| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Relapsed/refractory hematological malignancies |
| Neoplasias hematológicas malignas recidivantes o refractarias |
|
| E.1.1.1 | Medical condition in easily understood language |
| Relapsed/refractory hematological malignancies |
| Neoplasias hematológicas malignas recidivantes o refractarias |
|
| E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 21.1 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10066481 |
| E.1.2 | Term | Hematological malignancy |
| E.1.2 | System Organ Class | 100000004864 |
|
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
| 1. Part 1: To determine the safety and tolerability of MK-7684A (Cohorts A to F) |
| 1. Primera parte: Determinar la seguridad y tolerabilidad de MK-7684A (cohortes A a F). |
|
| E.2.2 | Secondary objectives of the trial |
1. Part 1: To evaluate ORR following administration of MK-7684A (Cohorts A to F) per disease-specific criteria as assessed by the investigator
2. Part 1: To evaluate the DOR following administration of MK-7684A (Cohorts A to F)
3. Part 1: To evaluate the DCR following administration of MK-7684A (Cohorts A to F)
4. Part 1: To characterize the PK profile of vibostolimab (Cohorts A to F) |
1. Primera parte: Determinar la TRO tras la administración de MK-7684A (cohortes A a F) conforme a criterios específicos de la enfermedad evaluados por el investigador.
2. Primera parte: Determinar la DR tras la administración de MK-7684A (cohortes A a F).
3. Primera parte: Determinar la TCE tras la administración de MK-7684A (cohortes A a F).
4. Primera parte: Definir el perfil farmacocinético de vibostolimab (cohortes A a F). |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
1. Cohort A
cHL
a) Diagnosis of cHL, according to the WHO classification
b) Relapsed or refractory cHL to at least 1 prior line of therapy
c) Not been previously treated with an anti-PD-1 or anti-PD-L1 therapy
PMBCL
d) Diagnosis of PMBCL, according to the WHO classification
e) Relapsed or refractory PMBCL to at least 2 prior lines of therapies
f) Mus have previously received rituximab as part of prior treatment
g) Not been previously treated with an anti-PD-1 or anti-PD-L1 therapy
2. Cohort B
cHL
a) Diagnosis of cHL, according to the WHO classification
b) Relapsed or refractory cHL to at least 2 prior lines of therapies
c) Have progressed on treatment with an anti-PD-1/L1 mAb administered as monotherapy or with other checkpoint inhibitors or other therapies
PMBCL
d) Diagnosis of PMBCL, according to the WHO classification
e) Relapsed or refractory PMBCL to at least 3 prior lines of therapies
f) Must have previously received rituximab as part of prior treatment
g) Have progressed on treatment with an anti-PD-1/L1 mAb administered as monotherapy or with other checkpoint inhibitors or other therapies
3. Cohort C
a) Diagnosis of FL (all grades permitted; 1 to 3b), according to the WHO classification
b) Relapsed or refractory to at least 2 prior lines of therapy, chemoimmunotherapy and immunomodulatory agents
4. Cohort D
a) Diagnosis of DLBCL, according to the WHO classification. Cell of Origin is known for DLBCL, NOS, germinal center B-cell type or activated B-cell type.
b) Must have progressed after at least 2 lines of previous therapy, including progression after an auto-SCT, or are not a candidate for an auto-SCT
5. Cohort E
a) Histologically or cytologically confirmed diagnosis of active MM as per IMWG criteria
b) Measurable disease defined as meeting at least 1 of the following criteria:
i. Serum monoclonal protein (M-protein) levels ≥0.5 g/dL (≥5 g/L), OR
ii. Urine monoclonal protein (M-protein) levels ≥200 mg/24 h, OR
iii. Abnormal serum-free light chain ratio (FLC k/l <0.26 or >1.65) with involved FLC level ≥100 mg/L (normal serum FLC k/l value: 0.26-1.65)
c) Must have undergone stem cell transplant and have relapsed after auto-SCT or have failed to achieve a CR or PR following auto-SCT, or is considered ineligible for auto-SCT
d) Participants must have received all regionally approved antimyeloma therapy including IMiD (pomalidomide, lenalidomide, or thalidomide), proteasome inhibitor (bortezomib, carfilzomib, or ixazomib), anti-CD38 monoclonal antibody, selenixor, and anti BCMA therapies alone or in combination.
