<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/NCT02978222</url>
  </required_header>
  <id_info>
    <org_study_id>FRV-004</org_study_id>
    <nct_id>NCT02978222</nct_id>
  </id_info>
  <brief_title>Folate Receptor Alpha Peptide Vaccine With GM-CSF Versus GM-CSF Alone in Patients With Platinum Sensitive Ovarian Cancer</brief_title>
  <official_title>A Randomized Multicenter Phase II Trial to Evaluate the Safety, Efficacy and Immunogenicity of Vaccination With Folate Receptor Alpha Peptides With GM-CSF Versus GM-CSF Alone in Patients With Platinum Sensitive Ovarian Cancer and a Response or Stable Disease to Platinum Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Marker Therapeutics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Marker Therapeutics, 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>
      This is a double-blind, randomized, parallel groups Phase II trial. Patients with&#xD;
      platinum-sensitive advanced ovarian cancer, defined as a lack of progression by RECIST v1.1&#xD;
      criteria following completion of standard-of-care chemotherapy, including a minimum of 4&#xD;
      cycles of a platinum-containing regimen. Patients will be randomized to either the vaccine&#xD;
      regimen with GM-CSF adjuvant or GM-CSF adjuvant alone as a control group. Treatment will be&#xD;
      administered as a consolidation therapy within one year of the last administration of&#xD;
      platinum, targeting the first remission.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a multicenter double-blind controlled randomized Phase II study to evaluate the&#xD;
      activity of folate receptor alpha (FRα) peptide vaccine as a consolidation treatment&#xD;
      following completion of no less than 4 cycles of a platinum containing regimen in patients&#xD;
      with platinum-sensitive, non-mucinous ovarian, fallopian tube or primary peritoneal cancer.&#xD;
&#xD;
      The patients will have demonstrated a tumor response or stable disease upon their last&#xD;
      regimen (per RECIST v1.1 and/or CA125 GCIG criteria) prior to enrolment in this study.&#xD;
&#xD;
      Following randomization, patients will be administered TPIV200 with GM-CSF adjuvant or GM-CSF&#xD;
      control alone. Patients will have booster doses and tumor assessments done every 12 weeks ± 1&#xD;
      week for up to 1.5 years, until objective disease progression or the patient withdraws&#xD;
      consent. Tumor responses will be assessed at the study sites by evaluating tumor images/scans&#xD;
      according to RECIST v1.1.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Futility analysis did not support continuation of the trial&#xD;
  </why_stopped>
  <start_date type="Actual">July 20, 2017</start_date>
  <completion_date type="Actual">January 15, 2020</completion_date>
  <primary_completion_date type="Actual">January 15, 2020</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Progression Free Survival</measure>
    <time_frame>2 years</time_frame>
    <description>Time to disease progression or recurrence of ovarian cancer defined as disease progression by RECIST 1.1., disease recurrence, death without progression or CA125 progression</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>2 years</time_frame>
    <description>Death with or without ovarian cancer progression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Best Overall Response Rate</measure>
    <time_frame>2 years</time_frame>
    <description>Best overall response defined as sum of Complete Responses and Partial Responses in the subset of patients with measurable tumor lesions at baseline.&#xD;
Best overall response is a binary endpoint and defined as a best overall response of either CR or PR among subjects with measurable lesions at baseline, using RECIST v1.1.&#xD;
Disease control rate is the percentage of subjects with a response of CR, PR, or SD or non-CR/non-PR vs PD among subjects with measurable lesions at baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease Control Rate</measure>
    <time_frame>2 years</time_frame>
    <description>Disease control rate defined as the sum of Complete Responses, Partial Responses and Stable Disease.&#xD;
Best overall response is a binary endpoint and defined as a best overall response of either CR or PR among subjects with measurable lesions at baseline, using RECIST v1.1.&#xD;
Disease control rate is the percentage of subjects with a response of CR, PR, or SD or non-CR/non-PR vs PD among subjects with measurable lesions at baseline.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Platinum Sensitive Ovarian Cancer</condition>
  <condition>Ovarian Cancer</condition>
  <arm_group>
    <arm_group_label>FRα peptide plus adjuvant (GM-CSF)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>FRα peptide vaccine with GM-CSF adjuvant ID administration monthly for 6 months followed by booster administrations every 3 months for up to 1.5 years</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Adjuvant (GM-CSF) Alone</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>GM-CSF adjuvant alone ID administration monthly for 6 months followed by booster administrations every 3 months for up to 1.5 years</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>FRα peptide plus Adjuvant (GM-CSF)</intervention_name>
    <description>Intradermal injection FRα peptides, 500μg each - plus GM-CSF 125 μg</description>
    <arm_group_label>FRα peptide plus adjuvant (GM-CSF)</arm_group_label>
