E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Lymphoma. Non-Hodgkin |
Linfoma non-Hodgkin |
|
E.1.1.1 | Medical condition in easily understood language |
Lymphoma. Non-Hodgkin |
Linfoma non-Hodgkin |
|
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 | 16.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10029547 |
E.1.2 | Term | Non-Hodgkin's lymphoma |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The purpose of this study is to assess the clinical benefit of nivolumab, as measured by independent radiologic review committee (IRRC)-assessed objective response rate (ORR) in subjects with FL lymphoma who have failed therapy with both rituximab and an alkylating agent. |
El objetivo principal de este estudio es evaluar el beneficio clínico de nivolumab, medido por la tasa de respuestas objetivas (ORR) evaluada por el comité de revisión radiológica independiente (CRRI) en sujetos con LF en los que ha fracasado el tratamiento tanto con rituximab como con un agente alquilante. |
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E.2.2 | Secondary objectives of the trial |
? To assess the duration of response based on IRRC assessments ? To assess the complete remission rate based on IRRC assessment ? To assess the progression free survival based on IRRC assessment ? To assess the ORR, based on investigator assessments. |
Evaluar la duración de la respuesta (DOR) basada en las evaluaciones por el CRRI Evaluar la tasa de remisión completa (CRR) basada en la evaluación por el CRRI Evaluar la supervivencia libre de progresión (SLP) de acuerdo con la evaluación por el CRRI Evaluar la ORR, basada en las valoraciones de los investigadores. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
? Grade 1, 2, or 3a FL without pathologic evidence of transformation. ? Male and female, ages 18 and above, with relapsed or refractory FL lymphoma after > or = 2 prior treatment lines; each of the 2 prior treatment lines must include at least rituximab and/or an alkylating agent ? ECOG PS 0-1 |
LF de grado 1, 2 o 3a sin pruebas anatomopatológicas de transformación. Varones y mujeres con 18 años de edad con Linfoma folicular después de 2 o más lineas de tratamiento previas ; cada una de las 2 lineas de trtamiento previas deben incluir al menos rituximab y/o agentes alquilantes. Estado funcional (EF) del Eastern Cooperative Oncology Group (ECOG) de 0 ó 1. |
|
E.4 | Principal exclusion criteria |
? Known central nervous system lymphoma. ? History of interstitial lung disease ? Subjects with active, known or suspected autoimmune disease. ? Prior allogeneic or autologous stem cell transplant. |
Linfoma conocido del sistema nervioso central. Historial de enfermedad pulmonar intersticial Sujetos con enfermedad autoinmune activa, conocida o sospechada. TPH alogénico o autólogo previo |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is ORR as determined by an IRRC according to the revised International Working Group Criteria for non-Hodgkin Lymphoma. |
Ell objetivo primario es la tasa de respuestas objetivas (ORR) evaluada por el comité de revisión radiológica independiente (CRRI) para Linfoma non-Hodgkin. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Assessments (CT/MRI) begin 8 weeks after the start of nivolumab and continue at 8 weeks intervals through Month 8, 12-week intervals Month 9 to 2 years and then every 6 months after 2 years |
Las evaluaciones mediante pruebas de imagen (TC helicoidal/RM) comenzando la semana 8 después del tratamiento con nivolumab continuando en intervalos de 8 semanas hasta los 8 meses; intervalos de 12 semanas del mes 9 hasta los dos años y cada seis meses después de los dos años. |
|
E.5.2 | Secondary end point(s) |
? To assess the duration of response based on IRRC assessments ? To assess the complete remission rate based on IRRC assessment ? To assess the progression free survival based on IRRC assessment ? To assess the ORR, based on investigator assessments. |
Evaluar la duración de la respuesta basada en las evaluaciones del CRRI Evaluar la tasa de remisión completa basada en las evaluaciones del CRRI Evaluar la supervivencia libre de progresión basada en las evaluaciones del CRRI Evaluar la tasa de respuestas objetivas (ORR) basada en las valoraciones de los investigadores |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Assessed at the same timepoints as the primary endpoint |
Se evaluán al mismo tiempo que el objetivo principal |
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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 | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Biomarker Assessments, Outcomes Research Assessments, Immunogenicity Assessments, Results of Central Assessments |
Evaluaciones de biomarcador, evaluaciones de investigación de resultados |
|
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 | No |
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 | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 25 |
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 |
Belgium |
Canada |
France |
Italy |
Norway |
Sweden |
Australia |
Germany |
Spain |
Singapore |
United Kingdom |
United States |
|
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
|
Last follow-up visit of the Last subject |
ültima visita del último paciente |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
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 | 2 |