<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/NCT03821272</url>
  </required_header>
  <id_info>
    <org_study_id>217672</org_study_id>
    <nct_id>NCT03821272</nct_id>
  </id_info>
  <brief_title>A Phase I/II Clinical Trial of PepCan in Head and Neck Cancer Patients</brief_title>
  <official_title>A Phase I/II Clinical Trial of PepCan in Head and Neck Cancer Patients in Remission to Reduce Recurrence Regardless of HPV Status</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Arkansas</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Arkansas</source>
  <oversight_info>
    <has_dmc>No</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 study has been designed to evaluate the safety and efficacy of giving seven injections&#xD;
      of PepCan or placebo over approximately a 24-month period in subjects with head and neck&#xD;
      cancers who achieved remission. PepCan may prove to be beneficial in treating many stages of&#xD;
      HPV-related malignancies starting from infection to cancer. Safety, efficacy in terms of&#xD;
      reduced cancer recurrence, immunological responses and profiles, and gut microbiome changes&#xD;
      will be assessed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a Phase I/II study to evaluate the efficacy and safety of an HPV therapeutic vaccine&#xD;
      called PepCan (HPV-16 E6 peptides) in adults over a two (2) year period. Each subject will be&#xD;
      receiving a total of 7 injections of PepCan (50 µg per peptide dose) or placebo (saline) at a&#xD;
      3:1 ratio in a randomized double-blinded design. Subjects will receive one injection every 3&#xD;
      weeks until they receive 4 injections. Then, subjects will receive one injection every 3&#xD;
      months until they receive a total of 7 injections. Subjects will have 2 more visits&#xD;
      approximately 6 months apart after the last injection. Immunological assessment by&#xD;
      enzyme-linked immunospot (ELISPOT) assay will be made at 4 time points (Visits 1, 5, 8, and&#xD;
      9), and by fluorescent activated cell sorter analysis will be made at times points at Visits&#xD;
      1, 3, 5, 6, 7, 8, and 9. Oral wash samples and stool samples will be collected at the&#xD;
      Screening Visit, Visit 5, Visit 7 and Visit 8 for microbiome diversity analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">November 13, 2019</start_date>
  <completion_date type="Anticipated">June 2026</completion_date>
  <primary_completion_date type="Anticipated">December 2025</primary_completion_date>
  <phase>Phase 1/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>
    <intervention_model_description>PepCan or placebo randomized at a 3:1 ratio in a double-blinded design.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adverse events - evaluate safety of a 7-injection regimen of PepCan.</measure>
    <time_frame>2 years</time_frame>
    <description>To evaluate the safety of a 7-injection regimen of PepCan, adverse events will be captured and assessed per NCI CTCAE Version 5.0 whether they are treatment-related or not by a physician.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cancer recurrence rate - efficacy of a 7-injection regimen of PepCan</measure>
    <time_frame>2 years</time_frame>
    <description>To evaluate the efficacy, cancer recurrence rates will be compared between the PepCan and placebo arms.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Head and Neck Cancer</condition>
  <arm_group>
    <arm_group_label>PepCan</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Four injections (one every 3 weeks) of PepCan, then three injections (one every 3 months) of PepCan for a total of 7 injections.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Four injections (one every 3 weeks) of placebo, then three injections (one every 3 months) of placebo for a total of 7 injections.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>PepCan</intervention_name>
    <description>50 μg peptide + 0.3mL Candin® per dose administered intradermally in the extremities</description>
    <arm_group_label>PepCan</arm_group_label>
    <other_name>HPV 16 E6 peptides combined with Candin®</other_name>
    <other_name>PepCan Vaccine Regime</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>0.9% Saline solution per dose administered intradermally in the extremities</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Saline</other_name>
    <other_name>Placebo Vaccine Regimen</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Able to provide informed consent&#xD;
&#xD;
          2. Male or female 18 years of age or older&#xD;
&#xD;
          3. Squamous cell carcinoma of the head and neck who have completed curative therapy&#xD;
             (surgery and/or radiation and/or chemotherapy) therapy within the previous 120 days&#xD;
&#xD;
          4. Performance status of Eastern Cooperative Oncology Group (ECOG) 0-2&#xD;
&#xD;
          5. No Evidence of Disease (NED) based on clinical and/or radiographic evaluations&#xD;
&#xD;
          6. Vital Signs recorded&#xD;
&#xD;
               1. Blood pressure (≤160/95 mm Hg acceptable)&#xD;
&#xD;
               2. Heart rate (50-100 beats per min acceptable)&#xD;
&#xD;
               3. Respiratory rate (≥ 12 ≤25 breaths per min acceptable)&#xD;
&#xD;
               4. Temperature (≤100°F acceptable)&#xD;
&#xD;
          7. Blood work done at Screening Visit&#xD;
&#xD;
               1. White count (≥3x109/L acceptable)&#xD;
