<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/NCT03030378</url>
  </required_header>
  <id_info>
    <org_study_id>NCI-2017-00091</org_study_id>
    <secondary_id>NCI-2017-00091</secondary_id>
    <secondary_id>HCC 17-003</secondary_id>
    <secondary_id>10061</secondary_id>
    <secondary_id>10061</secondary_id>
    <secondary_id>UM1CA186690</secondary_id>
    <nct_id>NCT03030378</nct_id>
  </id_info>
  <brief_title>Pembrolizumab and Recombinant Interleukin-12 in Treating Patients With Solid Tumors</brief_title>
  <official_title>A Phase 1 Study of Pembrolizumab (MK-3475) in Combination With Recombinant Interleukin-12 in Patients With Solid Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Cancer Institute (NCI)</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 phase I trial studies the side effects and best dose of pembrolizumab and recombinant&#xD;
      interleukin-12 in treating patients with solid tumors. Immunotherapy with monoclonal&#xD;
      antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and&#xD;
      may interfere with the ability of tumor cells to grow and spread. Recombinant interleukin-12&#xD;
      may kill tumor cells by blocking blood flow to the tumor and by stimulating white blood cells&#xD;
      to kill tumor cells. Giving pembrolizumab and recombinant interleukin-12 may work better than&#xD;
      giving pembrolizumab alone in treating patients with solid tumors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVE:&#xD;
&#xD;
      I. Establish the maximum tolerated dose (MTD) and the recommended phase II dose (RP2D) of&#xD;
      edodekin alfa (recombinant human interleukin [rhIL]-12) in combination with pembrolizumab&#xD;
      (MK-3475).&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. Evaluate the safety of the regimen by continuously monitoring adverse events that will be&#xD;
      documented utilizing Common Terminology Criteria for Adverse Events (CTCAE) version (v).5.0.&#xD;
&#xD;
      II. Evaluate the overall response rate (Response Evaluation Criteria in Solid Tumors [RECIST]&#xD;
      v.1.1) and the progression free survival of patients enrolled on the study.&#xD;
&#xD;
      III. Measure CD8+ T cell infiltration by immunohistochemistry in tumor biopsies obtained&#xD;
      pre-treatment, after one week of rhIL-12 and after 2 cycles of pembrolizumab (MK-3475) in&#xD;
      combination with rhIL-12.&#xD;
&#xD;
      EXPLORATORY OBJECTIVE:&#xD;
&#xD;
      I. Conduct exploratory translational laboratory correlative studies utilizing banked&#xD;
      biospecimens (tumor, blood, and stool) obtained pre-treatment and during therapy.&#xD;
&#xD;
      OUTLINE: This is a dose-escalation study of recombinant interleukin-12.&#xD;
&#xD;
      Patients receive recombinant interleukin-12 subcutaneously (SC) on days 2, 5, 9, and 12 and&#xD;
      pembrolizumab intravenously (IV) over 30 minutes on day 8 of cycle 1 and day 1 of subsequent&#xD;
      cycles. Treatment continues for 28 days for cycle 1 and repeats every 21 days for subsequent&#xD;
      cycles for up to 8 cycles in the absence of disease progression or unacceptable toxicity.&#xD;
      Patient then receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21&#xD;
      days for up to 8 additional cycles in the absence of disease progression or unacceptable&#xD;
      toxicity. Patients undergo a computed tomography (CT), positron emission tomography (PET),&#xD;
      and/or magnetic resonance imaging (MRI), as well as collection of blood during screening, on&#xD;
      study, and during follow-up. Patients also undergo a tumor biopsy during screening and on&#xD;
      study.&#xD;
&#xD;
      After completion of study treatment, patients are followed up every 12 weeks for 2 year and&#xD;
      then every 24 weeks for up to 5 years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 11, 2017</start_date>
  <completion_date type="Anticipated">December 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2023</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maximum tolerated dose (MTD)</measure>
    <time_frame>Up to 5 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Recommended phase 2 dose</measure>
    <time_frame>Up to 5 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of adverse events</measure>
    <time_frame>Up to 30 days after last dose</time_frame>
    <description>Adverse events will be tabulated by Common Terminology Criteria for Adverse Events (CTCAE) grade, CTCAE category, relatedness to treatment and dose level.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression free survival</measure>
    <time_frame>From start of treatment to time of progression or death, whichever comes, first assessed up to 5 years</time_frame>
    <description>The product-limit (Kaplan-Meier) progression-free survival function, with a 95% confidence region, will be determined for all patients and for patients treated at the MTD.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall response rate</measure>
    <time_frame>From start of treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started), assessed up to 5 years</time_frame>
