<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/NCT04455503</url>
  </required_header>
  <id_info>
    <org_study_id>EVX-02-001</org_study_id>
    <nct_id>NCT04455503</nct_id>
  </id_info>
  <brief_title>Study of Adjuvant Immunotherapy With EVX-02 and Anti-PD-1</brief_title>
  <official_title>A Phase 1/2, Study of Adjuvant Immunotherapy With EVX-02 and Anti-PD-1 After Complete Resection of Stage IIIB/IIIC/IIID or Stage IV Melanoma in Patients at High Risk for Recurrence</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Evaxion Biotech A/S</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Novotech (Australia) Pty Limited</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Evaxion Biotech A/S</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a Phase 1/2, open label, multi-centre study to assess the safety, tolerability, PD,&#xD;
      and efficacy of adjuvant immunotherapy EVX-02 vaccine and anti-PD-1 (Nivolumab) in patients&#xD;
      who have had a complete resection of a Stage IIIB/IIIC/IIID or Stage IV melanoma who are at&#xD;
      high risk of recurrence.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will be conducted in two parts: a safety, efficacy and PD response part using two&#xD;
      different drug delivery methods and an expansion cohort.&#xD;
&#xD;
      All patients will be administered with anti-PD-1 once every 4 weeks for up to 1 year&#xD;
      commencing on Day 1 and with EVX-02 vaccine as soon as it is produced.&#xD;
&#xD;
      Part 1 will consist of two cohorts:&#xD;
&#xD;
      Cohort A: Will receive EVX- 02A delivered by delivery methodology 1. Cohort B: Will receive&#xD;
      EVX- 02B delivered by delivery device 2. Part 2 (Cohort C) will be an expansion cohort. In&#xD;
      this part, only one delivery methods, either EVX-02A or EVX-02B with will be used.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">July 13, 2020</start_date>
  <completion_date type="Anticipated">March 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">March 31, 2023</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>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>Safety and tolerability (Incidence of Treatment-Emergent Adverse Events)</measure>
    <time_frame>Measurements at Baseline through study completion, an average of 1 year</time_frame>
    <description>Measure through CTCAE version 5.0</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety and tolerability (Incidence of Treatment-Emergent Adverse Events) measure through Vital Sign- blood pressure</measure>
    <time_frame>Measurements at Baseline through study completion, an average of 1 year</time_frame>
    <description>Measured by result of the Vital Sign- blood pressure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety and tolerability (Incidence of Treatment-Emergent Adverse Events) measure through Vital Sign-heart rate</measure>
    <time_frame>Measurements at Baseline through study completion, an average of 1 year</time_frame>
    <description>Measured by result of the Vital Sign- heart rate</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety and tolerability (Incidence of Treatment-Emergent Adverse Events) measure through Physical exam</measure>
    <time_frame>Measurements at Baseline through study completion, an average of 1 year</time_frame>
    <description>Measured by result of the physical exam which includes general appearance, skin, eyes/ears/nose/throat, head and neck.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacodynamic response (PD) of EVX-02 assessed by IFN-y ELISPOT</measure>
    <time_frame>Measurements at Baseline through study completion, an average of 1 year</time_frame>
    <description>The pharmacodynamic (PD) response of EVX-02 will be assessed by detecting vaccine induced circulating neoepitope-specific T cells. Blood samples will be collected prior, during and after immunization and the immunotherapy induced T cell responses will be assayed by IFN-y ELISPOT.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacodynamic response (PD) of EVX-02 assessed by MHC I multimer analysis</measure>
    <time_frame>Measurements at Baseline through study completion, an average of 1 year</time_frame>
    <description>The pharmacodynamic (PD) response of EVX-02 will be assessed by detecting vaccine induced circulating neoepitope-specific T cells. Blood samples will be collected prior, during and after immunization. The samples will be analyzed by MHC I multimer analyses detecting neoepitope-recognizing CD8+ T cells reported as frequencies of positive cell out of CD8+ T cells.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacodynamic response (PD) of EVX-02 by intracellular cytokine staining and flow cytometry</measure>
    <time_frame>Measurements at Baseline through study completion, an average of 1 year</time_frame>
