E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Relapsed Refractory Non Hodgkin Lymphomas with CD30 Expression |
Linfomi Non Hodgkin Recidivi o Refrattari con Espressione di CD30 |
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E.1.1.1 | Medical condition in easily understood language |
Non-Hodgkin Lymphomas |
Linfomi Non-Hodgkin |
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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 | 20.0 |
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 |
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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 |
Determinare la sicurezza ed efficacia di nivolumab in combinazione con brentuximab vedotin in alcuni sottotipi di linfomi non-hodgkin |
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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) |
- Determinare la durata di risposta complessia (DOR) - Determinare il tasso di risposta completa (CRR) e durata - Sopravvivenza libera da malattia - Sopravvivenza globale |
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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), relapsed/refractory Cutaneous T cell lymphoma (CTCL) mycosis fungoides/sezary syndrome (MF/SS), relapsed/refractory primary mediastinal B lymphoma (PMBL), and relapsed/refractory mediastinal gray zone lymphoma (MGZL) • Expression of CD30 • Subjects must be 18 years or older (= 15 years for PMBL) |
- Linfoma Diffuso a Grandi Cellule B recidivo o refrattario (DLBCL), linfoma a Cellule T Periferico (PTCL) recidivo o refrattario (tutti i sottotipi ad esclusione del linfoma a Cellule Larghe Anaplastiche), Linfoma Cutaneo a Cellule T (CTCL) recidivo o refrattario (solo sottotipi Mycosis Fungoides/Sezary Syndrome, MF/SS), Linfoma Primitivo del Mediastino a cellule B recidivo/refrattario (PMBL) e Linfoma Mediastinico Grey Zone (MGZL) - Espressione di CD30 nel tumore o nei linfociti infiltranti il tumore (TILs) - Soggetti di età uguale o superiore a 18 anni (per soggetti PMBL: età uguale o superiore a 15 anni)
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E.4 | Principal exclusion criteria |
- Location of the NHL in the central nervous system (CNS) - Positive test for autoimmune disease |
- ubicazione di Linfoma non-Hodgkin a livello di Sistema Nervoso Centrale - malattie auto-immuni attive note o sospette
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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) |
- sicurezza e tollerabilità della combinazione di nivoluab e brentuximab vedotin in soggetti con diagnosi di DLBCL, PTCL, CTCL - determinare il beneficio clinico della combinazione di nivolumba e brentuximab vedotin in soggetti come misurato dal tasso di risposta globale (ORR)
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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 |
- dalla prima dose fino a 100 giorni dopo l’ultima dose del trattamento di studio - 8 mesi dopo che l’ultimo paziente ha ricevuto la prima dose
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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) |
- determinare la durata globale di risposta (DOR) - Determinare il tasso di risposta completa (CRR) e durata - Sopravvivenza libera da malattia - Sopravvivenza Globale (OS)
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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 mesi dopo che l’ultimo paziente ha ricevuto la prima dose - 8 mesi dopo che l’ultimo paziente ha ricevuto la prima dose - 8 mesi dopo che l’ultimo paziente ha ricevuto la prima dose - 1 anno dopo che l’ultimo paziente ha ricevuto la prima dose
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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 | 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 |
Espressione di biomarkers, Outocomes Research, Analisi di Immunogenicità |
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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 |
Fase I/II, per valutare la combinazione di Nivolumab e Brentuximab Vedotin |
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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.8.2.4 | 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 | 3 |
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 | Information not present in EudraCT |
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 |
United States |
France |
Italy |
Spain |
United Kingdom |
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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
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Last follow-up visit of the last patient |
Last follow-up visit of the last patient |
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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 | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 0 |