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    Summary
    EudraCT Number:2021-001967-26
    Sponsor's Protocol Code Number:ACT16444
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-07-06
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2021-001967-26
    A.3Full title of the trial
    Open-label study of tusamitamab ravtansine (SAR408701) in combination with ramucirumab in participants previously treated for advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma with CEACAM5-positive tumors
    Estudio abierto con tusamitamab ravtansina (SAR408701) en combinación con ramucirumab en participantes con adenocarcinoma gástrico o de la unión gastroesofágica (UGE) avanzado, que hayan sido previamente tratados y con tumores positivos a CEACAM5.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Tusamitamab ravtansine (SAR408701) in combination with ramucirumab in pretreated participants with gastric cancer
    Tusamitamab ravtansina (SAR408701) en combinación con ramucirumab en participantes con cáncer gástrico tratados previamente.
    A.3.2Name or abbreviated title of the trial where available
    CARMEN-GC01
    CARMEN-GC01
    A.4.1Sponsor's protocol code numberACT16444
    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 SponsorSanofi aventis recherche & développement
    B.1.3.4CountryFrance
    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 supportSanofi-Aventis Recherche & Développement
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationsanofi-aventis, s.a.
    B.5.2Functional name of contact pointUnidad Estudios Clínicos
    B.5.3 Address:
    B.5.3.1Street Addressc/ Josep Pla 2, 4ª planta
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08019
    B.5.3.4CountrySpain
    B.5.4Telephone number93 485 94 00
    B.5.6E-mailes-reg-estudiosclinicos@sanofi.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 nameTusamitamab ravtansine
    D.3.2Product code SAR408701
    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 INNTusamitamab ravtansine
    D.3.9.2Current sponsor codeSAR408701
    D.3.9.3Other descriptive nameSAR408701
    D.3.9.4EV Substance CodeSUB130908
    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 Yes
    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 Yes
    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 No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeAnti-CEACAM 5 antibody maytansine conjugate.
    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 CYRAMZA
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Nederland 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 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 INNCyramza
    D.3.9.1CAS number 947687-13-0
    D.3.9.3Other descriptive nameRAMUCIRUMAB
    D.3.9.4EV Substance CodeSUB32795
    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 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
    Cancer
    Cáncer
    E.1.1.1Medical condition in easily understood language
    Cancer
    Cáncer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10062878
    E.1.2Term Gastrooesophageal 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 10001150
    E.1.2Term Adenocarcinoma gastric
    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
    • Part 1: to confirm the recommended tusamitamab ravtansine loading dose Q2W in combination with ramucirumab in advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma population
    • Part 2: to assess the antitumor activity of tusamitamab ravtansine loading dose Q2W in combination with ramucirumab in advanced gastric or GEJ adenocarcinoma
    Parte 1: Confirmar la dosis de carga recomendada de tusamitamab ravtansina cada dos semanas (C2S) cuando se administra en combinación con ramucirumab en la población con adenocarcinoma gástrico o de la unión gastroesofágica (UGE) avanzado
    Parte 2: Evaluar la actividad antitumoral de la dosis de carga cada dos semanas de tusamitamab ravtansina en combinación con ramucirumab en el adenocarcinoma gástrico o de la UGE avanzado.
    E.2.2Secondary objectives of the trial
    • To assess safety
    • To assess durability
    • To assess progression-free survival (PFS)
    • To assess the disease control rate (DCR)
    • To assess the pharmacokinetics (PK)
    • To assess the immunogenicity
    Evaluar la seguridad,
    Evaluar la durabilidad,
    Evaluar la supervivencia libre de progresión (SLP),
    Evaluar la tasa de control de la enfermedad (TCE),
    Evaluar la farmacocinética (FC)
    Evaluar la la inmunogenicidad
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Histologically or cytologically confirmed diagnosis of gastric or GEJ adenocarcinoma.
    • Metastatic disease or locally advanced, unresectable disease.
    • Participants who have measurable target lesion.
    • Participants with high carcinoembryonic antigen-related cell adhesion molecule (CEACAM5) expression as per central assessment on tumor biospsy
    • Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
    • Female participant who agrees to use effective contraceptive methods during and for at least 7 months after the last dose of treatment administration
    • Male participant who agrees to use effective contraception methods during and for at least 4 months after the last dose of treatment administration
    • Signed informed consent
    • Diagnóstico histológico o citológico confirmado de adenocarcinoma gástrico o de la UGE.
    • Enfermedad metastásica o enfermedad irresecable localmente avanzada.
    • Participantes que tengan al menos 1 lesión medible.