    <description>Will be assessed by Response Evaluation Criteria in Solid Tumors version 1.1. The proportion of patients experiencing confirmed overall (complete or partial) response will be calculated, as will a 95% exact (Klopper-Pearson) binomial confidence interval for all patients, and patients treated at the MTD (a confirmed clinical tumor response is defined to be either a complete response or partial response noted as the objective status on 2 consecutive evaluations at least &gt;= 4 weeks apart.).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CD8+ T cell infiltration</measure>
    <time_frame>Up to 2 cycles of treatment</time_frame>
    <description>Will be assessed by immunohistochemistry. Will be compared to pre-treatment biopsy specimens by the Wilcoxon signed-rank test.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Biomarker analysis</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>Will conduct exploratory translational laboratory correlative studies utilizing banked biospecimens (tumor, blood and stool) obtained at baseline and during therapy.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">36</enrollment>
  <condition>Metastatic Malignant Solid Neoplasm</condition>
  <condition>Unresectable Malignant Solid Neoplasm</condition>
  <arm_group>
    <arm_group_label>Treatment (recombinant interleukin-12, pembrolizumab)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive recombinant interleukin-12 SC on days 2, 5, 9, and 12 and pembrolizumab IV over 30 minutes on day 8 of cycle 1 and day 1 of subsequent cycles. Treatment continues for 28 days for cycle 1 and repeats every 21 days for subsequent cycles for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Patient then receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 8 additional cycles in the absence of disease progression or unacceptable toxicity. Patients undergo a CT, PET, and MRI, as well as collection of blood during screening, on study, and during follow-up. Patients also undergo a tumor biopsy during screening and on study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Biopsy</intervention_name>
    <description>Undergo a tumor biopsy</description>
    <arm_group_label>Treatment (recombinant interleukin-12, pembrolizumab)</arm_group_label>
    <other_name>BIOPSY_TYPE</other_name>
    <other_name>Bx</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Biospecimen Collection</intervention_name>
    <description>Undergo collection of blood</description>
    <arm_group_label>Treatment (recombinant interleukin-12, pembrolizumab)</arm_group_label>
    <other_name>Biological Sample Collection</other_name>
    <other_name>Biospecimen Collected</other_name>
    <other_name>Specimen Collection</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Computed Tomography</intervention_name>
    <description>Undergo a CT scan</description>
    <arm_group_label>Treatment (recombinant interleukin-12, pembrolizumab)</arm_group_label>
    <other_name>CAT</other_name>
    <other_name>CAT Scan</other_name>
    <other_name>Computed Axial Tomography</other_name>
    <other_name>Computerized Axial Tomography</other_name>
    <other_name>Computerized axial tomography (procedure)</other_name>
    <other_name>Computerized Tomography</other_name>
    <other_name>CT</other_name>
    <other_name>CT Scan</other_name>
    <other_name>tomography</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Edodekin alfa</intervention_name>
    <description>Given SC</description>
    <arm_group_label>Treatment (recombinant interleukin-12, pembrolizumab)</arm_group_label>
    <other_name>Cytotoxic Lymphocyte Maturation Factor</other_name>
    <other_name>IL-12</other_name>
    <other_name>Interleukin 12</other_name>
    <other_name>Interleukin-12</other_name>
    <other_name>Natural Killer Cell Stimulatory Factor</other_name>
    <other_name>NM-IL-12</other_name>
    <other_name>Recombinant human interleukin-12 (IL-12) cytokine</other_name>
    <other_name>Ro 24-7472</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Magnetic Resonance Imaging</intervention_name>
    <description>Undergo a MRI</description>
    <arm_group_label>Treatment (recombinant interleukin-12, pembrolizumab)</arm_group_label>
    <other_name>Magnetic Resonance</other_name>
    <other_name>Magnetic resonance imaging (procedure)</other_name>
    <other_name>Magnetic Resonance Imaging Scan</other_name>
    <other_name>Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance</other_name>
    <other_name>MR</other_name>
    <other_name>MR Imaging</other_name>
    <other_name>MRI</other_name>
    <other_name>MRI Scan</other_name>
    <other_name>NMR Imaging</other_name>
    <other_name>NMRI</other_name>
    <other_name>Nuclear Magnetic Resonance Imaging</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Pembrolizumab</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Treatment (recombinant interleukin-12, pembrolizumab)</arm_group_label>
    <other_name>BCD-201</other_name>
    <other_name>Keytruda</other_name>
    <other_name>Lambrolizumab</other_name>
    <other_name>MK-3475</other_name>
    <other_name>Pembrolizumab Biosimilar BCD-201</other_name>
    <other_name>SCH 900475</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Positron Emission Tomography</intervention_name>
    <description>Undergo a PET scan</description>
    <arm_group_label>Treatment (recombinant interleukin-12, pembrolizumab)</arm_group_label>
    <other_name>Medical Imaging, Positron Emission Tomography</other_name>
    <other_name>PET</other_name>
    <other_name>PET Scan</other_name>
    <other_name>Positron emission tomography (procedure)</other_name>
    <other_name>Positron Emission Tomography Scan</other_name>
