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    Summary
    EudraCT Number:2021-004594-32
    Sponsor's Protocol Code Number:IO102-IO103-013/MK3475-D18
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-12-17
    Trial 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 ConcernedFrance - ANSM
    A.2EudraCT number2021-004594-32
    A.3Full title of the trial
    An open-label, randomized, Phase 3 clinical trial of IO102-IO103 in combination with pembrolizumab versus pembrolizumab alone in patients with previously untreated, unresectable, or metastatic (advanced) melanoma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    IO102-IO103 in Combination With Pembrolizumab Versus Pembrolizumab Alone in Advanced Melanoma
    (IOB-013/KN-D18)
    A.3.2Name or abbreviated title of the trial where available
    IO102-IO103 in Combination With Pembrolizumab Versus Pembrolizumab Alone in Advanced Melanoma
    A.4.1Sponsor's protocol code numberIO102-IO103-013/MK3475-D18
    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 SponsorIO Biotech ApS
    B.1.3.4CountryDenmark
    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 supportIO Biotech ApS
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportMSD International GmbH
    B.4.2CountrySwitzerland
    B.4.1Name of organisation providing supportMSD International Business GmbH
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIO Biotech ApS
    B.5.2Functional name of contact pointclinical trials information
    B.5.3 Address:
    B.5.3.1Street AddressOle Maaløesvej 3
    B.5.3.2Town/ cityCopenhagen N,
    B.5.3.3Post codeDK-2200
    B.5.3.4CountryDenmark
    B.5.6E-mailinfo@iobiotech.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 nameIO102-IO103 + Montanide ISA 51 VG Sterile
    D.3.2Product code IO102-IO103
    D.3.4Pharmaceutical form Emulsion for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot yet assigned
    D.3.9.1CAS number 2130836-27-8
    D.3.9.2Current sponsor codeIO102
    D.3.9.3Other descriptive nameIO102, IDO LONG
    D.3.9.4EV Substance CodeSUB191065
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.255
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot yet assigned
    D.3.9.1CAS number 1431550-68-3
    D.3.9.2Current sponsor codeIO103
    D.3.9.3Other descriptive nameIO103
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.255
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    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 Yes
    D.2.1.1.1Trade name Keytruda
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme B.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical form Powder for concentrate 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 INNPembrolizumab
    D.3.9.2Current sponsor codepembrolizumab
    D.3.9.3Other descriptive namepembrolizumab
    D.3.9.4EV Substance CodeSUB167136
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number200 to 400
    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) 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.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
    Patients with previously untreated, unresectable or metastatic (advanced) melanoma
    E.1.1.1Medical condition in easily understood language
    Patients with untreated advanced skin cancer
    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 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to investigate the efficacy of IO102-IO103 in combination with pembrolizumab (compared with pembrolizumab alone) in terms of PFS.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to further explore the efficacy of IO102-IO103 in combination with pembrolizumab compared with pembrolizumab alone in terms of ORR, DRR, CRR and OS (see Section 6.2 and Section 17 of the protocol for the full list of secondary efficacy endpoints) and to investigate the safety and tolerability of the treatment.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Histologically or cytologically confirmed stage III (unresectable) or stage IV melanoma., as per American Joint Committee on Cancer 8th edition guidelines not amenable to local therapy (90).

    2. Patients are treatment naive, that is, no previous systemic anticancer therapy for unresectable or metastatic melanoma. For clarification, the following patients are eligible:
    a. Patients with BRAFV600 mutation-positive melanoma are eligible if treatment naive and without rapidly progressive disease as per investigator assessment.
    b. Patients who have received previous adjuvant and/or neoadjuvant therapy with targeted therapy or immune therapy are eligible if administered the last dose at least 6 months before inclusion in this trial (randomization), and if relapse did not occur during active treatment or within 6 months of treatment discontinuation.

    3. ECOG performance status score 0 or 1 assessed 7-10 days before randomization

    4. Life expectancy of >24 weeks at the time of signed informed consent per investigator assessment.

    5. At least 1 measurable lesion (not a cutaneous lesion) according to RECIST v1.1 and confirmed by IRC.

    6. Provision of archival (max 3 months), or newly acquired biopsy tissue not previously irradiated, and blood at screening for biomarker assessments. FFPE tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue.
    Note:
    • Use of archival tissue >3 months old, may be considered after communication with and agreement by the Sponsor.
    • If submitting unstained cut slides, newly cut slides should be submitted to the testing laboratory within 14 days from the date slides are cut (details pertaining to tumor tissue submission can be found in the Lab Manual).

