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    Summary
    EudraCT Number:2018-001708-12
    Sponsor's Protocol Code Number:4518000
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-09-17
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - PEI
    A.2EudraCT number2018-001708-12
    A.3Full title of the trial
    A single arm phase II, open-label, multicenter trial to investigate the clinical activity and safety of avelumab in combination with cetuximab in subjects with unresectable stage III or stage IV cutaneous squamous cell carcinoma (cSCC)
    Einarmige, offene, multizentrische Phase II Studie zur Untersuchung der klinischen Aktivität und Sicherheit von Avelumab in Kombination mit Cetuximab bei Studienteilnehmern mit nicht reserzierbarem Plattenepithelkarzinom im Stadium III oder IV.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to test activity and safety of treatment with avelumab in combination with cetuximab in patients suffering from non-operable squamous cell skin cancer.
    Eine Studie zur Prüfung der Aktivität und Sicherheit einer Behandlung mit Avelumab in Kombination mit Cetuximab bei Patienten mit nicht operablen Plattenepithelkarzinom.
    A.3.2Name or abbreviated title of the trial where available
    AliCe (Avelumab in combination with cetuximab)
    AliCe (Avelumab in combination with cetuximab)
    A.4.1Sponsor's protocol code number4518000
    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 SponsorAlcedis GmbH
    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 Healthcare KGaA
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedizinische Hochschule Hannover
    B.5.2Functional name of contact pointSkin Cancer Center, Dermatology
    B.5.3 Address:
    B.5.3.1Street AddressCarl Neuberg Str. 1
    B.5.3.2Town/ cityHannover
    B.5.3.3Post code30625
    B.5.3.4CountryGermany
    B.5.4Telephone number+495115320
    B.5.5Fax number+4951153217
    B.5.6E-mailGutzmer.Ralf@mh-hannover.de
    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 Yes
    D.2.1.1.1Trade name BAVENCIO
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Europe B.V., Gustav Mahlerplein 102, NL-1082 MA Amsterdam
    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 nameAvelumab
    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 INNAVELUMAB
    D.3.9.1CAS number 1537032-82-8
    D.3.9.4EV Substance CodeSUB180078
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.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 ERBITUX
    D.2.1.1.2Name of the Marketing Authorisation holderMerck KGaA , D-64271 Darmstadt
    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 nameCetuximab
    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 INNCETUXIMAB
    D.3.9.1CAS number 205923-56-4
    D.3.9.4EV Substance CodeSUB01178MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Unresectable stage III or stage IV cutaneous squamous cell carcinoma (cSCC)
    Nicht resezierbares Plattenepithelkarzinom im Stadium III oder IV
    E.1.1.1Medical condition in easily understood language
    Non-operable squamous cell skin cancer
    Nicht operables Plattenepithelkarzinom
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10041834
    E.1.2Term Squamous cell carcinoma of skin
    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
    To evaluate efficacy in terms of objective response rate (ORR) after 3 months of combination therapy of avelumab and cetuximab according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
    Untersuchung der objektiven Ansprechrate (ORR) nach 3 Monaten unter Kombinationstherapie mit Avelumab und Cetuximab gemäß RECIST-Kriterien, v1.1 (Response Evaluation Criteria in Solid Tumors).
    E.2.2Secondary objectives of the trial
    • To evaluate efficacy in terms of progression-free survival (PFS) of avelumab in combination with cetuximab
    • To evaluate efficacy in terms of duration of objective response (DOR) of avelumab in combination with cetuximab
    • To evaluate efficacy in terms of overall survival (OS) of of avelumab in combination with cetuximab
    • To evaluate the safety profile according to CTCAE, Version 5.0 criteria of avelumab in combination with cetuximab
    • To evaluate the Quality of Life (QoL) of cSCC patients treated with avelumab in combination with cetuximab by use of the QLQ-C30 questionnaire
    • To evaluate best objective response and PFS according to immune related response criteria (irRC)
    • To identify biomarkers including PD-L1, gene and protein expression, genetic alteration predictive to the combination treatment
    • To identify biomarkers in relation to disease responses to avelumab
    • Progressionsfreies Überleben unter Kombinationstherapie von Avelumab und Cetuximab
    • Dauer des objektiven Ansprechens unter Kombinationstherapie von Avelumab und Cetuximab
    • Gesamtüberleben unter Kombinationstherapie von Avelumab und Cetuximab
    • Sicherheitsprofil (nach CTCAE-Kriterien, Version 5.0) der Kombinationstherapie von Avelumab und Cetuximab
    • Erhebung der Lebensqualität mit Hilfe des QLQ-C30 Fragebogens bei Patienten mit Plattenepithelkarzinom, die mit Avelumab in Kombination mit Cetuximab behandelt werden.