    <other_name>Positron-Emission Tomography</other_name>
    <other_name>proton magnetic resonance spectroscopic imaging</other_name>
    <other_name>PT</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients must have histologically confirmed malignancy that is metastatic or&#xD;
             unresectable&#xD;
&#xD;
          -  Eligibility is restricted to patients who have tumors for which there is a Food and&#xD;
             Drug Administration (FDA)-approved indication for anti-PD-(L)1 therapy. Patients must&#xD;
             have received and have progressed past anti-PD(L)1 singly or in combination. There is&#xD;
             no restriction on the number of prior lines of therapy. Anti-PD-(L)1 therapy need not&#xD;
             be the most recent therapy received&#xD;
&#xD;
               -  NOTE: Prior to slot reservation, sites must provide the following information to&#xD;
                  ETCTN10061@upmc.edu for study chair review: histology, nature of prior therapy&#xD;
                  (therapies) and indication for prior PD-(L)1 therapy&#xD;
&#xD;
          -  Age &gt;= 18 years&#xD;
&#xD;
               -  Because no dosing or adverse event data are currently available on the use of&#xD;
                  pembrolizumab (MK-3475) in combination with rhIL-12 in patients &lt; 18 years of&#xD;
                  age, children are excluded from this study, but will be eligible for future&#xD;
                  pediatric trials&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status =&lt; 1 (Karnofsky &gt;= 70%)&#xD;
&#xD;
          -  Life expectancy of greater than 12 weeks&#xD;
&#xD;
          -  Leukocytes &gt;= 2,000/mcL (within 28 days of treatment initiation)&#xD;
&#xD;
          -  Absolute neutrophil count &gt;= 1,500/mcL (within 28 days of treatment initiation)&#xD;
&#xD;
          -  Platelets &gt;= 100,000/mcL (within 28 days of treatment initiation)&#xD;
&#xD;
          -  Hemoglobin &gt;= 9 g/dL OR &gt;= 5.6 mmol/L (within 28 days of treatment initiation)&#xD;
&#xD;
          -  Serum total bilirubin =&lt; upper limit of normal (ULN) OR direct bilirubin =&lt; ULN for&#xD;
             patients with total bilirubin levels &gt; ULN; (except patients with Gilbert's syndrome,&#xD;
             who must have a total bilirubin less than 3.0 mg/dL) (within 28 days of treatment&#xD;
             initiation)&#xD;
&#xD;
          -  Aspartate aminotransferase (AST) serum glutamic-oxaloacetic transaminase&#xD;
             (SGOT)/alanine aminotransferase (ALT) serum glutamate pyruvate transaminase (SGPT) =&lt;&#xD;
             2.5 x institutional ULN (within 28 days of treatment initiation)&#xD;
&#xD;
          -  Serum creatinine =&lt; 1.5 x ULN OR measured or calculated creatinine clearance (CrCl)&#xD;
             (glomerular filtration rate [GFR] can also be used in place of creatinine or CrCl) &gt;=&#xD;
             60 mL/min for subject with creatinine levels &gt; 1.5 x institutional ULN (within 28 days&#xD;
             of treatment initiation)&#xD;
&#xD;
               -  Creatinine clearance should be calculated per institutional standard&#xD;
&#xD;
          -  International normalized ratio (INR) or prothrombin time (PT) =&lt; 1.5 x ULN unless&#xD;
             subject is receiving anticoagulant therapy as long as (PT) or partial thromboplastin&#xD;
             time (PTT) is within therapeutic range of intended use of anticoagulants (within 28&#xD;
             days of treatment initiation)&#xD;
&#xD;
          -  Activated partial thromboplastin time (aPTT) =&lt; 1.5 x ULN unless subject is receiving&#xD;
             anticoagulant therapy as long as prothrombin time (PT) or partial thromboplastin time&#xD;
             (PTT) is within therapeutic range of intended use of anticoagulants (within 28 days of&#xD;
             treatment initiation)&#xD;
&#xD;
          -  Willingness to undergo tumor biopsies at three timepoints: (1) pre-treatment; (2)&#xD;
             after one week of rhIL12; and (3) after 2 cycles of pembrolizumab&#xD;
             (MK-3475)-interleukin (IL) 12 (i.e., approximately 7 weeks from the first dose of&#xD;
             rhIL-12)&#xD;
&#xD;
               -  At each timepoint, a core biopsy is preferable (although in suitable patients,&#xD;
                  punch biopsy may be substituted)&#xD;
&#xD;
                    -  Cytopathologist should be present to ensure adequacy of tumor biopsy sample&#xD;
&#xD;
                    -  At least 4 16 gauge (G) core biopsies are to be obtained and triaged&#xD;
&#xD;
               -  Pre-treatment biopsy can be substituted with an archival tissue sample if the&#xD;
                  sample is&#xD;
&#xD;
                    -  Adequate (capable of providing at least 20 unstained slides); and&#xD;
&#xD;
                    -  Recent (within 8 weeks of study entry); and&#xD;
&#xD;
                    -  Patient has not had any intervening therapy&#xD;
&#xD;
          -  Patients must have measurable disease based on RECIST 1.1&#xD;
&#xD;
          -  The effects of pembrolizumab (MK-3475) and/or rIL-12 on the developing human fetus are&#xD;
             unknown; for this reason, women of child-bearing potential and men must agree to use&#xD;
             adequate contraception (hormonal or barrier method of birth control; abstinence) prior&#xD;
             to study entry and for the duration of study participation&#xD;