    <other_name>TPIV200 with GM-CSF adjuvant</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Adjuvant (GM-CSF) Alone</intervention_name>
    <description>Intradermal injection 125 μg GM-CSF</description>
    <arm_group_label>Adjuvant (GM-CSF) Alone</arm_group_label>
    <other_name>Leukine®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Criteria for Inclusion:&#xD;
&#xD;
          1. Female patient ≥ 18 years&#xD;
&#xD;
          2. Willing and able to give informed consent&#xD;
&#xD;
          3. Stage III-IV platinum-sensitive (defined as a lack of progression by RECIST v1.1&#xD;
             criteria following completion of standard-of-care chemotherapy, including a minimum of&#xD;
             4 cycles of a platinum-containing regimen) epithelial ovarian, fallopian tube or&#xD;
             primary peritoneal carcinoma in first remission.&#xD;
&#xD;
          4. Histologic documentation of diagnosis of carcinoma is required and the following&#xD;
             histologic subtypes are eligible: high grade (grade ≥3+) serous or endometrioid&#xD;
             carcinoma, carcinosarcoma, or poorly-differentiated adenocarcinoma, or mixed&#xD;
             (including above subtypes only). Note that synchronous serous or endometrioid uterine&#xD;
             or fallopian cancers are allowed.&#xD;
&#xD;
          5. The patient must have demonstrated an objective response (PR or CR) or stable disease&#xD;
             (SD) with the last chemotherapy prior to enrollment and this response must be stable&#xD;
             (without progressive disease) before randomization.&#xD;
&#xD;
          6. Patients must receive their first dose of vaccine within 1 year of completion of their&#xD;
             final dose of a chemotherapeutic agent of the platinum-containing regimen&#xD;
&#xD;
          7. Adequate normal organ and marrow function within 14 days prior to first vaccine&#xD;
             administration:&#xD;
&#xD;
               -  Absolute neutrophil count &gt; 1.5 x 109/L&#xD;
&#xD;
               -  Platelet &gt; 100 x 109/L&#xD;
&#xD;
               -  Hemoglobin &gt; 9.0 g/dL&#xD;
&#xD;
               -  Serum bilirubin &lt; 1.5 times ULN (unless Gilbert's syndrome without concurrent&#xD;
                  clinically significant liver disease&#xD;
&#xD;
               -  AST/ALT &lt; 2.5 ULN unless liver metastasis in which case it must be &lt; 5 x ULN&#xD;
&#xD;
               -  Serum creatinine CL &gt; 40 mL/min by Cockcroft-Gault formula.&#xD;
&#xD;
          8. Anti-nuclear antibody (ANA) negative or low-positive institutional range, as&#xD;
             determined within 28 days from registration. Intermediate values (usually defined by a&#xD;
             titer of ≤1:80, or as indicated by institutional range) are acceptable if there are,&#xD;
             in the opinion of the Investigator, no early signs of an autoimmune disease.&#xD;
&#xD;
          9. Female subjects must either be of non-reproductive potential (i.e. post-menopause by&#xD;
             history: &gt; 60 years old and no menses for &gt; 12 months naturally or secondary to&#xD;
             radiation/chemotherapy; OR serum FSH, LH and estradiol levels in the post-menopausal&#xD;
             range; OR history of hysterectomy; OR history of bilateral tubal ligation; OR history&#xD;
             of bilateral oophorectomy), or must have a negative serum pregnancy test upon study&#xD;
             entry&#xD;
&#xD;
         10. Life expectancy &gt; 24 weeks&#xD;
&#xD;
         11. ECOG performance status of 0 or 1&#xD;
&#xD;
         12. Formalin fixed, paraffin embedded tumor sample from the primary cancer must be sent&#xD;
             for central testing.&#xD;
&#xD;
        Criteria for Exclusion&#xD;
&#xD;
          1. Histology consistent with non-serous, non-endometrioid (i.e. mucinous or clear cell),&#xD;
             or low-grade or borderline serous ovarian carcinoma&#xD;
&#xD;
          2. Patients with a history of other cancers (other than non-melanoma skin cancers [i.e.&#xD;
             basal or squamous cell]) within the past 3 years.&#xD;
&#xD;
          3. Receipt of the last dose of anti-cancer therapy (chemotherapy, immunotherapy, targeted&#xD;
             therapy, biological/cell therapy, tumor embolization, monoclonal antibodies, other&#xD;
             investigational agent) &lt; 28 days prior to the first dose of study drug.&#xD;
&#xD;
          4. Current or prior use of immunosuppressive medication within 28 days prior to the fist&#xD;
             dose of study drug with the exception of topical, intranasal or inhaled&#xD;
             corticosteroids or systemic corticosteroids at physiological doses, which are not to&#xD;
             exceed 10 mg/day of prednisone, or an equivalent corticosteroid.&#xD;
&#xD;
          5. Active autoimmune disease requiring therapy within the past 2 years. Note: patients&#xD;
             with vitiligo, Grave's disease or psoriasis not requiring systemic treatment within&#xD;
             the past 2 years are not excluded.&#xD;
&#xD;
          6. History of hypersensitivity to GM-CSF&#xD;
&#xD;
          7. Uncontrolled intercurrent illness including, but not limited to, ongoing or active&#xD;
             infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable&#xD;
             angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, active&#xD;
             bleeding diatheses including any subject known to have evidence of acute or chronic&#xD;
