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    Summary
    EudraCT Number:2020-004175-41
    Sponsor's Protocol Code Number:NIT-109
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-08-13
    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 number2020-004175-41
    A.3Full title of the trial
    A Multicenter, Open-label, Randomized, Phase 2 Study of NT-I7 in Combination with Nivolumab versus Nivolumab Monotherapy in Subjects with Advanced or Metastatic Gastric or Gastro-Esophageal Junction or Esophageal Adenocarcinoma who Progressed on or Intolerant to 2 or more Prior Lines of Systemic Therapy
    Estudio de fase II, multicéntrico, abierto y aleatorizado de NT-I7 en combinación con nivolumab frente a nivolumab en monoterapia en pacientes con adenocarcinoma gástrico, de la unión gastroesofágica o esofágico avanzado o metastásico que presentaron progresión o intolerancia a 2 o más líneas previas de tratamiento sistémico
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Multicenter, Open-label, Randomized, Phase 2 Study of NT-I7 in Combination with Nivolumab versus Nivolumab Alone in Subjects with Advanced or Metastatic Stomach, Esophageal Cancers who Progressed on or Were Intolerant to 2 or More Previous Therapies
    Estudio de fase II, multicéntrico, abierto y aleatorizado de NT-I7 en combinación con nivolumab frente a nivolumab solo en pacientes con cánceres de estómago y esófago avanzado o metastásico que presentaron progresión o intolerancia a 2 o más terapias previas.
    A.3.2Name or abbreviated title of the trial where available
    NT-I7 in Combination with Nivolumab in Advanced Gastric, GEJ, or EAC
    NT-I7 en combinación con Nivolumab en Gástrico, UGE o ACE avanzado
    A.4.1Sponsor's protocol code numberNIT-109
    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 SponsorNeoImmuneTech, Inc.
    B.1.3.4CountryUnited States
    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 supportNeoImmuneTech, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNeoImmuneTech, Inc.
    B.5.2Functional name of contact pointClinical Division
    B.5.3 Address:
    B.5.3.1Street Address2400 Research Blvd. Suite 250
    B.5.3.2Town/ cityRockville
    B.5.3.3Post code20850
    B.5.3.4CountryUnited States
    B.5.6E-mailNIT109@neoimmunetech.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 nameNT-I7
    D.3.2Product code NT-I7
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEfineptakin alfa
    D.3.9.2Current sponsor codeNT-I7
    D.3.9.3Other descriptive namerhIL-7-hyFc
    D.3.9.4EV Substance CodeSUB213575
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 RoleComparator
    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 nameNivolumab
    D.3.2Product code BMS-936558
    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 INNnivolumab
    D.3.9.2Current sponsor codeBMS-936558
    D.3.9.4EV Substance CodeSUB122750
    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
    Advanced or metastatic gastric or gastro-esophageal junction (GEJ) or esophageal adenocarcinoma (EAC) progressed on or intolerant to 2 or more prior lines of systemic therapy
    Adenocarcinoma gástrico, de la unión gastroesofágica (UGE) o esofágico (ACE) avanzado o metastásico que haya progresado o intolerante a 2 o más líneas previas de tratamiento sistémico
    E.1.1.1Medical condition in easily understood language
    Cancer in the stomach and/or esophagus, called gastric, gastro-esophageal junction (GEJ) or esophageal adenocarcinoma (EAC).
    Cáncer en el estómago y/o esófago, llamado adenocarcinoma gástrico, de la unión gastroesofágica (UGE) o esofágico (ACE).
