<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/NCT03839524</url>
  </required_header>
  <id_info>
    <org_study_id>TG4050.01</org_study_id>
    <nct_id>NCT03839524</nct_id>
  </id_info>
  <brief_title>A Trial Evaluating TG4050 in Ovarian Carcinoma.</brief_title>
  <official_title>A Phase I Trial Evaluating a Mutanome-directed Immunotherapy in Patients With High Grade Serous Carcinoma (HGSC) of the Ovary, Fallopian Tube or Peritoneum.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Transgene</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Transgene</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>
      This is a multicenter, open-label, single arm phase I study evaluating the safety and&#xD;
      tolerability as well as some activity parameters of TG4050 in patients with ovarian,&#xD;
      fallopian or peritoneal serous carcinoma.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 9, 2019</start_date>
  <completion_date type="Anticipated">September 2024</completion_date>
  <primary_completion_date type="Anticipated">September 2023</primary_completion_date>
  <phase>Phase 1</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>Safety and tolerability (Adverse Event reported per CTCAE v5)</measure>
    <time_frame>At each study visit up to final safety follow up visit: every week for the first 6 weeks and then every 3 weeks</time_frame>
    <description>Incidence of Adverse Event reported per CTCAE v5</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Best overall response rate as assessed by the Gynecological Cancer Intergroup (GCIC) Carbohydrate Antigen 125 (CA-125) criteria</measure>
    <time_frame>Every 3 weeks</time_frame>
    <description>Percentage of patients with a minimum 50% reduction in CA-125 serum levels lasting for 28 days relative to pre-treatment CA-125 serum level per the GCIC criteria.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Best Overall Tumor Response Rate</measure>
    <time_frame>Within 21 days of treatment initiation and then every 9 weeks</time_frame>
    <description>Percentage of patients whose best overall response is either a Complete Response or a Partial Response according to Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) criteria over the the total number of patients evaluable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of patients with immune response</measure>
    <time_frame>Days 64, 85 and 211</time_frame>
    <description>Percentage of patients who achieve an immune response established by the detection of antigen-specific T cell.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">23</enrollment>
  <condition>Ovarian Carcinoma</condition>
  <condition>Fallopian Tube Cancer</condition>
  <condition>Peritoneal Carcinoma</condition>
  <arm_group>
    <arm_group_label>TG4050 arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in this arm will receive injections of TG4050 Investigational Medicinal Product.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TG4050</intervention_name>
    <description>Subcutaneous injections weekly for the first 6 weeks and then every 3 weeks.</description>
    <arm_group_label>TG4050 arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Signed written informed consent.&#xD;
&#xD;
          2. Female patients ≥ 18 years&#xD;
&#xD;
          3. Histologically confirmed high grade, advanced stage serous ovarian, fallopian tube or&#xD;
             primary peritoneal carcinoma.&#xD;
&#xD;
          4. Patients who have undergone primary debulking surgery or interval debulking surgery&#xD;
             and have completed standard first-line platinum-based chemotherapy and for whom tumor&#xD;
             tissue has been banked.&#xD;
&#xD;
          5. Patients must have achieved a complete response to therapy&#xD;
&#xD;
          6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at treatment&#xD;
             period initiation&#xD;
&#xD;
          7. Adequate hematological, hepatic and renal functions.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patient having received any cancer immunotherapy including cancer vaccines, any&#xD;
             antibody/drug targeting T cell co-regulatory proteins such as anti-Programmed cell&#xD;
             death 1 (anti-PD1), anti-Programmed death-ligand 1 (anti-PDL1) or anti-cytotoxic&#xD;
             T-lymphocyte-associated protein 4 (anti-CTL4)&#xD;
&#xD;
          2. Patients with other active malignancy ≤ 3 years prior to registration except&#xD;
             non-melanoma skin cancer, stage 0 in situ carcinoma.&#xD;
&#xD;
          3. Patient post-organ transplantation, including allogeneic stem cell or bone marrow&#xD;
             transplantation.&#xD;
&#xD;
          4. Known history of positive testing for Human Immunodeficiency Virus (HIV) or known AIDS&#xD;
             (Acquired Immune Deficiency Syndrome).&#xD;
&#xD;
          5. Any known allergy or reaction to eggs or attributed to compounds of similar chemical&#xD;
             or biological composition to therapeutic vaccines/immunotherapeutic products.&#xD;
