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    Summary
    EudraCT Number:2016-003239-38
    Sponsor's Protocol Code Number:PH-L19TNFDOX2-03/16
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-08-30
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2016-003239-38
    A.3Full title of the trial
    A phase III study comparing the efficacy of the combination of doxorubicin and the tumor-targeting human antibody-cytokine fusion protein L19TNF to doxorubicin alone as first-line therapy in patients with advanced or metastatic soft tissue sarcoma
    Studio di fase III che confronta l'efficacia della combinazione di doxorubicina e della proteina di fusione anticorpo tumore specifico-citochina umana, L19TNF, con la sola doxorubicina come terapia di prima linea in pazienti con sarcoma dei tessuti molli in stato avanzato o metastatico
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study comparing the efficacy of the combination of doxorubicin and L19TNF to doxorubicin alone a in patients with advanced or metastatic soft tissue sarcoma
    Studio che confronta l'efficacia della combinazione di doxorubicina e L19TNF, con la sola doxorubicina in pazienti con sarcoma dei tessuti molli in stato avanzato o metastatico
    A.3.2Name or abbreviated title of the trial where available
    FIBROSARC
    FIBROSARC
    A.4.1Sponsor's protocol code numberPH-L19TNFDOX2-03/16
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04650984
    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 SponsorPHILOGEN S.P.A.
    B.1.3.4CountryItaly
    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 supportPhilogen S.p.A.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPhilogen S.p.A.
    B.5.2Functional name of contact pointRegulatory Department
    B.5.3 Address:
    B.5.3.1Street AddressLoc. Bellaria, 35
    B.5.3.2Town/ citySovicille (Siena)
    B.5.3.3Post code53018
    B.5.3.4CountryItaly
    B.5.4Telephone number057717816
    B.5.5Fax number05771781690
    B.5.6E-mailregulatory@philogen.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/16/1739
    D.3 Description of the IMP
    D.3.1Product nameOnfekafusp alfa
    D.3.2Product code [L19TNF]
    D.3.4Pharmaceutical form Solution for injection
    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 INNOnfekafusp alfa
    D.3.9.1CAS number 1957239-88-1
    D.3.9.2Current sponsor codeL19TNF
    D.3.9.3Other descriptive nameFibromun
    D.3.9.4EV Substance CodeSUB29010
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typeL19TNF è un nuovo agente con potenziale attività antitumorale, simile a un altro farmaco antitumorale già disponibile chiamato Tasonermin, Beromun (TNFalpha).
    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
    Unresectable or metastatic soft tissue sarcoma
    Sarcoma dei tessuti molli in stato avanzato non resecabile o metastatico
    E.1.1.1Medical condition in easily understood language
    Advanced or metastatic soft tissue sarcoma
    Sarcoma in stato avanzato o metastatico
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the trial is to evaluate whether L19TNF in combination with doxorubicin given for advanced or metastatic soft tissue sarcoma prolongs progression free survival, as compared to doxorubicin alone.

    The following efficacy endpoint will be considered:
    - Progression-free survival (PFS)
    L'obiettivo primario della sperimentazione è quello di valutare se L19TNF in combinazione con doxorubicina somministrato per il sarcoma dei tessuti molli in stato avanzato o metastatico prolunga la sopravvivenza libera da progressione, rispetto alla sola doxorubicina.

    Saranno considerati i seguenti endpoint di efficacia:
    - Sopravvivenza libera da progressione (PFS)
    E.2.2Secondary objectives of the trial
    To assess the efficacy, the following measurements will be considered:

    - Overall survival (OS)
    - Median Progression Free Survival (mPFS)
    - Median Overall Survival (mOS).
    - Overall Response Rate (ORR, consisting of CR and PR) and Best Overall Response Rate (BORR)

    To assess the safety profile of L19TNF combined with doxorubicin. The following safety endpoints will be considered:
    - Adverse Events (AEs) assessment based on CTCAE v.4.03.
    - Standard laboratory (haematology, biochemistry and urinalysis) parameters.
    - Physical examination findings including assessment of vital signs and physical measurements.
    Per valutare l'efficacia, saranno considerate le seguenti misure:
    - Sopravvivenza globale (OS)
    - Sopravvivenza mediana libera da progressione (mPFS)
    - Sopravvivenza globale mediana (mOS).
    - Tasso di risposta globale (ORR, composto da CR e PR) e miglior tasso di risposta globale (BORR)

