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    Summary
    EudraCT Number:2019-003714-14
    Sponsor's Protocol Code Number:4213000
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-12-14
    Trial results View 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 ConcernedAustria - BASG
    A.2EudraCT number2019-003714-14
    A.3Full title of the trial
    Modulation of the FOLFIRI-based standard 1st-line therapy with cetuximab, controlled by monitoring the RAS mutation load by liquid biopsy in RAS-mutated mCRC patients
    Anpassung einer FOLFIRI-Erstlinientherapie mit Cetuximab durch Kontrolle des RAS-Mutationsstatus mittels ‚Liquid Biopsy‘ bei Patienten mit RAS-mutiertem, metastasiertem Kolorektalkarzinom
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study evaluating the efficacy of cetuximab in combination with FOLFIRI in patients with metastatic colorectal cancer after positive genetic testing of cancer cells
    Eine Studie zur Überprüfung der Wirksamkeit von Cetuximab in Kombination mit FOLFIRI bei Patienten mit metastasiertem Darmkrebs nach erfolgter positiver genetischer Untersuchung der Krebszellen
    A.3.2Name or abbreviated title of the trial where available
    MoLiMoR
    MoLiMoR
    A.4.1Sponsor's protocol code number4213000
    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 SponsorTheraOp gGmbH
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMerck Serono GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEvangelisches Krankenhaus Hamm
    B.5.2Functional name of contact pointPD Dr. med. Alexander Baraniskin
    B.5.3 Address:
    B.5.3.1Street AddressWerler Str. 110
    B.5.3.2Town/ cityHamm
    B.5.3.3Post code59063
    B.5.3.4CountryGermany
    B.5.4Telephone number+4923815891863
    B.5.5Fax number+4923819058395
    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 Erbitux
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Europe B.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form 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
    Histologically confirmed, UICC stage IV adenocarcinoma of the left-sided colon or rectum with metastases (metastatic colorectal cancer), primarily non-resectable or surgery refused by the patient, confirmed RAS mutations proven in the primary tumor or metastasis (KRAS and NRAS exon 2, 3, 4)
    Histologisch bestätigtes Adenokarzinom des linksseitig gelegenen Colons oder Rectums, UICC Stadium IV, mit Metastasen (mCRC), primär nicht operable oder Operation vom Patienten abgelehnt, mit bestätigten RAS Mutation(en) des Primärtumors oder der Metastase (KRAS und NRAS Exon 2, 3, 4)
    E.1.1.1Medical condition in easily understood language
    Metastatic colorectal cancer with a tissue confirmed gene change in a particular gene involved in the regulation of growth and cell differentiation processes.
    Metastasierter Darmkrebs mit einer durch Gewebeproben bestätigten Genveränderung in einem bestimmten Gen, welches an der Regulation von Wachstums- und Zelldifferenzierungsprozessen beteiligt ist
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10061451
    E.1.2Term Colorectal cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The aim of this randomized study is to evaluate whether patients with left sided RAS-mutant mCRC at diagnosis will derive a benefit from the adaptation of adding cetuximab to first-line therapy (FOLFIRI) after RAS-mutation status has changed to wild-type and changing back to FOLFIRI, as required if RAS-mutation status has changed to mutant, depending upon, and monitored by longitudinal ctDNA liquid biopsies. The primary objective is to evaluate efficacy in terms of progression free survival (PFS) from the start of the 1st line treatment in the study according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria in experimental and control arms.
    Das Ziel dieser randomisierten Studie ist es, zu evaluieren, ob Patienten mit Diagnose eines linksseitigen RAS-mutierten mCRC einen Nutzen von die Anpassung einer Cetuximab-Zugabe zur Erstlinien-Therapie (FOLFIRI) haben, wenn sich der RAS-Mutationsstatus zu Wildtyp ändert und, bei Änderung zu RAS-mutiert, wieder zu FOLFIRI wechseln. Der RAS-Mutationsstaus wird mittels longitudinaler ctDNA-Flüssigkeitsbiopien überwacht. Das Primärziel ist es die Wirksamkeit in Bezug auf das progressionsfreie Überleben (PFS) ab Start der Erstlinientherapie in der Studie entsprechend der RECIST-Kriterien, Version 1.1, für den experimentellen Arm und den Kontrollarm zu bestimmen.