&#xD;
               -  Female patients of childbearing potential should have a negative urine or serum&#xD;
                  pregnancy test within 72 hours prior to receiving the first dose of study&#xD;
                  medication; if the urine test is positive or cannot be confirmed as negative, a&#xD;
                  serum pregnancy test will be required&#xD;
&#xD;
               -  Female patients of childbearing potential should be willing to use 2 methods of&#xD;
                  birth control or be surgically sterile, or abstain from heterosexual activity for&#xD;
                  the course of the study through 120 days after the last dose of study medication;&#xD;
                  patients of childbearing potential are those who have not been surgically&#xD;
                  sterilized or have not been free from menses for &gt; 1 year&#xD;
&#xD;
               -  Should a woman become pregnant or suspect she is pregnant while she is&#xD;
                  participating in this study, she should inform her treating physician immediately&#xD;
&#xD;
               -  Men treated or enrolled on this protocol must also agree to use adequate&#xD;
                  contraception prior to the study, for the duration of study participation, and 4&#xD;
                  months after completion of pembrolizumab (MK-3475) and/or rhIL-12 administration&#xD;
&#xD;
          -  Ability to understand and the willingness to sign a written informed consent document&#xD;
&#xD;
          -  Patients who are human immunodeficiency virus (HIV) positive may participate IF they&#xD;
             meet the following eligibility requirements:&#xD;
&#xD;
               -  They must be stable on their anti-retroviral regimen, and they must be healthy&#xD;
                  from an HIV perspective&#xD;
&#xD;
               -  They must have an undetectable viral load&#xD;
&#xD;
               -  They must have a CD4 count of greater than 250 cells/mcL&#xD;
&#xD;
               -  They must not be receiving prophylactic therapy for an opportunistic infection&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with a secondary active hematological malignancy including but not limited to&#xD;
             chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), Hodgkins&#xD;
             lymphoma, non-Hodgkins lymphoma (NHL)&#xD;
&#xD;
               -  NOTE: Patients with a history of hematological malignancy that was previously&#xD;
                  treated and resolved may be enrolled if otherwise meeting inclusion/exclusion&#xD;
                  (I/E) criteria&#xD;
&#xD;
          -  Patients with a prior history of autoimmune cytopenias of any etiology including&#xD;
             hemolytic anemia, (AIHA), idiopathic thrombocytopenia purpura (ITP), and/or other&#xD;
             cytopenia are excluded&#xD;
&#xD;
               -  NOTE: This exclusion is regardless of whether or not this cytopenia(s) required&#xD;
                  prior therapy&#xD;
&#xD;
          -  Patients who have had chemotherapy, targeted small molecule therapy, or radiotherapy&#xD;
             within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to first dose of trial&#xD;
             treatment, or those who have not recovered from adverse events due to agents&#xD;
             administered more than 4 weeks earlier&#xD;
&#xD;
               -  Note: Patients with =&lt; grade 2 neuropathy are an exception to this criterion and&#xD;
                  may qualify for the study&#xD;
&#xD;
               -  Note: If patients received major surgery, they must have recovered adequately&#xD;
                  from the toxicity and/or complications from the intervention prior to starting&#xD;
                  therapy&#xD;
&#xD;
          -  Patients who are currently participating in or have participated in a study of an&#xD;
             investigational agent or using an investigational device within 4 weeks of the first&#xD;
             dose of trial treatment&#xD;
&#xD;
          -  Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any&#xD;
             other form of immunosuppressive therapy within 7 days prior to the first dose of trial&#xD;
             treatment&#xD;
&#xD;
          -  Has had a prior monoclonal antibody within 4 weeks prior to study day 1 or who has not&#xD;
             recovered (i.e., =&lt; grade 1 or at baseline) from adverse events (AEs) due to agents&#xD;
             administered more than 4 weeks earlier; non-clinically significant adverse events may&#xD;
             be considered as an exception after discussion with and approval by the principal&#xD;
             investigator&#xD;
&#xD;
          -  Has a known additional malignancy that is progressing or requires active treatment;&#xD;
             exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the&#xD;
             skin, or in situ cervical cancer that has undergone potentially curative therapy&#xD;
&#xD;
          -  Patients with known active and untreated brain metastases should be excluded from this&#xD;
             clinical trial because of their poor prognosis and because they often develop&#xD;
             progressive neurologic dysfunction that would confound the evaluation of neurologic&#xD;
             and other adverse events&#xD;
&#xD;
          -  Patients with primary brain tumors or carcinomatous meningitis should also be excluded&#xD;
&#xD;
