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    Summary
    EudraCT Number:2017-002474-39
    Sponsor's Protocol Code Number:VBN-01
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2017-08-04
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - PEI
    A.2EudraCT number2017-002474-39
    A.3Full title of the trial
    An open-label first-in-human phase 1/2a study to evaluate safety, feasibility and efficacy of multiple dosing with individualised VB10.NEO or VB10.NEO and bempegaldesleukin (NKTR-214) immunotherapy in patients with locally advanced or metastatic melanoma, NSCLC, clear renal cell carcinoma, urothelial cancer or squamous cell carcinoma of head
    and neck, who did not reach complete responses with current standard of care immune checkpoint blockade
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A first in-human study to evaluate safety, feasibility and efficacy of multiple dosing with individualised immunotherapy (VB10.NEO) or VB10.NEO and bempegaldesleukin (NKTR-214) immunotherapy in patients with locally advanced or metastatic melanoma, NSCLC, clear renal cell carcinoma, urothelial cancer or squamous cell carcinoma of head and neck, who did not reach complete responses with current standard of care immune checkpoint blockade
    A.4.1Sponsor's protocol code numberVBN-01
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNykode Therapeutics AS
    B.1.3.4CountryNorway
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNykode Therapeutics AS
    B.4.2CountryNorway
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNykode Therapeutics AS
    B.5.2Functional name of contact pointMedical Expert
    B.5.3 Address:
    B.5.3.1Street AddressOslo Science Park, Gaustadalléen 21
    B.5.3.2Town/ cityOslo
    B.5.3.3Post code0349
    B.5.3.4CountryNorway
    B.5.4Telephone number+4722958193
    B.5.6E-mailstorhaug@nykode.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameVB10.NEO
    D.3.2Product code pVB10.NEO
    D.3.4Pharmaceutical form Solution for injection in needle-free injector
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNpVB10.NEO
    D.3.9.2Current sponsor codeVB10.NEO
    D.3.9.3Other descriptive nameAntineoplastic agent
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Yes
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product Yes
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameBempegaldesleukin
    D.3.2Product code NKTR-214
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBempegaldesleukin (NKTR-214)
    D.3.9.2Current sponsor codeNKTR-214
    D.3.9.3Other descriptive nameImmunotherapeutic protein drug
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Locally advanced or metastatic solid tumours including melanoma, NSCLC, clear renal cell carcinoma, urothelial cancer or SCCHN
    E.1.1.1Medical condition in easily understood language
    Locally advanced or metastatic melanoma, non-small cell lung cancer, clear renal cell carcinoma, urothelial cancer or squamous cell carcinoma of head and neck
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10027481
    E.1.2Term Metastatic melanoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10029514
    E.1.2Term Non-small cell lung cancer NOS
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10038409
    E.1.2Term Renal cell carcinoma NOS
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10077840
    E.1.2Term Urothelial cancer of renal pelvis
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10041823
    E.1.2Term Squamous cell carcinoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the safety/tolerability of multiple doses of 3 mg VB10.NEO immunotherapy and of multiple doses of
    3 mg VB10.NEO immunotherapy in combination with 0.006 mg/kg bempegaldesleukin.

    To determine the feasibility of VB10.NEO (overall process feasibility from biopsy, sequencing, neoepitope selection and vaccine manufacturing).
    E.2.2Secondary objectives of the trial
    To assess the immunogenicity of multiple doses of 3 mg VB10.NEO immunotherapy and of multiple doses of
    3 mg VB10.NEO immunotherapy in combination with 0.006 mg/kg bempegaldesleukin.

    To make additional preliminary assessments of the efficacy of multiple doses of 3 mg VB10.NEO immunotherapy and of multiple doses of 3 mg VB10.NEO immunotherapy in combination with 0.006 mg/kg bempegaldesleukin.

