xml: <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/NCT05996523</url>
    </required_header>
    <id_info>
      <org_study_id>10001536</org_study_id>
      <secondary_id>001536-C</secondary_id>
      <nct_id>NCT05996523</nct_id>
    </id_info>
    <brief_title>Phase II Trial of Immunotherapeutic HPV Vaccine PRGN-2009 With Pembrolizumab Before Standard Treatment in Subjects With Newly Diagnosed HPV-Associated Oropharyngeal Cancer</brief_title>
    <official_title>Phase II Trial of Immunotherapeutic HPV Vaccine PRGN-2009 With Pembrolizumab Before Standard Treatment in Subjects With Newly Diagnosed HPV-Associated Oropharyngeal Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>National Cancer Institute (NCI)</agency>
        <agency_class>NIH</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>National Institutes of Health Clinical Center (CC)</source>
    <oversight_info>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Background:&#xD;
  &#xD;
        Cancers in and around the mouth associated with human papilloma virus (HPV) are common. Two&#xD;
        treatments (the drug pembrolizumab and the HPV vaccine PRGN-2009) have been shown to work&#xD;
        well when used individually against these cancers. Researchers want to find out if they might&#xD;
        work better when used together.&#xD;
  &#xD;
        Objective:&#xD;
  &#xD;
        To test pembrolizumab combined with PRGN-2009 in people with HPV-positive cancers in and&#xD;
        around the mouth.&#xD;
  &#xD;
        Eligibility:&#xD;
  &#xD;
        Adults aged 18 and older newly diagnosed with HPV-positive cancers in and around the mouth.&#xD;
  &#xD;
        Design:&#xD;
  &#xD;
        Participants will be screened. They will have a physical exam with blood tests. They will&#xD;
        have imaging scans. They may need to have a biopsy: A sample of tissue will be taken from the&#xD;
        tumor.&#xD;
  &#xD;
        PRGN-2009 is given as an injection under the skin. Pembrolizumab is given through a tube&#xD;
        attached to a needle inserted into a vein in the arm.&#xD;
  &#xD;
        Participants will have at least 3 clinic visits: At the first, they will receive both the&#xD;
        drug and the vaccine; 15 days later, they will receive a second shot of the vaccine. At the&#xD;
        third visit, about 1 week after the second, they will have follow-up tests.&#xD;
  &#xD;
        During these visits, participants will give samples of blood, urine, and saliva. Imaging&#xD;
        scans and biopsies will be repeated. They will have tests of their heart function.&#xD;
  &#xD;
        Participants may opt to return for another follow-up visit about 1 month after their second&#xD;
        dose of the vaccine.&#xD;
  &#xD;
        Participants will have follow-up contacts by phone 3 and 6 months after starting the study.&#xD;
        The calls will continue once a year for 5 years.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Background&#xD;
  &#xD;
        -Human papilloma virus-associated oropharyngeal cancer (HPV-OPC) is the most common&#xD;
        HPV-associated malignancy in the United States, with an increasing incidence. Although the&#xD;
        prognosis for stage I HPV-OPC is favorable, about 20 percent of patients with stage II&#xD;
  &#xD;
        disease and 35 percent of patients with stage III disease will die within four years.&#xD;
  &#xD;
          -  The standard-of-care primary treatment for HPV-OPC without distant metastasis is&#xD;
             definitive concurrent chemoradiotherapy (primarily) or surgery (which may be followed by&#xD;
             adjuvant chemoradiotherapy).&#xD;
  &#xD;
          -  Neoadjuvant/induction immunotherapy is in clinical trials aiming to induce&#xD;
             antigen-specific immunity prior to primary treatment and to reduce the risk of disease&#xD;
             relapse. Pembrolizumab, an anti-PD-1 monoclonal antibody that is FDA-approved for&#xD;
             first-line treatment of recurrent/metastatic head and neck squamous cell cancer (HNSCC)&#xD;
             has been used in these trials and shown to be safe and active.&#xD;
  &#xD;
          -  PRGN-2009 is an anti-HPV immunotherapeutic vaccine. It has demonstrated induction of HPV&#xD;
             antigen-specific responses and tumor growth inhibition in pre-clinical models of&#xD;
             HPV-associated malignancy, with improved anti-tumor efficacy upon addition of T-cell&#xD;
             immune checkpoint blockade. In a Phase I/II trial at the NCI it has demonstrated&#xD;
             excellent safety and tolerability as monotherapy or in combination with checkpoint&#xD;
             blockade in recurrent/metastatic disease but also as monotherapy in&#xD;
             neoadjuvant/induction context for HPV-OPC.&#xD;
  &#xD;
        Objective:&#xD;
  &#xD;
        -To determine if the use of PRGN-2009 with pembrolizumab in participants with p16-positive&#xD;
        OPC can result in a &gt;= 2-fold increase in CD3+ tumor infiltrating T cells post treatment&#xD;
        compared with pre-treatment.&#xD;
  &#xD;
        Eligibility:&#xD;
  &#xD;
          -  Age &gt;= 18 years.&#xD;
  &#xD;
          -  Pathologically confirmed newly diagnosed Stage I (T1, T2; N1), II or III p16-positive&#xD;
             OPC.&#xD;
  &#xD;
        Design:&#xD;
  &#xD;
          -  This is a Phase II study to evaluate the effect of PRGN-2009 and pembrolizumab before&#xD;
             definitive treatment in subjects with p16-positive OPC.&#xD;
  &#xD;
          -  Participants will receive PRGN-2009 and pembrolizumab prior to definitive treatment.&#xD;
  &#xD;
          -  Participants will receive two doses of PRGN-2009 5x10^11 viral particles (VP)&#xD;