             hepatitis B, hepatitis C or human immunodeficiency virus (HIV), or psychiatric&#xD;
             illness/social situations that would limit compliance with study requirements or&#xD;
             compromise the ability of the subject to give written informed consent&#xD;
&#xD;
          8. Symptomatic thyroid disease, unless negative for thyroid antibodies (TSH receptor,&#xD;
             TPO, thyroglobulin).&#xD;
&#xD;
          9. Subjects who are pregnant or are breast feeding.&#xD;
&#xD;
         10. Subjects who or of reproductive potential, and are either:&#xD;
&#xD;
               -  Not abstinent;&#xD;
&#xD;
               -  Not in an exclusive relationship with a partner who is surgically sterile;&#xD;
&#xD;
               -  Not employing an effective method of birth control.&#xD;
&#xD;
         11. Any condition that, in the opinion of the investigator, would interfere with&#xD;
             evaluation of study treatment or interpretation of patient safety or study results&#xD;
&#xD;
         12. Symptomatic or uncontrolled brain metastasis requiring concurrent treatment, inclusive&#xD;
             of but not limited to surgery, radiation and/or corticosteroids&#xD;
&#xD;
         13. Subject with uncontrolled seizures&#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_official>
    <last_name>Richard Kenney, MD</last_name>
    <role>Study Director</role>
    <affiliation>Marker Therapeutics, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UAB Gynecology Oncology</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35233</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic Cancer Center</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85054</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Women's Cancer Research Foundation</name>
      <address>
        <city>Newport Beach</city>
        <state>California</state>
        <zip>92663</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Stamford Hospital/Bennett Cancer Center</name>
      <address>
        <city>Stamford</city>
        <state>Connecticut</state>
        <zip>06904</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic Florida</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mt. Sinai Comprehensive Cancer Center</name>
      <address>
        <city>Miami Beach</city>
        <state>Florida</state>
        <zip>33140</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Moffitt Cancer Center</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Cancer Specialist</name>
      <address>
        <city>West Palm Beach</city>
        <state>Florida</state>
        <zip>33401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Partners</name>
      <address>
        <city>Jackson</city>
        <state>Mississippi</state>
        <zip>39202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MidAmerica Division, Inc. c/o Research Medical Center</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64132</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Of New Mexico Comprehensive Cancer Center</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hematology/Oncology Lenox Hill Hospital</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10075</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OHSU</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Abington Memorial Hospital</name>
      <address>
        <city>Abington</city>
        <state>Pennsylvania</state>
        <zip>19001</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tennessee Oncology/Sarah Cannon Research Institute</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>November 22, 2016</study_first_submitted>
  <study_first_submitted_qc>November 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 30, 2016</study_first_posted>
  <results_first_submitted>August 22, 2022</results_first_submitted>
  <results_first_submitted_qc>November 21, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">December 15, 2022</results_first_posted>
  <last_update_submitted>November 21, 2022</last_update_submitted>
  <last_update_submitted_qc>November 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 15, 2022</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>Ovarian Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Ovarian Epithelial</mesh_term>
    <mesh_term>Hypersensitivity</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Molgramostim</mesh_term>
    <mesh_term>Sargramostim</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>April 12, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/22/NCT02978222/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 31, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/22/NCT02978222/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The first subject screened for trial 20 Jul 2017 and the last subject enrolled was screened 29Nov2018. Seventeen sites (academic and private clinics) in the United States enrolled and treated patients in the trial. The trial was terminated on 18 Oct 2019, after a blinded analysis by the DSMB determined that the futility requirements were not met. While the trial was terminated on 10/18/2019, the last patient could not return for a final visit/safety evaluation until January 15, 2020.</recruitment_details>
      <pre_assignment_details>Enrolled subjects were only excluded from the trial if it was found that inclusion/exclusion criteria were not met for continued participation.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>FRα Peptide Plus Adjuvant (GM-CSF)</title>
