Immatics is conducting clinical studies which target patients with advanced and/or metastatic
      solid cancers. Patients who are HLA subtype phenotype positive and whose tumors express one
      or more of the tumor antigen targets of interest may be eligible for ongoing clinical studies
      of adoptive cell therapy (ACT).
observational model: Case-Only
time perspective: Prospective
measure: Frequency of patients with protocol-specified HLA subtype
time frame: 3 years
measure: Frequency of patients with expression of analyzed tumor antigen targets
time frame: 3 years
measure: Incidence of antigen target expression in solid tumors
time frame: 3 years
measure: Comparison of antigen target expression in fresh and FFPE tumor samples
time frame: 3 years
Tumor Biopsy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Cedrik Britten, M.D.
role: Study Director
affiliation: Immatics US
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Recurrence