          -  Patients with previously treated brain metastases may participate provided they are&#xD;
             stable (without evidence of progression by imaging for at least 4 weeks prior to the&#xD;
             first dose of trial treatment and any neurologic symptoms have returned to baseline),&#xD;
             have no evidence of new or enlarging brain metastases, and are not requiring steroids&#xD;
             for at least 7 days prior to trial treatment&#xD;
&#xD;
          -  History of allergic reactions attributed to compounds of similar chemical or biologic&#xD;
             composition to pembrolizumab (MK-3475) and/or rhIL-12 or other agents used in study&#xD;
&#xD;
          -  Has an active autoimmune disease requiring systemic treatment within the past 3 months&#xD;
             or a documented history of clinically severe autoimmune disease, or a syndrome that&#xD;
             requires systemic steroids or immunosuppressive agents; patients with vitiligo or&#xD;
             resolved childhood asthma/atopy would be an exception to this rule; patients that&#xD;
             require intermittent use of bronchodilators or local steroid injections would not be&#xD;
             excluded from the study; patients with hypothyroidism stable on hormone replacement or&#xD;
             Sjogren's syndrome will not be excluded from the study&#xD;
&#xD;
          -  Has a history or current evidence of any condition, therapy, or laboratory abnormality&#xD;
             that might confound the results of the trial, interfere with the patient's&#xD;
             participation for the full duration of the trial, or is not in the best interest of&#xD;
             the patient to participate, in the opinion of the treating investigator&#xD;
&#xD;
          -  Has known psychiatric or substance abuse disorders that would interfere with&#xD;
             cooperation with the requirements of the trial&#xD;
&#xD;
          -  Patients on any systemic corticosteroid therapy within one week before the planned&#xD;
             date for first dose on study would not be eligible; exception: patients on physiologic&#xD;
             replacement doses of corticosteroids are permitted&#xD;
&#xD;
          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active&#xD;
             infection, interstitial lung disease or active, non-infectious pneumonitis,&#xD;
             symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or&#xD;
             psychiatric illness/social situations that would limit compliance with study&#xD;
             requirements&#xD;
&#xD;
          -  Is pregnant or breastfeeding, or expecting to conceive or father children within the&#xD;
             projected duration of the trial, starting with the pre-screening or screening visit&#xD;
             through 120 days after the last dose of trial treatment; pregnant women are excluded&#xD;
             from this study because pembrolizumab (MK-3475) is an agent with the potential for&#xD;
             teratogenic or abortifacient effects; because there is an unknown but potential risk&#xD;
             for adverse events in nursing infants secondary to treatment of the mother with&#xD;
             pembrolizumab (MK-3475), breastfeeding should be discontinued if the mother is treated&#xD;
             with pembrolizumab (MK-3475); these potential risks may also apply to other agents&#xD;
             used in this study; pembrolizumab (MK-3475) may have adverse effects on a fetus in&#xD;
             utero; furthermore, it is not known if pembrolizumab (MK-3475) has transient adverse&#xD;
             effects on the composition of sperm&#xD;
&#xD;
          -  Men and non-pregnant, non-breast-feeding women may be enrolled if they are willing to&#xD;
             use 2 methods of birth control or are considered highly unlikely to conceive; highly&#xD;
             unlikely to conceive is defined as 1) surgically sterilized, or 2) postmenopausal (a&#xD;
             woman who is &gt;= 45 years of age and has not had menses for greater than 2 years will&#xD;
             be considered postmenopausal), or 3) not heterosexually active for the duration of the&#xD;
             study; the two birth control methods can be barrier method or a barrier method plus a&#xD;
             hormonal method to prevent pregnancy; patients should start using birth control from&#xD;
             study visit 1 throughout the study period up to 120 days after the last dose of study&#xD;
             therapy; the following are considered adequate barrier methods of contraception:&#xD;
             diaphragm, condom (by the partner), copper intrauterine device, sponge, or spermicide;&#xD;
             appropriate hormonal contraceptives will include any registered and marketed&#xD;
             contraceptive agent that contains an estrogen and/or a progestational agent (including&#xD;
             oral, subcutaneous, intrauterine, or intramuscular agents)&#xD;
&#xD;
               -  Patients should be informed that taking the study medication may involve unknown&#xD;
                  risks to the fetus (unborn baby) if pregnancy were to occur during the study; in&#xD;
                  order to participate in the study they must adhere to the contraception&#xD;
                  requirement (described above) for the duration of the study and during the&#xD;