    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 LLT
    E.1.2Classification code 10058526
    E.1.2Term Oesophageal adenocarcinoma metastatic
    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 22.0
    E.1.2Level LLT
    E.1.2Classification code 10082464
    E.1.2Term Advanced gastric carcinoma
    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 23.1
    E.1.2Level LLT
    E.1.2Classification code 10084873
    E.1.2Term Gastrooesophageal junction cancer metastatic
    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 PT
    E.1.2Classification code 10063916
    E.1.2Term Metastatic gastric 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 21.0
    E.1.2Level LLT
    E.1.2Classification code 10079913
    E.1.2Term Adenocarcinoma of the gastroesophageal junction stage IV
    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 10030145
    E.1.2Term Oesophageal adenocarcinoma stage IV
    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 make a preliminary assessment of the antitumor activity and long-term survival of NT-I7 in combination with nivolumab in subjects with advanced or metastatic gastric or GEJ or EAC after 2 or more prior lines of systemic therapy, based on:
    o Objective response rate (ORR) per Investigators’ assessment using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
    o Overall survival (OS)
    Realizar una evaluación preliminar de la actividad antitumoral y la supervivencia a largo plazo de NT-I7 en combinación con nivolumab en sujetos con adenocarcinoma gástrico, de la UGE o ACE avanzado o metastásico después de 2 o más líneas previas de tratamiento sistémico,basándose en:
    o Tasa de respuesta objetiva (TRO) según la evaluación de los investigadores utilizando Criterios de evaluación de la respuesta en tumores sólidos (RECIST) versión 1.1
    o Supervivencia global (SG)
    E.2.2Secondary objectives of the trial
    To make further assessment of the antitumor activity of NT-I7 in combination with nivolumab in the treated subjects, based on Duration of Response (DoR), Disease Control Rate (DCR), and Progression-Free Survival (PFS);
    To evaluate the immunogenicity of NT-I7 administered in combination with nivolumab.
    Realizar una evaluación adicional de la actividad antitumoral de NT-I7 en combinación con nivolumab en los pacientes tratados, basándose en la duración de la respuesta (DdR), la tasa de control de la enfermedad (TCE) y la supervivencia sin progresión (SSP);
    Evaluar la inmunogenicidad de NT-I7 administrado en combinación con nivolumab.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Key Inclusion Criteria
    1. Have histologically or cytologically confirmed locally locally advanced or metastatic carcinoma of gastric or GEJ or EAC who progressed on or intolerant to 2 or more prior lines of chemotherapy and/or targeted therapy in the advanced/metastatic setting. Subjects with HER2-overexpresing tumor who progressed on trastuzumab-based therapy and at least 1 other line of therapy are also eligible.
    Note: GEJ adenocarcinomas are defined as tumors that have their center within 5 cm proximal and distal of the anatomical cardia, as described in the Siewert classification system (Siewert et al, 2000)
    2. Have at least one measurable lesion according to RECIST 1.1.
    3. Subjects enrolling in the dose escalation phase must have biopsiable disease. Subjects must agree to provide a) pre- treatment tumor tissue sample and b) on-treatment tumor biopsy.
    4. Subjects enrolled in the Phase 2 must agree to provide tumor tissue sample prior to the start of treatment.
    5. PD-L1 expression status must be determined by the study-designated central lab prior to randomization (CPS <5 versus CPS ≥ 5) for subjects enrolled in Phase 2.
    6. Female subjects are either postmenopausal for at least 1 year, are surgically sterile for at least 6 weeks; if a female subject is of childbearing potential, she must agree to remain abstinent (refrain from heterosexual intercourse) or to follow instructions for one highly effective method of contraception for the duration of study treatment and for 5 months after the last dose of study treatment.
    7. Non-sterile male subjects who are sexually active with female partners of childbearing potential must agree to remain abstinent (refrain from heterosexual intercourse) or to follow instructions for one highly effective method of contraception for the duration of study treatment and for 3 months after the last dose of study treatment.
    Criterios de Inclusión clave
    1. Presentar carcinoma gástrico, de la UGE o ACE localmente avanzado o metastásico, confirmado histológica o citológicamente o con progresión o intolerancia a 2 o más líneas previas de quimioterapia y/o tratamiento dirigido en un contexto avanzado/metastásico. También son aptos los pacientes con tumores con sobreexpresión de HER2 que experimentaran progresión con trastuzumab y al menos otra línea de tratamiento.
    Nota: Los adenocarcinomas de la UGE se definen como tumores que tienen su centro a menos de 5 cm en dirección proximal y distal del cardias anatómico, tal como se describe en el sistema de clasificación de
    Siewert (Siewert et ál., 2000).
    2. Tener al menos una lesión mensurable de acuerdo a la versión 1.1 de RECIST.
    3. Los pacientes incluidos en la fase de escalada de dosis deben tener enfermedad biopsiable. Los pacientes deben aceptar proporcionar a) una muestra de tejido tumoral previa al tratamiento y b) una biopsia tumoral durante el tratamiento.
    4. Los pacientes incluidos en la fase II deben aceptar proporcionar una muestra de tejido tumoral antes del inicio del tratamiento.
    5. El laboratorio central designado por el estudio debe determinar el estado de expresión de PD-L1 antes de la aleatorización (PPC <5 frente a PPC ≥5) para los pacientes incluidos en la fase II.