    7. Adequate organ function as defined by:
    a. Haematology:
    i. Absolute neutrophil count ≥1500/μL or ≥1.5 × 10^9/L
    ii. Platelets ≥100,000/μL or ≥100 × 10^9/L
    iii. Hemoglobin ≥9.0 g/dL or ≥5.6 mmol/L
    b. Renal:
    i. Creatinine ≤1.5 × upper limit of normal (ULN), or
    ii. Measured or calculated creatinine clearance (CrCl) ≥60 mL/min for patients with creatinine levels > 1.5 × institutional ULN; Glomerular filtration rate can also be used in place of creatinine or CrCl
    c. Hepatic:
    i. Total bilirubin ≤1.5 × ULN or direct bilirubin ≤ ULN for patients with total bilirubin levels between 1.5 × ULN and ≤3 × ULN
    ii. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN (≤5 × ULN for patients with liver metastases)
    iii. Alkaline phosphatase ≤2.5 × ULN
    d. Endocrine:
    i. Thyroid stimulating hormone (TSH) within normal limits, or
    ii. Total triiodothyronine (T3) is within normal limits, or
    iii. Free T3 and free thyroxine (T4) are within the normal limits
    e. Coagulation:
    i. International randomized ratio, prothrombin time (PT) or activated PT time (aPTT) ≤1.5 × ULN unless patient is receiving anticoagulant therapy if PT or aPTT is within therapeutic range of intended use of anticoagulants

    8. Has recovered from major surgery or radiation therapy–(> 30 Gray [Gy]) induced AEs.

    9. AEs from previous anticancer therapies or interventions have resolved to at least Grade 1 or
    baseline value from screening (except for alopecia). Patients with Grade </-2 neuropathy may
    be eligible. Patients with endocrine-related AEs Grade </-2 requiring treatment or hormone
    replacement may be eligible.

    10. Patients are able and willing to provide written informed consent for the trial in accordance with ICH-GCP and local legislation before admission to the trial. The patient may also provide consent for future biomedical research; however, the patient may still participate in the trial without participating in future biomedical research.

    11. Aged ≥18 years on day of signing informed consent.

    12. A woman is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
    a. Not a woman of childbearing potential (WOCBP)
    b. A WOCBP who agrees to follow contraceptive guidance to 120 days after last dose.

    13. Patients who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis b virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load before randomization.
    Note: Patients should remain on anti-viral therapy throughout trial treatment and follow local guidelines for HBV anti-viral therapy after completion of trial treatment. Hepatitis B screening tests are not required unless:
    • Known history of HBV infection
    • As mandated by local health authority

    14. Patients with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening. Note: Patients must have completed curative anti-viral therapy at least 4 weeks before randomization. Hepatitis C screening tests are not required unless:
    a. Known history of HCV infection
    b. As mandated by local health authority.
    E.4Principal exclusion criteria
    1. Uveal/ocular melanoma

    2. Patients with known or suspected central nervous system (CNS) metastases or with the CNS as the only site of active disease are excluded with the following exception:
    • Patients with controlled (stable) brain metastases will be allowed to enroll

    3. Patient has received previous radiotherapy within 2 weeks of start of trial treatment (visit 2). A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.

    4. Patients with BRAFV600-positive disease who are experiencing rapidly progressing disease and/or have received standard first-line therapy with BRAF and/or MEK inhibitor for unresectable or metastatic disease.

    5. Active known or suspected autoimmune disease that has required systemic treatment in the past 2 years.

    6. Presence of other primary malignancies, with the exception of nonmelanoma skin cancer, carcinoma in situ or stage I nonulcerative melanoma, in situ cervical cancer, in situ breast cancer, and prostate cancer for patients who are receiving androgen deprivation therapy only. Other primary malignancies are only acceptable if there is no ongoing active disease and no biomarker indication of active disease.

    7. Active infection requiring systemic therapy

    8. History of active tuberculosis

    9. Active noninfectious pneumonitis/interstitial lung disease or a history of noninfectious pneumonitis/interstitial lung disease which required systemic steroids

    10. History of HIV infection. HIV testing is not required unless mandated by local health authorites.

    11. Concurrent active hepatitis B virus (defined as HBsAg positive and/or detectable HBV DNA) and /or concurrent Hepatitis C Virus (defined as anti-HCV Ab positive and detectable HCV RNA) infection.