    Per valutare il profilo di sicurezza di L19TNF in combinazione con doxorubicina, saranno considerati i seguenti endpoint di sicurezza:
    - Valutazione degli eventi avversi (AE) basata su CTCAE v.4.03.
    - Parametri di laboratorio standard (ematologia, biochimica e analisi delle urine).
    - Risultati dell'esame fisico, compresa la valutazione dei segni vitali e delle misurazioni fisiche.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patients must have histological evidence of advanced unresectable and/or metastatic high-grade soft tissue sarcoma (grade 2 – 3 according to the FNCLCC grading system) not amenable to curative treatment with surgery or radiotherapy. The following tumor types are included:
    – Malignant fibrous histiocytoma
    – Myxoid and round cell liposarcoma, pleomorphic liposarcoma or dedifferentiated
    – Liposarcoma
    – Pleomorphic rhabdomyosarcoma
    – Myxofibrosarcoma intermediate and high-grade
    – Fibrosarcoma
    – Leiomyosarcoma
    – Angiosarcoma
    – Alveolar rhabdomyosarcoma
    – Unclassified sarcoma NOS

    The following tumor types will not be included:
    – GIST
    – Mixed mesodermal tumor
    – Chondrosarcoma
    – Synovial sarcoma
    – Malignant peripheral nerve sheath tumor
    – Epithelioid sarcoma
    – Embryonal rhabdomyosarcoma
    – Malignant mesothelioma
    – Neuroblastoma
    – Osteosarcoma
    – Ewing's sarcoma / primitive neuroectodermal tumor
    – Desmoplastic small round cell tumor
    – Alveolar soft part sarcoma
    • Patients aged 18-75 years.
    • No prior therapy (except surgery and radiation) for the advanced or metastatic stage of soft tissue sarcoma.
    • Patients who had received prior anthracyclines will not be eligible.
    • Patients must have at least one unidimensionally measurable lesion by computed tomography as defined by RECIST criteria 1.1. This lesion should not have been irradiated during previous treatments.
    • Eastern Cooperative Oncology Group (ECOG) performance status of = 2.
    • Life expectancy of at least 3 months.
    I pazienti devono avere evidenza istologica di un sarcoma dei tessuti molli di alto grado in stato avanzato non resecabile e/o metastatico (grado 2 - 3 secondo il sistema di classificazione FNCLCC) non suscettibile di trattamento curativo con chirurgia o radioterapia. Sono inclusi i seguenti tipi di tumore:
    - Istiocitoma fibroso maligno
    - Liposarcoma mixoide e a cellule rotonde, liposarcoma pleomorfo o dedifferenziato
    - Liposarcoma
    - Rabdomiosarcoma pleomorfo
    - Mixofibrosarcoma di grado intermedio e alto
    - Fibrosarcoma
    - Leiomiosarcoma
    - Angiosarcoma
    - Rabdomiosarcoma alveolare
    - Sarcoma non classificato NOS

    I seguenti tipi di tumore non saranno inclusi:
    - GIST
    - Tumore mesodermico misto
    - Condrosarcoma
    - Sarcoma sinoviale
    - Tumore maligno della guaina del nervo periferico
    - Sarcoma epitelioide
    - Rabdomiosarcoma embrionale
    - Mesotelioma maligno
    - Neuroblastoma
    - Osteosarcoma
    - Sarcoma di Ewing / tumore neuroectodermico primitivo
    - Tumore desmoplastico a piccole cellule rotonde
    - Sarcoma alveolare delle parti molli