    <description>The pharmacodynamic (PD) response of EVX-02 will be assessed by detecting vaccine induced circulating neoepitpe-specific T cells. Blood samples will be collected prior, during and after immunization. The samples will be analysed by flow cytometry to detect vaccine induced intracellular cytokine response, reported as frequencies of neoepitope-reactive CD4+ cells and CD8+ T cells.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Efficacy measure through Relapse-free survival (RFS)</measure>
    <time_frame>Measurements at Baseline through study completion, an average of 1 year</time_frame>
    <description>Measured by result of Relapse-free survival (RFS)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>PD response of EVX-02 assessed by monitoring the quantity of cfDNA in plasma</measure>
    <time_frame>Measured at Screening, Day -84 to Day -1, Day 1, Day 84, Day 168, Day 252, Day 336 and early termination</time_frame>
    <description>To monitor the plasma level cfDNA, blood sample will be obtained prior, during and after treatment with EVX-02 and the fluctuations of the level cfDNA will be analysed.</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Melanoma Stage IV</condition>
  <condition>Melanoma Stage III</condition>
  <arm_group>
    <arm_group_label>Cohort A: Nivolumab and EVX-02A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>EVX-02A administered IM.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort B: Nivolumab and EVX-02B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>EVX-02B administered IM.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort C: Nivolumab and EVX-02A OR Nivolumab and EVX-02B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The selected delivery methodology either EVX02A or EVX-02B.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>EVX-02A</intervention_name>
    <description>Up to 8 patients will receive EVX-02A administered IM.</description>
    <arm_group_label>Cohort A: Nivolumab and EVX-02A</arm_group_label>
    <other_name>A</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>EVX-02B</intervention_name>
    <description>Up to 8 patients will receive EVX-02B administered IM.</description>
    <arm_group_label>Cohort B: Nivolumab and EVX-02B</arm_group_label>
    <other_name>B</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>EVX-02A OR EVX-02B</intervention_name>
    <description>EVX-02A or EVX-02B will be used. Patients: 24 to 30</description>
    <arm_group_label>Cohort C: Nivolumab and EVX-02A OR Nivolumab and EVX-02B</arm_group_label>
    <other_name>C</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Signed and dated written ICF prior to performing any protocol-related procedures,&#xD;
             which are not part of normal standard care.&#xD;
&#xD;
          2. Patients must be willing and able to comply with scheduled visits, treatment schedule,&#xD;
             laboratory tests, tumour sample including core needle biopsy as required, and other&#xD;
             requirements of the study.&#xD;
&#xD;
          3. Male or female ≥ 18 years of age at the time of informed consent.&#xD;
&#xD;
          4. Stage IIIB/IIIC/IIID or Stage IV AJCC (8th edition) (AJCC, 2018) before complete&#xD;
             resection.&#xD;
&#xD;
             Please note: If Stage III melanoma (whether Stage IIIB or IIIC or IIID) the patients&#xD;
             must have clinically detectable lymph nodes that are confirmed as malignant on the&#xD;
             pathology report and/or ulcerated primary lesions, and/or in transit metastasis. The&#xD;
             pathology report must be reviewed, signed and dated by the Investigator; this process&#xD;
             must be done prior to enrolling patients into the study. Clinically detectable lymph&#xD;
             nodes are defined as:&#xD;
&#xD;
               1. a palpable node (confirmed as malignant by pathology) after the CLND&#xD;
&#xD;
               2. a non-palpable but enlarged lymph node by CT scan (at least 15 mm in short axis)&#xD;
                  and confirmed as malignant by pathology after the CLND&#xD;
&#xD;
               3. a PET scan positive lymph node of any size confirmed by pathology after CLND&#xD;
&#xD;
               4. evidence of pathologically macro metastatic disease in one or more lymph nodes&#xD;
                  defined by one or more foci of melanoma at least 1 cm in diameter If Stage IV&#xD;
                  melanoma, the pathology report confirming negative margins must be reviewed,&#xD;
                  dated, and signed by the Investigator prior to randomisation.&#xD;
&#xD;
          5. Cutaneous Melanoma, with metastases to regional lymph nodes or distant metastases, or&#xD;
             in transit metastases, that can be surgically resected with negative margin on&#xD;
