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    Summary
    EudraCT Number:2021-000179-36
    Sponsor's Protocol Code Number:MS200647_0054
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-09-15
    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 number2021-000179-36
    A.3Full title of the trial
    An Open-label, Multicenter Follow-up Study to Collect Long-term Data on Participants from Multiple Bintrafusp alfa (M7824) Clinical Studies
    Studio di follow-up multicentrico in aperto per la raccolta di dati a lungo termine sui partecipanti di vari studi clinici su bintrafusp alfa (M7824)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An Open-label, Multicenter Follow-up Study to Collect Long-term Data on Participants from Multiple Bintrafusp alfa (M7824) Clinical Studies
    Studio di follow-up multicentrico in aperto per la raccolta di dati a lungo termine sui partecipanti di vari studi clinici su bintrafusp alfa (M7824)
    A.3.2Name or abbreviated title of the trial where available
    Bintrafusp alfa Program Rollover Study
    Studio di rollover del programma Bintrafusp alfa
    A.4.1Sponsor's protocol code numberMS200647_0054
    A.5.4Other Identifiers
    Name:IND numberNumber:124757
    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 SponsorMERCK KGAA
    B.1.3.4CountryGermany
    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 supportMerck KGaA
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck KGaA
    B.5.2Functional name of contact pointCommunication Center
    B.5.3 Address:
    B.5.3.1Street AddressFrankfurter Strasse 250
    B.5.3.2Town/ cityDarmstadt
    B.5.3.3Post code64293
    B.5.3.4CountryGermany
    B.5.4Telephone number496151725200
    B.5.5Fax number496151722000
    B.5.6E-mailservice@merckgroup.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 nameM7824
    D.3.2Product code [M7824]
    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 INNM7824
    D.3.9.2Current sponsor codeM7824
    D.3.9.3Other descriptive nameBintrafusp alfa
    D.3.9.4EV Substance CodeSUB179957
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 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
    Non-small cell lung cancer (NSCLC), biliary tract cancer (BTC), cervical cancer, and triple-negative breast cancer (TNBC)
    Carcinoma polmonare non a piccole cellule (NSCLC), carcinoma del tratto biliare (BTC), carcinoma della cervice uterina e carcinoma mammario triplo negativo (TNBC)
    E.1.1.1Medical condition in easily understood language
    Non-small cell lung cancer (NSCLC), biliary tract cancer (BTC), cervical cancer, and triple-negative breast cancer (TNBC)
    Carcinoma polmonare non a piccole cellule (NSCLC), carcinoma del tratto biliare (BTC), carcinoma della cervice uterina e carcinoma mammario triplo negativo (TNBC)
    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 10061873
    E.1.2Term Non-small cell lung 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 10073077
    E.1.2Term Intrahepatic cholangiocarcinoma
    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 10074879
    E.1.2Term Extrahepatic cholangiocarcinoma
    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 10017614
    E.1.2Term Gallbladder 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 PT
    E.1.2Classification code 10075566
    E.1.2Term Triple negative breast 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 Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate clinical safety of bintrafusp alfa in participants with solid tumors who continue treatment after completion of the primary/main analyses in parent bintrafusp alfa studies
    Valutare la sicurezza clinica di bintrafusp alfa nei partecipanti con tumori solidi che continuano il trattamento dopo il completamento delle analisi primarie/principali negli studi sui genitori bintrafusp alfa
    E.2.2Secondary objectives of the trial
    To evaluate clinical efficacy of bintrafusp alfa based on overall survival
    Per valutare l'efficacia clinica di bintrafusp alfa in base alla sopravvivenza globale
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Are = 18 years of age at the time of signing the informed consent. In Japan, if a participant is at least 18 but < 20 years of age, written informed consent from his/her parent or guardian will be required in addition to the participant’s written consent.
    2. Are participants currently enrolled in an eligible bintrafusp alfa parent study, as indicated in the protocol, where the primary/main analysis has been completed or after discontinuation of study before primary/main analysis has been completed and who:
    • Are currently on active bintrafusp alfa treatment (alone as a monotherapy or following discontinuation of other combination treatment agents) in the parent study and without treatment interruption at the time of rollover study enrollment, OR.
    • Experienced a confirmed CR, PR, or SD in an eligible parent study, discontinued bintrafusp alfa treatment according to the parent study protocol, and subsequently developed disease progression and are willing to re-start bintrafusp alfa treatment deemed potentially beneficial by the participants’ physicians OR.