    - Pazienti di età compresa tra i 18 e i 75 anni.
    - Nessuna terapia precedente (eccetto chirurgia e radiazioni) per lo stato avanzato o metastatico del sarcoma dei tessuti molli.
    - I pazienti che hanno ricevuto in precedenza antracicline non saranno eligibili.
    - I pazienti devono avere almeno una lesione unidimensionalmente misurabile tramite tomografia computerizzata come definito dai criteri RECIST 1.1. Questa lesione non deve essere stata irradiata durante i trattamenti precedenti.
    - Eastern Cooperative Oncology Group (ECOG) performance status di = 2.
    - Aspettativa di vita di almeno 3 mesi
    E.4Principal exclusion criteria
    1. Prior therapy (except surgery and radiation) for unresectable or metastatic malignant soft tissue sarcoma.
    2. Previous treatment with anthracycline-containing chemotherapy.
    3. Radiotherapy within 4 weeks prior therapy.
    4. Known history of allergy to TNFa, anthracyclines or other intravenously administered human proteins/peptides/antibodies.
    5. Absolute neutrophil count (ANC) < 1.5 x 109/L, platelets < 100 x 109/L and haemoglobin (Hb) < 9.0 g/dl.
    6. Chronically impaired renal function as expressed by creatinine = 2.0 x ULN.
    7. Inadequate liver function (ALT, AST, ALP or total bilirubin = 2.5 x ULN, except for patients with liver metastasis , in which case values up to 3.0 x ULN are allowed).
    8. Any severe concomitant condition which makes it undesirable for the patient to participate in the study or which could jeopardize compliance with the protocol.
    9. History within the last year of acute or subacute coronary syndromes including myocardial infarction, unstable or severe stable angina pectoris.
    10. Heart insufficiency (> Grade II, New York Heart Association (NYHA) criteria).
    11. Clinically significant cardiac arrhythmias or requiring permanent medication.
    12. Uncontrolled hypertension, despite optimal therapy.
    13. Ischemic peripheral vascular disease (Grade IIb-IV according to Leriche-Fontaine classification).
    14. Severe diabetic retinopathy such as severe non-proliferative retinopathy and proliferative retinopathy.
    15. Major trauma including major surgery (such as abdominal/cardiac/thoracic surgery) within 4 weeks of administration of study treatment.
    16. Pregnancy or breast-feeding.
    17. Requirement of chronic administration of corticosteroids or other immunosuppressant drugs. Limited use of corticosteroids to treat or prevent acute hypersensitivity reactions is not considered an exclusion criterion.
    18. Presence of active and uncontrolled infections or other severe concurrent disease, which, in the opinion of the investigator, would place the patient at undue risk or interfere with the study.
    19. Known active or latent tuberculosis (TB).
    20. Concurrent malignancies other than Soft Tissue Sarcoma, unless the patient has been disease-free for at least 2 years.
    21. Growth factors or immunomodulatory agents within 7 days prior to the administration of study treatment.
    22. Serious, non-healing wound, ulcer or bone fracture.
    23. Allergy to study medication or excipients in study medication.
    24. Concurrent therapy with oral anticoagulants .
    25. Concurrent use of other anti-cancer treatments or agents other than study medication
    1. Terapia precedente (eccetto chirurgia e radiazioni) per sarcoma maligno non resecabile o metastatico dei tessuti molli.
    2. Precedente trattamento con chemioterapia contenente antracicline.
    3. Radioterapia nelle 4 settimane precedenti la terapia.
    4. Storia nota di allergia al TNFa, alle antracicline o ad altre proteine/peptidi/anticorpi umani somministrati per via endovenosa.
    5. Conta assoluta dei neutrofili (ANC) < 1.5 x 109/L, piastrine < 100 x 109/L ed emoglobina (Hb) < 9.0 g/dl.
    6. Funzione renale cronicamente compromessa espressa da creatinina = 2.0 x ULN.
    7. Funzione epatica inadeguata (ALT, AST, ALP o bilirubina totale = 2,5 x ULN, eccetto per i pazienti con metastasi epatiche, nel qual caso sono ammessi valori fino a 3,0 x ULN).
    8. Qualsiasi condizione concomitante grave che renda indesiderabile la partecipazione del paziente allo studio o che possa compromettere la conformità al protocollo.
    9. Storia nell'ultimo anno di sindromi coronariche acute o subacute incluso infarto miocardico, angina pectoris stabile instabile o grave.
    10. Insufficienza cardiaca (> Grado II, criteri New York Heart Association (NYHA)).
    11. Aritmie cardiache clinicamente significative o che richiedono una medicazione permanente.
    12. Ipertensione non controllata, nonostante la terapia ottimale.
    13. Malattia vascolare periferica ischemica (grado IIb-IV secondo la classificazione di Leriche-Fontaine).
    14. Retinopatia diabetica grave come la retinopatia non proliferativa grave e la retinopatia proliferativa.
    15. Trauma maggiore, compresa la chirurgia maggiore (come la chirurgia addominale/cardiaca/toracica) entro 4 settimane dalla somministrazione del trattamento di studio.
    16. Gravidanza o allattamento.
    17. Richiesta di somministrazione cronica di corticosteroidi o altri farmaci immunosoppressori. L'uso limitato di corticosteroidi per trattare o prevenire reazioni acute di ipersensibilità non è considerato un criterio di esclusione.
    18. Presenza di infezioni attive e incontrollate o altre gravi malattie concomitanti che, secondo l'opinione dello sperimentatore, metterebbero il paziente a rischio eccessivo o interferirebbero con lo studio.
    19. Tubercolosi attiva o latente (TB) nota.
    20. Tumori maligni concomitanti diversi dal sarcoma dei tessuti molli, a meno che il paziente sia stato libero da malattia per almeno 2 anni.
    21. Fattori di crescita o agenti immunomodulatori nei 7 giorni precedenti la somministrazione del trattamento di studio.
    22. Ferita grave e non cicatrizzante, ulcera o frattura ossea.
    23. Allergia al farmaco in studio o agli eccipienti del farmaco in studio.
    24. Terapia concomitante con anticoagulanti orali.
    25. Uso concomitante di altri trattamenti anti-tumorale o agenti diversi dal farmaco in studio
    E.5 End points
    E.5.1Primary end point(s)
    The primary objective of the trial is to evaluate whether L19TNF in combination with doxorubicin given for advanced or metastatic soft tissue sarcoma prolongs progression free survival, as compared to doxorubicin alone.