    6. Las pacientes son posmenopáusicas durante al menos 1 año, son quirúrgicamente estériles durante un mínimo de 6 semanas; si una paciente tiene capacidad de concebir, debe aceptar practicar la abstinencia (abstenerse de mantener relaciones sexuales heterosexuales) o seguir las instrucciones para un método anticonceptivo altamente eficaz durante el tratamiento del estudio y durante 5 meses después de la última dosis del tratamiento del estudio.
    7. Los hombres no estériles que sean sexualmente activos con parejas femeninas en edad fértil deben aceptar practicar la abstinencia (abstenerse de mantener relaciones sexuales heterosexuales) o seguir las instrucciones de un método anticonceptivo altamente eficaz durante el tratamiento del estudio y durante los 3 meses posteriores a la última dosis del tratamiento del estudio.
    E.4Principal exclusion criteria
    Key Exclusion Criteria
    1. Pregnant, or breastfeeding or expecting to conceive or father children within the study duration from screening through 5 months (for female subjects) or 3 months (for male subjects) after the last dose of study treatment.
    2. Receiving any investigational therapy or any approved therapy for investigational use within 4 weeks or 5 half-lives, whichever is longer, prior to first dose of study treatment.
    3. Has previously received checkpoint inhibitor (CPI) treatment for gastric cancer or GEJ or EAC.
    4. Has received prior radiotherapy within 2 weeks of start of study treatment.
    5. Has received treatment with complementary medications (ex, herbal supplements, or traditional Chinese medications) to treat the disease under study within 2 weeks prior to the first dose of study treatment.
    6. Subjects are eligible if CNS metastases are asymptomatic and do not require immediate treatment or have been treated and subjects have neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment).
    7. History of severe hypersensitivity reactions to monoclonal antibodies (mAbs) or intravenous immunoglobulin preparation.
    8. Clinically significant cardiac disease.
    9. Has a history of allergy or intolerance (unacceptable AEs) to study drug components or polysorbate-80-containing infusions.
    Note: Polysorbate 80 is a buffer used to make NT-I7.
    10. Has received a live vaccine within 4 weeks prior to the first dose of study drug. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed.
    11. Has had an allogenic tissue/solid organ transplant or bone marrow transplant.
    Criterios de Exclusión clave
    1. Mujeres embarazadas, en período de lactancia o sujetos que tengan previsto concebir o engendrar hijos dentro de la duración del estudio desde la selección hasta los 5 meses (para las mujeres) o 3 meses (para los varones) después de la última dosis del tratamiento del estudio.
    2. Recibir cualquier tratamiento en investigación o algún tratamiento aprobado para el uso en investigación en las 4 semanas o 5 semividas, lo que sea más largo, antes de la primera dosis del tratamiento del estudio.
    3. Haber recibido previamente tratamiento con inhibidores del punto de control (IPC) para el cáncer gástrico o la UGE o el ACE.
    4. Haber recibido radioterapia previa dentro de las 2 semanas anteriores al inicio del tratamiento del estudio.
    5. Haber recibido tratamiento con medicamentos complementarios (p. ej., suplementos a base de hierbas o medicina china tradicional) para tratar la enfermedad en estudio en las 2 semanas previas a la primera dosis del tratamiento del estudio.
    6. Los pacientes son aptos si las metástasis en el SNC son asintomáticas y no requieren tratamiento inmediato o se han tratado y los pacientes han regresado desde un punto de vista neurológico al periodo inicial (excepto los signos o síntomas residuales relacionados con el tratamiento del SNC).
    7. Antecedentes de reacciones de hipersensibilidad graves a anticuerpos monoclonales (AcM) o preparaciones de inmunoglobulinas intravenosas.
    8. Enfermedad cardíaca de importancia clínica.
    9. Antecedentes de alergia o intolerancia (AA inaceptables) a los componentes del fármaco del estudio o infusiones que contengan polisorbato 80.
    Nota: Polisorbato 80 es un tampón utilizado para fabricar NT-I7.
    10. Haber recibido una vacuna viva en las 4 semanas anteriores a la primera dosis del fármaco del estudio. Por lo general, las vacunas antigripales estacionales inyectables son vacunas inactivadas y se permiten.
    11. Haberse sometido a un trasplante alógeno de tejido o vísceras macizas o de médula ósea.
    E.5 End points
    E.5.1Primary end point(s)
    Overall survival (OS) and objective response rate (ORR) assessed by the investigators using RECIST 1.1 criteria are the primary endpoints for Phase 2.