    E.2.2Secondary objectives of the trial
    • Overall survival (OS) in experimental and control arms
    • Time to failure of treatment strategy (TFTS) in experimental and control arms
    • PFS rate 1 year after the start of the 1st line treatment
    • Depth of response in terms of reduction of tumor mass in experimental and control arms
    • Metastasis resections in experimental and control arms
    • Objective response rate (ORR) defined as patients with partial or complete response (CR + PR) in experimental and control arms
    • Safety profile according to CTCAE, Version 5.0 criteria in experimental and control arms
    • Gesamtüberleben im experimentellen Arm und im Kontrollarm
    • Zeit bis zum Versagen der Behandlungsstrategie im experimentellen Arm und im Kontrollarm
    • Progressionsfreie Überlebensrate 1 Jahr nach Start der Erstlinientherapie
    • Ausmaß der Verringerung der Tumormasse im experimentellen Arm und im Kontrollarm
    • Resektion von Metastasen im experimentellen Arm und im Kontrollarm
    • Objektive Ansprechrate definiert als Patienten mit partiellem oder komplette, Ansprechen im experimentellen Arm und im Kontrollarm
    • Sicherheit / Toxizität nach CTCAE Kriterien, Version 5.0, im experimentellen Arm und im Kontrollarm
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Histologically confirmed, UICC stage IV adenocarcinoma of the left-sided colon or rectum with metastases (metastatic colorectal cancer), primarily non-resectable, confirmed RAS mutations proven in the primary tumor or metastasis (KRAS and NRAS exon 2, 3, 4)
    • Age ≥ 18 years on day of signing informed consent
    • No previous chemotherapy for metastatic disease
    • Patients suitable for chemotherapy administration
    • ECOG performance status 0-1
    • Consent to liquid biopsy and RAS mutation analysis
    • Estimated life expectancy > 3 months
    • Presence of at least one measurable reference lesion according to the RECIST 1.1 criteria (chest CT and abdominal CT 4 weeks or less before enrollment)
    • Adequate bone marrow function defined as:
    o Leukocytes 3.0 x 109/L with neutrophils 1.5 x 109/L
    o Thrombocytes 100 x 109/L
    o Hemoglobin 9 g/dL
    • Adequate hepatic function defined as:
    o Serum bilirubin 1.5 x ULN
    o ALAT and ASAT 2.5 x ULN (in the presence of hepatic metastases, ALAT and ASAT 5 x ULN)
    • Adequate renal function: Creatinine clearance 50 mL/min
    • Adequate cardiac function defined as
    o Normal ECG and echocardiogram with a left ventricular ejection fraction (LVEF) of 55%
    • INR < 1.5 and aPTT < 1.5 x ULN (patients without anticoagulation). Therapeutic anticoagulation is allowed if INR and aPTT have remained stable within the therapeutic range for at least 2 weeks.
    • Time interval of at least 6 months since last administration of any previous neoadjuvant/adjuvant chemotherapy or radiochemotherapy of the primary tumor in curative treatment intention
    • Any relevant toxicities of prior treatments must have resolved to grade ≤ 1 according to the CTCAE (version 5), except alopecia
    • Women of childbearing potential (WOCBP) should have a negative urine pregnancy test within 72 hours prior to receiving the first dose of study medication.
    • Highly effective contraception for both male and female patients throughout the study and for at least 3 months 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
    • Signed written informed consent and capacity of understanding the informed consent
    • Histologisch bestätigtes Adenokarzinom des linksseitig gelegenen Colons oder Rectums, UICC Stadium IV, mit Metastasen (mCRC), primär nicht operabel, mit bestätigten RAS Mutation(en) des Primärtumors oder der Metastase (KRAS und NRAS Exon 2, 3, 4)
    • Alter ≥ 18 Jahre am Tag des schriftlichen Einverständnisses
    • Keine vorherige Chemotherapie der metastasierten Erkrankung
    • Patienten sind geeignet für die Verabreichung der Chemotherapie
    • ECOG Performance Status von 0-1
    • Zustimmung zur “liquid biopsy” und zur RAS-Mutationsanalyse
    • Geschätzte Lebenserwartung > 3 Monate
    • Vorhandensein von mindestens einer messbaren Referenzläsion entsprechend RECIST 1.1 Kriterien (CT des Brustraums und des Abdomens innerhalb von 4 Wochen vor Einschluss)
    • Adäquate Knochenmarkfunktion definiert als:
    o Leukozyten 3,0 x 109/L mit Neutrophilen 1,5 x 109/L
    o Thrombozyten 100 x 109/L
    o Hämoglobin 9 g/dL
    • Adäquate Leberfunktion definiert als:
    o Serumbilirubin 1,5 x ULN