&#xD;
               2. Hemoglobin (≥ 7 g/dL acceptable)&#xD;
&#xD;
          8. Willing and able to comply with the requirements of the protocol&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Positive urine pregnancy test for women of childbearing potential&#xD;
&#xD;
          2. Being pregnant or attempting to be pregnant within the period of study participation&#xD;
&#xD;
          3. Women who are breast feeding or plan to breast feed within the period of study&#xD;
             participation&#xD;
&#xD;
          4. Patients who are allergic to Candin® or yeast&#xD;
&#xD;
          5. History of severe asthma requiring emergency room visit or hospitalization within the&#xD;
             past 5 years&#xD;
&#xD;
          6. Patients who have previously received PepCan&#xD;
&#xD;
          7. History of recurrence of squamous cell carcinoma of the head and neck&#xD;
&#xD;
          8. If in the opinion of the Principal Investigator or other Investigators, it is not in&#xD;
             the best interest of the patient to enter or continue in this study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Omar T Atiq, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Arkansas</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Arkansas for Medical Sciences</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>January 23, 2019</study_first_submitted>
  <study_first_submitted_qc>January 28, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 29, 2019</study_first_posted>
  <last_update_submitted>July 24, 2023</last_update_submitted>
  <last_update_submitted_qc>July 24, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Squamous cell carcinoma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Head and Neck Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vaccines</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>February 15, 2023</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/72/NCT03821272/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03821272
org study id: 217672
nct id: NCT03821272
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This study has been designed to evaluate the safety and efficacy of giving seven injections
      of PepCan or placebo over approximately a 24-month period in subjects with head and neck
      cancers who achieved remission. PepCan may prove to be beneficial in treating many stages of
      HPV-related malignancies starting from infection to cancer. Safety, efficacy in terms of
      reduced cancer recurrence, immunological responses and profiles, and gut microbiome changes
      will be assessed.
This is a Phase I/II study to evaluate the efficacy and safety of an HPV therapeutic vaccine
      called PepCan (HPV-16 E6 peptides) in adults over a two (2) year period. Each subject will be
      receiving a total of 7 injections of PepCan (50 µg per peptide dose) or placebo (saline) at a
      3:1 ratio in a randomized double-blinded design. Subjects will receive one injection every 3
      weeks until they receive 4 injections. Then, subjects will receive one injection every 3
      months until they receive a total of 7 injections. Subjects will have 2 more visits
      approximately 6 months apart after the last injection. Immunological assessment by
      enzyme-linked immunospot (ELISPOT) assay will be made at 4 time points (Visits 1, 5, 8, and
      9), and by fluorescent activated cell sorter analysis will be made at times points at Visits
      1, 3, 5, 6, 7, 8, and 9. Oral wash samples and stool samples will be collected at the
      Screening Visit, Visit 5, Visit 7 and Visit 8 for microbiome diversity analysis.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: PepCan or placebo randomized at a 3:1 ratio in a double-blinded design.
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Adverse events - evaluate safety of a 7-injection regimen of PepCan.
time frame: 2 years
description: To evaluate the safety of a 7-injection regimen of PepCan, adverse events will be captured and assessed per NCI CTCAE Version 5.0 whether they are treatment-related or not by a physician.
measure: Cancer recurrence rate - efficacy of a 7-injection regimen of PepCan
time frame: 2 years
description: To evaluate the efficacy, cancer recurrence rates will be compared between the PepCan and placebo arms.
arm group label: PepCan
arm group type: Experimental
description: Four injections (one every 3 weeks) of PepCan, then three injections (one every 3 months) of PepCan for a total of 7 injections.
arm group label: Placebo
arm group type: Placebo Comparator
description: Four injections (one every 3 weeks) of placebo, then three injections (one every 3 months) of placebo for a total of 7 injections.
intervention type: Biological
intervention name: PepCan
description: 50 μg peptide + 0.3mL Candin® per dose administered intradermally in the extremities
arm group label: PepCan
other name: HPV 16 E6 peptides combined with Candin®
other name: PepCan Vaccine Regime
intervention type: Biological
intervention name: Placebo
description: 0.9% Saline solution per dose administered intradermally in the extremities
arm group label: Placebo
other name: Saline
other name: Placebo Vaccine Regimen
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Omar T Atiq, MD
role: Principal Investigator
affiliation: University of Arkansas
facility: 
country: United States
responsible party type: Sponsor
mesh term: Head and Neck Neoplasms
mesh term: Vaccines
provided document: 