e) Participants must have failed their last line of therapy
6. Cohort F
a) Have histologically confirmed diagnosis of B-cell lymphoma other than cHL, PMBCL, DLBCL, or FL, according to the WHO classification
b) Participants must have progressed after at least 2 lines of previous therapy
7. Cohorts A, B, C, D, and F (non-FDG-avid lymphoma participants):
a) Have measurable disease, defined as at least 1 lesion that can be accurately measured in at least 2 dimensions with spiral CT scan
b) Be able to provide newly obtained bone marrow biopsy material for tumor response assessment by local investigator sites
8. Cohort E (MM participants): Be able to provide newly obtained (within 3 months) bone marrow biopsy or aspirate material for disease assessment and submit biomarker analysis
9. Participants who have received CAR T-cell therapy at least 3 months before study entry and have experienced disease progression post therapy may be considered for the study.
10. Is male or female, ≥18 years of age, at the time of signing the informed consent
11. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
• Is not a WOCBP
OR
• Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1% per year), or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), during the intervention period and for at least 120 days after the last dose of study intervention
- A WOCBP must have a negative highly sensitive pregnancy test within 72 h for serum sample and within 24 h for urine test before the first dose of study intervention
12. The participant provided documented informed consent for the study
13. Participants with endocrine-related conditions, are eligible if controlled with treatment (≤ Grade 1).
14. Have a performance status of 0 or 1 on the ECOG PS
15. Have adequate organ function. Specimens must be collected within 7 days before the start of study intervention
16. Participants who are HBsAg positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load before allocation
17. Participants with history of HCV infection are eligible if HCV viral load is undetectable at screening |
Por favor ver criterios completos en resumen protocolo.
1.Cohorte A:
LHc
a)Diagnóstico LHc,clasificación OMS.
b)Presencia LHc recidivante o refractario a un mínimo de una línea previa tratamiento.
c)Ausencia tratamiento previo con fármacos anti-PD-1 o anti-PD-L1.
LBMP
d)Diagnóstico LBMP,clasif OMS.
e)Presencia LBMP recidivante o refractario a un mínimo de 2 líneas previas de tratamiento.
f)Recepción de rituximab como parte del tratamiento previo.
g)Ausencia de tratam. previo con fármacos anti-PD-1 o anti-PD-L1.
2.Cohorte B:
LHc
a)Diagnóstico LHc,clasif OMS.
b)Presencia LHc recidivante o refractario a un mínimo de 2 líneas previas tratamiento.
c)Progresión durante tratamiento con Ac monoclonal anti-PD-1/L1 administrado en monoterapia o en combinación con otros inhibidores de puntos de control inmunológico u otros tratamientos.
LBMP
d)Diagnóstico LBMP,clasif OMS.
e)Presencia de LBMP recidivante o refractario a un mínimo de 3 líneas previas de tratamiento.
f)Recepción de rituximab como parte del tratam. previo.
g)Progresión durante tratam. con Ac monoclonal anti-PD-1/L1 administrado en monoterapia o en combinación con otros inhib. de puntos de control inmunológico u otros tratamientos.
3.Cohorte C:
a)Diagnóstico de LF (se permiten todos grados; 1 a 3b), clasif OMS.
b)Recidiva o refractariedad a un mínimo de 2 líneas previas de tratamiento, quimioinmunoterapia e inmunomoduladores.
4.Cohorte D:
a)Diagnóstico LBDCG, clasif OMS. La célula de origen del LBDCG es conocida, sin especificar, tipo de linfocitos B de centros germinales o tipo linfocitos B activados.
b)Progresión tras mínimo 2 líneas previas de tratam., incluida progresión tras auto-TPH o no ser candidato a auto-TPH.
5.Cohorte E:
a)Diagnóstico confirmado histológica o citológicamente de MM activo según criterios IMWG.
b)Presencia de enfermedad mensurable definida como cumplimiento de al menos 1 de los criterios: i.Concentración sérica proteína monoclonal (proteína M) ≥0,5g/dl (≥ 5g/l).
ii.Concentración urinaria proteína monoclonal (proteína M) ≥200mg/24h.
iii.Cociente anormal de cadenas ligeras libres en suero (CLL k/l <0,26 o >1,65) con concentración de CLL afectadas ≥100 mg/l (valor normal de CLL k/l en suero: 0,26–1,65).
c)Haberse sometido a trasplante de progenitores hematopoyéticos y haber presentado recidiva tras autoTPH o ausencia de RC o RP después de autoTPH o se considera que no es apto para autoTPH.
d)Recepción previa de todos los tratam. contra el mieloma aprobados a nivel regional, incluidos un inmunomodulador, inhibidor del proteasoma, anticuerpo monoclonal anti-CD38, selinexor y tratam. contra antígeno de maduración de células B (BCMA) solo o en combinación.
e)Ausencia de respuesta a la última línea de tratamiento.