             resected specimens.&#xD;
&#xD;
          6. Specimen from the resected tumour tissue must be provided for evaluation by NGS.&#xD;
&#xD;
          7. ECOG performance status score of 0 or 1.&#xD;
&#xD;
          8. Screening laboratory values must meet the following criteria and must be reconfirmed&#xD;
             for eligibility within 72 hours prior to first dose of anti-PD-1 on Day 1:&#xD;
&#xD;
             i. WBCs ≥ 2000/μL (2.0 x 109/L) ii. Neutrophils ≥ 1500/μL (1.5 x109/L) iii. Platelets&#xD;
             ≥ 100 x 10³/μL (100 x 109/L) iv. Haemoglobin ≥ 9.0 g/dL (90 g/L) v. Creatinine Serum&#xD;
             creatinine ≤ 1.5 x ULN or creatinine clearance &gt; 40 mL/minute (using Cockcroft/Gault&#xD;
             formula) vi. AST ≤ 3 x ULN vii. ALT ≤ 3 x ULN viii. Total Bilirubin ≥ 1.5 x ULN&#xD;
             (except patients with Gilbert Syndrome who must have total bilirubin &lt; 3.0 mg/dL)&#xD;
&#xD;
          9. Life expectancy &gt; 6 months at Screening.&#xD;
&#xD;
         10. WOCBP and men must agree to use adequate contraception (hormonal or barrier method of&#xD;
             birth control, abstinence) prior to study entry and for the duration of study&#xD;
             participation. Should a woman become pregnant or suspect she is pregnant while&#xD;
             participating in this study, she should inform her treating physician immediately.&#xD;
&#xD;
         11. WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L&#xD;
             or equivalent units of hCG]) within 24 hours prior to first dose of anti-PD-1 on Day&#xD;
             1.&#xD;
&#xD;
         12. WOCBP must agree to follow instructions for method(s) of contraception for the&#xD;
             duration of treatment with study drug (s) plus 5 half-lives of study drug plus 30 days&#xD;
             (duration of ovulatory cycle). The half-life of nivolumab is up to 25 days. WOCBP&#xD;
             should therefore use an adequate method to avoid pregnancy for a total of 23 weeks&#xD;
             post-treatment completion.&#xD;
&#xD;
         13. Men who are sexually active with a WOCBP must agree to follow instructions for&#xD;
             method(s) of contraception for the duration of treatment with study drug(s) plus 5&#xD;
             half-lives of the study drug(s) plus 90 days (duration of sperm turnover). The&#xD;
             half-life of nivolumab is up to 25 days, men should therefore use an adequate method&#xD;
             of contraception for a total of 31 weeks post-treatment completion.&#xD;
&#xD;
         14. Azoospermic males and WOCBP who are continuously not heterosexually active are exempt&#xD;
             from contraceptive requirements. However, WOCBP must still undergo pregnancy testing.&#xD;
&#xD;
         15. Disease-free at study enrolment (after surgery) based upon pathology report review by&#xD;
             the Investigator.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Known or active other malignancies that have needed treatment (excluding palliative&#xD;
             radiation) within 2 years prior to Cycle 1 Day 1 are excluded except for the&#xD;
             following:&#xD;
&#xD;
               1. Curatively resected non-melanomatous skin cancer&#xD;
&#xD;
               2. Curatively treated cervical carcinoma in situ&#xD;
&#xD;
               3. Non-metastatic breast and prostate cancer patients with stable disease &gt; 12&#xD;
                  months&#xD;
&#xD;
               4. Other stable malignancies may be permitted based on case-by-case discussions with&#xD;
                  Sponsor and Medical Monitor approval.&#xD;
&#xD;
          2. Patients with clinically occult lymph nodes (i.e. detected by SLN biopsy) stage N1a&#xD;
             and N2a.&#xD;
&#xD;
          3. Participated in any other investigational study, unless treatment in that study has&#xD;
             been discontinued at least 30 days or period of five half-lives prior to Screening.&#xD;
&#xD;
          4. Known or suspected allergy or hypersensitivity to any of the therapeutic agents to be&#xD;
             administered during the study.&#xD;
&#xD;
          5. Uncontrolled concurrent illness including, but not limited to, active infection,&#xD;
             symptomatic congestive heart failure or cardiac arrhythmia.&#xD;
&#xD;
          6. Has a history of clinically significant GI disease, renal, hepatic, neurologic,&#xD;
             haematologic, endocrine, oncologic, pulmonary, immunologic, or cardiovascular disease&#xD;
             or any other condition which, in the opinion of the Investigator, would jeopardise the&#xD;
             safety of the patient or impact the validity of the study results.&#xD;
&#xD;
          7. Uncontrolled mental disease or psychotic manifestation that, in the opinion of the&#xD;
