<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/NCT03835533</url>
  </required_header>
  <id_info>
    <org_study_id>PICI0033</org_study_id>
    <nct_id>NCT03835533</nct_id>
  </id_info>
  <brief_title>Platform Study for Prostate Researching Translational Endpoints Correlated to Response to Inform Use of Novel Combinations</brief_title>
  <acronym>PORTER</acronym>
  <official_title>A Multicenter, Open-Label, Exploratory Platform Study to Evaluate Biomarkers and Immunotherapy Combinations for the Treatment of Patients With Metastatic Castration-resistant Prostate Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Parker Institute for Cancer Immunotherapy</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Bristol-Myers Squibb</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Celldex Therapeutics</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Cancer Research Institute, New York City</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Inovio Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Oncovir, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Parker Institute for Cancer Immunotherapy</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 study is designed to evaluate multiple clinical hypotheses and mechanistically-defined&#xD;
      combinations to evaluate the safety and efficacy of immunotherapy combinations in&#xD;
      participants with mCRPC who have received prior secondary androgen receptor signaling&#xD;
      inhibitor therapy (eg, abiraterone, enzalutamide, apalutamide).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an open-label, non-randomized, exploratory platform protocol designed to assess the&#xD;
      safety and antitumor activity of multiple immunotherapy combinations in participants with&#xD;
      mCRPC who have received prior therapy. The platform study will consist of 2 stages: Stage 1,&#xD;
      an initial stage to evaluate safety, biomarkers, and clinical activity of a combination and&#xD;
      Stage 2, an expanded cohort, when warranted, based on the safety, clinical activity, and/or&#xD;
      biomarker results from Stage 1. The Sponsor intends to modify and/or add new combinations to&#xD;
      the protocol as data emerge from this and other trials.&#xD;
&#xD;
      Participants must provide consent for archival tissue from a prior biopsy or surgery for&#xD;
      prostate cancer and must consent to baseline and on-treatment biopsies, if medically&#xD;
      feasible. Participants will be assigned to receive one of the enrolling combination study&#xD;
      interventions and will be monitored for safety and response.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 21, 2019</start_date>
  <completion_date type="Actual">October 3, 2022</completion_date>
  <primary_completion_date type="Actual">October 3, 2022</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence and severity of adverse events</measure>
    <time_frame>Up to 2.5 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Objective response rate (ORR)</measure>
    <time_frame>Up to 2.5 years</time_frame>
    <description>ORR is a composite endpoint where response is defined as a participant meeting at least one of the following: circulating tumor cells change from unfavorable to favorable ; ≥ 50% reduction in Prostate-Specific Antigen (PSA) from baseline; confirmed complete response (CR) or partial response (PR)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease control rate</measure>
    <time_frame>At 9 months</time_frame>
    <description>Defined as CR, PR, or stable disease (SD) for 9 months as best response by Prostate Cancer Clinical Trials Working Group 3 (PCWG3)-modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiographic progression-free survival (rPFS)</measure>
    <time_frame>Up to 2.5 years</time_frame>
    <description>Defined as time from initiation of study intervention to the first objective evidence of radiographic progression, or death due to any cause (whichever occurs first)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>Up to 2.5 years</time_frame>
    <description>Defined as the time from initiation of study invention until death due to any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS) at 12 months</measure>
    <time_frame>At 12 months</time_frame>
    <description>Defined as the time from initiation of study invention until death due to any cause</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">43</enrollment>
  <condition>Metastatic Castration-resistant Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Cohort A: NKTR-214 + Nivolumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort B: SBRT + CDX-301 + Poly-ICLC + Nivolumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort C: CDX-301 + INO-5151 + Nivolumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>NKTR-214 (Cohort A)</intervention_name>