          <description>FRα peptide vaccine with GM-CSF adjuvant ID administration monthly for 6 months followed by booster administrations every 3 months for up to 1.5 years&#xD;
FRα peptide plus Adjuvant (GM-CSF): Intradermal injection FRα peptides, 500μg each - plus GM-CSF 125 μg</description>
        </group>
        <group group_id="P2">
          <title>Adjuvant (GM-CSF) Alone</title>
          <description>GM-CSF adjuvant alone ID administration monthly for 6 months followed by booster administrations every 3 months for up to 1.5 years&#xD;
Adjuvant (GM-CSF) Alone: Intradermal injection 125 μg GM-CSF</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="62"/>
                <participants group_id="P2" count="58"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="61"/>
                <participants group_id="P2" count="56"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Disease Progression</title>
              <participants_list>
                <participants group_id="P1" count="32"/>
                <participants group_id="P2" count="32"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Early Study Termination</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
                <participants group_id="P2" count="21"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>FRα Peptide Plus Adjuvant (GM-CSF)</title>
          <description>FRα peptide vaccine with GM-CSF adjuvant ID administration monthly for 6 months followed by booster administrations every 3 months for up to 1.5 years&#xD;
FRα peptide plus Adjuvant (GM-CSF): Intradermal injection FRα peptides, 500μg each - plus GM-CSF 125 μg</description>
        </group>
        <group group_id="B2">
          <title>Adjuvant (GM-CSF) Alone</title>
          <description>GM-CSF adjuvant alone ID administration monthly for 6 months followed by booster administrations every 3 months for up to 1.5 years&#xD;
Adjuvant (GM-CSF) Alone: Intradermal injection 125 μg GM-CSF</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="62"/>
            <count group_id="B2" value="58"/>
            <count group_id="B3" value="120"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                    <measurement group_id="B2" value="34"/>
                    <measurement group_id="B3" value="74"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="62"/>
                    <measurement group_id="B2" value="58"/>
                    <measurement group_id="B3" value="120"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="58"/>
                    <measurement group_id="B2" value="52"/>
                    <measurement group_id="B3" value="110"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="55"/>
                    <measurement group_id="B2" value="53"/>
                    <measurement group_id="B3" value="108"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="62"/>
                    <measurement group_id="B2" value="58"/>
                    <measurement group_id="B3" value="120"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>More than 6 months to last date of platinum therapy</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Progression Free Survival</title>
        <description>Time to disease progression or recurrence of ovarian cancer defined as disease progression by RECIST 1.1., disease recurrence, death without progression or CA125 progression</description>
        <time_frame>2 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>FRα Peptide Plus Adjuvant (GM-CSF)</title>
            <description>FRα peptide vaccine with GM-CSF adjuvant ID administration monthly for 6 months followed by booster administrations every 3 months for up to 1.5 years&#xD;
FRα peptide plus Adjuvant (GM-CSF): Intradermal injection FRα peptides, 500μg each - plus GM-CSF 125 μg</description>
          </group>
          <group group_id="O2">
            <title>Adjuvant (GM-CSF) Alone</title>
            <description>GM-CSF adjuvant alone ID administration monthly for 6 months followed by booster administrations every 3 months for up to 1.5 years&#xD;
Adjuvant (GM-CSF) Alone: Intradermal injection 125 μg GM-CSF</description>
          </group>
        </group_list>
        <measure>
          <title>Progression Free Survival</title>
          <description>Time to disease progression or recurrence of ovarian cancer defined as disease progression by RECIST 1.1., disease recurrence, death without progression or CA125 progression</description>
          <units>Months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="61"/>
                <count group_id="O2" value="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.1" lower_limit="8.1" upper_limit="NA">The confidence interval upper bound is not able to be estimated because the Kaplan-Meier curve representing the upper confidence limits of the survival function lies above 0.5</measurement>
                    <measurement group_id="O2" value="10.9" lower_limit="8.0" upper_limit="16.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Survival (OS)</title>
        <description>Death with or without ovarian cancer progression</description>
        <time_frame>2 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>FRα Peptide Plus Adjuvant (GM-CSF)</title>
            <description>FRα peptide vaccine with GM-CSF adjuvant ID administration monthly for 6 months followed by booster administrations every 3 months for up to 1.5 years&#xD;