             Investigator, would prohibit compliance with the protocol, the understanding of the&#xD;
             ICF, or the ability to withdraw from the study.&#xD;
&#xD;
          8. Known history of or positive test for HIV or known immunodeficiency syndrome (AIDS).&#xD;
&#xD;
          9. For patients with evidence of chronic HBV infection, the HBV viral load must be&#xD;
             undetectable on suppressive therapy, if indicated.&#xD;
&#xD;
         10. Patients with a history of HCV infection must have been treated and cured. For&#xD;
             patients with HCV infection who are currently on treatment, they are eligible if they&#xD;
             have an undetectable HCV viral load.&#xD;
&#xD;
         11. Pregnant or nursing women.&#xD;
&#xD;
         12. Ocular or uveal melanoma.&#xD;
&#xD;
         13. History of carcinomatosis meningitis.&#xD;
&#xD;
         14. History of Grade ≥ 3 allergy to human monoclonal antibodies.&#xD;
&#xD;
         15. Active, known, or suspected autoimmune disease or immunosuppressive conditions with&#xD;
             the exception of vitiligo, type 1 diabetes, residual autoimmune-related hypothyroidism&#xD;
             requiring hormone replacement, or psoriasis not requiring systemic treatment.&#xD;
&#xD;
         16. Prior treatment with immune-modulatory agents including, but not limited to: IL-2,&#xD;
             CTLA-4 blockade, PD-1/PD-L1 blockade, CD40 stimulation, CD137 stimulation - with the&#xD;
             exception of IFN-α given as adjuvant treatment for high risk, surgically resected&#xD;
             melanoma (Note. IFN-α therapy must have been discontinued more than 4 weeks prior to&#xD;
             enrolment in the study).&#xD;
&#xD;
         17. Prior investigational melanoma-directed cancer vaccine therapy.&#xD;
&#xD;
         18. Prior chemotherapy, including targeted therapy such as BRAF or MEK inhibition.&#xD;
&#xD;
         19. Use of a non-oncology vaccine therapy for prevention of infectious diseases up to 4&#xD;
             weeks prior to enrolment in the study.&#xD;
&#xD;
         20. Patients with a condition requiring systemic treatment with either corticosteroids&#xD;
             (&gt;10 mg daily prednisone equivalent) or other immunosuppressive medications within 14&#xD;
             days prior to first dose of anti-PD-1 on Day 1. Inhaled or topical steroids are&#xD;
             permitted in the absence of active autoimmune disease.&#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>Dr Bavanthi Balakrishnar</last_name>
    <role>Principal Investigator</role>
    <affiliation>Liverpool Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Liverpool Hospital</name>
      <address>
        <city>Goulburn</city>
        <state>New South Wales</state>
        <zip>2170</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Flinders Medical Centre</name>
      <address>
        <city>Adelaide</city>
        <state>South Australia</state>
        <zip>5042</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Monash Medical Centre</name>
      <address>
        <city>Clayton</city>
        <state>Victoria</state>
        <zip>3168</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ballarat Health Services</name>
      <address>
        <city>Drummond</city>
        <state>Victoria</state>
        <zip>3350</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peter Maccallum Cancer Centre</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Linear Cancer Trials</name>
      <address>
        <city>Nedlands</city>
        <state>Western Australia</state>
        <zip>6009</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>June 14, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>August 1, 2022</last_update_submitted>
  <last_update_submitted_qc>August 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 2, 2022</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>Melanoma</mesh_term>
  </condition_browse>
  <!-- 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/NCT04455503
org study id: EVX-02-001
nct id: NCT04455503
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a Phase 1/2, open label, multi-centre study to assess the safety, tolerability, PD,
      and efficacy of adjuvant immunotherapy EVX-02 vaccine and anti-PD-1 (Nivolumab) in patients
      who have had a complete resection of a Stage IIIB/IIIC/IIID or Stage IV melanoma who are at
      high risk of recurrence.
This study will be conducted in two parts: a safety, efficacy and PD response part using two
      different drug delivery methods and an expansion cohort.

      All patients will be administered with anti-PD-1 once every 4 weeks for up to 1 year
      commencing on Day 1 and with EVX-02 vaccine as soon as it is produced.

