E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Metastatic basal cell carcinoma or unresectable locally advanced basal cell carcinoma |
Carcinoma basocellulare metastatico o carcinoma basocellulare non resecabile localmente avanzato |
|
E.1.1.1 | Medical condition in easily understood language |
Advanced basal cell carcinoma, which is a type of skin cancer |
Carcinoma basocellulare avanzato, che è un tipo di cancro della pelle |
|
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 | PT |
E.1.2 | Classification code | 10004146 |
E.1.2 | Term | Basal cell carcinoma |
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 | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To estimate the overall response rate (ORR) for metastatic Basal Cell Carcinoma (BCC) (group 1) or for unresectable locally advanced BCC (group 2) when treated with REGN2810 as a monotherapy |
Obiettivo primario dello studio è stimare il tasso complessivo di risposta (ORR) per il carcinoma basocellulare metastatico (BCC) (gruppo 1) o BCC non resecabile localmente avanzato (gruppo 2) quando trattato con RGN2810 come monoterapia |
|
E.2.2 | Secondary objectives of the trial |
- Duration of response - Progression free survival - Complete response rate - Change in scores of patient-reported outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) - Change in scores of patient-reported outcomes in Skindex-16 - Overall Survival |
- Durata della risposta - Sopravvivenza libera da progressione - Tasso di risposta completa - Modifica dei punteggi degli esiti riferiti dai pazienti nel questionario ”European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30” (EORTC QLQ-C30) - Cambio nei punteggi degli esiti riferiti dai pazienti in Skindex-16 - Sopravvivenza globale |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Histologically confirmed diagnosis of invasive BCC - At least 1 measurable lesion - Eastern Cooperative Oncology Group (ECOG) performance status ≤1 - At least 18 years old - Willing and able to comply with clinic visits and study-related procedures - Provide signed informed consent prior to any screening procedures
|
- BCC (Carcinoma Basocellulare) invasivo confermato istologicamente - Almeno 1 lesione misurabile - Performance status ECOG (Eastern Cooperative Oncology Group) ≤1 - Età minima 18 anni - Volontà e capacità di sottoporsi alle visite presso il centro e alle procedure dello studio - Fornire il consenso informato firmato prima di qualsiasi criterio di procedura di screening
|
|
E.4 | Principal exclusion criteria |
- Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-related adverse events - Prior treatment with an agent that blocks the PD-1/PD-L1 pathway - History of pneumonitis within the last 5 years - Allergic reactions or acute hypersensitivity reaction attributed to antibody treatments - Patients with a history of solid organ transplant - Prior treatment with other immune modulating agents within fewer than 28 days prior to the first dose of REGN2810. Examples of immune modulating include therapeutic vaccines, cytokine treatments, or agents that target cytotoxic T-lymphocyte antigen 4 (CTLA-4), 4-1BB (CD137), or OX-40 - Untreated brain metastasis(es) that may be considered active |
- Evidenza in corso o recente (entro 5 anni) di malattia autoimmune significativa che richiede trattamento con terapie immunosoppressive sistemiche, che potrebbe porre il rischio di eventi avversi immuno-correlati - Trattamento precedente con un agente che blocca la via di segnalazione PD-1/PD-L1 - Anamnesi di polmonite negli ultimi 5 anni - Reazioni allergiche o reazione di ipersensibilità acuta attribuita a trattamenti con anticorpi - Pazienti con anamnesi di trapianto d’organo solido -Precedente trattamento con altri agenti immuno-modulanti meno di 28 giorni prima della prima dose di REGN2810. Esempi di immuno-modulanti comprendono vaccini terapeutici, trattamenti a base di citochine o agenti che hanno come bersaglio l’antigene 4 del linfocita T citotossico (CTLA-4), 4-1BB (CD137) o OX-40 - Una o più metastasi cerebrali non trattate che possono essere considerate attive |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy endpoint for this study is the ORR as determined by central review. The ORR will be assessed separately for patients with metastatic BCC (Group 1) or unresectable locally advanced BCC (Group 2) |
L’endpoint primario di efficacia per questo studio è l’ORR determinato secondo la revisione centrale. L’ORR verrà valutato separatamente per i pazienti con BCC metastatico (gruppo 1) o BCC non resecabile localmente avanzato (gruppo 2) |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
5 treatment cycles of 9 weeks and 4 treatment cycles of 12 weeks |
5 cicli di trattamento di 9 settimane e 4 cicli di trattamento di 12 settimane. |
|
E.5.2 | Secondary end point(s) |
Duration of response, PFS, OS, CR rate, Change in scores of patient-reported outcomes in the EORTC QLQ-C30 and the Skindex-16, AEs, Concentrations of REGN2810 in serum |
Durata della risposta, PFS, OS, Tasso di CR,Variazione dei punteggi degli esiti riportati dal paziente in EORTC QLQ-C30 e Skindex-16 • Eventi avversi (EA) • Concentrazione di REGN2810 nel siero |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
5 treatment cycles of 9 weeks and 4 treatment cycles of 12 weeks |
5 cicli di trattamento di 9 settimane e 4 cicli di trattamento di 12 settimane. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
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 | No |
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 | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
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 | 7 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 45 |
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 |
Austria |
Belgium |
Canada |
France |
Germany |
Greece |
Italy |
Spain |
Switzerland |
United States |
|
E.8.7 | Trial has a data monitoring committee | Yes |
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
|
When the last patient to enter retreatment completes the retreatment plus safety follow up |
Quando l'ultimo paziente entra nell'ultimo ciclo di trattamento e lo completa incluse le visite di follow up sulla sicurezza |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | 22 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 9 |
E.8.9.2 | In all countries concerned by the trial days | 22 |