<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/NCT02193503</url>
  </required_header>
  <id_info>
    <org_study_id>MVX-2011-01</org_study_id>
    <nct_id>NCT02193503</nct_id>
  </id_info>
  <brief_title>MVX-ONCO-1 in Patients With Solid Tumor</brief_title>
  <official_title>An Open Phase I Clinical Study Assessing Safety and Tolerability of MVX-ONCO-1 in Patients With Solid Tumor Who Are Not/Not Any Longer Amenable to Standard Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Maxivax SA</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Maxivax SA</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objectives are to assess the safety and tolerability of 6 vaccine doses of MVX-ONCO-1,&#xD;
      administered sub-cutaneously (injections and capsules implantations), in patients with&#xD;
      advanced metastatic solid tumor in progression who are not or not any longer amenable to any&#xD;
      standard therapy of their tumour disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Endpoints:&#xD;
&#xD;
      Primary: To assess safety parameters including adverse and serious adverse events (incidence,&#xD;
      causality, severity), local and systemic tolerance to the administered study treatment,&#xD;
      changes in laboratory values and vital signs in patients with solid tumor; Secondary: to&#xD;
      measure some tumor responses in using imaging technique, serological tumor markers, immune&#xD;
      monitoring and metabolic monitoring.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">March 2014</start_date>
  <completion_date type="Anticipated">December 2026</completion_date>
  <primary_completion_date type="Actual">March 2022</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>Number of patients with Adverse Events and/or Serious Adverse Events</measure>
    <time_frame>18 weeks</time_frame>
    <description>Adverse events will be followed carefully at each clinic visit by the Investigator, to determine their incidence, causality and severity.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Delayed type hypersensitivity reactions, Induction of a specific CD8 response</measure>
    <time_frame>18 weeks</time_frame>
    <description>immune monitoring</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>imaging and metabolic monitoring</measure>
    <time_frame>18 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>tumor size</measure>
    <time_frame>18 weeks</time_frame>
    <description>document of tumor number, sites, size of lesions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>tumor pain</measure>
    <time_frame>18 weeks</time_frame>
    <description>intensity, site, frequency of pain, use of analgesics</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Solid Tumor</condition>
  <condition>Cancer</condition>
  <arm_group>
    <arm_group_label>treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MVX-1-loaded capsules and injection of irradiated autologous tumor cells</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Treatment</intervention_name>
    <description>Treatment is the implantation of loaded capsules + injection of irradiated autologous tumor cells</description>
    <arm_group_label>treatment</arm_group_label>
    <other_name>- capsules MVX-1-loaded (medical device)</other_name>
    <other_name>- irradiated autologous tumor cells (cell therapy)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female patients aged 18 years and older with advanced metastatic cancer in&#xD;
             progression of various sites [Carcinoma of lung (either small cell or non-small cell),&#xD;
             colon, breast, pancreas (exocrine or endocrine), stomach, oesophagus, head&amp;neck,&#xD;
             thyroid, kidney, bladder, prostate, ovary, uterus (cervix or corpus); Sarcoma of soft&#xD;
             tissue, bone, uterus, melanoma; primary brain tumor] where all recognized treatment&#xD;
             are exhausted or not feasible.&#xD;
&#xD;
          -  Life expectancy: estimate of at least 4 months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have participated in any other investigational study or received an experimental&#xD;
             therapeutic procedure considered to interfere with the study in the 4 preceding weeks.&#xD;
&#xD;
          -  Have received any chemotherapy treatment in the 4 preceding weeks.&#xD;
&#xD;
          -  Serious concomitant health condition such as organ transplant requiring&#xD;
             immunosuppressive drugs, severe psychiatric disorders.&#xD;
&#xD;
          -  History of second cancer within the last 2 years with the exception of basal cell&#xD;
             carcinoma of skin and localized cervical carcinoma treated with curative intent.&#xD;
&#xD;
          -  Patient with a systemic disease other than cancer, that is not controlled by usual&#xD;
             medication.&#xD;
&#xD;
          -  Therapeutic anticoagulation with coumarine or continues iv heparin. Low-molecular&#xD;
             weight heparin (LMWH) is permitted as long as treatment can be withheld several hours&#xD;
             prior to subcutaneous implantation.&#xD;
&#xD;
          -  Positive HIV-1, HIV-2, HTLV-1, HTLV-2, hepatitis B surface antigen, or hepatitis C&#xD;
             antibody.&#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>Eugenio Fernandez, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>HUG</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hopitaux Universitaires de Genève - HUG</name>
      <address>
        <city>Geneva</city>
        <state>Genève</state>
        <zip>1205</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>August 26, 2013</study_first_submitted>
  <study_first_submitted_qc>July 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 17, 2014</study_first_posted>
  <last_update_submitted>August 23, 2022</last_update_submitted>
  <last_update_submitted_qc>August 23, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 24, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cancer</keyword>
  <keyword>solid tumors</keyword>
  <keyword>gene therapy</keyword>
  <keyword>cell therapy</keyword>
  <keyword>encapsulation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</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/NCT02193503
org study id: MVX-2011-01
nct id: NCT02193503
lead sponsor: 
has dmc: Yes
The objectives are to assess the safety and tolerability of 6 vaccine doses of MVX-ONCO-1,
      administered sub-cutaneously (injections and capsules implantations), in patients with
      advanced metastatic solid tumor in progression who are not or not any longer amenable to any
      standard therapy of their tumour disease.
Endpoints:

      Primary: To assess safety parameters including adverse and serious adverse events (incidence,
      causality, severity), local and systemic tolerance to the administered study treatment,
      changes in laboratory values and vital signs in patients with solid tumor; Secondary: to
      measure some tumor responses in using imaging technique, serological tumor markers, immune
      monitoring and metabolic monitoring.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of patients with Adverse Events and/or Serious Adverse Events
time frame: 18 weeks
description: Adverse events will be followed carefully at each clinic visit by the Investigator, to determine their incidence, causality and severity.
measure: Delayed type hypersensitivity reactions, Induction of a specific CD8 response
time frame: 18 weeks
description: immune monitoring
measure: imaging and metabolic monitoring
time frame: 18 weeks
measure: tumor size
time frame: 18 weeks
description: document of tumor number, sites, size of lesions
measure: tumor pain
time frame: 18 weeks
description: intensity, site, frequency of pain, use of analgesics
arm group label: treatment
arm group type: Experimental
description: MVX-1-loaded capsules and injection of irradiated autologous tumor cells
intervention type: Other
intervention name: Treatment
description: Treatment is the implantation of loaded capsules + injection of irradiated autologous tumor cells
arm group label: treatment
other name: - capsules MVX-1-loaded (medical device)
other name: - irradiated autologous tumor cells (cell therapy)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Eugenio Fernandez, MD
role: Principal Investigator
affiliation: HUG
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Neoplasms