             subcutaneously (SC) approximately two weeks apart, and one dose of pembrolizumab 200 mg&#xD;
             intravenously (IV) concurrently with the first vaccine dose.&#xD;
  &#xD;
          -  Up to 20 evaluable participants will be enrolled.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 21, 2023</start_date>
    <completion_date type="Anticipated">November 1, 2027</completion_date>
    <primary_completion_date type="Anticipated">November 1, 2024</primary_completion_date>
    <phase>Phase 2</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>Determine if there is an increase in CD3+ tumor infiltrating T cells post treatment compared with pre-treatment</measure>
      <time_frame>4-5 weeks</time_frame>
      <description>CD3+ tumor infiltrating lymphocytes will be assessed by multiplex immunofluorescence from the surgical/ biopsy tissue collected at week 4-5 and compared with pre-treatment</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Prolonged Survival</measure>
      <time_frame>3-6 months</time_frame>
      <description>Assess if PRGN-2009 plus pembrolizumab results in significantly prolonged survival as compared to the expected 80% three-year historical survival in p16-positive OPC participants</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall Survival</measure>
      <time_frame>5 years</time_frame>
      <description>Assess OS and RFS once a year for 5 years</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Safety</measure>
      <time_frame>Up to 28 days after last treatment</time_frame>
      <description>Incidence of treatment-related serious adverse events at baseline, W1, W3, on day 29, and 28 days after last treatment as defined by Common Terminology Criteria for Adverse Events (CTCAE) v5.0</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Determine the rate of increase in TILs by immunohistologyCHANGE TO: Determine the rate of increase in tumor infiltrating lymphocytes (TILs) by immunohistology</measure>
      <time_frame>4 weeks CHANGE TO: 4-5 weeks</time_frame>
      <description>Compare the induction of immune response of PRGN-2009 plus pembrolizumab with PRGN-2009 at completion visit compared with pre-treatment with endpoint the &gt;=2-fold increase in tumor infiltrating lymphocytes</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">29</enrollment>
    <condition>Oropharyngeal Squamous Cell Carcinoma (SCC)</condition>
    <arm_group>
      <arm_group_label>Arm 1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>PRGN 5x10^11 Viral Particles (VP) SC plus pembrolizumab 200mg IV as induction/ neoadjuvant therapy</description>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>PRGN-2009</intervention_name>
      <description>PRGN-2009 5x10^11 viral particles (VP) subcutaneously (SC) approximately two weeks apart</description>
      <arm_group_label>Arm 1</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Pembrolizumab</intervention_name>
      <description>Pembrolizumab 200 mg intravenously (IV) concurrently with the first vaccine dose</description>
      <arm_group_label>Arm 1</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          -  INCLUSION CRITERIA:&#xD;
  &#xD;
            -  Subjects must have cytologically or histologically confirmed newly diagnosed stage I&#xD;
               (T1,2 N1), II or III p16-positive oropharyngeal squamous cell carcinoma (SCC) planned&#xD;
               for definitive therapy (surgery or chemoradiotherapy).&#xD;
  &#xD;
            -  Subjects must have measurable disease, per RECIST 1.1.&#xD;
  &#xD;
            -  Age &gt;=18 years.&#xD;
  &#xD;
            -  Eastern Cooperative Oncology Group [ECOG] performance status &lt;= 2.&#xD;
  &#xD;
            -  Adequate hematologic function at screening, as follows:&#xD;
  &#xD;
                 -  Absolute neutrophil count (ANC) &gt;=1 x 10^9/L;&#xD;
  &#xD;
                 -  Hemoglobin (Hgb) &gt;= 9 g/dL;&#xD;
  &#xD;
                 -  Platelets &gt;= 75,000/microliter.&#xD;
  &#xD;
            -  Adequate renal and hepatic function at screening, as follows:&#xD;
  &#xD;
                 -  Serum creatinine &lt;= 1.5 x upper limit of normal (ULN) OR measured or calculated&#xD;
                    creatinine clearance &gt;= 40 mL/min for participant with creatinine levels &gt; 1.5 x&#xD;
                    ULN (glomerular filtration rate [GFR] can also be used in place of creatinine or&#xD;
                    CrCl);&#xD;
  &#xD;
                 -  Total bilirubin &lt;= 1.5 x ULN OR in subjects with Gilbert s syndrome, a total&#xD;
                    bilirubin &lt;= 3.0 x ULN;&#xD;
  &#xD;
                 -  Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) &lt;= 2.5 x ULN,&#xD;
                    unless liver metastases are present, then values must be &lt;= 3 x ULN.&#xD;
  &#xD;
            -  Participants serologically positive for HIV, Hepatitis B, or Hepatitis C are eligible&#xD;
               if the viral loads are undetectable by quantitative PCR. Note: HIV positive&#xD;
               participants must have CD4 count &gt;= 200 cells/mm^3 at enrollment, be on stable&#xD;
               antiretroviral therapy for at least 4 weeks and have no reported opportunistic&#xD;
               infections or Castleman s disease within 12 months prior to enrollment.&#xD;
  &#xD;
            -  Women of child-bearing potential (WOCBP) must agree to use effective contraception&#xD;
               (hormonal or barrier method of birth control; abstinence) prior to study entry and for&#xD;
               the duration of study participation and for at least 4 months following the last dose&#xD;
               of pembrolizumab.&#xD;
  &#xD;