    • Erfassung des besten objektiven Ansprechens und progressionsfreies Überleben mit Hilfe immunbedingter Response-Kriterien (irRC)
    • Identifikation von Biomarkern inklusive PD-L1, Gen- und Protein-Expression, genetische Veränderungen, die für die Kombinationsbehandlung prädiktiv sind
    • Identifikation von Biomarkern in Bezug auf die Krankheitsantwort auf Avelumab
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Translational Research Project
    Translationales Forschungsprojekt
    E.3Principal inclusion criteria
    • Male or female subjects aged ≥ 18 years on day of signing informed consent
    • Histologically proven cSCC in stage III, not amendable to surgery / curative radiation, or stage IV (according to the 8th AJCC edition; see chapter 18.6)
    • ECOG performance status of 0 or 1
    • Measurable disease, i.e. at least one measurable lesion per RECIST, v1.1
    • Required values for initial laboratory tests:
    o Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L
    o Platelet count ≥ 100 × 10^9/L
    o Hemoglobin ≥ 9 g/dL (may have been transfused)
    o Total bilirubin level ≤ 1.5 × the upper limit of normal (ULN)
    o ALT and AST ≤ 2.5 × ULN (for subjects with documented metastatic disease to the liver: ≤ 5 x ULN)
    o Estimated creatinine clearance ≥ 30 mL/min according to the Cockcroft-Gault formula (or local institutional standard method)
    • No active or chronic infection with HIV, Hepatitis B or C
    • Negative serum pregnancy test for women of childbearing potential
    • Highly effective contraception for both male and female patients throughout the study and for at least 30 days after last dose of study medication administration if the risk of conception exists. Highly effective contraception has to be in line with the definition of the CTFG (Clinical Trial Facilitation Group) recommendation (see 18.7)
    • Signed written informed consent and capacity of understanding the informed consent
    • Männer oder Frauen ≥ 18 Jahre (am Tag der Unterschrift auf der Einverständniserklärung)
    • Histologisch nachgewiesenes Plattenepithelkarzinom Stadium III, das nicht durch Operation/kurative Bestrahlung beeinflussbar ist, oder Stadium IVemäß der 8. AJCC-Ausgabe; siehe Kapitel 18.6)
    • ECOG Status 0 oder 1
    • Messbare Erkrankung, d.h. mindestens eine messbare Läsion nach RECIST v1.1 Kriterien
    • Mindestvoraussetzungen für die initialen Laborwerte:
    o Absolute Neutrophilenzahl (ANC) ≥ 1.5 × 10^9/L
    o Thrombozyten ≥ 100 × 10^9/L
    o Hämoglobin ≥ 9 g/dL (ggfs. nach Transfusion)
    o Bilirubin (gesamt) ≤ 1.5 × oberer Normwert (ULN)
    o ALT und AST ≤ 2.5 × ULN (bei Studienteilnehmern mit dokumentierten Lebermetastasen: ≤ 5 x ULN)
    o Geschätzte Kreatinin-Clearance ≥ 30 mL/min nach der Cockcroft-Gault-Formel(oder örtlichem Laborstandard)
    • Keine aktive oder chronische Infection mit HIV, Hepatitis B oder C
    • Negativer Serumschwangerschaftstest bei Frauen im gebärfähigen Alter
    • Sowohl männliche als auch weibliche Studienteilnehmer müssen hochwirksame Verhütung während der Studie und bis mindestens 30 Tage nach der letzten Gabe der Studienmedikamente anwenden, sofern ein Konzeptionsrisiko besteht. Die hochwirksame Verhütung muss der Definition der Empfehlung der CTFG (Clinical Trial Facilitation Group) entsprechen (siehe 18.7).
    • Unterschriebene Einverständniserklärung von Patienten, die in der Lage sind, die Aufklärung zu verstehen
    E.4Principal exclusion criteria
    • Known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (NCI CTCAE v5.0 Grade ≥ 3)
    • Patients with brain metastases
    • Current use of immunosuppressive medication, EXCEPT for the following:
    o Intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection)
    o Systemic corticosteroids at physiologic doses ≤ 10 mg/day of prednisone or equivalent
    o Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)
    • Active autoimmune disease that might deteriorate when receiving an immuno-stimulatory agent. Patients with diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment are eligible.