    • Discontinued from bintrafusp alfa treatment in an eligible parent study due to an AE(s) that was subsequently well controlled or completely resolved after stopping therapy, provided that the parent study protocol permits reinitiation of bintrafusp alfa if a participant discontinued treatment due to toxicity and these participants are willing to re-start bintrafusp alfa treatment deemed potentially beneficial by the participants’ physicians. Participants who have had AEs requiring permanent treatment discontinuation, like certain irAEs or certain bleeding events, as described in the protocol, are excluded from participation in this Rollover study.
    • Have completed End of treatment (EoT) assessment of a parent study.
    3. Male and Female participants must agree to use appropriate contraception and barriers, if applicable. For female participants of childbearing potential or for male participants who have female partners of childbearing potential, the following applies:
    Participants on active treatment must agree to continue to use highly effective contraception (i.e., methods with a failure rate of less than 1% per year; as described in the protocol) for both male and female participants if the risk of conception exists (Note: The effects of the study intervention on the developing human fetus are unknown as described in the protocol; thus, women of childbearing potential and men must agree to use highly effective contraception as stipulated in national or local guidelines). Highly effective contraception must be used 28 days prior to the first study intervention administration, for the duration of study intervention, and at least for 2 months (for female participants) or 4 months (for male participants) after stopping study intervention. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, the treating physician should be informed immediately.
    4. Capable of giving signed informed consent as indicated in the protocol and to comply with the requirements and restrictions listed in the ICF and this protocol.
    1. Hanno = 18 anni di età al momento della firma del consenso informato. In Giappone, se un partecipante ha almeno 18 anni ma < 20 anni, oltre al consenso scritto del partecipante sarà richiesto il consenso informato scritto del suo genitore o tutore.
    2. I partecipanti sono attualmente arruolati in uno studio parente bintrafusp alfa idoneo, come indicato nel protocollo, in cui l'analisi primaria/principale è stata completata o dopo l'interruzione dello studio prima del completamento dell'analisi primaria/principale e che:
    • Sono attualmente in trattamento attivo con bintrafusp alfa (da solo come monoterapia o dopo l'interruzione di altri agenti di trattamento di combinazione) nello studio parentale e senza interruzione del trattamento al momento dell'arruolamento nello studio di rollover, OPPURE.
    • Ha riscontrato una CR, PR o SD confermata in uno studio genitore idoneo, ha interrotto il trattamento con bintrafusp alfa secondo il protocollo dello studio genitore e successivamente ha sviluppato una progressione della malattia ed è disposto a riprendere il trattamento con bintrafusp alfa ritenuto potenzialmente vantaggioso dai medici dei partecipanti O.
    • Interruzione del trattamento con bintrafusp alfa in uno studio genitore eleggibile a causa di uno o più eventi avversi che sono stati successivamente ben controllati o completamente risolti dopo l'interruzione della terapia, a condizione che il protocollo dello studio genitore consenta la ripresa di bintrafusp alfa se un partecipante ha interrotto il trattamento a causa di tossicità e questi partecipanti sono disposti a riprendere il trattamento con bintrafusp alfa ritenuto potenzialmente vantaggioso dai medici dei partecipanti. I partecipanti che hanno avuto eventi avversi che richiedono l'interruzione permanente del trattamento, come alcuni irAE o determinati eventi di sanguinamento, come descritto nel protocollo, sono esclusi dalla partecipazione a questo studio Rollover.
    • Aver completato la valutazione di fine trattamento (EoT) di uno studio parentale.
    3. I partecipanti di sesso maschile e femminile devono accettare di utilizzare contraccettivi e barriere appropriati, se applicabile. Per i partecipanti di sesso femminile in età fertile o per i partecipanti di sesso maschile che hanno partner di sesso femminile in età fertile, si applica quanto segue:
    I partecipanti al trattamento attivo devono accettare di continuare a utilizzare una contraccezione altamente efficace (cioè metodi con un tasso di fallimento inferiore all'1% all'anno, come descritto nel protocollo) sia per i partecipanti maschi che per le femmine se esiste il rischio di concepimento (Nota: Gli effetti dell'intervento dello studio sul feto umano in via di sviluppo sono sconosciuti come descritto nel protocollo; pertanto, le donne in età fertile e gli uomini devono accettare di utilizzare una contraccezione altamente efficace come previsto dalle linee guida nazionali o locali). Una contraccezione altamente efficace deve essere utilizzata 28 giorni prima della somministrazione del primo intervento di studio, per la durata dell'intervento di studio e almeno per 2 mesi (per i partecipanti di sesso femminile) o 4 mesi (per i partecipanti di sesso maschile) dopo l'interruzione dell'intervento di studio. Se una donna rimane incinta o sospetta di essere incinta mentre lei o il suo partner sta partecipando a questo studio, il medico curante deve essere informato immediatamente.