            -  Participants must be willing to undergo two research biopsies on this study.&#xD;
  &#xD;
            -  Ability of participant to understand and the willingness to sign a written informed&#xD;
               consent document.&#xD;
  &#xD;
          EXCLUSION CRITERIA:&#xD;
  &#xD;
            -  Participants with prior investigational drug, live vaccine, chemotherapy,&#xD;
               immunotherapy, or any prior radiotherapy (except for palliative bone directed therapy)&#xD;
               within the past 4 weeks prior to the first drug administration. Participants may&#xD;
               continue adjuvant hormonal therapy in the setting of a definitively treated cancer&#xD;
               (e.g., breast).&#xD;
  &#xD;
            -  Major surgery within 28 days prior to the first drug administration (minimally&#xD;
               invasive procedures such as diagnostic biopsies are permitted).&#xD;
  &#xD;
            -  Pregnant individuals as evaluated by a positive serum or urine Beta-hCG at screening&#xD;
  &#xD;
            -  Active autoimmune disease that might deteriorate when receiving an immunostimulatory&#xD;
               agent with the exception of:&#xD;
  &#xD;
                 -  Diabetes type I, eczema, vitiligo, alopecia, psoriasis, hypo- or hyperthyroidism&#xD;
                    or other mild autoimmune disorders not requiring immunosuppressive treatment.&#xD;
  &#xD;
                 -  Administration of glucocorticoids through a route known to result in a minimal&#xD;
                    systemic exposure (topical, intranasal, intraocular, or inhalation).&#xD;
  &#xD;
            -  Systemic (intravenous or oral) glucocorticoid (except for physiologic doses of&#xD;
               corticosteroids, i.e., &lt;= the equivalent of prednisone 10 mg/day) or other&#xD;
               immunosuppressors such as azathioprine or cyclosporin A, are excluded because of&#xD;
               potential immune suppression. These treatments must be discontinued at least 1 week&#xD;
               prior to enrollment for recent short course use (&lt;= 14 days). Glucocorticoids as&#xD;
               premedication for contrast-enhanced studies is allowed prior to enrollment and on&#xD;
               study.&#xD;
  &#xD;
            -  Participants with a prior or concurrent malignancy whose natural history or treatment&#xD;
               that has potential to interfere with the safety or efficacy assessment of the regimen.&#xD;
  &#xD;
            -  Prior allogenic tissue/solid organ transplant.&#xD;
  &#xD;
            -  Participants with pulse oximetry &lt; 92% on room air at screening.&#xD;
  &#xD;
            -  Uncontrolled intercurrent illness that would limit compliance with study requirements&#xD;
               suggested by medical history, physical examination or standard clinical assessments&#xD;
               such as imaging and laboratory studies.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>120 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Charalampos Floudas, M.D.</last_name>
      <role>Principal Investigator</role>
      <affiliation>National Cancer Institute (NCI)</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Marissa B Mallek, R.N.</last_name>
      <phone>(240) 760-7498</phone>
      <email>marissa.mallek@nih.gov</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Charalampos Floudas, M.D.</last_name>
      <phone>(240) 858-3032</phone>
      <email>charalampos.floudas@nih.gov</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>National Institutes of Health Clinical Center</name>
        <address>
          <city>Bethesda</city>
          <state>Maryland</state>
          <zip>20892</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>National Cancer Institute Referral Office</last_name>
        <phone>888-624-1937</phone>
        <email>ncimo_referrals@mail.nih.gov</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>https://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_001536-C.html</url>
      <description>NIH Clinical Center Detailed Web Page</description>
    </link>
    <verification_date>September 6, 2023</verification_date>
    <study_first_submitted>August 16, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>September 15, 2023</last_update_submitted>
    <last_update_submitted_qc>September 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>HPV16/18</keyword>
    <keyword>PD-1 inhibitor</keyword>
    <keyword>Monoclonal Antibody</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Oropharyngeal Neoplasms</mesh_term>
      <mesh_term>Squamous Cell Carcinoma of Head and Neck</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pembrolizumab</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>.All collected IPD will be shared.@@@@@@All IPD recorded in the medical record will be shared with intramural investigators upon request. In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP.@@@@@@</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_time_frame>Data from this study may be requested from other researchers no sooner than 3 years after the completion of the primary endpoint.@@@@@@Genomic data are available once genomic data are uploaded per protocol GDS plan for as long as database is active@@@@@@@@@@@@</ipd_time_frame>
      <ipd_access_criteria>Data from this study may be requested by contacting the PI@@@@@@Genomic data are made available via dbGaP through requests to the data custodians.@@@@@@</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05996523
  org study id: 10001536
  secondary id: 001536-C
  nct id: NCT05996523
  lead sponsor: 
  is fda regulated drug: Yes
  is fda regulated device: No
  Background:
  
