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/NCT06015724</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY00005625</org_study_id>
      <nct_id>NCT06015724</nct_id>
    </id_info>
    <brief_title>Anti-CD38 Antibody With KRAS Vaccine and Anti-PD-1 Antibody in Subjects With Pancreatic Ductal Adenocarcinoma and Refractory Non-Small Cell Lung Cancer</brief_title>
    <acronym>DARANIVOVAX</acronym>
    <official_title>A Phase 2 Study Evaluating the Efficacy of Anti-CD38 Antibody in Combination With KRAS Vaccine and Anti-PD-1 Antibody in Subjects With Pancreatic Ductal Adenocarcinoma and Refractory Non-Small Cell Lung Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Georgetown University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Bristol-Myers Squibb</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
      <collaborator>
        <agency>Janssen, LP</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
      <collaborator>
        <agency>Targovax ASA</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Georgetown University</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>
        The goal of this clinical trial is to test the safety and tolerability of anti-CD38&#xD;
        monoclonal antibody (mAb), daratumumab, in combination with KRAS vaccine (Targovax&#xD;
        TG-01/Stimulon QS-21) when given with anti-PD-1 (programmed cell death protein 1) mAb&#xD;
        (nivolumab) in patients with advanced non-small cell lung cancer (NSCLC) or pancreatic ductal&#xD;
        adenocarcinoma (PDAC). The main questions it aims to answer are:&#xD;
  &#xD;
          -  How well does daratumumab and nivolumab, when given with a vaccine, control or stop&#xD;
             these types of cancer?&#xD;
  &#xD;
          -  How well does participants bodies handle these study drugs?&#xD;
  &#xD;
          -  Does this combination of study drugs help participants live longer? Participants will&#xD;
             receive daratumumab, nivolumab with KRAS vaccine and have regular tests and procedures&#xD;
             to follow how the participants are doing on these study drugs.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">January 2026</completion_date>
    <primary_completion_date type="Anticipated">January 2025</primary_completion_date>
    <phase>Phase 2</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>Objective Response Rate (ORR) (Efficacy)</measure>
      <time_frame>every 8 weeks, approximately 2 years</time_frame>
      <description>Evaluation of response by ORR by irRECIST criteria. Response classification will follow the irRECIST criteria and will be defined as PR or CR. Patients who are lost to follow-up without a valid response assessment will be classified as NR (non-responder, progression). The ORR will be computed for all patients with at least one cycle of the study drug.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]</measure>
      <time_frame>From start of intervention until 30 days following discontinuation of intervention, approximately 2 years</time_frame>
      <description>Incidence rate of Adverse Events</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Progression Free Survival (PFS)</measure>
      <time_frame>at 6 months and 9 months</time_frame>
      <description>PFS will be defined as the time in days from study entry until progression or death.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of Response (DOR)</measure>
      <time_frame>approximately 3 years</time_frame>
      <description>DoR is defined as the length of time tumor continues to respond to the treatment.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Clinical Benefit Rate (CBR)</measure>
      <time_frame>approximately 2 years</time_frame>
      <description>CBR classification will follow the irRECIST criteria and will be defined as the percentage of patients who achieved stable disease (SD) or better response.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall Survival</measure>
      <time_frame>approximately 3 years</time_frame>
      <description>OS will be defined as the time in days from study entry until death. All events of death will be included, regardless of whether the event occurred while the subject was still taking study drug, or after the subject discontinued study drug.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">54</enrollment>
    <condition>Pancreatic Ductal Adenocarcinoma</condition>
    <condition>Refractory Non-Small Cell Lung Cancer</condition>
    <arm_group>
      <arm_group_label>Pancreatic Ductal Adenocarcinoma</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Refractory Non-Small Cell Lung Cancer</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Daratumumab</intervention_name>
      <description>anti-CD38 monoclonal antibody (mAb)</description>
      <arm_group_label>Pancreatic Ductal Adenocarcinoma</arm_group_label>
      <arm_group_label>Refractory Non-Small Cell Lung Cancer</arm_group_label>
      <other_name>Darzalex Faspro</other_name>
