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 determine whether nivolumab is effective in the treatment of DLBCL in patients that have failed or are ineligible for ASCT |
El objetivo principal es determinar si nivolumab, es efectivo en el tratamiento de LDCGB refractario o que ha recidivado en pacientes que han fracasado o no sean elegibles para TAPH |
|
E.2.2 | Secondary objectives of the trial |
Duration of response Complete remission rate Progression free survival |
Duración de la respuesta Tasa de remisión completa Supervivencia libre de progresión |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Confirmation of relapsed or refractory DLBCL or transformed lymphoma (TL);. ECOG performance status of 0 -1; At least one lesion that measures > 1.5 cm; Prior therapy and screening lab criteria must be met; Appropriate contraceptive measures must be taken |
Confirmación de LDCGB en recidiva o refractario o linfoma transformado (LT) . Estado funcional (EF) del Eastern Cooperative Oncology Group (ECOG) de 0 ó 1. Como mínimo una lesión que mida >1,5 cm. Haber recibido tatamiento previo y que se cumplan los criterios del laboratorio de screening Deben tomarse medidas anticonceptivas apropiadas. |
|
E.4 | Principal exclusion criteria |
Known CNS lymphoma; History of interstitial lung disease, prior malignancy, active autoimmune disease, positive test for hepatitis B or hepatitis C virus; Prior allogeneic SCT, chest radiation < 24 weeks from study drug, ? 1000mg of carmustine (BCNU) as part of pre-transplant conditioning regimen, prior treatment with drug targeting t-cell costimulation or immune checkpoint pathways. Women who are breastfeeding or pregnant |
Linfoma conocido del sistema nervioso central Antecedentes de enfermedad pulmonar intersticial, tumor, previo, enfermedad autoinmune activa, test positivo de Hepatitis B o C TPH alogénico previo, Radioterapia en el tórax ? 24 semanas de la primera dosis del fármaco del estudio, que hayan recibido ? 1.000 mg de carmustina (BCNU) como parte de su régimen de acondicionamiento previo al trasplante, Tratamiento previo con cualquier otro fármaco dirigido específicamente a la coestimulación o las vías de punto de control de los linfocitos T |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Evidence of clinical benefit, as demonstrated by a clinically meaningful objective response rate. |
Evidencia de beneficio clínico , demostrado por la tasa de respuestas objetivas (ORR) cilinicamente significativa. |
|
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 week intervals through month 8, 12 week intervals month 9 to 2 years and then every 6 months after 2 years. |
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) |
Duration of response Complete remission rate Progression free survival |
Duración de la respuesta Tasa de remisión completa Supervivencia libre de progresión |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Assessed at the same time points as the primary endpoint |
Evaluados en el mismo punto temporal que el objetivo principal |
|
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 | 30 |
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 |
Netherlands |
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 | 10 |
E.8.9.1 | In the Member State concerned days | 15 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 10 |
E.8.9.2 | In all countries concerned by the trial days | 15 |