        Cancers in and around the mouth associated with human papilloma virus (HPV) are common. Two
        treatments (the drug pembrolizumab and the HPV vaccine PRGN-2009) have been shown to work
        well when used individually against these cancers. Researchers want to find out if they might
        work better when used together.
  
        Objective:
  
        To test pembrolizumab combined with PRGN-2009 in people with HPV-positive cancers in and
        around the mouth.
  
        Eligibility:
  
        Adults aged 18 and older newly diagnosed with HPV-positive cancers in and around the mouth.
  
        Design:
  
        Participants will be screened. They will have a physical exam with blood tests. They will
        have imaging scans. They may need to have a biopsy: A sample of tissue will be taken from the
        tumor.
  
        PRGN-2009 is given as an injection under the skin. Pembrolizumab is given through a tube
        attached to a needle inserted into a vein in the arm.
  
        Participants will have at least 3 clinic visits: At the first, they will receive both the
        drug and the vaccine; 15 days later, they will receive a second shot of the vaccine. At the
        third visit, about 1 week after the second, they will have follow-up tests.
  
        During these visits, participants will give samples of blood, urine, and saliva. Imaging
        scans and biopsies will be repeated. They will have tests of their heart function.
  
        Participants may opt to return for another follow-up visit about 1 month after their second
        dose of the vaccine.
  
        Participants will have follow-up contacts by phone 3 and 6 months after starting the study.
        The calls will continue once a year for 5 years.
  Background
  
        -Human papilloma virus-associated oropharyngeal cancer (HPV-OPC) is the most common
        HPV-associated malignancy in the United States, with an increasing incidence. Although the
        prognosis for stage I HPV-OPC is favorable, about 20 percent of patients with stage II
  
        disease and 35 percent of patients with stage III disease will die within four years.
  
          -  The standard-of-care primary treatment for HPV-OPC without distant metastasis is
             definitive concurrent chemoradiotherapy (primarily) or surgery (which may be followed by
             adjuvant chemoradiotherapy).
  
          -  Neoadjuvant/induction immunotherapy is in clinical trials aiming to induce
             antigen-specific immunity prior to primary treatment and to reduce the risk of disease
             relapse. Pembrolizumab, an anti-PD-1 monoclonal antibody that is FDA-approved for
             first-line treatment of recurrent/metastatic head and neck squamous cell cancer (HNSCC)
             has been used in these trials and shown to be safe and active.
  