    </intervention>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>KRAS vaccine</intervention_name>
      <description>Stimulon QS-21 and Targovax TG01</description>
      <arm_group_label>Pancreatic Ductal Adenocarcinoma</arm_group_label>
      <arm_group_label>Refractory Non-Small Cell Lung Cancer</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Nivolumab</intervention_name>
      <description>anti-PD-1 (programmed cell death protein 1) monoclonal antibody (mAb)</description>
      <arm_group_label>Pancreatic Ductal Adenocarcinoma</arm_group_label>
      <arm_group_label>Refractory Non-Small Cell Lung Cancer</arm_group_label>
      <other_name>BMS-936558</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age ≥18 years&#xD;
  &#xD;
            2. Patients with advanced NSCLC, progressing on frontline anti-PD-1/PD-L1 containing&#xD;
               therapy (patient with rapid tumor progression will be excluded) and PDAC patients who&#xD;
               failed one prior treatment.&#xD;
  &#xD;
            3. Measurable disease as defined by irRECIST criteria (See Section 7) NOTE: Tumor lesions&#xD;
               in a previously irradiated area are not considered measurable disease; Disease that is&#xD;
               measurable by physical examination only is not eligible.&#xD;
  &#xD;
            4. All patients with mutant KRAS status in either codon 12 (12A, C, D, R, S, V) or 13&#xD;
               (13D) will be included. The status of KRAS and LKB1 will be determined. For patients&#xD;
               with KRAS G12C-mutated NSCLC, prior treatment with G12C-targeted therapy will be&#xD;
               allowed; a wash-out period of 1 week from the last administration of targeted therapy&#xD;
               would be allowed.&#xD;
  &#xD;
            5. Patients with known actionable driver alterations such as EGFR, ALK, ROS1, BRAF,&#xD;
               NTRK1/2/3, METex14, RET, ERBB2 (HER2) and concurrent KRAS mutations will be reviewed&#xD;
               on a case-by-case basis and patients must have experienced progression on appropriate&#xD;
               first-line targeted therapy and anti-PD-1/PD-L1 as indicated.&#xD;
  &#xD;
            6. Prior treatment:&#xD;
  &#xD;
                 -  For NSCLC: Anti-PD1/PD-L1 containing therapy; a wash-out period of 4 weeks from&#xD;
                    the last administration of therapy would be allowed.&#xD;
  &#xD;
                 -  For PDAC: Patients who failed one prior treatment.&#xD;
  &#xD;
            7. Provide written informed consent.&#xD;
  &#xD;
            8. Willing to return to enrolling institution for follow-up (during the Active Monitoring&#xD;
               Phase of the study).&#xD;
  &#xD;
            9. Ability to complete questionnaire(s) by themselves or with assistance.&#xD;
  &#xD;
           10. Willingness to provide mandatory blood specimens for correlative research.&#xD;
  &#xD;
           11. Willingness to provide mandatory tissue specimens for correlative research.&#xD;
  &#xD;
           12. ECOG Performance Status (PS) 0, 1 or 2.&#xD;
  &#xD;
           13. The following laboratory values obtained ≤14 days prior to registration:&#xD;
  &#xD;
               • Hemoglobin ≥9.0 g/dL&#xD;
  &#xD;
                 -  Absolute neutrophil count (ANC) ≥1500/mm3&#xD;
  &#xD;
                 -  Platelet count ≥100,000/mm3&#xD;
  &#xD;
                 -  Total bilirubin ≤1.5 x ULN (upper limit of normal)&#xD;
  &#xD;
                 -  ALT and AST ≤3 x ULN (≤5 x ULN for patients with liver involvement)&#xD;
  &#xD;
                 -  PT (prothrombin time)/INR/aPTT (activated partial thromboplastin time) ≤1.5 x ULN&#xD;
                    OR if patient is receiving anticoagulant therapy and INR or aPTT is within target&#xD;
                    range of therapy&#xD;
  &#xD;
                 -  Calculated creatinine clearance (CrCl) ≥20 mL/min using the Cockcroft-Gault&#xD;
                    formula&#xD;
  &#xD;
           14. Negative pregnancy test done ≤7 days prior to registration, for persons of&#xD;
               childbearing potential only.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Any of the following because this study involves an investigational agent whose&#xD;
               genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are&#xD;
               unknown:&#xD;
  &#xD;
               • Pregnant persons&#xD;
  &#xD;
                 -  Nursing persons&#xD;
  &#xD;
                 -  Persons of childbearing potential who are unwilling to employ adequate&#xD;
                    contraception&#xD;
  &#xD;
            2. Any of the following prior therapies:&#xD;
  &#xD;
               • Daratumumab or other anti-CD38 therapies&#xD;
  &#xD;
                 -  Surgery ≤3 weeks prior to registration&#xD;
  &#xD;
                 -  Chemotherapy ≤4 weeks prior to registration&#xD;
  &#xD;
                 -  For NSCLC: anti-PD-1/PD-L1 therapy ≤4 weeks prior to registration; for PDAC:&#xD;
                    Prior treatment with an anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibody, or any&#xD;