6.Cohorte F:
a)Diagnóstico confirmado histológicamente de linfoma B distinto de LHc, LBMP, LDLBG o LF sg clasif OMS.
b)Los participantes deben haber presentado progresión tras un mínimo de 2 líneas de tratam. previo.
7.Cohortes A, B, C, D y F (participantes con linfoma sin avidez por FDG):
a)Presencia de enfermedad mensurable definida como la existencia de al menos una lesión que pueda medirse con precisión en dos dimensiones, mínimo, mediante TC helicoidal.
b)Capacidad de proporcionar material biopsia médula ósea de obtención reciente para una evaluación de la respuesta tumoral en el centro.
8.Cohorte E (con MM): Capacidad de proporcionar muestras aspirado o biopsia médula ósea de obtención reciente (en los 3 meses previos) para evaluación enfermedad en el centro y envío muestras al laboratorio central para análisis biomarcadores.
9.Posible participación pacientes que hayan recibido terapia T-CAR al menos 3 meses antes de incorporación al estudio y que hayan presentado progresión tras tratamiento.
10.Mujeres no embarazadas ni período de lactancia y cumplan al menos 1 de las condiciones siguientes: No en edad fértil O en edad fértil y utiliza método anticonceptivo muy eficaz o practica la abstinencia de relaciones heterosexuales como modo de vida preferido y habitual durante el período de intervención y hasta, mínimo, 120 días después de recibir la última dosis de la intervención del estudio. Mujeres en edad fértil deberán dar negativo prueba de embarazo alta sensibilidad (orina o suero, según normativa) en las 72 h (suero) o las 24 horas (orina) previas a primera dosis de intervención del estudio.
11.Los participantes con enfermedades en el sistema endocrino podrán participar si pueden controlarse con tratamiento (≤ grado 1).
12.Presencia de una función orgánica adecuada. Muestras en 7 días previos al comienzo de la intervención del estudio.
13.Participantes que den positivo para HBsAg podrán participar si han recibido tratamiento antiviral contra VHB durante al menos 4 semanas y tienen carga viral indetectable de VHB antes de la asignación.
14.Participantes con antecedentes de infección por VHC si carga viral VHC es indetectable en período selección. |
|
| E.4 | Principal exclusion criteria |
1. For Cohort D and F (DLBCL and NHL): Has lymphoplasmacytic lymphomas, Waldenstrom’s macroglobulinema, chronic lymphocytic leukemia (not associated with small lymphocytic lymphoma), Burkitt (-like) lymphoma, mature T cell and NK cell neoplasms, immunodeficiency associated lymphoproliferative neoplasms, or histiocytic and dendritic cell neoplasms.
2. For Cohort E (MM):
a) Has oligo-secretory myeloma, plasma cell leukemia, smoldering multiple myeloma, monoclonal gammopathy of undetermined significance.
b) History of primary amyloidosis, hyperviscosity or POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).
3. Has known prior or current CNS involvement.
4. A WOCBP who has a positive urine pregnancy test within 72 hours before study intervention allocation. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
5. Has clinically significant cardiovascular disease within 12 months from first dose of study intervention, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability.
6. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.
7. Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 3 years.
8. Has received prior therapy with an mAb blocking TIGIT or its coreceptors, or an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137).
9. Has received prior therapy with an anti-TIGIT agent.
10. Any PMBCL participants in Cohort A and B that require the use of urgent cytoreductive therapy.
11. Has received prior systemic anticancer therapy, including investigational agents, within 2 weeks (small molecules like kinase inhibitors) or 4 weeks (chemotherapies and monoclonal antibodies) before cohort allocation.
12. If the participant had major surgery, the participant must have recovered adequately from the procedure and/or any complications from the surgery before starting study intervention.
13. Has received prior radiotherapy within 2 weeks of start of study intervention.
14. Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.
15. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention.
16. Known severe hypersensitivity to MK-7684A, vibostolimab or pembrolizumab and/or any of its excipients.
17. Has a known history of HIV infection. No HIV testing is required unless mandated by local health authority.
18. Has an active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs).
19. Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
20. Has an active infection requiring systemic therapy.
21. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.
22. Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.
23. Has present or progressive accumulation of pleural, ascitic, or pericardial fluid requiring drainage or diuretic drugs within 2 weeks before enrollment.