      Part 1 will consist of two cohorts:

      Cohort A: Will receive EVX- 02A delivered by delivery methodology 1. Cohort B: Will receive
      EVX- 02B delivered by delivery device 2. Part 2 (Cohort C) will be an expansion cohort. In
      this part, only one delivery methods, either EVX-02A or EVX-02B with will be used.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Safety and tolerability (Incidence of Treatment-Emergent Adverse Events)
time frame: Measurements at Baseline through study completion, an average of 1 year
description: Measure through CTCAE version 5.0
measure: Safety and tolerability (Incidence of Treatment-Emergent Adverse Events) measure through Vital Sign- blood pressure
time frame: Measurements at Baseline through study completion, an average of 1 year
description: Measured by result of the Vital Sign- blood pressure
measure: Safety and tolerability (Incidence of Treatment-Emergent Adverse Events) measure through Vital Sign-heart rate
time frame: Measurements at Baseline through study completion, an average of 1 year
description: Measured by result of the Vital Sign- heart rate
measure: Safety and tolerability (Incidence of Treatment-Emergent Adverse Events) measure through Physical exam
time frame: Measurements at Baseline through study completion, an average of 1 year
description: Measured by result of the physical exam which includes general appearance, skin, eyes/ears/nose/throat, head and neck.
measure: Pharmacodynamic response (PD) of EVX-02 assessed by IFN-y ELISPOT
time frame: Measurements at Baseline through study completion, an average of 1 year
description: The pharmacodynamic (PD) response of EVX-02 will be assessed by detecting vaccine induced circulating neoepitope-specific T cells. Blood samples will be collected prior, during and after immunization and the immunotherapy induced T cell responses will be assayed by IFN-y ELISPOT.
measure: Pharmacodynamic response (PD) of EVX-02 assessed by MHC I multimer analysis
time frame: Measurements at Baseline through study completion, an average of 1 year
description: The pharmacodynamic (PD) response of EVX-02 will be assessed by detecting vaccine induced circulating neoepitope-specific T cells. Blood samples will be collected prior, during and after immunization. The samples will be analyzed by MHC I multimer analyses detecting neoepitope-recognizing CD8+ T cells reported as frequencies of positive cell out of CD8+ T cells.
measure: Pharmacodynamic response (PD) of EVX-02 by intracellular cytokine staining and flow cytometry
time frame: Measurements at Baseline through study completion, an average of 1 year
description: The pharmacodynamic (PD) response of EVX-02 will be assessed by detecting vaccine induced circulating neoepitpe-specific T cells. Blood samples will be collected prior, during and after immunization. The samples will be analysed by flow cytometry to detect vaccine induced intracellular cytokine response, reported as frequencies of neoepitope-reactive CD4+ cells and CD8+ T cells.
measure: Efficacy measure through Relapse-free survival (RFS)
time frame: Measurements at Baseline through study completion, an average of 1 year
description: Measured by result of Relapse-free survival (RFS)
measure: PD response of EVX-02 assessed by monitoring the quantity of cfDNA in plasma
time frame: Measured at Screening, Day -84 to Day -1, Day 1, Day 84, Day 168, Day 252, Day 336 and early termination
description: To monitor the plasma level cfDNA, blood sample will be obtained prior, during and after treatment with EVX-02 and the fluctuations of the level cfDNA will be analysed.
arm group label: Cohort A: Nivolumab and EVX-02A
arm group type: Experimental
description: EVX-02A administered IM.
arm group label: Cohort B: Nivolumab and EVX-02B
arm group type: Experimental
description: EVX-02B administered IM.
arm group label: Cohort C: Nivolumab and EVX-02A OR Nivolumab and EVX-02B
arm group type: Experimental
description: The selected delivery methodology either EVX02A or EVX-02B.
intervention type: Drug
intervention name: EVX-02A
description: Up to 8 patients will receive EVX-02A administered IM.
arm group label: Cohort A: Nivolumab and EVX-02A
other name: A
intervention type: Drug
intervention name: EVX-02B
description: Up to 8 patients will receive EVX-02B administered IM.
arm group label: Cohort B: Nivolumab and EVX-02B
other name: B
intervention type: Drug
intervention name: EVX-02A OR EVX-02B
description: EVX-02A or EVX-02B will be used. Patients: 24 to 30
arm group label: Cohort C: Nivolumab and EVX-02A OR Nivolumab and EVX-02B
other name: C
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dr Bavanthi Balakrishnar
role: Principal Investigator
affiliation: Liverpool Hospital
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Australia
responsible party type: Sponsor
mesh term: Melanoma