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    Summary
    EudraCT Number:2021-003166-12
    Sponsor's Protocol Code Number:FRAME-001
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2022-01-06
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2021-003166-12
    A.3Full title of the trial
    A Phase II Trial of Personalized Tumor Neoantigen Based Vaccine FRAME-001 for Advanced Non-Small Cell Lung Cancer
    Een Fase II studie naar gepersonaliseerd tumor neoantigeen gebaseerd vaccin FRAME-001 voor Gevorderd Niet- Kleincellig Long Carcinoom
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    FRAME-001 personalized vaccine in NSCLC
    FRAME-001 gepersonaliseerd vaccin in Niet- Kleincellig Long Carcinoom
    A.3.2Name or abbreviated title of the trial where available
    FRAME-001
    A.4.1Sponsor's protocol code numberFRAME-001
    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 SponsorFrame Pharmaceuticals B.V.
    B.1.3.4CountryNetherlands
    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 supportFrame Pharmaceuticals B.V.
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFrame Pharmaceuticals B.V.
    B.5.2Functional name of contact pointOperations Manager
    B.5.3 Address:
    B.5.3.1Street AddressScience Park 106
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1098XG
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031202374970
    B.5.6E-mailtrials@frametherapeutics.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 nameFRAME-001
    D.3.2Product code FRAME-001
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    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) Yes
    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.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
    Advanced Non- small cell lung carcinoma (NSCLC)
    Gevorderd niet- kleincellig long carcinoom
    E.1.1.1Medical condition in easily understood language
    Advanced Non- small cell lung carcinoma (NSCLC)
    Gevorderd niet- kleincellig long carcinoom
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine FRAME-001-specific immune responses in peripheral blood after administration of FRAME-001 to patients with advanced NSCLC.
    Frame- 001 specifieke immuunreacties in perifeer bloed na toediening van FRAME- 001 in patienten met gevorderd NSCLC.
    E.2.2Secondary objectives of the trial
    Secondary objectives
    - To assess safety and tolerability of FRAME-001.
    - To evaluate clinical anti-tumor response to FRAME-001.
    - To assess survival after treatment with FRAME-001.

    Exploratory objectives
    - To determine changes in the peripheral blood immune profile following FRAME-001 vaccination.
    - To assess molecular responses based on circulating tumor DNA (ctDNA) in plasma.
    - To assess immune responses in the tumor tissue before and after administration of FRAME-001.
    - Correlate FRAME-001-specific immune response to PD-L1 expression of the tumor and to Framome status.
    Secudaire doelen
    - Bepalen van veiligheid en telerantie van FRAME- 001
    - Evalueren van klinische anti tumor respons op FRAME- 001
    - Bepalen van overleving na behandeling met FRAME- 001