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    For patients with melanoma:
    1. Have histologically confirmed locally advanced or metastatic melanoma not amenable to local treatment
    2. Patients must be on CPI (i.e. anti-programmed cell death protein 1 [anti-PD-1] or anti-programmed cell death protein ligand 1[anti-PD-L1]) or must initiate treatment with CPI (e.g. nivolumab or pembrolizumab) as part of their cancer treatment as prescribed by the treating physician
    For patients with lung cancer:
    1. Have histologically confirmed locally advanced or metastatic NSCLC not amenable to local treatment
    2. Patients must have been on CPI (i.e. anti-PD1 or anti-PD-L1) for at least 12 weeks before screening and must be on CPI treatment as part of their cancer treatment as prescribed by the treating physician, n, e.g. nivolumab, pembrolizumab, atezolizumab or durvalumab.
    For patients with renal cancer:
    1. Have histologically confirmed locally advanced or metastatic clear RCC not amenable to local treatment
    2. Patients must have been on CPI (i.e. anti-PD1 or anti-PD-L1) for at least 12 weeks before screening and must be on CPI treatment as part of their cancer treatment as prescribed by the treating physician, e.g. nivolumab
    For patients with urothelial carcinoma:
    1. Have histologically confirmed locally advanced or metastatic urothelial carcinoma not amenable to local treatment
    2. Patients must have been on CPI (i.e. anti-PD1 or anti-PD-L1) for at least 12 weeks before screening and must be on CPI treatment as part of their cancer treatment as prescribed by the treating physician, e.g. nivolumab, pembrolizumab or atezolizumab
    Inclusion criteria for patients with head and neck cancer:
    1. Have histologically confirmed locally advanced or metastatic SCCHN not amenable to local treatment.
    2. Patients must be on CPI (i.e. anti-PD-1 or anti-PD-L1) or must initiate treatment with CPI at screening as part of their cancer treatment as prescribed by the treating physician, e.g. nivolumab or pembrolizumab.
    Inclusion criteria for patients in all arms:
    3. 18 years or older
    4. Patients who have been on CPI for longer than 12 weeks at screening need to be per RECIST:
    a. in partial response or
    b. stable disease or
    c. in progression, i.e. in case of a mixed response to CPI treatment, provided that at least 1 lesion shows measurable regression and who, according to the investigator, have a clinical benefit of continued immunotherapy.
    5. Adequate tumour specimen (at least 1 core biopsy) must be available for exome sequencing, preferably a newly acquired FF sample. Archival FFPE samples from biopsies or resected tumour material taken < 4 months before screening can be accepted.
    Inclusion criteria 6 was deleted.
    Inclusion criteria 7 was deleted.
    8. Measurable disease per RECIST v1.1. Preferably 2 tumour sites should be available, one for biopsy and one for RECIST assessment.
    9. ECOG performance status ≤ 1
    10. Life expectancy of at least 6 months in the best judgement of the investigator
    11. Willing and able to sign a written informed consent form (ICF)
    E.4Principal exclusion criteria
    1. Ocular melanoma
    2. Brain metastases (unless treated, controlled, stable for at least 6 weeks) or leptomeningeal spread of disease
    3. Positive serological test for hepatitis B or C virus surface antigen or HIV
    4. Other concomitant or prior malignant disease except for adequately treated basal cell carcinoma or other non-melanomatous skin cancer, low-grade urothelial cancer or other malignancies treated with curative intent within 2 or more years pre-study entry and in complete remission at study entry
    5. Immune disorder requiring the continued use (> 7 days) of high-dose systemic steroids or immunosuppressive agents for any concurrent condition, or a documented history of clinically significant autoimmune disease, as assessed by the investigator. Systemically administered corticosteroids must be discontinued > 4 weeks prior to first study vaccine administration.
    Exclusion criteria 6 deleted.
    7. Known allergy to aminoglycosides or to any of the IMP’s components/excipients
    Exclusion criteria 8 deleted.
    9. History of toxic shock syndrome
    10. Evidence or history of clinically significant cardiac disease including congestive heart failure, unstable angina, acute myocardial infarction or cerebrovascular accident within the last 6 months, and symptomatic arrhythmia requiring therapy
    11. Ongoing toxicity from prior therapy that is > Grade 2 for skin toxicities and > Grade 1 for all other toxicities, or that is progressing in severity, except toxicities not considered a safety risk
    12. History of life-threatening organ toxicity of Grade 4 related to CPI exposure, excluding endocrinopathies
    13. Acute infections
    14. Active lesions/rashes or any implantable devices within 2cm of the site of vaccination
    15. Current participation in a clinical trial (allowed if not exposed to IMP)
    16. Planned vaccination against infections within 30 days before start of treatment.
    17. Previous transplantations
    18. Inadequate bone marrow function: Platelet count < 50,000 cells/µL
    19. Patients requiring therapeutic anticoagulation due to medical condition are eligible but have to be excluded in case of not sufficiently manageable anticoagulation treatment or history of severe bleeding episodes due to therapeutic anticoagulation
    20. Inadequate liver function:
    • Serum total bilirubin >1.5 x ULN for the institution; patients with Gilbert’s Syndrome >3 x ULN
    • AST or ALT >3 x ULN; patients with liver metastases > 5 x ULN
    • By the investigator's judgement, patients exceeding the above limits as an effect of CPI treatment should be excluded; patients exceeding the above limits due to the course of malignancy may be enrolled
    21. Inadequate renal function:
    • Estimated CrCl of ≤30 mL/min
    • Proteinuria >100 mg/dL
    22. Clinically significant uncorrected electrolyte abnormalities that are CTCAE Grade 3 or higher for both low and high values
    23. Female patients of childbearing potential not willing to use a highly effective form of contraception during treatment and for at least 6 months after the last dose of VB10.NEO or NKTR-214
    24. Pregnancy or intention to become pregnant during the study period (serum/urine pregnancy test: screening, day of vaccination, prior to treatment start)
    25. Nursing women
    26. Evidence of any other medical conditions that may interfere with study participation, affect patient compliance or place the patient at high risk from treatment-related complications
    Exclusion criteria for patients enrolled to arm 5B:
    27. Patient has received prior IL-2 therapy
    28. Need for > 2 antihypertensive medications for management of hypertension. Patients must be on a stable antihypertensive regimen for the last 14 days prior to the first NKTR-214 dose.
    29. Documented left ventricular ejection fraction ≤ 45% using standard echocardiogram within 60 days prior to the first NKTR-214 dose
    30. Known cardiovascular history including unstable or deteriorating cardiac disease within the previous 12 months prior to screening including but not limited to unstable angina or myocardial infarction, TIA/CVA, congestive heart failure, uncontrolled clinically significant arrhythmias
    31. History of pulmonary embolism, deep vein thrombosis, or prior clinically significant venous or non-CVA/TIA
    arterial thromboembolic event within 3 months prior to the first NKTR-214 dose
    32. Male patients who have a female partner of childbearing potential and do not agree to use double-barrier contraception throughout the duration of the study until 6 months following the last dose of IMP, female partner must agree to use either an intrauterine device or hormonal contraception throughout their male partner’s study duration until 6 months following the last dose of IMP. Not applicable for male patients who have had a vasectomy > 6 months before signing the ICF.
    33. Significant clinical chemistry abnormalities (including inadequate organ function) as per investigator and within 14 days prior to the first NKTR-214 dose
    E.5 End points
    E.5.1Primary end point(s)
    Safety/Tolerability:
    • Rate of adverse events (AEs) including serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) and CTCAE grade
    - total number and severity
    - leading to treatment discontinuation
    • Results of physical examinations and vital signs
    • Results of safety laboratory
    • Changes in ECOG performance status
    • Changes in electrocardiogram (ECG) results