&#xD;
          6. Acute or chronic infection with hepatitis C Virus (HCV) or Hepatitis B Virus (HBV).&#xD;
&#xD;
          7. Major surgery within 4 weeks of treatment start.&#xD;
&#xD;
          8. Treatment with another investigation agent within 30 days prior to TG4050 treatment&#xD;
             initiation.&#xD;
&#xD;
          9. Patients under chronic treatment with systemic corticosteroids or other&#xD;
             immunosuppressive drugs . Steroids with no or minimal systemic effect (topical,&#xD;
             inhalation) are allowed.&#xD;
&#xD;
         10. Use of live vaccine for the prevention of infectious diseases during the four-week&#xD;
             period prior to TG4050 treatment initiation planned date. Furthermore, patients should&#xD;
             not receive any live vaccine during the period of study treatment administration.&#xD;
&#xD;
         11. Uncontrolled intercurrent illness.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Transgene EU, Clinical Operations Department</last_name>
    <phone>+ 33.3.88.27.91.00</phone>
    <email>clinicaltrials@transgene.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Mayo Clinic Phoenix</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85259</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Dr Seetharam</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic Jacksonville</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32224</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Dr Colon-Otero</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Dr Block</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Institut Curie</name>
      <address>
        <city>Paris</city>
        <zip>75005</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Pr Le Tourneau</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hôpital Pitié-Salpêtrière</name>
      <address>
        <city>Paris</city>
        <zip>75013</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Pr Spano</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>IUCT Toulouse</name>
      <address>
        <city>Toulouse</city>
        <zip>31100</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Dr Martinez</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>February 6, 2019</study_first_submitted>
  <study_first_submitted_qc>February 12, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>September 22, 2021</last_update_submitted>
  <last_update_submitted_qc>September 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 23, 2021</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>Carcinoma</mesh_term>
    <mesh_term>Fallopian Tube Neoplasms</mesh_term>
    <mesh_term>Ovarian Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Ovarian Epithelial</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/NCT03839524
org study id: TG4050.01
nct id: NCT03839524
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This is a multicenter, open-label, single arm phase I study evaluating the safety and
      tolerability as well as some activity parameters of TG4050 in patients with ovarian,
      fallopian or peritoneal serous carcinoma.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Safety and tolerability (Adverse Event reported per CTCAE v5)
time frame: At each study visit up to final safety follow up visit: every week for the first 6 weeks and then every 3 weeks
description: Incidence of Adverse Event reported per CTCAE v5
measure: Best overall response rate as assessed by the Gynecological Cancer Intergroup (GCIC) Carbohydrate Antigen 125 (CA-125) criteria
time frame: Every 3 weeks
description: Percentage of patients with a minimum 50% reduction in CA-125 serum levels lasting for 28 days relative to pre-treatment CA-125 serum level per the GCIC criteria.
measure: Best Overall Tumor Response Rate
time frame: Within 21 days of treatment initiation and then every 9 weeks
description: Percentage of patients whose best overall response is either a Complete Response or a Partial Response according to Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) criteria over the the total number of patients evaluable.
measure: Rate of patients with immune response
time frame: Days 64, 85 and 211
description: Percentage of patients who achieve an immune response established by the detection of antigen-specific T cell.
arm group label: TG4050 arm
arm group type: Experimental
description: Patients in this arm will receive injections of TG4050 Investigational Medicinal Product.
intervention type: Drug
intervention name: TG4050
description: Subcutaneous injections weekly for the first 6 weeks and then every 3 weeks.
arm group label: TG4050 arm
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Transgene EU, Clinical Operations Department
phone: + 33.3.88.27.91.00
email: clinicaltrials@transgene.fr
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
country: France
country: United States
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Fallopian Tube Neoplasms
mesh term: Ovarian Neoplasms
mesh term: Carcinoma, Ovarian Epithelial