                    other antibody or drug specifically targeting T cell co-stimulation or checkpoint&#xD;
                    pathways.&#xD;
  &#xD;
                 -  Focal radiation therapy within 14 days prior to first study treatment with the&#xD;
                    exception of palliative radiotherapy for symptomatic management but not on&#xD;
                    measurable extramedullary plasmacytoma. Participants must have recovered (ie,&#xD;
                    Grade ≤1 or at baseline) from radiation-related toxicities prior to first study&#xD;
                    treatment.&#xD;
  &#xD;
                 -  Treatment with complementary medications (e.g., herbal supplements or traditional&#xD;
                    Chinese medicines) to treat the disease under study within &lt;2 weeks prior to&#xD;
                    first study treatment. Such medications are permitted if they are used as&#xD;
                    supportive care.&#xD;
  &#xD;
                 -  Treatment with any live / attenuated vaccine within 30 days of first study&#xD;
                    treatment.&#xD;
  &#xD;
            3. Co-morbid systemic illnesses or other severe concurrent disease, which, in the&#xD;
               judgment of the investigator, would make the patient inappropriate for entry into this&#xD;
               study or interfere significantly with the proper assessment of safety and toxicity of&#xD;
               the prescribed regimens.&#xD;
  &#xD;
            4. Uncontrolled intercurrent illness including, but not limited to:&#xD;
  &#xD;
               • Ongoing or active infection&#xD;
  &#xD;
               • Symptomatic CHF (class II and above that are not properly controlled on maintenance&#xD;
               therapy or that have been hospitalized in the last 4 weeks for heart failure)&#xD;
  &#xD;
               • Unstable angina pectoris&#xD;
  &#xD;
               • Cardiac arrhythmia&#xD;
  &#xD;
                 -  Or psychiatric illness/social situations that would limit compliance with study&#xD;
                    requirements.&#xD;
  &#xD;
            5. Receiving any other investigational agent, which would be considered as a treatment&#xD;
               for the primary neoplasm.&#xD;
  &#xD;
            6. Other active malignancy ≤5 years prior to registration. EXCEPTIONS: Squamous and basal&#xD;
               cell carcinomas of the skin, carcinoma in situ of the cervix or breast, or other&#xD;
               non-invasive lesions that in the opinion of the investigator, with concurrence with&#xD;
               the sponsor's medical monitor, is considered cured with minimal risk of recurrence&#xD;
               within 3 years.&#xD;
  &#xD;
            7. History of myocardial infarction ≤6 months, or CHF (class II and above that are not&#xD;
               properly controlled on maintenance therapy or that have been hospitalized in the last&#xD;
               4 weeks for heart failure) requiring use of ongoing maintenance therapy for&#xD;
               life-threatening ventricular arrhythmias.&#xD;
  &#xD;
            8. Patients with known primary CNS malignancy or symptomatic CNS metastases are excluded,&#xD;
               with the following exceptions:&#xD;
  &#xD;
                 -  Patients with asymptomatic untreated CNS disease may be enrolled, provided all of&#xD;
                    the following criteria are met:&#xD;
  &#xD;
                    o Evaluable or measurable disease outside the CNS&#xD;
  &#xD;
                    o No metastases to brain stem, midbrain, pons, medulla, cerebellum, or within 10&#xD;
                    mm of the optic apparatus (optic nerves and chiasm)&#xD;
  &#xD;
                      -  No history of intracranial hemorrhage or spinal cord hemorrhage&#xD;
  &#xD;
                      -  No ongoing requirement for dexamethasone for CNS disease; patients on a&#xD;
                         stable dose of anticonvulsants are permitted.&#xD;
  &#xD;
                      -  No neurosurgical resection or brain biopsy ≤28 days prior to registration&#xD;
  &#xD;
                 -  Patients with asymptomatic treated CNS metastases may be enrolled, provided all&#xD;
                    the criteria listed above are met as well as the following:&#xD;
  &#xD;
                      -  Radiographic demonstration of improvement upon the completion of&#xD;
                         CNS-directed therapy and no evidence of interim progression between the&#xD;
                         completion of CNS-directed therapy and the screening radiographic study&#xD;
  &#xD;
                      -  No stereotactic radiation or whole-brain radiation ≤28 days prior to&#xD;
                         registration&#xD;
  &#xD;
                      -  Screening CNS radiographic study ≥4 weeks from completion of radiotherapy&#xD;
                         and ≥ 2 weeks from discontinuation of corticosteroids&#xD;
  &#xD;
            9. a. History of severe allergic, anaphylactic, or other hypersensitivity reactions to&#xD;
               chimeric or humanized antibodies or fusion proteins or vaccines.&#xD;