                  follow-up period; if there is any question that a patient will not reliably&#xD;
                  comply with the requirements for contraception, that patient should not be&#xD;
                  entered into the study&#xD;
&#xD;
               -  Pregnancy: If a patient inadvertently becomes pregnant while on treatment with&#xD;
                  pembrolizumab (MK-3475), the patient will immediately be removed from the study;&#xD;
                  the site will contact the patient at least monthly and document the patient's&#xD;
                  status until the pregnancy has been completed or terminated; the outcome of the&#xD;
                  pregnancy will be reported without delay and within 24 hours if the outcome is a&#xD;
                  serious adverse experience (e.g., death, abortion, congenital anomaly, or other&#xD;
                  disabling or life-threatening complication to the mother or newborn); the study&#xD;
                  investigator will make every effort to obtain permission to follow the outcome of&#xD;
                  the pregnancy and report the condition of the fetus or newborn; if a male patient&#xD;
                  impregnates his female partner the study personnel at the site must be informed&#xD;
                  immediately and the pregnancy reported and followed&#xD;
&#xD;
               -  It is unknown whether pembrolizumab (MK-3475) is excreted in human milk; since&#xD;
                  many drugs are excreted in human milk, and because of the potential for serious&#xD;
                  adverse reactions in the nursing infant, patients who are breast-feeding are not&#xD;
                  eligible for enrollment&#xD;
&#xD;
          -  Has known active hepatitis B (e.g., hepatitis B surface antigen [HBsAg] reactive) or&#xD;
             hepatitis C (e.g., hepatitis C virus [HCV] ribonucleic acid [RNA] [qualitative] is&#xD;
             detected)&#xD;
&#xD;
          -  Has received a live vaccine within 30 days prior to the first dose of trial treatment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Diwakar Davar</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pittsburgh Cancer Institute LAO</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UC San Diego Moores Cancer Center</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92093</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>University of California Davis Comprehensive Cancer Center</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>UCSF Medical Center-Mount Zion</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94115</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <location>
    <facility>
      <name>UCHealth University of Colorado Hospital</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Smilow Cancer Center/Yale-New Haven Hospital</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06510</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>203-785-5702</phone>
      <email>canceranswers@yale.edu</email>
    </contact>
    <investigator>
      <last_name>Patricia M. LoRusso</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Yale University</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06520</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of Florida Health Science Center - Gainesville</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32610</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>352-273-8010</phone>
      <email>cancer-center@ufl.edu</email>
    </contact>
    <investigator>
      <last_name>Thomas J. George</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Emory University Hospital Midtown</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30308</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Emory University Hospital/Winship Cancer Institute</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Emory Saint Joseph's Hospital</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30342</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of Iowa/Holden Comprehensive Cancer Center</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins University/Sidney Kimmel Cancer Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>410-955-8804</phone>
      <email>jhcccro@jhmi.edu</email>
    </contact>
    <investigator>
      <last_name>Nilofer S. Azad</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital Cancer Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Brigham and Women's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Beth Israel Deaconess Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Dana-Farber Cancer Institute</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Siteman Cancer Center at West County Hospital</name>
      <address>
        <city>Creve Coeur</city>
        <state>Missouri</state>
        <zip>63141</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Washington University School of Medicine</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Siteman Cancer Center-South County</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63129</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Siteman Cancer Center at Christian Hospital</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63136</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Siteman Cancer Center at Saint Peters Hospital</name>
      <address>
        <city>Saint Peters</city>
        <state>Missouri</state>