    Feasibility:
    Duration of manufacturing time for VB10.NEO drug products and failure to treat (feasibility).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Extent of exposure will be described by whether the patient took any investigational product along with the number of days of exposure (last date of dosing minus first day of dosing plus 1).
    E.5.2Secondary end point(s)
    Immunogenicity, Biomarkers and Cytokines:
    • Descriptive analysis of the cellular immune response against the individual neoepitopes (enzyme-linked immunospot assay).
    • Descriptive analysis of potential predictive biomarkers for immunological activity or clinical efficacy.
    • Descriptive analysis of proteomics.
    • Descriptive analysis of the development of the mutagenic landscape over time.
    • Descriptive analysis of the fine characterisation of neoantigen-specific T cells (for patients in arms 5A and 5B).
    • Descriptive analysis of the flow cytometry to analyse changes in markers of immune cell populations, including, but not limited to, markers for T lymphocytes, regulatory T cells, and T cell activation.

    Efficacy:
    Description of early signs of efficacy of VB10.NEO and NKTR-214 immunotherapy by means of:
    • Objective Response Rate (ORR)
    • Duration of Response (DOR)
    • Progression-free survival (PFS)
    • Overall survival (OS)
    • Lesion development over time

    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy analyses will be done separately for each tumour entity-specific cohort. The efficacy endpoints will be analysed descriptively including 95% confidence intervals for proportions wherever applicable.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans Yes
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned9
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 70
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 21
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state101
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    All subjects who end their participation in the trial will continue to be monitored by their respective physicians, using standard medical care.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-01-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-11-17
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2023-01-30
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