FRα peptide plus Adjuvant (GM-CSF): Intradermal injection FRα peptides, 500μg each - plus GM-CSF 125 μg</description>
          </group>
          <group group_id="O2">
            <title>Adjuvant (GM-CSF) Alone</title>
            <description>GM-CSF adjuvant alone ID administration monthly for 6 months followed by booster administrations every 3 months for up to 1.5 years&#xD;
Adjuvant (GM-CSF) Alone: Intradermal injection 125 μg GM-CSF</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival (OS)</title>
          <description>Death with or without ovarian cancer progression</description>
          <units>Months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="61"/>
                <count group_id="O2" value="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">Point estimates are not able to be estimates because the Kaplan-Meier does not cross 0.5. Confidence interval upper bounds cannot be estimated because the Kaplan-Meier curve representing the upper confidence limits of the survival function lies above 0.5. Additionally, the confidence interval lower bound for the FRα Peptide Plus Adjuvant (GM-CSF) Alone group cannot be estimated because the Kaplan-Meier curve representing the lower confidence limits of the survival function lies above 0.5.</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="22.8" upper_limit="NA">Point estimates are not able to be estimates because the Kaplan-Meier does not cross 0.5. Confidence interval upper bounds cannot be estimated because the Kaplan-Meier curve representing the upper confidence limits of the survival function lies above 0.5. Additionally, the confidence interval lower bound for the FRα Peptide Plus Adjuvant (GM-CSF) Alone group cannot be estimated because the Kaplan-Meier curve representing the lower confidence limits of the survival function lies above 0.5.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Best Overall Response Rate</title>
        <description>Best overall response defined as sum of Complete Responses and Partial Responses in the subset of patients with measurable tumor lesions at baseline.&#xD;
Best overall response is a binary endpoint and defined as a best overall response of either CR or PR among subjects with measurable lesions at baseline, using RECIST v1.1.&#xD;
Disease control rate is the percentage of subjects with a response of CR, PR, or SD or non-CR/non-PR vs PD among subjects with measurable lesions at baseline.</description>
        <time_frame>2 years</time_frame>
        <population>Subject in MITT with measurable disease at baseline.</population>
        <group_list>
          <group group_id="O1">
            <title>FRα Peptide Plus Adjuvant (GM-CSF)</title>
            <description>FRα peptide vaccine with GM-CSF adjuvant ID administration monthly for 6 months followed by booster administrations every 3 months for up to 1.5 years&#xD;
FRα peptide plus Adjuvant (GM-CSF): Intradermal injection FRα peptides, 500μg each - plus GM-CSF 125 μg</description>
          </group>
          <group group_id="O2">
            <title>Adjuvant (GM-CSF) Alone</title>
            <description>GM-CSF adjuvant alone ID administration monthly for 6 months followed by booster administrations every 3 months for up to 1.5 years&#xD;
Adjuvant (GM-CSF) Alone: Intradermal injection 125 μg GM-CSF</description>
          </group>
        </group_list>
        <measure>
          <title>Best Overall Response Rate</title>
          <description>Best overall response defined as sum of Complete Responses and Partial Responses in the subset of patients with measurable tumor lesions at baseline.&#xD;
Best overall response is a binary endpoint and defined as a best overall response of either CR or PR among subjects with measurable lesions at baseline, using RECIST v1.1.&#xD;
Disease control rate is the percentage of subjects with a response of CR, PR, or SD or non-CR/non-PR vs PD among subjects with measurable lesions at baseline.</description>
          <population>Subject in MITT with measurable disease at baseline.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Disease Control Rate</title>
        <description>Disease control rate defined as the sum of Complete Responses, Partial Responses and Stable Disease.&#xD;
Best overall response is a binary endpoint and defined as a best overall response of either CR or PR among subjects with measurable lesions at baseline, using RECIST v1.1.&#xD;
Disease control rate is the percentage of subjects with a response of CR, PR, or SD or non-CR/non-PR vs PD among subjects with measurable lesions at baseline.</description>
        <time_frame>2 years</time_frame>
        <population>Subjects in MITT with measurable lesions at baseline.</population>
        <group_list>
          <group group_id="O1">
            <title>FRα Peptide Plus Adjuvant (GM-CSF)</title>
            <description>FRα peptide vaccine with GM-CSF adjuvant ID administration monthly for 6 months followed by booster administrations every 3 months for up to 1.5 years&#xD;
FRα peptide plus Adjuvant (GM-CSF): Intradermal injection FRα peptides, 500μg each - plus GM-CSF 125 μg</description>
          </group>
          <group group_id="O2">
            <title>Adjuvant (GM-CSF) Alone</title>
            <description>GM-CSF adjuvant alone ID administration monthly for 6 months followed by booster administrations every 3 months for up to 1.5 years&#xD;