  &#xD;
          9. b. Patients with a plan to receive yellow fever or other live (attenuated) vaccines&#xD;
          during the course of study.&#xD;
  &#xD;
          9. c. Patients who have a history or current evidence of bleeding disorder, i.e., any&#xD;
          hemorrhage/bleeding event of CTCAE Grade ≥2, ≤28 days prior to registration.&#xD;
  &#xD;
          9. d. Patients on supraphysiologic doses of steroids or use of such ≤ 6weeks prior to&#xD;
          registration.&#xD;
  &#xD;
          9. e. Known clinically significant liver disease, including active viral, alcoholic, or&#xD;
          other hepatitis; cirrhosis; fatty liver; and inherited liver disease.&#xD;
  &#xD;
          9. f. History or risk of autoimmune disease, including, but not limited to, systemic lupus&#xD;
          erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis&#xD;
          associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome,&#xD;
          Bell's palsy, Guillain-Barré syndrome, multiple sclerosis, autoimmune thyroid disease,&#xD;
          vasculitis, or glomerulonephritis. Note: Patients with a history of autoimmune&#xD;
          hypothyroidism on a stable dose of thyroid replacement hormone are eligible. Patients with&#xD;
          controlled Type 1 diabetes mellitus (T1DM) on a stable insulin regimen are eligible.&#xD;
          Patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic&#xD;
          manifestations only (e.g., patients with psoriatic arthritis would be excluded) are&#xD;
          permitted provided that they meet the following conditions:&#xD;
  &#xD;
          o Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular&#xD;
          manifestations&#xD;
  &#xD;
            -  Rash must cover less than 10% of body surface area (BSA)&#xD;
  &#xD;
            -  Disease is well controlled at baseline and only requiring low potency topical steroids&#xD;
               (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, flucinolone 0.01%, desonide&#xD;
               0.05%, aclometasone dipropionate 0.05%)&#xD;
  &#xD;
            -  No acute exacerbations of underlying condition within the last 12 months (not&#xD;
               requiring psoralen plus ultraviolet A radiation [PUVA], methotrexate, retinoids,&#xD;
               biologic agents, oral calcineurin inhibitors; high potency or oral steroids).&#xD;
  &#xD;
               9. g. History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced),&#xD;
               organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing&#xD;
               pneumonia, etc.), or evidence of active pneumonitis on screening chest CT scan. Note:&#xD;
               History of radiation pneumonitis in the radiation field (fibrosis) is permitted.&#xD;
  &#xD;
               9. h. Any infection &gt; Grade 2 ≤4 weeks prior to registration, including, but not&#xD;
               limited to, hospitalization for complications of infection, bacteremia, or severe&#xD;
               pneumonia.&#xD;
  &#xD;
               9. i. History of peripheral neuropathy ≥Grade 2.&#xD;
  &#xD;
               10. Subject is Seropositive for HIV. Seropositive for hepatitis B (defined by a&#xD;
               positive test for HBsAg). Subjects with resolved infection (i.e., subjects who are&#xD;
               HBsAg negative but positive for anti-HBc and/or anti-HBs) must be screened using&#xD;
               RT-PCR measurement of HBV DNA levels. Those who are PCR positive will be excluded.&#xD;
               EXCEPTION: Subjects with serologic findings suggestive of HBV vaccination (anti-HBs&#xD;
               positivity as the only serologic marker) AND a known history of prior HBV vaccination,&#xD;
               do not need to be tested for HBV DNA by PCR. Seropositive for hepatitis C (except in&#xD;
               the setting of a SVR, defined as aviremia at least 12 weeks after completion of&#xD;
               antiviral therapy).&#xD;
  &#xD;
               11. COPD with a FEV1 &lt; 50% of predicted normal. Note that FEV1 testing is required for&#xD;
               participants suspected of having COPD and participants must be excluded if FEV1 is &lt;&#xD;
               50% of predicted normal.&#xD;
  &#xD;
               12. Moderate or severe persistent asthma within the past 2 years, or uncontrolled&#xD;
               asthma of any classification. Note that participants who currently have controlled&#xD;
               intermittent asthma or controlled mild persistent asthma are allowed to participate.&#xD;
  &#xD;
               13. Prisoners or subjects who are compulsory detained.&#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>Samir Khleif, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Georgetown University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Samir Khleif, MD</last_name>
      <phone>202-687-9194</phone>
      <email>snk48@georgetown.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Georgetown Lombardi Comprehensive Cancer Center</name>
        <address>