    <description>NKTR-214 will be administered intravenously every 3 weeks for up to 2 years</description>
    <arm_group_label>Cohort A: NKTR-214 + Nivolumab</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nivolumab (Cohort A, B and C)</intervention_name>
    <description>Nivolumab will be administered intravenously every 3 weeks for up to 2 years to cohort A, every 4 weeks for up to 2 years for cohort B and C.</description>
    <arm_group_label>Cohort A: NKTR-214 + Nivolumab</arm_group_label>
    <arm_group_label>Cohort B: SBRT + CDX-301 + Poly-ICLC + Nivolumab</arm_group_label>
    <arm_group_label>Cohort C: CDX-301 + INO-5151 + Nivolumab</arm_group_label>
    <other_name>Opdivo</other_name>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Stereotactic body radiation therapy (SBRT) (Cohort B)</intervention_name>
    <description>Radiation therapy will be administered at 30 - 50 Gy in 1 - 5 doses, starting on Day 1 or 2 of Cycle 1</description>
    <arm_group_label>Cohort B: SBRT + CDX-301 + Poly-ICLC + Nivolumab</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CDX-301 (Cohort B and C)</intervention_name>
    <description>CDX-301 will be subcutaneously once a day for 5 days for cohort B. CDX-301 will be subcutaneously once a day for 10 days of immune-priming lead-in for cohort C.</description>
    <arm_group_label>Cohort B: SBRT + CDX-301 + Poly-ICLC + Nivolumab</arm_group_label>
    <arm_group_label>Cohort C: CDX-301 + INO-5151 + Nivolumab</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Poly-ICLC (Cohort B)</intervention_name>
    <description>Poly-ICLC will be administered intramuscularly twice weekly for 3 weeks starting on Day 1 of Cycle 1</description>
    <arm_group_label>Cohort B: SBRT + CDX-301 + Poly-ICLC + Nivolumab</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>INO-5151 (Cohort C)</intervention_name>
    <description>INO-5151 will be administered intramuscularly on Day 8 of the Immune-priming Lead-in, and on day 1 of Cycle 1, 2 and 3, then every 12 weeks thereafter</description>
    <arm_group_label>Cohort C: CDX-301 + INO-5151 + Nivolumab</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Cellectra 2000</intervention_name>
    <description>Electroporation device</description>
    <arm_group_label>Cohort C: CDX-301 + INO-5151 + Nivolumab</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          1. Metastatic castration resistant prostate cancer with castrate-level testosterone (&lt; 50&#xD;
             ng/dL) at screening.&#xD;
&#xD;
          2. Disease progression per Prostate Cancer Working Group 3 (PCWG3) criteria.&#xD;
&#xD;
          3. Provide fresh pre-treatment core needle or incisional biopsy of a metastatic tumor&#xD;
             lesion not previously irradiated. Fine needle aspiration is not acceptable.&#xD;
&#xD;
               1. Additionally, if a pre-treatment biopsy is not medically feasible for&#xD;
                  participants with bone only disease, formalin-fixed paraffin-embedded (FFPE)&#xD;
                  tumor specimen in a paraffin block (preferred) or at least 10 slides containing&#xD;
                  unstained, freshly cut, serial sections must be provided.&#xD;
&#xD;
               2. For all participants, in addition to fresh pre-treatment biopsy, consent for&#xD;
                  archival tissue is required.&#xD;
&#xD;
          4. Must be willing to undergo tumor biopsy(ies) on treatment, if medically feasible.&#xD;
&#xD;
          5. Have received and progressed on prior secondary androgen receptor signaling inhibitor&#xD;
             therapy (eg, abiraterone, enzalutamide, apalutamide).&#xD;
&#xD;
          6. Participants must discontinue antiandrogen therapy (ie, bicalutamide, flutamide,&#xD;
             nilutamide) at least 4-6 weeks prior to registration with no evidence of PSA decline&#xD;
             after washout.&#xD;
&#xD;
               1. Bicalutamide: Washout period at least 6 weeks&#xD;
&#xD;
               2. Flutamide and nilutamide: Washout period at least 4 weeks&#xD;
&#xD;
          7. Participants must discontinue therapies for mCRPC for 5 half-lives or 28 days,&#xD;
             whichever is shorter.&#xD;
&#xD;
               1. Participants will remain on gonadotropin-releasing hormone (GnRH) agents&#xD;
                  throughout this study.&#xD;
&#xD;
               2. Prior chemotherapy is allowed if no progression of disease on chemotherapy as&#xD;
                  defined by PCWG3-modified RECIST 1.1.&#xD;
&#xD;
               3. Prior treatment with sipuleucel-T, radium-223, or poly ADP ribose polymerase&#xD;
                  (PARP) inhibitor (eg, olaparib) is allowed.&#xD;
&#xD;
               4. Tissue biopsy may be performed during washout period.&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          1. Has a diagnosis of immunodeficiency or conditions that need systemic corticosteroid&#xD;