    • Participantes con una elevada expresión de antígeno carcinoembrionario relacionado con la adhesión molecular (CEACAM5), demostrada mediante biopsia tumoral evaluada a nivel central.
    • Estado funcional de 0-1 según el Grupo Oncológico Cooperativo del Este (ECOG).
    • Mujer que acepte usar un método de contracepción efectivo, durante el período de tratamiento y al menos 7 meses después de la última dosis del tratamiento.
    • Hombre que acepte usar un método de contracepción efectivo, durante el período de tratamiento y al menos 4 meses después de la última dosis del tratamiento del estudio.
    • Consentimiento informado firmado.
    E.4Principal exclusion criteria
    Participants are excluded from the study if any of the following criteria apply:
    • Untreated brain metastases, leptomeningeal disease, or uncontrolled spinal cord compression.
    • Significant concomitant illness.
    • History within the last 3 years of an invasive malignancy other than that treated in this study
    • Known uncontrolled infection
    • Nonresolution of any prior treatment-related toxicity
    • Unresolved corneal disorder or any previous corneal disorder considered by an ophthalmologist to predict higher risk of drug-induced keratopathy
    • Use of contact lenses
    • Radiographic evidence of major airway or blood vessel invasion or intratumor cavitation
    • History of uncontrolled hereditary or acquired thrombotic disorder or history of aneurism
    • Major surgery within 28 days prior to Day 1/first IMP infusion; subcutaneous venous access device placement within 7 days prior to Day 1; or postoperative bleeding complications or wound complications from a surgical procedure performed in the last 2 months
    • History of gross hemoptysis (defined as bright red blood or ≥1/2 teaspoon) within 2 months before the first treatment administration
    • Any arterial thrombotic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, within 6 months before the first administration of treatment administration
    • Uncontrolled arterial hypertension (systolic ≥150 mmHg or diastolic ≥90 mmHg) despite standard medical management.
    • Serious or nonhealing wound, skin ulcer, or bone fracture within 28 days before the first administration of treatment administration
    • Gastrointestinal (GI) perforation and/or fistulae within 6 months prior to first administration of treatment administration
    • Significant bleeding disorders, vasculitis, or Grade 3-4 gastrointestinal (GI) bleeding within 3 months before the first administration of study intervention.
    • Bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection Crohn's disease, ulcerative colitis, or chronic diarrhea
    • Medical condition requiring concomitant administration of a medication with a narrow therapeutic window and metabolized by CYP450 or a strong CYP3A inhibitor
    • Concurrent treatment with any other anticancer therapy
    • Prior treatment targeting CEACAM5 or containing maytansinoid DM1 or DM4 or ramucirumab or taxane or targeting VEGF/VEGFR
    • Poor organ function
    Se excluirá del estudio a los participantes que cumplan cualquiera de los siguientes criterios:
    • Metástasis cerebrales no tratadas, enfermedad leptomeníngea o compresión de la médula espinal no controlada.
    • Enfermedad concomitante importante.
    • Antecedentes de neoplasia maligna invasiva distinta de la tratada en este estudio en los 3 años anteriores.
    • Infección conocida no controlada.
    • La no resolución de cualquier toxicidad relacionada con algún tratamiento previo.
    • Trastorno corneal sin resolver o cualquier trastorno previo de córnea que, en opinión de un oftalmólogo, suponga un mayor riesgo de queratopatía de origen farmacológico.
    • Uso de lentes de contacto.
    • Evidencia radiográfica de invasión grande de vías respiratorias o vasos sanguíneos o cavitación intratumoral.
    • Antecedentes de trastorno trombótico no controlado hereditario o adquirido o antecedentes de aneurisma.
    • Cirugía mayor en los 28 días anteriores al día 1/primera infusión del MI; colocación de un dispositivo de acceso venoso subcutáneo en los 7 días anteriores al día 1; o complicaciones hemorrágicas o de la herida posoperatorias debido a un procedimiento quirúrgico realizado en los últimos 2 meses.
    • Antecedentes de hemoptisis macroscópica (definida como sangre de color rojo brillante o ≥1/2 cucharaditas) en los 2 meses previos a la primera administración del tratamiento del estudio.
    • Acontecimientos trombóticos arteriales, incluyendo infarto de miocardio, angina inestable, accidente cerebrovascular o accidente isquémico transitorio, en un plazo de 6 meses antes de la primera administración del tratamiento del estudio.
    • Hipertensión arterial no controlada (sistólica ≥150 mmHg o diastólica ≥90 mmHg) a pesar del tratamiento médico estándar.
    • Herida grave o que no cicatriza, úlcera cutánea o fractura ósea en los 28 días previos a la primera administración del tratamiento del estudio.