    o ALAT und ASAT 2,5 x ULN (bei Vorhandensein von Lebermetastasen: ALAT und ASAT 5 x ULN)
    • Adäquate Nierenfunktion: Kreatinin-Clearance 50 mL/min
    • Adäquate Herzfunktion definiert als
    o Normales EKG und Echokardiografie mit einer linksventrikulären Auswurffraktion (LVEF) von 55%
    • INR < 1,5 und aPTT < 1,5 x ULN (Patienten ohne Antikoagulation). Therapeutische Antikoagulation ist erlaubt, wenn INR und aPTT für mindestens 2 Wochen stabil innerhalb des therapeutischen Bereichs geblieben sind
    • Zeitintervall von wenigstens 6 Monaten seit letzter Verabreichung einer vorherigen neoadjuvanten/adjuvanten Chemotherapie oder Radiochemotherapie zur kurativen Behandlung des Primärtumors
    • Jede relevante Nebenwirkung der vorherigen Behandlung muss Grad ≤ 1 nach CTCAE (Version 5) sein, mit Ausnahme von Alopezie
    • Bei Frauen im gebärfähigen Alter muss innerhalb von 72 Stunden vor der ersten Gabe Studienmedikation ein negativer Urin-Schwangerschaftstest vorliegen
    • Männliche und weibliche Patienten müssen während der Studiendauer und mindestens 3 Monate nach letzter Gabe Studienmedikation eine hochwirksame Methode der Verhütung entsprechend der Empfehlungen der CTFG (Clinical Trial Facilitation Group) anwenden, wenn das Risiko einer Empfängnis besteht.
    • Unterschriebene Einverständniserklärung und Fähigkeit, die Einwilligung nach Aufklärung zu verstehen
    E.4Principal exclusion criteria
    • Right sided mCRC
    • Primarily resectable metastases
    • Previous chemotherapy for the colorectal cancer with the exception of adjuvant treatment, completed at least 6 months before entering the study
    • Patients with known brain metastases
    • Symptomatic peritoneal carcinosis
    • Progressive disease before randomization
    • History of acute or subacute intestinal occlusion, inflammatory bowel disease, immune colitis or chronic diarrhea
    • Grade II heart failure (NYHA classification), Myocardial infarction, balloon angioplasty (PTCA) with or without stenting, and cerebral vascular accident/stroke within the past 12 months before enrollment, unstable angina pectoris, serious cardiac arrhythmia according to investigator’s judgment requiring medication
    • Active infection with hepatitis B or C
    • Medical or psychological impairments associated with restricted ability to give consent or not allowing conduct of the study
    • Additional cancer; Exceptions include adequately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy without evidence of recurrence
    • Uncontrolled hypertension
    • Marked proteinuria (nephrotic syndrome)
    • Arterial thromboembolism or severe hemorrhage within 6 months prior to randomization (with the exception of tumor bleeding before tumor resection surgery)
    • Hemorrhagic diathesis or tendency towards thrombosis
    • Participation in a clinical study or experimental drug treatment within 30 days prior to study
    • Known hypersensitivity or allergic reaction to any of the study medications
    • Severe, non-healing wounds, ulcers, bone fractures or an infection requiring systemic therapy
    • Known history of alcohol or drug abuse
    • Known dihydropyrimidine dehydrogenase (DPD) deficiency or glucuronidation deficiency (Gilbert's syndrome) (specific screening not required)
    • Absent or restricted legal capacity
    • For female patients only: Pregnancy (absence to be confirmed by ß-HCG test) or lactating
    • Rechtsseitig gelegenes mCRC
    • Primär operable Metastasen
    • Vorherige Chemotherapie des kolotektalen Karzinoms mit Ausnahme einer adjuvanten Behandlung, die wenigstens 6 Monate vor Studieneinschluss beendet wurde
    • Patienten mit bekannten Hirnmetastasen
    • Symptomatische Peritonealkarzinose
    • Progression der Erkrankung vor der Randomisierung
    • Vorgeschichte eines akuten oder subakuten Darmverschlusses, einer entzündlichen Darmerkrankung, einer immunvermittelten Dickdarmentzündung oder einer chronischen Durchfallerkrankung
    • Herzinsuffizienz Grad II (NYHA Klassifikation); Herzinfarkt; Ballon-Angioplastie (PTCA) mit oder ohne Stent-Implantation; oder Schlaganfall innerhalb der letzten 12 Monate vor Studieneinschluss; instabile Angina Pectoris; schwerwiegende Herzrhythmusstörungen, die nach Einschätzung des Prüfarztes medikamentös behandelt werden müssen
    • Aktive Infektion mit Hepatitis B oder C
    • Medizinische oder psychologische Beeinträchtigungen verbunden mit eingeschränkter Fähigkeit, die Zustimmung zu geben oder die die Durchführung der Studie nicht zulassen