          <city>Washington</city>
          <state>District of Columbia</state>
          <zip>20007</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Nicole Swanson</last_name>
        <phone>202-687-9194</phone>
        <email>ns1209@georgetown.edu</email>
      </contact>
      <investigator>
        <last_name>Benjamin Weinberg, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Joshua Reuss, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Samin N. Khleif, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 23, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 29, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 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>Lung Neoplasms</mesh_term>
      <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term>
      <mesh_term>Adenocarcinoma</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Nivolumab</mesh_term>
      <mesh_term>Daratumumab</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT06015724
  org study id: STUDY00005625
  nct id: NCT06015724
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  The goal of this clinical trial is to test the safety and tolerability of anti-CD38
        monoclonal antibody (mAb), daratumumab, in combination with KRAS vaccine (Targovax
        TG-01/Stimulon QS-21) when given with anti-PD-1 (programmed cell death protein 1) mAb
        (nivolumab) in patients with advanced non-small cell lung cancer (NSCLC) or pancreatic ductal
        adenocarcinoma (PDAC). The main questions it aims to answer are:
  
          -  How well does daratumumab and nivolumab, when given with a vaccine, control or stop
             these types of cancer?
  
          -  How well does participants bodies handle these study drugs?
  
          -  Does this combination of study drugs help participants live longer? Participants will
             receive daratumumab, nivolumab with KRAS vaccine and have regular tests and procedures
             to follow how the participants are doing on these study drugs.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Objective Response Rate (ORR) (Efficacy)
  time frame: every 8 weeks, approximately 2 years
  description: Evaluation of response by ORR by irRECIST criteria. Response classification will follow the irRECIST criteria and will be defined as PR or CR. Patients who are lost to follow-up without a valid response assessment will be classified as NR (non-responder, progression). The ORR will be computed for all patients with at least one cycle of the study drug.
  measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
  time frame: From start of intervention until 30 days following discontinuation of intervention, approximately 2 years
  description: Incidence rate of Adverse Events
  measure: Progression Free Survival (PFS)
  time frame: at 6 months and 9 months
  description: PFS will be defined as the time in days from study entry until progression or death.
  measure: Duration of Response (DOR)
  time frame: approximately 3 years
  description: DoR is defined as the length of time tumor continues to respond to the treatment.
  measure: Clinical Benefit Rate (CBR)
  time frame: approximately 2 years
  description: CBR classification will follow the irRECIST criteria and will be defined as the percentage of patients who achieved stable disease (SD) or better response.
  measure: Overall Survival
  time frame: approximately 3 years
  description: OS will be defined as the time in days from study entry until death. All events of death will be included, regardless of whether the event occurred while the subject was still taking study drug, or after the subject discontinued study drug.
  arm group label: Pancreatic Ductal Adenocarcinoma
  arm group type: Experimental
  arm group label: Refractory Non-Small Cell Lung Cancer
  arm group type: Experimental
  intervention type: Drug
  intervention name: Daratumumab
  description: anti-CD38 monoclonal antibody (mAb)
  arm group label: Pancreatic Ductal Adenocarcinoma
  arm group label: Refractory Non-Small Cell Lung Cancer
  other name: Darzalex Faspro
  intervention type: Biological
  intervention name: KRAS vaccine
  description: Stimulon QS-21 and Targovax TG01
  arm group label: Pancreatic Ductal Adenocarcinoma
  arm group label: Refractory Non-Small Cell Lung Cancer
  intervention type: Drug
  intervention name: Nivolumab
  description: anti-PD-1 (programmed cell death protein 1) monoclonal antibody (mAb)
  arm group label: Pancreatic Ductal Adenocarcinoma
  arm group label: Refractory Non-Small Cell Lung Cancer
  other name: BMS-936558
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Samir Khleif, MD
  role: Principal Investigator
  affiliation: Georgetown University
  last name: Samir Khleif, MD
  phone: 202-687-9194
  email: snk48@georgetown.edu
  facility: 
  contact: 
  investigator: 
  investigator: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Lung Neoplasms
  mesh term: Carcinoma, Non-Small-Cell Lung
  mesh term: Adenocarcinoma
  mesh term: Nivolumab
  mesh term: Daratumumab
  sharing ipd: No