    • Perforación gastrointestinal (GI) y/o fístulas en los 6 meses previos a la primera administración del tratamiento del estudio.
    • Trastornos hemorrágicos significativos, vasculitis o sangrado gastrointestinal (GI) de grado 3-4 dentro de los 3 meses anteriores a la primera administración del tratamiento del estudio.
    • Obstrucción intestinal, antecedentes o presencia de enteropatía inflamatoria o resección intestinal extensa, enfermedad de Crohn, colitis ulcerosa o diarrea crónica.
    • Afección médica que requiera la administración concomitante de un medicamento con un margen terapéutico estrecho y metabolizado por CYP450 o un inhibidor CYP3A.
    • Tratamiento concomitante con cualquier otro tratamiento antineoplásico.
    • Tratamiento previo dirigido a CEACAM5, con maitansinoide (CAF de DM1 o DM4) o cualquier tratamiento sistémico previo con taxanos o terapia dirigida al VEGF o a las vías de señalización del VEGFR.
    • Función orgánica deficiente.
    E.5 End points
    E.5.1Primary end point(s)
    1.Incidence of study drug related dose-limiting toxicities (DLTs) - Part 1: Number of participants with DLTs

    2.Objective Response Rate - Part 2: Objective Response Rate (ORR), defined as the proportion of participants with confirmed complete response (CR) or partial response (PR) as best overall response (BOR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
    1. Incidencia de toxicidades limitantes de la dosis (TLD) relacionadas con el medicamento del estudio. - Parte 1: Número de participantes con TLD.
    2. Tasa de respuesta objetiva (TRO) - Parte 2: Tasa de respuesta objetiva (TRO) definida como la proporción de participantes con respuesta completa (RC) o respuesta parcial (RP) confirmadas como mejor respuesta global (MRG), según los criterios de evaluación de respuesta en tumores sólidos (RECIST) 1.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Cycle 1 (C1) and Cycle 2 (C2) (C1 Day 1 and C2 Day 14). Each cycle has a duration of 2 weeks.
    2. From baseline up to approximately 24 months
    1. Ciclo 1 y Ciclo 2 (C2) (C1 día 1 y C2 día 14). Cada ciclo tiene una duración de 2 semanas.
    2. Desde el momento basal hasta los 24 meses aproximadamente.
    E.5.2Secondary end point(s)
    1. Incidence of Adverse Events - Number of participants with adverse events
    2. Duration of Response - Duration of response (DOR), defined as the time from first documented evidence of CR or PR until progressive disease (PD) determined per RECIST 1.1 or death from any cause, whichever occurs first
    3. Progression-free survival - Progression-free survival, defined as the time from the first investigational medicinal product (IMP) administration to the date of the first documented disease progression or death due to any cause, whichever comes first
    4. Disease control rate - Disease control rate, defined as the proportion of participants with confirmed CR or PR or SD as BOR per RECIST 1.1
    5. Pharmacokinetic parameters of tusamitamab ravtansine and ramucirumab - Pharmacokinetic parameters of tusamitamab ravtansine and ramucirumab
    6. Incidence of antitherapeutic antibodies (ATAs) against tusamitamab ravtansine - Incidence of antitherapeutic antibodies (ATAs) against tusamitamab ravtansine
    1. Incidencia de acontecimientos adversos.
    2. Duración de la respuesta (DR), definida como el tiempo desde la primera evidencia documentada de RC o RP hasta la enfermedad progresiva (EP), determinada según RECIST 1.1, o la muerte por cualquier causa, lo que ocurra primero.
    3. Supervivencia libre de progresión, definida como el tiempo desde la primera administración del medicamento en investigación (MI) hasta la fecha de la primera progresión de la enfermedad documentada o la muerte por cualquier causa, lo que ocurra primero.
    4. Tasa de control de la enfermedad, definida como la proporción de participantes con RC, RP o EE (enfermedad estable) confirmadas como MRG según RECIST 1.1.
    5. Parámetros farmacocinéticos de tusamitamab ravtansina y ramucirumab.
    6. Incidencia de anticuerpos antiterapéuticos (AAT) contra tusamitamab ravtansina.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. to 6. - From baseline up to approximately 24 months
    Del 1 al 6. - Desde el momento basal hasta los 24 meses aproximadamente.
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA7
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Japan
    Korea, Republic of
    Russian Federation
    Turkey
    Belgium
    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
    LVLS
    Última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months17
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months17
    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: 24
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 14
    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 state7
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 16
    F.4.2.2In the whole clinical trial 38
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    Ninguno
    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 Decision2021-08-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-07-28
    P. End of Trial
    P.End of Trial StatusOngoing
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