    4. In grado di fornire il consenso informato firmato come indicato nel protocollo e di rispettare i requisiti e le restrizioni elencati nell'ICF e nel presente protocollo.
    E.4Principal exclusion criteria
    1. Pregnancy or currently in lactation.
    2. Known hypersensitivity to any of the study intervention ingredients.
    3. For participants reinitiating treatment with bintrafusp alfa at study entry: have received any systemic anticancer therapies/treatments since discontinuing bintrafusp alfa treatment.
    4. Concurrent treatment with prohibited drugs as indicated in the protocol.
    5. Participant has withdrawn consent from the parent study for any reason.
    6. Any other reason that, in the opinion of the Investigator, precludes the participant from participating in the study.
    1. Gravidanza o attualmente in allattamento.
    2. Ipersensibilità nota a uno qualsiasi degli ingredienti dell'intervento in studio.
    3. Per i partecipanti che hanno ripreso il trattamento con bintrafusp alfa all'inizio dello studio: hanno ricevuto qualsiasi terapia/trattamento antitumorale sistemico dall'interruzione del trattamento con bintrafusp alfa.
    4. Trattamento concomitante con farmaci proibiti come indicato nel protocollo.
    5. Il partecipante ha ritirato il consenso allo studio genitore per qualsiasi motivo.
    6. Qualsiasi altro motivo che, a giudizio dello Sperimentatore, precluda al partecipante di partecipare allo studio.
    E.5 End points
    E.5.1Primary end point(s)
    Occurrence of AEs and treatment-related AEs
    Presenza di AE e AE correlati al trattamento
    E.5.1.1Timepoint(s) of evaluation of this end point
    Starting from baseline in parent study
    A partire dal basale nello studio parent
    E.5.2Secondary end point(s)
    Overall survival
    Sopravvivenza Globale
    E.5.2.1Timepoint(s) of evaluation of this end point
    Starting from baseline in parent study
    A partire dal basale nello studio parent
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    Tollerabilità
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Studio in Aperto
    Open Trial
    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.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA8
    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 Information not present in EudraCT
    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
    Brazil
    China
    Japan
    Korea, Republic of
    Turkey
    Ukraine
    United States
    Belgium
    France
    Italy
    Spain
    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
    The end of the study is defined as the date of the last scheduled procedure shown in the SoA for the last participant in the study and when there are no other eligible parent studies ongoing from which participants could enroll in this rollover study.
    La fine dello studio è definita come la data dell'ultima procedura programmata indicata nella SoA per l'ultimo partecipante allo studio e quando non sono in corso altri studi parentali idonei da cui i partecipanti potrebbero iscriversi a questo studio di rollover.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months3
    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: 22
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 17
    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 state1
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 10
    F.4.2.2In the whole clinical trial 39
    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 a participant has completed the study, has withdrawn consent, or has been withdrawn early, no further treatment is foreseen within the scope of this protocol. If required and in accordance with the study site’s SOC, symptom-guided appropriate treatment may be administered per the generally accepted medical practice and depending on the participant’s individual medical needs.
    On withdrawal from the study, participants may receive care they and their physicians agree upon.
    Dopo che un partecipante ha completato lo studio,ritirato il consenso o è stato ritirato in anticipo,non sono previsti ulteriori trattamenti in questo protocollo.Se necessario e in conformità con il SOC del sito di studio,può essere somministrato un trattamento appropriato guidato dai sintomi secondo la pratica medica generalmente accettata e in base alle esigenze mediche individuali del partecipante.
    Al ritiro dallo studio,i partecipanti possono ricevere cure concordate con i loro medici.
    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 Decision2021-11-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-09-29
    P. End of Trial
    P.End of Trial StatusCompleted
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