    OS is defined as the time from first study treatment to death from any cause.
    ORR is defined as the percentage of participants with a best overall response (BOR) of a complete response (CR) or partial response (PR), per RECIST 1.1.
    La Supervivencia global (SG) y Tasa de respuesta objetiva (TRO) evaluados por los investigadores mediante criterios RECIST 1.1. son los criterios de valoración principales de la Fase 2.
    SG se define como el tiempo transcurrido desde el primer tratamiento del estudio hasta la muerte por cualquier causa.
    TRO se define como el porcentaje de participantes con una mejor respuesta global (MRG) de una respuesta completa (RC) o parcial (RP), según RECIST 1.1
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to 2 years.
    Hasta 2 años
    E.5.2Secondary end point(s)
    Duration of response (DoR), disease control rate (DCR), progression-free survival (PFS) and Incidence of anti-drug antibodies (ADA) to NT-I7 during the study relative to baseline are the secondary endpoints for Phase 2.
    DOR is defined as the time from the first occurrence of a documented objective response to the time of the first documented disease progression or death from any cause, whichever occurs first, per RECIST 1.1.
    DCR is defined as the percentage of participants with a best overall response (BOR) of complete response (CR), partial response (PR), or stable disease (SD), per RECIST 1.1.
    PFS is defined as the time from the first study treatment to the first occurrence of disease progression or death of any cause, whichever occurs first, per RECIST 1.1.
    Duración de la respuesta (DdR), la tasa de control de la enfermedad (TCE), supervivencia sin progresión (SSP) e incidencia de los anticuerpos monoclonales (AcM) contra NT-I7 durante el estudio en relación con la línea base son los criterios de valoración secundarios de la Fase 2.
    DdR se define como el tiempo transcurrido desde la primera aparición de una respuesta objetiva documentada hasta el momento de la primera progresión documentada de la enfermedad o la muerte por cualquier causa, lo que ocurra primero, según RECIST 1.1.
    TCE se define como el porcentaje de participantes con una mejor respuesta global (MRG) de una respuesta completa (RC) o parcial (RP), según RECIST 1.1.
    SSP se define como el tiempo transcurrido desde el primer tratamiento del estudio hasta la primera aparición de la progresión de la enfermedad o la muerte por cualquier causa, lo que ocurra primero, según RECIST 1.1.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Up to 3 years.
    Hasta 3 años.
    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 No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    To evaluate the immunogenicity of NT-I7 administered in combination with nivolumab;
    To make a preliminary assessment of biomarkers that might act as pharmacodynamic indicators of antitumor activity of NT-I7 in combination with nivolumab in the treated subjects;
    To make a preliminary assessment of biomarkers that might act as predictors of antitumor activity of NT-I7 in combination with nivolumab in the treated subjects.
    Evaluar la inmunogenicidad de NT-I7 administrado en combinación con nivolumab;
    Realizar una evaluación preliminar de los biomarcadores que podrían actuar como indicadores farmacodinámicos de la actividad antitumoral de NT-I7 en combinación con nivolumab en los pacientes tratados;
    Realizar una evaluación preliminar de los biomarcadores que podrían actuar como factores predictivos de la actividad antitumoral de NT-I7 en combinación con nivolumab en los pacientes tratados.
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA28
    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
    United States
    France
    Italy
    Poland
    Spain
    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
    LVLS
    Ultima Visita ultimo paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months2
    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 months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 107
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state21
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 88
    F.4.2.2In the whole clinical trial 127
    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)
    Subjects who continue to receive clinical benefit after 24 months from the date of first dose, may continue to receive the treatment on this study, via a rollover study requiring approval by the responsible Health Authority (HA) and ethics committee, or through another mechanism at the discretion of the Sponsor. The Sponsor reserves the right to terminate access to study treatment due to any of the resons described in the protocol (section 7.8).
    Pacientes que continúen recibiendo beneficios clínicos después de 24meses desde la fecha de primera dosis, podrán seguir recibiendo el tratamiento en este estudio, a través de un estudio de extensión que requiere la aprobación de la Autoridad Sanitaria (AS) y el comité de ética responsables, o a través de otro mecanismo a discreción del Promotor. El Promotor se reserva el derecho de terminar el acceso al tratamiento del estudio por cualquiera de los motivos descritos en el protocolo(sección7.8)
    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 Decision2021-08-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-06-11
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2023-05-26
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