24. Has dual active HBV infection (HBsAg (+) and /or detectable HBV DNA) and HCV infection (anti-HCV Ab (+) and detectable HCV RNA) at study entry.
25. Participant, in the judgment of the investigator, is unlikely to comply with the study procedures, restrictions, and requirements of the study.
26. Has had an allogenic hematopoietic stem cell/solid organ transplantation within the last 5 years. Participants who have had a transplant greater than 5 years ago are eligible as long as there are no symptoms of Graft versus Host Disease. |
Por favor ver criterios completos en resumen protocolo.
1.Cohortes D y F (LBDCG y LNH): Presencia de linfoma linfoplasmocítico, macroglobulinemia de Waldenström, leucemia linfocítica crónica (no asociada a linfoma linfocítico de células pequeñas), linfoma de (tipo) Burkitt, neoplasias de células T y NK maduras, neoplasias linfoproliferativas asociadas a inmunodeficiencia o neoplasias de células histiocíticas y dendríticas.
2.Cohorte E (MM):
a)Presencia de mieloma oligosecretor, leucemia de células plasmáticas, mieloma múltiple latente y gammapatía monoclonal de significado incierto.
b)Antecedentes amiloidosis primaria, hiperviscosidad o síndrome POEMS (discrasia de células plasmáticas con polineuropatía, organomegalia, endocrinopatía, proteína monoclonal y alteraciones de la piel).
3.Presencia previa o actual de afectación del SNC.
4.Resultado positivo en una prueba de embarazo en orina realizada a una mujer en edad fértil en las 72 horas previas a la asignación de la intervención del estudio.
5)Presencia de enfermedad cardiovascular clínicamente significativa en 12 meses previos a primera dosis de la intervención del estudio, como insuficiencia cardíaca congestiva en clase III o IV de la NYHA, angina inestable, infarto de miocardio, accidente cerebrovascular o arritmia cardíaca asociada a inestabilidad hemodinámica.
6.Antecedentes o datos presentes de cualquier proceso, tratamiento o anomalía analítica que, en opinión del investigador responsable del tratamiento, podría confundir los resultados del estudio, dificultar la participación durante la totalidad del estudio o motivar que la participación no sea lo más conveniente para el posible participante.
7.Antecedentes de una segunda neoplasia maligna, a menos que se haya completado un tratamiento potencialmente curativo sin signos de neoplasia maligna durante 3 años.
8.Tratamiento previo con un Ac monoclonal bloqueante de TIGIT o sus correceptores, con un fármaco anti-PD-1, anti-PD-L1 o anti-PD-L2 o con un fármaco dirigido contra otro receptor de los linfocitos T estimulador o coinhibidor (como CTLA-4, OX-40 o CD137).
9.Tratamiento previo con fármaco anti-TIGIT.
10.Participante con LBMP en cohortes A y B que requiera tratamiento citorreductor urgente.
11.Recepción de tratamiento antineoplásico sistémico previo, incluidos fármacos en investigación, en las 2 semanas (moléculas pequeñas como inhibidores de cinasas) o 4 semanas (quimioterapias y anticuerpos monoclonales) previas a la asignación a la cohorte.
12.Si el participante se ha sometido a una intervención de cirugía mayor, deberá haberse recuperado debidamente del procedimiento y/o las complicaciones antes de iniciar intervención del estudio.
13.Recepción radioterapia en las 2 semanas previas al comienzo de la intervención del estudio.
14.Recepción de vacuna de microorganismos vivos o atenuados en los 30 días previos a primera dosis de la intervención del estudio. Se permite la administración de vacunas inactivadas.
15.Participación activa o pasada en un estudio de un fármaco en investigación o uso de un dispositivo en investigación en las cuatro semanas previas a la administración de la primera dosis de la intervención del estudio.
16.Hipersensibilidad grave conocida a MK-7684A, vibostolimab o pembrolizumab y/o a cualquiera de sus excipientes.
17.Antecedentes de infección por VIH.
18.Presencia de una enfermedad autoinmunitaria activa que haya precisado tratamiento sistémico (es decir, fármacos modificadores de la enfermedad, corticoides o inmunodepresores) en los 2 últimos años.
19.Antecedentes neumonitis (no infecciosa)/neumopatía intersticial que precisó corticoides o presencia de neumonitis/neumopatía intersticial.
20.Presencia de infección activa con necesidad de tratamiento sistémico.