Adjuvant (GM-CSF) Alone: Intradermal injection 125 μg GM-CSF</description>
          </group>
        </group_list>
        <measure>
          <title>Disease Control Rate</title>
          <description>Disease control rate defined as the sum of Complete Responses, Partial Responses and Stable Disease.&#xD;
Best overall response is a binary endpoint and defined as a best overall response of either CR or PR among subjects with measurable lesions at baseline, using RECIST v1.1.&#xD;
Disease control rate is the percentage of subjects with a response of CR, PR, or SD or non-CR/non-PR vs PD among subjects with measurable lesions at baseline.</description>
          <population>Subjects in MITT with measurable lesions at baseline.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected for two years after the first vaccine administration.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>FRα Peptide Plus Adjuvant (GM-CSF)</title>
          <description>FRα peptide vaccine with GM-CSF adjuvant ID administration monthly for 6 months followed by booster administrations every 3 months for up to 1.5 years&#xD;
FRα peptide plus Adjuvant (GM-CSF): Intradermal injection FRα peptides, 500μg each - plus GM-CSF 125 μg</description>
        </group>
        <group group_id="E2">
          <title>Adjuvant (GM-CSF) Alone</title>
          <description>GM-CSF adjuvant alone ID administration monthly for 6 months followed by booster administrations every 3 months for up to 1.5 years&#xD;
Adjuvant (GM-CSF) Alone: Intradermal injection 125 μg GM-CSF</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (19.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="62"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="58"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="62"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="58"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>anemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="62"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="58"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>acute myocardial infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="62"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="58"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>vertigo</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="58"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>small intestinal obstruction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="58"/>
              </event>
              <event>
                <sub_title>Abdominal Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="58"/>
              </event>
              <event>
                <sub_title>oral mucositis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="62"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="58"/>
              </event>
              <event>
                <sub_title>small bowel obstruction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="58"/>
              </event>
              <event>
                <sub_title>small intestinal obstruction</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="62"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="58"/>
              </event>
              <event>
                <sub_title>colitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="62"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="58"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia-unknown etiology</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="62"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="58"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="62"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="58"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Closed Right Hip Fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="62"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="58"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Unspecified (incl) cysts and polyps; ovarian cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="58"/>
              </event>
              <event>
                <sub_title>malignant melanoma in situ</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="58"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="58"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="58"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="58"/>
              </event>
              <event>
                <sub_title>dyspnea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="62"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="58"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>thromboembolic event</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="62"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="58"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (19.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="61" subjects_at_risk="62"/>
                <counts group_id="E2" subjects_affected="56" subjects_at_risk="58"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>abdominal distension</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="62"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="58"/>
              </event>
              <event>
                <sub_title>abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="62"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="58"/>
              </event>
              <event>