    Onderzoekende doelen
    - Bepalen van veranderingen in perifeer bloed immuun profiel na FRAME- 001 vaccinatie
    - Bepalen van moleculaire response gebaseerd op circulerend tumor DNS in plasma
    - Bepalen van immuunreactie in tumorweefsel voor en na toediening van FRAME- 001
    - Correleren van FRAME- 001 specifieke immuunreactie aan PD-L1 expressie van de tumor en aan Framome status
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age ≥18 years.
    - Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
    - -Pathologically and radiologically confirmed advanced squamous or non-squamous NSCLC with SD after four cycles of treatment with pembrolizumab as monotherapy or in combination with chemotherapy (carboplatin/cisplatin and pemetrexed/paclitaxel) and suitable for maintenance treatment with pembrolizumab monotherapy.
    - Patient Framome identification with demonstrated frameshift mutations (Frames) completed as part of molecular pre-screening:
    o Presence of at least 3 expressed frameshift mutations;
    o A combined length of 100 amino acids for the neopeptides resulting from the frameshifts, with preferably more than 100 amino acids.
    o No mutations/genetic aberrations in genes relevant for MHC presentation (e.g., beta-2-microglobulin, human leukocyte antigen [HLA] genes).
    - An expected survival of at least 3 months.
    - Presence of tumor lesion(s) suitable for biopsy and radiological assessment as per RECIST v1.1 criteria.
    - Adequate renal function as defined by creatinine clearance > 40 mL/min based on the Cockroft-Gault glomerular filtration rate (GFR).
    - Adequate hepatic function as evidenced by:
    o Serum total bilirubin ≤ 2.5 × upper limit of normal (ULN) unless considered due to hepatic metastases.
    o Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤ 3.0 × ULN, unless considered due to hepatic metastases.
    - Ability to return to the hospital for adequate follow-up as required by this protocol.
    - For all women of childbearing potential (defined as < 2 years after last menstruation or not surgically sterile) must have a negative highly sensitive pregnancy test at screening (serum/urine) and agree to use highly effective method of contraconception according to European Union (EU) Clinical Trial Facilitation Group guidance from time of signing informed consent form until at least 120 days after the last administration of FRAME-001. The partners of participants of childbearing potential must also apply contraceptive methods and are recommended not to donate sperm.
    - Written informed consent according to International Conference on Harmonisation (ICH)-Good Clinical Practice (GCP).
    - Leeftijd ≥ 18 jaar
    - Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
    - Pathologische en radiologische bevestiging van squamous or non-squamous NSCLC met stabiele ziekte na vier cycli behandeling met pembrolizumab als monotherapie of in combinatie met chemotherapie (carboplatin/cisplatin en pemetrexed/paclitaxel) en geschikt voor onderhoudsbehandeling met pembrolizumab monotherapie.
    - Patient framome indetificatie met aangetoonde frameshift mutatie (frames) als onderdeel van de pre-screening:
    o Aanwezigheid van tenminste 3 tot expressie gebrachte frameshift mutaties
    o Een gecombineerde lengte van tenminste 100 aminozuren voor neopeptides als resultaat van de frameshifts met bij voorkeur meer dan 100 aminozuren
    o Geen mutaties/ genetic aberrations in genen die relevant zijn voor MHC presentatie (bijvoorbeeld beta-2-microglobuline, humaan leukocyte antigen [HLA] genen)
    - Een verwachte overleving van tenminste drie maanden
    - Aanwezigheid van tumorlesions geschikt voor biopsie en radiologisch onderzoek volgens RECIST 1.1 criteria
    - Adequate nierfunctie gedefinieerd door een Kreatinine klaring > 40 mL/min gebaseerd op de Cockroft-Gault glomerular filtration rate (GFR).
    - Adequate leverfunctie aangetoond door:
    o Serum totaal bilirubin ≤ 2.5 × upper limit of normal (ULN) tenzij veroorzaakt door levermetastasen
    o Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤ 3.0 × ULN, tenzij veroorzaakt door levermetastasen
    - Mogelijkheid om naar het ziekenhuis te komen voor voldoende opvolging
    - Voor alle vrouwen met de mogelijkheid zwanger te worden (gedefinieerd als < 2 jaar na de laatste menstruatie of niet gesteriliseerd) moeten een negatieve zwangerschapstest hebben en ermee instemmen voorbehoedsmiddelen te gebruiken volgens de European Union (EU) Clinical Trial Facilitation Group richtlijnen vanaf het moment van tekenen van informed consent form tot tenminste 120 dagen na de laatste FRAME- 001 toediening. De partners van deelnemers aan dit onderzoek moeten ook voorbehoedsmiddelen gebruiken en worden ontraden sperma te doneren.
    - Geschreven informed consent volgens de International Conference on Harmonisation (ICH)-Good Clinical Practice (GCP).
    E.4Principal exclusion criteria
    - Any active infection that according to investigator might interfere with FRAME-001 vaccination.
    - Patients planned or foreseen to receive systemic immunosuppressive treatment including corticosteroids during the trial are not eligible.
    - Use of systemic corticosteroids (or other immunosuppressive agents; >10mg daily prednisone equivalent). Inhaled, intranasal or topical and physiological replacement doses of up to 10 mg daily prednisone equivalent are permitted.
    - Live vaccine within 30 days prior to first dose of FRAME-001.
    - Concomitant participation in another clinical intervention trial (except participation in a
    biobank study).
    - Pregnant or lactating women.
    - Known allergy to any of the ingredients of the vaccine (i.e., synthetic long peptides, Montanide ISA 51 VG).
    - Any medical or psychological condition deemed by the Investigator to be likely to interfere with a patient’s ability to give informed consent or participate in the study.
    - Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
    - Patients with a currently active second malignancy. However, patients with the following history/concurrent conditions are allowed:
    o Basal or squamous cell carcinoma of the skin;
    o Carcinoma in situ of the cervix;
    o Carcinoma in situ of the breast;
    o Incidental histologic finding of prostate cancer.
    - Actieve infectie dat volgens de onderzoeker kan interfereren met FRAME- 001
    - Gelande of voorziene behandeling met immuunonderdrukkende middelen inclusief corticosteroiden tijdens de studiebehandeling
    - Gebruik van corticoseterioden (of andere immuunonderdrukkende middelen; >10mg dagelijkse prednison equivalent). Inhalatie, intranasaal of topicaal en fysiologische vervangings dosis tot 10 mg dagelijkse prednison equivalent is toegestaan)
    - Live vaccin binnen 30 dagen voorafgaand aan de eertste dosis FRAME- 001
    - Gelijktijdige deelname aan een andere klinische interventie studie (behalve deename aan een biobank studie)
    - Zwangere vrouwen of vrouwen die borstvoeding geven
    - Allergie voor een van de ingrdienten van het vaccin (bijvoorbeeld synthetische long peptides, Montanide ISA 51 VG).
    - Elke medische of fysiologische conditie die volgens de onderzoeker zou kunnen interfereren met de mogelijkheid van de patient om informed consent te geven of deel te nemen aan de studie
    - Elke fysiologische, familiaire, sociologische of geografische conditie die mogelijk het volgen van het studieprotocol en het opvolgschema kunnen belemmeren
    - Een actieve secundaire maligniteit. Patienten met die de volgende condities hebben gehad of hier nog aan voldoen zijn uitgezonderd:
    o Basale of squamous cel carcinoom van de huid
    o Carcinoma in situ van de baarmoederhals
    o Carcinoma in situ van de borst
    o Incidenteel histologisch prostaatkanker
    E.5 End points
    E.5.1Primary end point(s)
    Antigen-specific immune responses in peripheral blood to one or more Frame peptides following application of a personalized FRAME-001 vaccine, based on a positive outcome in one or more of the following assays:

    - 4-Day interferon gamma (IFNg) enzyme-linked immunospot (ELISpot) assay;
    - IFNg, tumor necrosis factor alpha (TNFa), and/or interleukin-2 (IL-2) producing CD4+ and/or CD8+ T cells determined in intracellular cytokine staining assay;
    - Specific cytokine production as measured by Th1/Th2 cytokine bead array in culture supernatants.
    Antigen-specifieke immuunreactie in perifeer bloed op een of meer Frame peptides na toediening van FRAME-001, gebaseerd op een positief resultaat in een of meer van de volgende testen:

    - Dag 4 interferon gamma (IFNg) enzyme-linked immunospot (ELISpot) testen;
    - IFNg, tumor necrosis factor alpha (TNFa), en/of interleukin-2 (IL-2) producerende CD4+ en/of CD8+ T cellen in een intracellulaire cytokine bepaling;
    - Specifieke cytokine productie bepaald met Th1/Th2 cytokine 'bead array' in kweek supernatanten.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primaire endpoint will be based on a positive outcome in one or more of the following assays:
    • 4-Day interferon gamma (IFNgamma) enzyme-linked immunospot (ELISpot) assay
    • IFNgamma, tumor necrosis factor alpha (TNFalpha), and/or interleukin-2 (IL-2) producing CD4+ and/or CD8+ T cells determined in intracellular cytokine staining assay
    • Specific cytokine production as measured by Th1/Th2 cytokine bead array in culture supernatants.
    Het primaire eindpunt zal worden gebaseerd op een positieve uitkomst in een of meerdere van de volgende assays:
    • 4-Day interferon gamma (IFNgamma) enzyme-linked immunospot (ELISpot) assay
    • IFNgamma, tumor necrosis factor alpha (TNFalfa), en/ of interleukin-2 (IL-2) producerende CD4+ en/ of CD8+ T cellen bepaald in intracellular cytokine staining assay
    • Specifieke cytokine productie gemeten inTh1/Th2 cytokine bead array in cultuur supernatanten.
    E.5.2Secondary end point(s)
    Secondairy endpoints
    - Incidence, type, grade, and number of adverse events (AEs) according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
    - Tumor response and tumor response duration according to Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 criteria.
    - Progression-free survival (PFS) and overall survival (OS).

    Exploratory endpoints
    - Phenotypic composition of and functional changes in immune cells in peripheral blood and changes in plasma cytokine levels after vaccination with FRAME-001 determined by immunomonitoring assays, including but not limited to multiparametric flow cytometry, enzyme-linked immunoadsorbent assay (ELISA), functional T cell assays (T cell proliferation, cytokine production), T cell receptor repertoire, and other relevant immunological assays.
    - Relative change in immune cell infiltration and expression of PD-1 on tumor infiltrating lymphocytes and PD-L1 on tumor and immune cells in tumor biopsy (if available) after vaccination with FRAME-001.
    - Analysis of ctDNA in plasma.
    - Correlation of immune responses to PD-L1 expression of the tumor, and to Framome status.
    Secundaire eindpunten
    - Voorkomen, type, gradering en aantal van adverse events (AEs) volgens to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
    - Tumor respons en duur van de tumor respons volgens Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 criteria.
    - Progressie vrije overleving en algehele overleving.

    Verkennende eindpunten
    - Fenotypische compositie van en functionele veranderingen in immuuncellen in perifeer bloed en veranderingen in plasma cytokine waarden na vaccinatie met FRAME- 001 bepaald door immunomonitoring assays, inclusief maar niet gelimiteerd aan multiparametric flow cytometry, enzyme-linked immunoadsorbent assay (ELISA), functionele T cell assays (T cell proliferatie, cytokine productie), T cell receptor repertoire, en andere relevante immunologischel assays.
    - Relatieve verandering in immuuncel infiltratie in tumorbiopten (indien beschikbaar) na vaccinatie met FRAME- 001
    - Analyse van ctDNA in plasma
    - Correlatie van immuunreactie aan PD-L1 expressie in de tumor en Framome status.
    E.5.2.1Timepoint(s) of evaluation of this end point
    These endpoints will be evaluated after termination of the trial after last patient last visit.
    De eindpunten zullen geevalueerd worden nadat de studie geeindigd is en de laatste patient de laatste visite heeft gehad.
    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) 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.8.3 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 concerned3
    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 No
    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. The trial will end when the last subject completes the last visit, discontinues from the trial or is lost to follow up.
    LVLS. Het onderzoek zal stoppen als het laatste subject de laatste visite heeft gehad, stopt met het onderzoek of niet langer gevolgd kan worden.
    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 months0
    E.8.9.1In the Member State concerned days0
    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: 5
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state15
    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
    Geen
    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 Decision2022-03-21
    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 StatusPrematurely Ended
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