21.Antecedentes o datos presentes de cualquier proceso, tratamiento o anomalía analítica que, en opinión del investigador, podría confundir los resultados del estudio, dificultar la participación durante la totalidad del estudio o motivar que la participación no sea lo más conveniente para el posible participante.
22.Presencia de un trastorno psiquiátrico o por abuso de sustancias que podría dificultar la capacidad del participante para colaborar en el cumplimiento de los requisitos del estudio.
23.Presencia o acumulación progresiva de líquido pleural, ascítico o pericárdico con necesidad de drenaje o diuréticos en las 2 semanas previas a inclusión.
24.Infección activa doble por VHB (HBsAg (+) y/o ADN del VHB detectable) y VHC (anti-VHC (+) y ARN del VHC detectable) en el momento de incorporación al estudio.
25.Recepción de alotrasplante de progenitores hematopoyéticos u órgano sólido en los últimos 5 años. Si el trasplante se ha practicado más de 5 años antes, podrá participar si no presenta síntomas de enfermedad del injerto contra el huésped. |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
1. Part 1: Number of Participants with a Dose-Limiting Toxicity (DLT)
2. Part 1: Number of Participants Who Experienced an Adverse Event (AE)
3. Part 1: Number of Participants Who Discontinued Study Treatment Due to an AE |
1. Primera parte: Número de participantes con una Toxicidad Limitante de Dosis (TLD)
2. Primera parte: Número de participantes que experimentaron un Acontecimiento Adverso (AA)
3. Primera parte: Número de participantes que interrumpieron el tratamiento del estudio debido a un AA |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
1. Up to approximately 6 weeks
2. Up to approximately 27 months
3. Up to approximately 24 months |
1. Hasta aproximadamente 6 semanas
2. Hasta aproximadamente 27 meses
3. Hasta aproximadamente 24 meses |
|
| E.5.2 | Secondary end point(s) |
1. Part 1: Objective Response Rate (ORR)
2. Part 1: Duration of Response (DOR)
3. Part 1: Disease Control Rate (DCR)
4. Part 1: Lowest Plasma Concentration (Ctrough) of Vibostolimab
5. Maximum Concentration (Cmax) of Vibostolimab |
1. Primera parte: Tasa de Respuesta Objetiva (TRO)
2. Primera parte: Duración de la Respuesta (DR)
3. Primera parte: Tasa de control de la enfermedad (TCE)
4. Primera parte: Concentración mínima (Cmín) de vibostolimab en plasma
5. Concentración máxima (Cmáx) de vibostolimab |
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. Up to approximately 24 months
2. Up to approximately 24 months
3. Up to approximately 24 months
4. Predose at Cycles 1, 2, 4, 8, and every 12 weeks afterwards (up to ~2 years). Cycle = 3 weeks
5. Postdose: after end of infusion (up to ~10 minutes) at Cycles 1 and 8. Cycle = 3 weeks |
1. Hasta aproximadamente 24 meses
2. Hasta aproximadamente 24 meses
3. Hasta aproximadamente 24 meses
4. Predosis en los Ciclos 1, 2, 4, 8, y luego cada 12 semanas (hasta ~ 2 años). Ciclo = 3 semanas
5. Posdosis: después del final de la infusión (hasta ~ 10 minutos) en los Ciclos 1 y 8. Ciclo = 3 semanas |
|
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | Yes |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | Yes |
| E.6.7 | Pharmacodynamic | Yes |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | Yes |
| E.6.11 | Pharmacogenomic | Yes |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | No |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | Yes |
| E.7.3 | Therapeutic confirmatory (Phase III) | No |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | No |
| E.8.1.1 | Randomised | No |
| E.8.1.2 | Open | Yes |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | No |
| E.8.1.5 | Parallel group | No |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | Yes |
| E.8.1.7.1 | Other trial design description |
|
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | No |
| E.8.2.2 | Placebo | No |
| E.8.2.3 | Other | No |
| E.8.2.4 | Number of treatment arms in the trial | 1 |
| 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.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 28 |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
| E.8.6.2 | Trial being conducted completely outside of the EEA | No |
| E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
| Brazil |
| Canada |
| Chile |
| Israel |
| Russian Federation |
| Taiwan |
| Turkey |
| Ukraine |
| United States |
| Denmark |
| France |
| Germany |
| Hungary |
| Italy |
| Poland |
| Spain |
|
| E.8.7 | Trial 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
|
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 5 |
| E.8.9.1 | In the Member State concerned months | |
| E.8.9.1 | In the Member State concerned days | |
| E.8.9.2 | In all countries concerned by the trial years | 5 |
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