    • Prior organ transplantation including allogeneic stem-cell transplantation
    • Active infection requiring systemic therapy
    • Known history of testing positive for HIV or known acquired immunodeficiency syndrome
    • Vaccination with any live vaccine (e.g. intranasal flu vaccine) within 4 weeks before the first dose of avelumab or planned vaccination with live vaccine during the trial
    • Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication
    • Current other malignancies, except
    o malignancies NOT requiring therapy such as B-CLL
    o adequately treated cone-biopsied in situ carcinoma of the cervix uteri and basal carcinoma of the skin
    • Other severe acute or chronic medical conditions including colitis, inflammatory bowel disease, pneumonitis, pulmonary fibrosis or psychiatric conditions including recent (within the past year) or active suicidal ideation or behavior; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study
    • Radiotherapy within 14 days prior to first dose of study treatment with the exception of palliative bone-directed radiotherapy, or radiotherapy administered on non-target superficial lesions
    • Any other systemic anti-tumor therapy in the last 4 weeks
    • Patients who discontinued prior check-point inhibitor therapy due to adverse reactions
    • Major surgery (excluding prior diagnostic biopsy) within 28 days prior to first dose of study treatment
    • Cytokine therapy (except erythropoietin) within 28 days prior to first dose of study treatment
    • Persisting toxicity related to prior therapy (NCI CTCAE v. 5.0 Grade > 1); however, alopecia, sensory neuropathy Grade ≤ 2, or other Grade ≤ 2 not constituting a safety risk based on investigator’s judgment are acceptable
    • Currently participating in or having participated in the treatment phase of a study of an investigational agent or using an investigational device within 4 weeks before registration and/or during study participation
    • Pregnancy or lactation period
    • Medical or psychological conditions that would not permit the patient to complete the study or sign informed consent
    • Known alcohol or drug abuse
    • Legal incapacity or limited legal capacity
    • Bekannte frühere Überempfindlichkeit gegen die Studienmedikation oder ihre Hilfsstoffe, inklusive schwerer Überempfindlichkeitsreaktionen gegenüber monoklonalen Antikörpern (NCI CTCAE v5.0 Grade ≥ 3)
    • Patienten mit Hirnmetastasen
    • Aktuelle Einnahme immunsupprimierender Medikamente, außer den folgenden:
    o Intranasale, inhalative, topische Steroide oder lokale Steroid-Injektionen (z.B. intra-artikuläre Injektionen)
    o Systemische Kortikosteroide in physiologischer Dosis (≤ 10 mg/Tag Prednison oder Äquivalent)
    o Steroide als Prämedikation gegen Überempfindlichkeitsreaktionen (z.B. Prämedikation für CT Untersuchungen)
    • Aktive Autoimmunerkrankungen, die bei Gabe eines Immunstimulators verschlechtert werden könnten. Patienten mit Typ I-Diabetes, Vitiligo, Psoriasis, oder Hypo- bzw. Hyperthyreose, die keine Immunsuppression benötigen, können in die Studie aufgenommen werden.
    • Vorherige Organtransplantation inklusiver allogener Stammzelltransplantation
    • Aktive Infektionen, die systemisch therapiert werden müssen
    • Bekannte Vorgeschichte von positivem HIV Test oder bekanntes erworbenes Immunschwächesyndrom (AIDS)
    • Impfung mit Lebendimpfstoff (z.B. intranasale Grippeimpfung) innerhalb von 4 Wochen vor der ersten Avelumab-Dosis oder geplante Impfung mit Lebendimpfstoff während der Studie
    • Klinisch signifikante (d.h. aktive) Herz-Kreislauf-Erkrankung: zerebraler Insult (<6 Monaten vor Einschluss in die Studie), Herzinfarkt (< 6 Monate vor Einschluss) instabile Angina pectoris, Herzversagen (≥ New York Heart Association Klassification Klasse II), oder schwerwiegende therapiepflichtige Arrhythmie
    • Aktuelle andere bösartige Erkrankungen mit Ausnahme von
    o bösartigen Erkrankungen, die NICHT therapiepflichtig sind, wie z.B. B-CLL
    o adäquat behandeltem konisiertem in situ Zervixkarzinom und Basaliom der Haut
    • Andere schwere akute oder chronische medizinische Zustände einschließlich Kolitis, entzündlicher Darmerkrankung, Pneumonitis, Lungenfibrose oder psychiatrischer Erkrankungen inklusive aktueller (innerhalb des letzten Jahres) Suizidgedanken oder Verhalten oder Laborwerte, die ein Risiko bei Studienteilnahme oder Anwendung des Prüfpräparates erwarten lassen oder die mit der Interpretation der Studienergebnisse interferieren könnten und durch die der Patient nach Meinung des Prüfarztes für die Studie ungeeignet würde
    • Radiotherapie innerhalb der 14 Tage vor Gabe der ersten Dosis des Studienmedikaments mit Ausnahme palliativer Bestrahlung der Knochen oder Bestrahlung oberflächlicher Läsionen, die keine Ziel-Läsionen sind.