                <sub_title>consipation</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="62"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="58"/>
              </event>
              <event>
                <sub_title>diarrhea</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="62"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="58"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="62"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="58"/>
              </event>
              <event>
                <sub_title>vomiting</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="62"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="58"/>
              </event>
              <event>
                <sub_title>Gastroesophageal Reflux Disease</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="62"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="58"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="62"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="58"/>
              </event>
              <event>
                <sub_title>injection site reaction</sub_title>
                <counts group_id="E1" subjects_affected="40" subjects_at_risk="62"/>
                <counts group_id="E2" subjects_affected="22" subjects_at_risk="58"/>
              </event>
              <event>
                <sub_title>pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="62"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="58"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="62"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="58"/>
              </event>
              <event>
                <sub_title>upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="62"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="58"/>
              </event>
              <event>
                <sub_title>urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="62"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="58"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>fall</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="62"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="58"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>white blood cell count decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="62"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="58"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="62"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="58"/>
              </event>
              <event>
                <sub_title>back pain</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="62"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="58"/>
              </event>
              <event>
                <sub_title>myalgia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="62"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="58"/>
              </event>
              <event>
                <sub_title>pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="62"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="58"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>headache</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="62"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="58"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>insomnia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="62"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="58"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>cough</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="62"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="58"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>alopecia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="62"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="58"/>
              </event>
              <event>
                <sub_title>pruritus</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="62"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="58"/>
              </event>
              <event>
                <sub_title>rash maculo-papular</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="62"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="58"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>hypertension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="62"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="58"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>The trial was stopped due futility. Therefore, results are not for the complete study as designed.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Gerald Garrett</name_or_title>
      <organization>Marker Therapeutics</organization>
      <phone>713.400.6400</phone>
      <email>ggarrett@markertherapeutics.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02978222
org study id: FRV-004
nct id: NCT02978222
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This is a double-blind, randomized, parallel groups Phase II trial. Patients with
      platinum-sensitive advanced ovarian cancer, defined as a lack of progression by RECIST v1.1
      criteria following completion of standard-of-care chemotherapy, including a minimum of 4
      cycles of a platinum-containing regimen. Patients will be randomized to either the vaccine
      regimen with GM-CSF adjuvant or GM-CSF adjuvant alone as a control group. Treatment will be
      administered as a consolidation therapy within one year of the last administration of
      platinum, targeting the first remission.