          -  PRGN-2009 is an anti-HPV immunotherapeutic vaccine. It has demonstrated induction of HPV
             antigen-specific responses and tumor growth inhibition in pre-clinical models of
             HPV-associated malignancy, with improved anti-tumor efficacy upon addition of T-cell
             immune checkpoint blockade. In a Phase I/II trial at the NCI it has demonstrated
             excellent safety and tolerability as monotherapy or in combination with checkpoint
             blockade in recurrent/metastatic disease but also as monotherapy in
             neoadjuvant/induction context for HPV-OPC.
  
        Objective:
  
        -To determine if the use of PRGN-2009 with pembrolizumab in participants with p16-positive
        OPC can result in a >= 2-fold increase in CD3+ tumor infiltrating T cells post treatment
        compared with pre-treatment.
  
        Eligibility:
  
          -  Age >= 18 years.
  
          -  Pathologically confirmed newly diagnosed Stage I (T1, T2; N1), II or III p16-positive
             OPC.
  
        Design:
  
          -  This is a Phase II study to evaluate the effect of PRGN-2009 and pembrolizumab before
             definitive treatment in subjects with p16-positive OPC.
  
          -  Participants will receive PRGN-2009 and pembrolizumab prior to definitive treatment.
  
          -  Participants will receive two doses of PRGN-2009 5x10^11 viral particles (VP)
             subcutaneously (SC) approximately two weeks apart, and one dose of pembrolizumab 200 mg
             intravenously (IV) concurrently with the first vaccine dose.
  
          -  Up to 20 evaluable participants will be enrolled.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Determine if there is an increase in CD3+ tumor infiltrating T cells post treatment compared with pre-treatment
  time frame: 4-5 weeks
  description: CD3+ tumor infiltrating lymphocytes will be assessed by multiplex immunofluorescence from the surgical/ biopsy tissue collected at week 4-5 and compared with pre-treatment
  measure: Prolonged Survival
  time frame: 3-6 months
  description: Assess if PRGN-2009 plus pembrolizumab results in significantly prolonged survival as compared to the expected 80% three-year historical survival in p16-positive OPC participants
  measure: Overall Survival
  time frame: 5 years
  description: Assess OS and RFS once a year for 5 years
  measure: Safety
  time frame: Up to 28 days after last treatment
  description: Incidence of treatment-related serious adverse events at baseline, W1, W3, on day 29, and 28 days after last treatment as defined by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
  measure: Determine the rate of increase in TILs by immunohistologyCHANGE TO: Determine the rate of increase in tumor infiltrating lymphocytes (TILs) by immunohistology
  time frame: 4 weeks CHANGE TO: 4-5 weeks
  description: Compare the induction of immune response of PRGN-2009 plus pembrolizumab with PRGN-2009 at completion visit compared with pre-treatment with endpoint the >=2-fold increase in tumor infiltrating lymphocytes
  arm group label: Arm 1
  arm group type: Experimental
  description: PRGN 5x10^11 Viral Particles (VP) SC plus pembrolizumab 200mg IV as induction/ neoadjuvant therapy
  intervention type: Biological
  intervention name: PRGN-2009
  description: PRGN-2009 5x10^11 viral particles (VP) subcutaneously (SC) approximately two weeks apart
  arm group label: Arm 1
  intervention type: Drug
  intervention name: Pembrolizumab
  description: Pembrolizumab 200 mg intravenously (IV) concurrently with the first vaccine dose
  arm group label: Arm 1
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 120 Years
  healthy volunteers: No
  last name: Charalampos Floudas, M.D.
  role: Principal Investigator
  affiliation: National Cancer Institute (NCI)
  last name: Marissa B Mallek, R.N.
  phone: (240) 760-7498
  email: marissa.mallek@nih.gov
  last name: Charalampos Floudas, M.D.
  phone: (240) 858-3032
  email: charalampos.floudas@nih.gov
  facility: 
  contact: 
  country: United States
  url: https://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_001536-C.html
  description: NIH Clinical Center Detailed Web Page
  responsible party type: Sponsor
  mesh term: Oropharyngeal Neoplasms
  mesh term: Squamous Cell Carcinoma of Head and Neck
  mesh term: Pembrolizumab
  sharing ipd: Yes
  ipd description: .All collected IPD will be shared.@@@@@@All IPD recorded in the medical record will be shared with intramural investigators upon request. In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP.@@@@@@
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd time frame: Data from this study may be requested from other researchers no sooner than 3 years after the completion of the primary endpoint.@@@@@@Genomic data are available once genomic data are uploaded per protocol GDS plan for as long as database is active@@@@@@@@@@@@
  ipd access criteria: Data from this study may be requested by contacting the PI@@@@@@Genomic data are made available via dbGaP through requests to the data custodians.@@@@@@