    The following efficacy endpoint will be considered:
    - Progression-free survival (PFS)
    L’obiettivo primario della sperimentazione sarà valutare se L19TNF in combinazione con doxorubicina possa prolungare la sopravvivenza libera da progressione da sarcoma dei tessuti molli in stadio avanzato o metastatico, rispetto alla sola doxorubicina.
    La sopravvivenza libera da progressione (PFS) sarà l'endpoint principale di efficacia che verrà preso in considerazione
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of study
    Fine dello studio
    E.5.2Secondary end point(s)
    To assess the efficacy, the following measurements will be considered:
    - Overall survival (OS)
    - Median Progression Free Survival (mPFS)
    - Median Overall Survival (mOS).
    - Overall Response Rate (ORR, consisting of CR and PR) and Best Overall Response Rate (BORR)

    To assess the safety profile of L19TNF combined with doxorubicin. The following safety endpoints will be considered:
    - Adverse Events (AEs) assessment based on CTCAE v.4.03.
    - Standard laboratory (haematology, biochemistry and urinalysis) parameters.
    - Physical examination findings including assessment of vital signs and physical measurements.
    ; Per valutare l’efficacia, saranno presi in considerazione i seguenti dati:
    - Sopravvivenza Globale (OS)
    - Sopravvivenza Libera da Progressione mediana (mPFS)
    - Sopravvivenza Globale mediana (mOS).
    - Percentuale di Risposta Complessiva al Trattamento (ORR, costituito da Risposta Completa e Parziale) e Miglior Percentuale di Risposta Complessiva al Trattamento (BORR)

    Per valutare il profilo di sicurezza di L19TNF in combinazione con doxorubicina, saranno considerati gli endpoint:
    - Analisi degli Eventi Avversi (AEs) sulla base del CTCAE v.4.03.
    - Parametri standard di laboratorio (ematologici, biochimici e analisi delle urine).
    - Esami fisici inclusa la valutazione dei segni vitali e misurazioni fisiche.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Median Overall survival (mOS) at 12 and 18 months
    - Overall response rate (ORR, consisting of CR and PR).
    - Progression-free survival (PFS) rate at 3, 6, 9, 12 and 18 months.
    - Overall survival (OS) rate at 12 and 18 months.

    Safety profile of L19TNF combined with doxorubicin: throughout the study; - Sopravvivenza globale mediana (mOS) a 12 e 18 mesi
    - Tasso di risposta globale (ORR, composto da CR e PR).
    - Tasso di sopravvivenza libera da progressione (PFS) a 3, 6, 9, 12 e 18 mesi.
    - Tasso di sopravvivenza globale (OS) a 12 e 18 mesi.

    Profilo di sicurezza di L19TNF in combinazione con doxorubicina: durante tutto lo studio
    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 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Doxorubicina
    Doxorubicin
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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 Information not present in EudraCT
    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
    Last Patient Last Visit
    Last Patient Last Visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years8
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial 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: 90
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 28
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 118
    F.4.2.2In the whole clinical trial 118
    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)
    Patients with partial response or stable disease after the maximum of 6 cylces of treatment will receive maintenance therapy with infusions of L19TNF every 3 weeks for up to 18 months, toxicity or until progression occurs.
    I pazienti con risposta parziale o malattia stabile dopo un massimo di 6 cicli di trattamento riceveranno una terapia di mantenimento con infusioni di L19TNF ogni 3 settimane per un massimo di 18 mesi, al presentarsi di tossicità o fino alla progressione della malattia.
    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 Decision2021-08-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-07-22
    P. End of Trial
    P.End of Trial StatusOngoing
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