This is a multicenter double-blind controlled randomized Phase II study to evaluate the
      activity of folate receptor alpha (FRα) peptide vaccine as a consolidation treatment
      following completion of no less than 4 cycles of a platinum containing regimen in patients
      with platinum-sensitive, non-mucinous ovarian, fallopian tube or primary peritoneal cancer.

      The patients will have demonstrated a tumor response or stable disease upon their last
      regimen (per RECIST v1.1 and/or CA125 GCIG criteria) prior to enrolment in this study.

      Following randomization, patients will be administered TPIV200 with GM-CSF adjuvant or GM-CSF
      control alone. Patients will have booster doses and tumor assessments done every 12 weeks ± 1
      week for up to 1.5 years, until objective disease progression or the patient withdraws
      consent. Tumor responses will be assessed at the study sites by evaluating tumor images/scans
      according to RECIST v1.1.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Progression Free Survival
time frame: 2 years
description: Time to disease progression or recurrence of ovarian cancer defined as disease progression by RECIST 1.1., disease recurrence, death without progression or CA125 progression
measure: Overall Survival (OS)
time frame: 2 years
description: Death with or without ovarian cancer progression
measure: Best Overall Response Rate
time frame: 2 years
description: Best overall response defined as sum of Complete Responses and Partial Responses in the subset of patients with measurable tumor lesions at baseline.
Best overall response is a binary endpoint and defined as a best overall response of either CR or PR among subjects with measurable lesions at baseline, using RECIST v1.1.
Disease control rate is the percentage of subjects with a response of CR, PR, or SD or non-CR/non-PR vs PD among subjects with measurable lesions at baseline.
measure: Disease Control Rate
time frame: 2 years
description: Disease control rate defined as the sum of Complete Responses, Partial Responses and Stable Disease.
Best overall response is a binary endpoint and defined as a best overall response of either CR or PR among subjects with measurable lesions at baseline, using RECIST v1.1.
Disease control rate is the percentage of subjects with a response of CR, PR, or SD or non-CR/non-PR vs PD among subjects with measurable lesions at baseline.
arm group label: FRα peptide plus adjuvant (GM-CSF)
arm group type: Experimental
description: FRα peptide vaccine with GM-CSF adjuvant ID administration monthly for 6 months followed by booster administrations every 3 months for up to 1.5 years
arm group label: Adjuvant (GM-CSF) Alone
arm group type: Placebo Comparator
description: GM-CSF adjuvant alone ID administration monthly for 6 months followed by booster administrations every 3 months for up to 1.5 years
intervention type: Biological
intervention name: FRα peptide plus Adjuvant (GM-CSF)
description: Intradermal injection FRα peptides, 500μg each - plus GM-CSF 125 μg
arm group label: FRα peptide plus adjuvant (GM-CSF)
other name: TPIV200 with GM-CSF adjuvant
intervention type: Drug
intervention name: Adjuvant (GM-CSF) Alone
description: Intradermal injection 125 μg GM-CSF
arm group label: Adjuvant (GM-CSF) Alone
other name: Leukine®
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Richard Kenney, MD
role: Study Director
affiliation: Marker Therapeutics, Inc.
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Ovarian Neoplasms
mesh term: Carcinoma, Ovarian Epithelial
mesh term: Hypersensitivity
mesh term: Molgramostim
mesh term: Sargramostim
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The trial was stopped due futility. Therefore, results are not for the complete study as designed.
point of contact: 