             replacement therapy &gt; 10 mg/day prednisone (or equivalent) or other immunosuppressive&#xD;
             medications within 28 days prior to the first dose of study intervention. Inhaled&#xD;
             steroids are permitted if necessary.&#xD;
&#xD;
          2. Has any active known or suspected autoimmune disease. Participants with vitiligo, type&#xD;
             I diabetes mellitus, controlled autoimmune hypothyroidism, psoriasis not requiring&#xD;
             systemic treatment, or other conditions under control are permitted to enroll.&#xD;
&#xD;
          3. Has a known history of active TB (Bacillus Tuberculosis).&#xD;
&#xD;
          4. Has known history of, or any evidence of active, non-infectious pneumonitis.&#xD;
&#xD;
          5. Known history of testing positive for human immunodeficiency virus (HIV), known&#xD;
             acquired immunodeficiency syndrome (AIDS), or any positive test for hepatitis B or&#xD;
             hepatitis C virus representing acute or chronic disease.&#xD;
&#xD;
          6. Has received a live vaccine within 30 days of planned start of study intervention.&#xD;
&#xD;
             Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines&#xD;
             and are allowed; however intranasal influenza vaccines (eg, Flu-Mist®) are live&#xD;
             attenuated vaccines, and are not allowed.&#xD;
&#xD;
          7. Has known active central nervous system (CNS) metastases and/or carcinomatous&#xD;
             meningitis. Participants with previously treated brain metastases may participate&#xD;
             provided they are stable (without evidence of progression by imaging for at least 4&#xD;
             weeks prior to the first dose of study intervention and any neurologic symptoms have&#xD;
             returned to baseline), have no evidence of new or enlarging brain metastases, and are&#xD;
             not using steroids for at least 7 days prior to study intervention. This exception&#xD;
             does not include carcinomatous meningitis which is excluded regardless of clinical&#xD;
             stability.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Parker Institute for Cancer Immunotherapy</last_name>
    <role>Study Director</role>
    <affiliation>Parker Institute for Cancer Immunotherapy</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Angeles Clinic</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90025</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94158</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mount Sinai</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</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>Oregon Health &amp; Science University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Texas MD Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
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    <citation>Scher HI, Morris MJ, Stadler WM, Higano C, Basch E, Fizazi K, Antonarakis ES, Beer TM, Carducci MA, Chi KN, Corn PG, de Bono JS, Dreicer R, George DJ, Heath EI, Hussain M, Kelly WK, Liu G, Logothetis C, Nanus D, Stein MN, Rathkopf DE, Slovin SF, Ryan CJ, Sartor O, Small EJ, Smith MR, Sternberg CN, Taplin ME, Wilding G, Nelson PS, Schwartz LH, Halabi S, Kantoff PW, Armstrong AJ; Prostate Cancer Clinical Trials Working Group 3. Trial Design and Objectives for Castration-Resistant Prostate Cancer: Updated Recommendations From the Prostate Cancer Clinical Trials Working Group 3. J Clin Oncol. 2016 Apr 20;34(12):1402-18. doi: 10.1200/JCO.2015.64.2702. Epub 2016 Feb 22.</citation>
    <PMID>26903579</PMID>
  </reference>
  <reference>
    <citation>Sydes MR, Spears MR, Mason MD, Clarke NW, Dearnaley DP, de Bono JS, Attard G, Chowdhury S, Cross W, Gillessen S, Malik ZI, Jones R, Parker CC, Ritchie AWS, Russell JM, Millman R, Matheson D, Amos C, Gilson C, Birtle A, Brock S, Capaldi L, Chakraborti P, Choudhury A, Evans L, Ford D, Gale J, Gibbs S, Gilbert DC, Hughes R, McLaren D, Lester JF, Nikapota A, O'Sullivan J, Parikh O, Peedell C, Protheroe A, Rudman SM, Shaffer R, Sheehan D, Simms M, Srihari N, Strebel R, Sundar S, Tolan S, Tsang D, Varughese M, Wagstaff J, Parmar MKB, James ND; STAMPEDE Investigators. Adding abiraterone or docetaxel to long-term hormone therapy for prostate cancer: directly randomised data from the STAMPEDE multi-arm, multi-stage platform protocol. Ann Oncol. 2018 May 1;29(5):1235-1248. doi: 10.1093/annonc/mdy072.</citation>
    <PMID>29529169</PMID>
  </reference>
  <reference>
    <citation>Topalian SL, Hodi FS, Brahmer JR, Gettinger SN, Smith DC, McDermott DF, Powderly JD, Carvajal RD, Sosman JA, Atkins MB, Leming PD, Spigel DR, Antonia SJ, Horn L, Drake CG, Pardoll DM, Chen L, Sharfman WH, Anders RA, Taube JM, McMiller TL, Xu H, Korman AJ, Jure-Kunkel M, Agrawal S, McDonald D, Kollia GD, Gupta A, Wigginton JM, Sznol M. Safety, activity, and immune correlates of anti-PD-1 antibody in cancer. N Engl J Med. 2012 Jun 28;366(26):2443-54. doi: 10.1056/NEJMoa1200690. Epub 2012 Jun 2.</citation>