        <zip>63376</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Rutgers Cancer Institute of New Jersey</name>
      <address>
        <city>New Brunswick</city>
        <state>New Jersey</state>
        <zip>08903</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>UNC Lineberger Comprehensive Cancer Center</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </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>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic Foundation</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <location>
    <facility>
      <name>University of Pittsburgh Cancer Institute (UPCI)</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15232</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>412-647-8073</phone>
    </contact>
    <investigator>
      <last_name>Diwakar Davar</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Texas Health Science Center at San Antonio</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>210-450-3800</phone>
      <email>phoresearchoffice@uthscsa.edu</email>
    </contact>
    <investigator>
      <last_name>John Sarantopoulos</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Virginia Commonwealth University/Massey Cancer Center</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23298</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>January 24, 2017</study_first_submitted>
  <study_first_submitted_qc>January 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 25, 2017</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>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pembrolizumab</mesh_term>
    <mesh_term>Interleukin-12</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03030378
org study id: NCI-2017-00091
secondary id: NCI-2017-00091
secondary id: HCC 17-003
secondary id: 10061
secondary id: 10061
secondary id: UM1CA186690
nct id: NCT03030378
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This phase I trial studies the side effects and best dose of pembrolizumab and recombinant
      interleukin-12 in treating patients with solid tumors. Immunotherapy with monoclonal
      antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and
      may interfere with the ability of tumor cells to grow and spread. Recombinant interleukin-12
      may kill tumor cells by blocking blood flow to the tumor and by stimulating white blood cells
      to kill tumor cells. Giving pembrolizumab and recombinant interleukin-12 may work better than
      giving pembrolizumab alone in treating patients with solid tumors.
PRIMARY OBJECTIVE:

      I. Establish the maximum tolerated dose (MTD) and the recommended phase II dose (RP2D) of
      edodekin alfa (recombinant human interleukin [rhIL]-12) in combination with pembrolizumab
      (MK-3475).

      SECONDARY OBJECTIVES:

      I. Evaluate the safety of the regimen by continuously monitoring adverse events that will be
      documented utilizing Common Terminology Criteria for Adverse Events (CTCAE) version (v).5.0.

      II. Evaluate the overall response rate (Response Evaluation Criteria in Solid Tumors [RECIST]
      v.1.1) and the progression free survival of patients enrolled on the study.

      III. Measure CD8+ T cell infiltration by immunohistochemistry in tumor biopsies obtained
      pre-treatment, after one week of rhIL-12 and after 2 cycles of pembrolizumab (MK-3475) in
      combination with rhIL-12.

      EXPLORATORY OBJECTIVE:

      I. Conduct exploratory translational laboratory correlative studies utilizing banked
      biospecimens (tumor, blood, and stool) obtained pre-treatment and during therapy.

      OUTLINE: This is a dose-escalation study of recombinant interleukin-12.

      Patients receive recombinant interleukin-12 subcutaneously (SC) on days 2, 5, 9, and 12 and
      pembrolizumab intravenously (IV) over 30 minutes on day 8 of cycle 1 and day 1 of subsequent
      cycles. Treatment continues for 28 days for cycle 1 and repeats every 21 days for subsequent
      cycles for up to 8 cycles in the absence of disease progression or unacceptable toxicity.
      Patient then receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21
      days for up to 8 additional cycles in the absence of disease progression or unacceptable
      toxicity. Patients undergo a computed tomography (CT), positron emission tomography (PET),
      and/or magnetic resonance imaging (MRI), as well as collection of blood during screening, on
      study, and during follow-up. Patients also undergo a tumor biopsy during screening and on
      study.

      After completion of study treatment, patients are followed up every 12 weeks for 2 year and
      then every 24 weeks for up to 5 years.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Maximum tolerated dose (MTD)
time frame: Up to 5 years
measure: Recommended phase 2 dose
time frame: Up to 5 years
measure: Incidence of adverse events
time frame: Up to 30 days after last dose
description: Adverse events will be tabulated by Common Terminology Criteria for Adverse Events (CTCAE) grade, CTCAE category, relatedness to treatment and dose level.
measure: Progression free survival
time frame: From start of treatment to time of progression or death, whichever comes, first assessed up to 5 years
description: The product-limit (Kaplan-Meier) progression-free survival function, with a 95% confidence region, will be determined for all patients and for patients treated at the MTD.
