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    Summary
    EudraCT Number:2021-004277-31
    Sponsor's Protocol Code Number:E012-HPV
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-09-10
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2021-004277-31
    A.3Full title of the trial
    A phase I/IIa open label study to assess the safety, tolerability, immunogenicity and clinical activity of EI-201 mRNA immunotherapy given intravenously in subjects with recurrent or metastatic HPV16 positive carcinoma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study to assess how safe and tolerable the therapy EI-201 is, how it induces an immune response and how it affects the tumor in cancer patients with a human papillomavirus 16 positive cancer
    A.4.1Sponsor's protocol code numberE012-HPV
    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 SponsoreTheRNA immunotherapies NV
    B.1.3.4CountryBelgium
    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 supporteTheRNA immunotherapies NV
    B.4.2CountryBelgium
    B.4.1Name of organisation providing supportHorizon2020 grant (no. 945011)
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCATO SMS
    B.5.2Functional name of contact pointProject Manager
    B.5.3 Address:
    B.5.3.1Street AddressStationsplein Noord-Oost 438
    B.5.3.2Town/ citySchiphol
    B.5.3.3Post code1117 CL
    B.5.3.4CountryNetherlands
    B.5.4Telephone number00310204350580
    B.5.6E-mailSSUReg@cato-sms.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 nameEI-201
    D.3.4Pharmaceutical form 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 INNmRNA encoding human papilloma virus (HPV)16 E6
    D.3.9.3Other descriptive namemRNA encoding Human Papillomavirus, serotype 16, E6 protein
    D.3.9.4EV Substance CodeSUB235419
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNmRNA encoding human papilloma virus (HPV)16 E7
    D.3.9.3Other descriptive namemRNA encoding Human Papillomavirus, serotype 16, E7 protein
    D.3.9.4EV Substance CodeSUB235395
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 Yes
    D.3.11.3.5.1CAT classification and reference numberNA. The EMA does not provide a reference number anymore.
    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.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.3.1Product namePembrolizumab
    D.3.2Product code MK-3475
    D.3.4Pharmaceutical form 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 codeMK-3475
    D.3.9.4EV Substance CodeSUB167136
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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.IMP: 3
    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.3.1Product namePembrolizumab
    D.3.2Product code MK-3475
    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 codeMK-3475
    D.3.9.4EV Substance CodeSUB167136
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    Incurable recurrent or metastatic (R/M) HPV16-positive (HPV16+) tumors (e.g. oropharyngeal cancer, cervical, vulvar, vaginal, anal, penile cancer, etc.)
    E.1.1.1Medical condition in easily understood language
    Incurable recurrent or spread cancer caused by the human papillomavirus type 16
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10067821
    E.1.2Term Head and neck cancer
    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 10008229
    E.1.2Term Cervical cancer
    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 10047777
    E.1.2Term Vulvar cancer
    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 PT
    E.1.2Classification code 10061424
    E.1.2Term Anal cancer
    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 PT
    E.1.2Classification code 10046885
    E.1.2Term Vaginal cancer
    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 PT
    E.1.2Classification code 10034299
    E.1.2Term Penile cancer
    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
    Cohort 1: To assess the safety and tolerability of IV administration of EI-201 as monotherapy in subjects with incurable R/M HPV16+ oropharyngeal and anogenital tumors and to select a starting dose of EI-201 for Cohort 2
    Cohort 2: To assess the safety and tolerability of IV administration of EI-201 as add on to pembrolizumab in subjects with incurable R/M HPV16+ oropharyngeal and anogenital tumors
    E.2.2Secondary objectives of the trial
    Cohort 1:
    - To assess the immune response following EI-201 administration in subjects with incurable R/M HPV16+HPV16+ oropharyngeal and R/M HPV16+ anogenital tumors
    - To assess the preliminary anti tumor activity of IV administration of EI-201 as monotherapy in subjects with incurable R/M HPV16+ oropharyngeal and anogenital tumors
    Cohort 2:
    - To assess the immunogenicity of EI-201 as add on to pembrolizumab in subjects with incurable R/M HPV16+HPV16+ oropharyngeal HNSCC and R/M HPV16+ anogenital tumors
    - To assess additional anti-cancer activity of EI-201 as add on to pembrolizumab in subjects with incurable R/M HPV16+HPV16+ oropharyngeal HNSCC and R/M HPV16+ anogenital tumors
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age greater than or equal to 18 years.