    <PMID>22658127</PMID>
  </reference>
  <reference>
    <citation>Wolchok JD, Hoos A, O'Day S, Weber JS, Hamid O, Lebbe C, Maio M, Binder M, Bohnsack O, Nichol G, Humphrey R, Hodi FS. Guidelines for the evaluation of immune therapy activity in solid tumors: immune-related response criteria. Clin Cancer Res. 2009 Dec 1;15(23):7412-20. doi: 10.1158/1078-0432.CCR-09-1624. Epub 2009 Nov 24.</citation>
    <PMID>19934295</PMID>
  </reference>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>February 7, 2019</study_first_submitted>
  <study_first_submitted_qc>February 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 8, 2019</study_first_posted>
  <last_update_submitted>November 10, 2022</last_update_submitted>
  <last_update_submitted_qc>November 10, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Metastatic Castration-resistant Prostate Cancer</keyword>
  <keyword>Immunotherapy</keyword>
  <keyword>Platform study</keyword>
  <keyword>NKTR-214</keyword>
  <keyword>Nivolumab</keyword>
  <keyword>CDX-301</keyword>
  <keyword>Poly-ICLC</keyword>
  <keyword>INO-5151</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nivolumab</mesh_term>
    <mesh_term>Poly ICLC</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>December 21, 2022</submitted>
  </pending_results>
  <!-- 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/NCT03835533
org study id: PICI0033
nct id: NCT03835533
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This study is designed to evaluate multiple clinical hypotheses and mechanistically-defined
      combinations to evaluate the safety and efficacy of immunotherapy combinations in
      participants with mCRPC who have received prior secondary androgen receptor signaling
      inhibitor therapy (eg, abiraterone, enzalutamide, apalutamide).
This is an open-label, non-randomized, exploratory platform protocol designed to assess the
      safety and antitumor activity of multiple immunotherapy combinations in participants with
      mCRPC who have received prior therapy. The platform study will consist of 2 stages: Stage 1,
      an initial stage to evaluate safety, biomarkers, and clinical activity of a combination and
      Stage 2, an expanded cohort, when warranted, based on the safety, clinical activity, and/or
      biomarker results from Stage 1. The Sponsor intends to modify and/or add new combinations to
      the protocol as data emerge from this and other trials.

      Participants must provide consent for archival tissue from a prior biopsy or surgery for
      prostate cancer and must consent to baseline and on-treatment biopsies, if medically
      feasible. Participants will be assigned to receive one of the enrolling combination study
      interventions and will be monitored for safety and response.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence and severity of adverse events
time frame: Up to 2.5 years
measure: Objective response rate (ORR)
time frame: Up to 2.5 years
description: ORR is a composite endpoint where response is defined as a participant meeting at least one of the following: circulating tumor cells change from unfavorable to favorable ; ≥ 50% reduction in Prostate-Specific Antigen (PSA) from baseline; confirmed complete response (CR) or partial response (PR)
measure: Disease control rate
time frame: At 9 months
description: Defined as CR, PR, or stable disease (SD) for 9 months as best response by Prostate Cancer Clinical Trials Working Group 3 (PCWG3)-modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
measure: Radiographic progression-free survival (rPFS)
time frame: Up to 2.5 years
description: Defined as time from initiation of study intervention to the first objective evidence of radiographic progression, or death due to any cause (whichever occurs first)
measure: Overall survival (OS)
time frame: Up to 2.5 years
description: Defined as the time from initiation of study invention until death due to any cause
measure: Overall survival (OS) at 12 months
time frame: At 12 months
description: Defined as the time from initiation of study invention until death due to any cause
arm group label: Cohort A: NKTR-214 + Nivolumab
arm group type: Experimental
arm group label: Cohort B: SBRT + CDX-301 + Poly-ICLC + Nivolumab
arm group type: Experimental
arm group label: Cohort C: CDX-301 + INO-5151 + Nivolumab
arm group type: Experimental
intervention type: Drug
intervention name: NKTR-214 (Cohort A)
description: NKTR-214 will be administered intravenously every 3 weeks for up to 2 years
arm group label: Cohort A: NKTR-214 + Nivolumab
intervention type: Drug
intervention name: Nivolumab (Cohort A, B and C)
description: Nivolumab will be administered intravenously every 3 weeks for up to 2 years to cohort A, every 4 weeks for up to 2 years for cohort B and C.