    • Weitere Krebserkrankung; Ausnahmen beinhalten adäquat behandelte Basalzellkarzinome der Haut, Plattenepithelkarzinome der Haut oder in situ Gebärmutterhalskrebs, die nach einer potenziell kurativen Therapie nicht wiederaufgetreten sind
    • Unkontrollierter Bluthochdruck
    • Ausgeprägte Proteinurie (nephrotisches Syndrom)
    • Arterielle Thromboembolie oder schwere Hämorrhagie innerhalb von 6 Monaten vor Randomisierung (mit Ausnahme von Blutungen des Tumors vor Tumorresektion)
    • Blutungsneigung oder Neigung zu Thrombosen
    • Teilnahme an einer klinischen Studie oder experimentellen medikamentösen Behandlung innerhalb von 30 Tagen vor Studieneinschluss
    • Bekannte Überempfindlichkeit gegen oder allergische Reaktion auf Substanzen der Studienbehandlung
    • Schwere, nicht heilende Wunden, Geschwüre, Knochenbrüche, oder eine Infektion, die eine systemische Therapie erfordert
    • Bekannte Vorgeschichte von Alkohol- oder Drogenmissbrauch
    • Bekannter Mangel an Dihydropyrimidin-Dehydrogenase (DPD) oder Glucuronidierung (Gilbert's Syndrom) (spezifisches Screening nicht nötig)
    • Fehlende oder eingeschränkte Geschäftsfähigkeit
    • Für weibliche Patienten: Schwangerschaft (bestätigt durch ß-HCG Test) oder Stillzeit
    E.5 End points
    E.5.1Primary end point(s)
    Progression free survival (PFS) from the start of the 1st line treatment in the study according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria in experimental and control arms.
    Progressionsfreie Überleben (PFS) ab Start der Erstlinientherapie in der Studie entsprechend der RECIST-Kriterien, Version 1.1, für den experimentellen Arm und den Kontrollarm.
    E.5.1.1Timepoint(s) of evaluation of this end point
    PFS from start date of start of 1st line therapy until date of progression or date of death, whichever occurs first.
    PFS vom Startdatum des Therapiebeginns bis zum Fortschreitungsdatum oder Sterbedatum, je nachdem, was zuerst eintritt.
    E.5.2Secondary end point(s)
    • OS in experimental and control arms
    • TFTS in experimental and control arms
    • PFS from start date of start of 1st line therapy
    • Depth of response in terms of reduction of tumor mass in experimental and control arms
    • Percentage of patients with metastasis resections in experimental and control arms
    • ORR defined as patients with partial or complete response (CR + PR) in experimental and control arms
    • Safety profile according to CTCAE, Version 5.0 criteria in experimental and control arms
    • OS in Versuchs- und Kontrollarm
    • TFTS in Versuchs- und Kontrollarmen
    • PFS-Rate vom Startdatum des Therapiebeginns
    • Reaktionstiefe in Bezug auf die Verringerung der Tumormasse in Versuchs- und Kontrollarmen
    • Prozentsatz der Patienten mit Metastasenresektion in Versuchs- und Kontrollarmen
    • ORR definiert als Patienten mit teilweiser oder vollständiger Remission (CR + PR) in Versuchs- und Kontrollarmen
    • Sicherheitsprofil nach CTCAE, Version 5.0 Kriterien in Versuchs- und Kontrollarmen
    E.5.2.1Timepoint(s) of evaluation of this end point
    • OS: until death from any cause
    • TFTS: from start to failure of treatment strategy
    • PFS rate: from start date of start of 1st line therapy
    • Depth of response (DpR): The time for DpR assessment varies between patients relating to the individual achievement of maximal tumor shrinkage, which typically occurs 4–6 months after the start of 1st-line therapy.
    • Percentage of patients with metastasis resections: until the end of the treatment strategy.
    • ORR: from start of 1st line therapy until documentation of CR or PR as best response
    • Safety: during whole study
    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 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 No
    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 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 years3
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months4
    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: 41
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 75
    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 state27
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 116
    F.4.2.2In the whole clinical trial 116
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-01-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-02-22
    P. End of Trial
    P.End of Trial StatusCompleted
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