    -
    Cohort 1: Confirmed recurrent and/or metastatic (R/M) HPV16+ cancer (including oropharyngeal, cervical, vulval, vaginal, anal, penile cancer) based on expression analysis of HPV type 16 in tumor tissue by HPV 16 ISH or HPV E1 PCR. Cancer must have progressed after at least 1 available standard therapy for incurable disease, or the subject is intolerant to or refuses standard therapy(ies) or has a tumor for which no standard therapy(ies) exists.
    Cohort 2: Confirmed R/M HPV16+ oropharyngeal (based on expression of HPV type 16 in tumor tissue by HPV 16 ISH or HPV E1 PCR), and eligible for 1st line monotherapy pembrolizumab treatment OR Subjects with confirmed R/M anogenital HPV16+ cancer (cervical, anal, penile, vulvar, or vaginal cancer) confirmed by HPV 16 ISH or HPV E1 PCR. Maximum 2 previous systemic therapies with chemotherapy and/or targeted therapies for recurrent and/or metastatic disease, no prior aPD(L)-1, and a CPS>1.
    - At least one measurable lesion, as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1; Eisenhauer et al, 2009).
    - Subjects entering the study will need to consent to provide a tumor tissue sample (formalin fixed paraffin embedded blocks/slides less than 2 months old or older only upon approval by Sponsor) or a fresh biopsy.
    - Adequate hematologic function
    - Adequate renal and hepatic function
    - Adequate coagulation parameters
    E.4Principal exclusion criteria
    - Grade 3 or 4 peripheral neuropathy at time of screening.
    - Subjects with active or history of autoimmune disease or immune deficiency.
    - Subjects with serious intercurrent chronic or acute illness.
    - Subjects who have had a splenectomy.
    - Subjects with known hypersensitivity to any component of the Investigational Medicinal Product and/or pembrolizumab (Cohort 2).
    - Prior treatment with HPV therapeutic vaccines. Subjects may have received a preventive HPV vaccine.
    - Subjects who received an mRNA LNP based vaccine less than 30 days prior to start of the therapy.
    Additional Criteria for Cohort 2:
    - Chemotherapy, targeted small molecule therapy, or radiotherapy within 4 weeks prior to start of treatment with EI-201 for subjects with anogenital cancers.
    - Subjects who have received prior systemic therapy and/or active immunotherapy for HNSCC, such as antigen loaded dendritic cells, chimeric antigen receptor (CAR) T cells, or checkpoint inhibitors are excluded.
    E.5 End points
    E.5.1Primary end point(s)
    Cohort 1: DLT, MTD, RP2D, SAEs, frequency and severity of AEs of escalating doses of EI-201 as monotherapy per dose level using NCI CTCAE 5.0
    Cohort 2: DLT, MTD, RP2D, SAEs, AEs of EI-201 as add on to pembrolizumab using NCI CTCAE 5.0
    Cohort 2: ORR (based on CR/PR using RECIST v1.1 and iRECIST for highest dose level only).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Cohort 1: At screening, day 1, day 8, day 15, day 22, day 29, day 43, day 50
    Cohort 2: At screening, day 1, day 8, day 15, day 22, day 29, day 50, day 57, day 71, day 92, day 113, day 134, day 155, day 69, day 183
    E.5.2Secondary end point(s)
    Cohort 1: Number of immune responders to EI-201 per dose level
    Cohort 1: ORR (based on CR/PR using RECIST v1.1 and iRECIST)
    Cohort 2: Immune response to EI-201 as add on to pembrolizumab at each visit
    Cohort 2:
    - BOR based on CR, SD, PR, progressive disease (PD) and overall response at each visit by RECIST 1.1 and iRECIST
    - ORR (based on CR/PR using iRECIST and RECIST 1,1 for all dose levels)
    - Overall survival (OS)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Cohort 1: At screening, day 1, day 8, day 15, day 22, day 29, day 43, day 50
    Cohort 2: At screening, day 1, day 8, day 15, day 22, day 29, day 50, day 57, day 71, day 92, day 113, day 134, day 155, day 69, day 183
    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 Yes
    E.6.7Pharmacodynamic Yes
    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) Yes
    E.7.1.1First administration to humans Yes
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Dose escalation and dose expansion
    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 Yes
    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.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA6
    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 years2
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months4
    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: 33
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 33
    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 state11
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 66
    F.4.2.2In the whole clinical trial 66
    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)
    After participation in the trial, subjects will continue treatment in accordance with clinical practice, i.e. as per local guidelines and SoC.
    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 Decision2021-11-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-12-23
    P. End of Trial
    P.End of Trial StatusOngoing
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