arm group label: Cohort A: NKTR-214 + Nivolumab
arm group label: Cohort B: SBRT + CDX-301 + Poly-ICLC + Nivolumab
arm group label: Cohort C: CDX-301 + INO-5151 + Nivolumab
other name: Opdivo
intervention type: Radiation
intervention name: Stereotactic body radiation therapy (SBRT) (Cohort B)
description: Radiation therapy will be administered at 30 - 50 Gy in 1 - 5 doses, starting on Day 1 or 2 of Cycle 1
arm group label: Cohort B: SBRT + CDX-301 + Poly-ICLC + Nivolumab
intervention type: Drug
intervention name: CDX-301 (Cohort B and C)
description: CDX-301 will be subcutaneously once a day for 5 days for cohort B. CDX-301 will be subcutaneously once a day for 10 days of immune-priming lead-in for cohort C.
arm group label: Cohort B: SBRT + CDX-301 + Poly-ICLC + Nivolumab
arm group label: Cohort C: CDX-301 + INO-5151 + Nivolumab
intervention type: Drug
intervention name: Poly-ICLC (Cohort B)
description: Poly-ICLC will be administered intramuscularly twice weekly for 3 weeks starting on Day 1 of Cycle 1
arm group label: Cohort B: SBRT + CDX-301 + Poly-ICLC + Nivolumab
intervention type: Drug
intervention name: INO-5151 (Cohort C)
description: INO-5151 will be administered intramuscularly on Day 8 of the Immune-priming Lead-in, and on day 1 of Cycle 1, 2 and 3, then every 12 weeks thereafter
arm group label: Cohort C: CDX-301 + INO-5151 + Nivolumab
intervention type: Device
intervention name: Cellectra 2000
description: Electroporation device
arm group label: Cohort C: CDX-301 + INO-5151 + Nivolumab
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Parker Institute for Cancer Immunotherapy
role: Study Director
affiliation: Parker Institute for Cancer Immunotherapy
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
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PMID: 26903579
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PMID: 29529169
citation: Topalian SL, Hodi FS, Brahmer JR, Gettinger SN, Smith DC, McDermott DF, Powderly JD, Carvajal RD, Sosman JA, Atkins MB, Leming PD, Spigel DR, Antonia SJ, Horn L, Drake CG, Pardoll DM, Chen L, Sharfman WH, Anders RA, Taube JM, McMiller TL, Xu H, Korman AJ, Jure-Kunkel M, Agrawal S, McDonald D, Kollia GD, Gupta A, Wigginton JM, Sznol M. Safety, activity, and immune correlates of anti-PD-1 antibody in cancer. N Engl J Med. 2012 Jun 28;366(26):2443-54. doi: 10.1056/NEJMoa1200690. Epub 2012 Jun 2.
PMID: 22658127
citation: Wolchok JD, Hoos A, O'Day S, Weber JS, Hamid O, Lebbe C, Maio M, Binder M, Bohnsack O, Nichol G, Humphrey R, Hodi FS. Guidelines for the evaluation of immune therapy activity in solid tumors: immune-related response criteria. Clin Cancer Res. 2009 Dec 1;15(23):7412-20. doi: 10.1158/1078-0432.CCR-09-1624. Epub 2009 Nov 24.
PMID: 19934295
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
mesh term: Nivolumab
mesh term: Poly ICLC
sharing ipd: Undecided
submitted: December 21, 2022