    12. Received a live or live-attenuated vaccine within 30 days before the first dose of trial treatment. Administration of killed vaccines, mRNA based (e.g., covid-19) and vector based vaccines are allowed.

    13. Patient suffering from symptoms related to COVID-19 infection, who does not have immunity from vaccination or previous infection, and who cannot provide a negative PCR COVID-19 test from the last 72 hours.

    14. Known or suspected hypersensitivity to components of IMP or PD-1 inhibitor.

    15. Known adrenal insufficiency function (that is, basal cortisol level <140 nmol/L or < 5 μg/dL

    16. Received any of the following medications or procedures:
    a. Within 2 weeks before time of treatment initiation:
    i. Systemic or topical corticosteroids at immunosuppressive doses >10 mg/day of hydrocortisone or >5 mg/day of prednisone equivalent. Inhaled or topical steroids and adrenal replacement steroid doses >5 mg/day prednisone equivalent are permitted in the absence of active autoimmune disease.
    ii. Palliative radiation or gamma knife radiosurgery
    iii. Treatment with complementary medications (e.g., herbal supplements or traditional Chinese medicines) to treat the disease being studied. Such medications are permitted if they are used as supportive care.
    b. Within 4 weeks before time of treatment initiation:
    i. Allergen hyposensitization therapy
    ii. Growth factors
    iii. Major surgery or the patient has not recovered from surgery at the time of treatment
    initiation

    17. In the opinion of the investigator, the patient is unlikely to comply with the clinical trial protocol or has a known psychiatric or substance abuse disorder.

    18. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient’s participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator.

    19. Patients in close affiliation with the trial personnel, patients being a member of the clinical trial personnel, or being an employee of the sponsor or a clinical research organization involved in the trial.

    20. Patients who are institutionalized by court order or by the local authority.

    21. A WOCBP who is breastfeeding or pregnant.

    22. Patients who have had an allogenic tissue/solid organ transplant.

    23. Is currently participating in the active treatment phase of another clinical trial or has participated in a trial of an investigational agent or has used an investigational device within 6 months before the first dose of trial treatment.

    24. Has received any previous therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or coinhibitory TCR (e.g., CTLA-4, OX-40, CD137) within 6 months before randomization.

    25. Has received any previous therapy with IO102 and/or IO103.
    E.5 End points
    E.5.1Primary end point(s)
    PFS, defined as the time from randomization to the first documented disease progression (based on Independent Review Committee in accordance with RECIST v1.1) or death from any cause. Patients who have not progressed or died at the time of analysis will be censored at the date of assessment from their last disease assessment.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Time of progression
    E.5.2Secondary end point(s)
    Secondary efficacy endpoints:

    • Overall Response Rate (ORR) defined as the percentage of patients achieving a confirmed partial response (PR) or confirmed complete response (CR). ORR will be determined by the IRC in accordance with RECIST v1.1.

    • Durable Response Rate (DRR), defined as the percentage of patients achieving a PR or CR >182 days. DRR will be determined by the IRC in accordance with RECIST v1.1

    • Complete Response Rate (CRR) which will be determined by the IRC in accordance with RECIST v1.1

    • OS, defined as the time from randomization until death from any cause. Patients not known to have died will be censored at the date they were last known to be alive

    Other secondary endpoints:
    • Duration of Response (DoR) based on IRC

    • Time to Response (TTR) based on IRC

    • Time to Complete Response (TTCR) based on IRC

    • Disease Control Rate (DCR) based on IRC

    • PFS and ORR, which will be assessed by the investigator according to RECIST v1.1

    • Progression-free rate at 6 months (PFR6) based on IRC

    • Progression-free rate at 12 months (PFR12) based on IRC

    Safety and tolerability endpoints:
    • Incidence of AEs

    • Incidence of SAEs

    • Incidence of treatment-related AEs

    • Incidence of treatment-related SAEs

    • Incidence of AEs causing discontinuation of trial treatment
    E.5.2.1Timepoint(s) of evaluation of this end point
    Per statement for each endpoint
    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 Yes
    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 No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3.1Comparator description
    Pembrolizumab given as background treatment
    E.8.2.4Number of treatment arms in the trial2
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA37
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Czechia
    Denmark
    Germany
    Italy
    Netherlands
    Spain
    United States
    France
    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 years5
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months5
    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: 195
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 105
    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 state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 111
    F.4.2.2In the whole clinical trial 300
    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)
    None
    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 Decision2022-02-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-02-01
    P. End of Trial
    P.End of Trial StatusOngoing
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