E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Relapsed Refractory Non Hodgkin Lymphomas with CD30 Expression |
Linfomas no Hodgkin con expresión de CD30 en recidiva y refractario |
|
E.1.1.1 | Medical condition in easily understood language |
Non-Hodgkin Lymphomas |
Linfomas no 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 | 18.1 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10029606 |
E.1.2 | Term | Non-Hodgkin's lymphomas transformed recurrent |
E.1.2 | System Organ Class | 100000004851 |
|
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 |
to assess whether nivolumab in combination with brentuximab vedotin is safe and effective in certain subtypes of non-hodgkin lymphomas |
Evaluar la seguridad y eficacia de la combinación de nivolumab y brentuximab en ciertos subtipos de linfomas no Hodgkin |
|
E.2.2 | Secondary objectives of the trial |
- Assess the overall duration of response (DOR) - Assess the complete response rate (CRR) and duration - Progression-Free Survival (PFS) - Overall Survival (OS) |
- Evaluar la duración de la respuesta (DdR) global - Evaluar la TRC con el régimen de combinación y la duración de la RC - Evaluar la SLP de acuerdo con las evaluaciones por los investigadores y - Evaluar la SG del régimen de combinación de brentuximab vedotin y nivolumab. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Relapsed/refractory Diffuse Large B Cell Lymphoma (DLBCL), relapsed/refractory Peripheral T Cell Lymphoma (PTCL) (all subtypes excluding Anaplastic Large Cell Lymphoma) and relapsed/refractory Cutaneous T Cell Lymphoma (CTCL) Mycosis Fungoides/Sezary Syndrome (MF/SS) Expression of CD30 Subjects must be 18 years or older |
- Diagnóstico de LDCBG en recidiva/refractario - LCTP en recidiva/refractario (excepto LACG) y LCCT en recidiva/refractario (MF/SS) - linfoma cutáneo de células T en recidiva/refractario - Micosis fungoides y síndrome de Sézary - expresión confirmada de CD30 - Sujetos deben ser mayores de 18 años |
|
E.4 | Principal exclusion criteria |
Known central nervous system (CNS) lymphomas; Active cerebral/meningeal disease related to the underlying malignancy Active, known, or suspected autoimmune disease |
- Linfomas conocidos en el Sistema Nervioso Central (SNC) - sujetos con enfermedades cerebrales o meníngeas relacionadas con una malignidad subyacentes - Sospecha o enfermedad confirmada autoinmune |
|
E.5 End points |
E.5.1 | Primary end point(s) |
- Safety and tolerability of the combination of nivolumab and brentuximab vedotin in subjects with diagnosis of DLBCL, PTCL, CTCL - Assess the clinical benefit of nivolumab and brentuximab vedotin combination regimen in subjects as measured by Overall Response Rate (ORR) |
- Evaluar la seguridad y tolerabilidad de la combinación de nivolumab y brentuximab en sujetos con diagnóstico de LDCBG, LCTP y LCCT - Evaluar el beneficio clínico del régimen de combinación de nivolumab y brentuximab vedotin mediante la Tasa de Respuesta objetiva |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
- First dose to up to 100 days after the last dose of study treatment - 8 months after the last patient receives their first dose |
- Desde la primera dosis hasta 100 días después del último tratamiento - 8 meses después de que el último paciente recibe su primera dosis |
|
E.5.2 | Secondary end point(s) |
- Assess the overall duration of response (DOR) - Assess the complete response rate (CRR) and duration - Progression-Free Survival (PFS) - Overall Survival (OS) |
- Evaluar la duración de la respuesta (DdR) global - Evaluar la TRC con el régimen de combinación y la duración de la RC - Evaluar la SLP de acuerdo con las evaluaciones por los investigadores - Evaluar la SG del régimen de combinación de brentuximab vedotin y nivolumab |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
- 8 months after the last patient receives their first dose - 8 months after the last patient receives their first dose - 8 months after the last patient receives their first dose - 1 year after the first patient receives their first dose |
- 8 meses después de que el último paciente recibe su primera dosis - 8 meses después de que el último paciente recibe su primera dosis - 8 meses después de que el último paciente recibe su primera dosis - 1 año después de que el primer paciente recibe su primera dosis |
|
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 | No |
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 | 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 |
Exploratory biomaker objectives, outcomes research and immunogenicity |
Evaluaciones de investigación de resultados, evaluaciones de inmunogenicidad y evaluaciones de biomarcadores |
|
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Yes |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | Yes |
E.7.1.3.1 | Other trial type description |
Phase I/II, the combination of nivolumab and brentuximab is evaluated |
Estudio fase I/II de nivolumab en combinación con brentuximab vedotin |
|
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 | No |
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.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 9 |
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 |
Canada |
France |
Italy |
Spain |
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 patient |
Última visita de seguimiento 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 | 7 |
E.8.9.1 | In the Member State concerned days | 26 |
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 |