measure: Overall response rate
time frame: From start of treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started), assessed up to 5 years
description: Will be assessed by Response Evaluation Criteria in Solid Tumors version 1.1. The proportion of patients experiencing confirmed overall (complete or partial) response will be calculated, as will a 95% exact (Klopper-Pearson) binomial confidence interval for all patients, and patients treated at the MTD (a confirmed clinical tumor response is defined to be either a complete response or partial response noted as the objective status on 2 consecutive evaluations at least >= 4 weeks apart.).
measure: CD8+ T cell infiltration
time frame: Up to 2 cycles of treatment
description: Will be assessed by immunohistochemistry. Will be compared to pre-treatment biopsy specimens by the Wilcoxon signed-rank test.
measure: Biomarker analysis
time frame: Up to 5 years
description: Will conduct exploratory translational laboratory correlative studies utilizing banked biospecimens (tumor, blood and stool) obtained at baseline and during therapy.
arm group label: Treatment (recombinant interleukin-12, pembrolizumab)
arm group type: Experimental
description: Patients receive recombinant interleukin-12 SC on days 2, 5, 9, and 12 and pembrolizumab IV over 30 minutes on day 8 of cycle 1 and day 1 of subsequent cycles. Treatment continues for 28 days for cycle 1 and repeats every 21 days for subsequent cycles for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Patient then receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 8 additional cycles in the absence of disease progression or unacceptable toxicity. Patients undergo a CT, PET, and MRI, as well as collection of blood during screening, on study, and during follow-up. Patients also undergo a tumor biopsy during screening and on study.
intervention type: Procedure
intervention name: Biopsy
description: Undergo a tumor biopsy
arm group label: Treatment (recombinant interleukin-12, pembrolizumab)
other name: BIOPSY_TYPE
other name: Bx
intervention type: Procedure
intervention name: Biospecimen Collection
description: Undergo collection of blood
arm group label: Treatment (recombinant interleukin-12, pembrolizumab)
other name: Biological Sample Collection
other name: Biospecimen Collected
other name: Specimen Collection
intervention type: Procedure
intervention name: Computed Tomography
description: Undergo a CT scan
arm group label: Treatment (recombinant interleukin-12, pembrolizumab)
other name: CAT
other name: CAT Scan
other name: Computed Axial Tomography
other name: Computerized Axial Tomography
other name: Computerized axial tomography (procedure)
other name: Computerized Tomography
other name: CT
other name: CT Scan
other name: tomography
intervention type: Biological
intervention name: Edodekin alfa
description: Given SC
arm group label: Treatment (recombinant interleukin-12, pembrolizumab)
other name: Cytotoxic Lymphocyte Maturation Factor
other name: IL-12
other name: Interleukin 12
other name: Interleukin-12
other name: Natural Killer Cell Stimulatory Factor
other name: NM-IL-12
other name: Recombinant human interleukin-12 (IL-12) cytokine
other name: Ro 24-7472
intervention type: Procedure
intervention name: Magnetic Resonance Imaging
description: Undergo a MRI
arm group label: Treatment (recombinant interleukin-12, pembrolizumab)
other name: Magnetic Resonance
other name: Magnetic resonance imaging (procedure)
other name: Magnetic Resonance Imaging Scan
other name: Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
other name: MR
other name: MR Imaging
other name: MRI
other name: MRI Scan
other name: NMR Imaging
other name: NMRI
other name: Nuclear Magnetic Resonance Imaging
intervention type: Biological
intervention name: Pembrolizumab
description: Given IV
arm group label: Treatment (recombinant interleukin-12, pembrolizumab)
other name: BCD-201
other name: Keytruda
other name: Lambrolizumab
other name: MK-3475
other name: Pembrolizumab Biosimilar BCD-201
other name: SCH 900475
intervention type: Procedure
intervention name: Positron Emission Tomography
description: Undergo a PET scan
arm group label: Treatment (recombinant interleukin-12, pembrolizumab)
other name: Medical Imaging, Positron Emission Tomography
other name: PET
other name: PET Scan
other name: Positron emission tomography (procedure)
other name: Positron Emission Tomography Scan
other name: Positron-Emission Tomography
other name: proton magnetic resonance spectroscopic imaging
other name: PT
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Diwakar Davar
role: Principal Investigator
affiliation: University of Pittsburgh Cancer Institute LAO
facility: 
status: Withdrawn
facility: 
status: Active, not recruiting
facility: 
status: Suspended
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Suspended
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Active, not recruiting
country: United States
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Pembrolizumab
mesh term: Interleukin-12
sharing ipd: Undecided