    • Jede andere systemische Anti-Tumortherapie innerhalb der letzten 4 Wochen
    • Patienten, die eine frühere Therapie mit Check-point Inhibitoren wegen Nebenwirkungen abgebrochen haben
    • Große Operationen (außer vorheriger diagnostischer Biopsie) innerhalb von 28 Tagen vor der ersten Dosis der Studienmedikation
    • Zytokintherapie (außer Erythropoietin) innerhalb von 28 Tagen vor der ersten Dosis der Studienmedikation
    • Fortbestehende Toxizität nach vorheriger Therapie (NCI CTCAE v. 5.0 Grad > 1); Alopezie, sensorische Neuropathie und andere Grad ≤ 2 Toxizitäten, die nach Meinung des Prüfarztes kein Risiko darstellen, sind zulässig
    • Teilnahme in der Behandlungsphase einer klinischen Studie (Medikament oder Device) während der Laufzeit der Studie oder innerhalb von 4 Wochen vor Registrierung
    • Schwangerschaft oder Stillzeit
    • Medizinische oder psychologische Bedingungen, die es dem Patienten nicht erlauben würden, die Studie zu beenden oder eine Einverständniserklärung zu unterschreiben
    • Bekannter Alkohol- oder Drogenmissbrauch
    • Rechtsunfähigkeit oder eingeschränkte Rechtsfähigkeit
    E.5 End points
    E.5.1Primary end point(s)
    Objective response rate (ORR) after 3 months of cetuximab / avelumab combination therapy judged by investigator according to RECIST v1.1.
    Objektive Ansprechrate (ORR) nach 3 Monaten unter Kombinationstherapie mit Avelumab und Cetuximab, bestimmt durch den Prüfer, gemäß RECIST v1.1 (Response Evaluation Criteria in Solid Tumors)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Clinical assessment of cutaneous tumor lesions, incl. photography and RECIST v1.1,will be determined at baseline, and every 6 weeks of therapy.
    Imaging procedures will be done at baseline, and every 12 weeks of therapy.
    Klinische Beurteilung von kutanen Tumorläsionen, inkl. Fotografie und RECIST v1.1, werden zu Beginn und alle 6 Wochen der Therapie bestimmt.
    Bildgebende Verfahren werden zu Beginn und alle 12 Wochen der Therapie durchgeführt.
    E.5.2Secondary end point(s)
    - Progression-free survival
    - Duration of objective response
    - Overall survival
    - Safety
    Maximum CTAE grade per patient for AE, ADR, SAE and SADR
    - Quality of life
    Quality of life by use of the QLQ-C30 questionaire
    - Progressionsfreies Überleben
    - Dauer des objektiven Ansprechens
    - Gesamtüberleben
    - Sicherheit
    Maximaler CTAE-Grad pro Patient für AE, ADR, SAE und SADR
    - Lebensqualität
    Die Lebensqualität wird mit Hilfe des EORTC QLQ-C30 Fragebogens bestimmt
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Overall response rate every 6 weeks as determined by RECIST 1.1 criteria
    - Overall survival: study enrolement until the day of progression/death
    - Safety: during the whole study
    - Quality of life: will be determined by use of the QLQ-C30 questionaire every 12 weeks
    - Allgemeine Ansprechrate alle 6 Wochen (die Bestimmung erfolgt gemäß den RECIST 1.1 Kriterien)
    - Gesamtüberleben: Studienaufnahme bis zum Tag des Fortschritts / Todes
    - Sicherheit: während der gesamten Studie
    - Lebensqualität: wird anhand des QLQ-C30-Fragebogens alle 12 Wochen ermittelt
    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.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned10
    E.8.5The trial involves multiple Member States 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 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 (LPLV)
    Letzter Besuch des letzten Patienten (LPLV)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned 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) No
    F.1.2.1Number of subjects for this age range: 26
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 26
    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 state52
    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)
    Following the end of treatment evaluation or the end of study for any other cause, patients will be treated and followed according to the guidelines of the German Cancer Society.
    Nach dem Ende der Behandlung im Rahmen der Studie oder nach dem Ende der Studie für welchen Grund auch immer, werden die Patienten nach den Leitlinien der Deutschen Krebsgesellschaft weiter behandelt oder in Nachsorge übernommen.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-12-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-12-04
    P. End of Trial
    P.End of Trial StatusOngoing
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