E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Hepatocellular Carcinoma |
Carcinoma hepatoelular |
|
E.1.1.1 | Medical condition in easily understood language |
Hepatocellular Carcinoma |
Carcinoma hepatoelular |
|
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 | PT |
E.1.2 | Classification code | 10073071 |
E.1.2 | Term | Hepatocellular 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 |
The purpose of this study is to determine if nivolumab or sorafenib is more effective in the treatment of Advanced Hepatocellular Carcinoma. |
El objetivo de este estudio es determinar si nivolumab o sorafenib en el tratamiento de carcinoma hepatocelular avanzado |
|
E.2.2 | Secondary objectives of the trial |
-Overall Response Rate (ORR) -Progression-Free Survival (PFS) -PD-L1 expression |
- Tasa de respuestas objetivas (TRO) - Supervivencia libre de progresión (SLP) - Expresión de PD-L1 en el tumor |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Histologically confirmed advanced hepatocellular carcinoma, not eligible for surgical and/or locoregional therapies; or progressive disease after surgical and /or locoregional therapies -Locoregional therapy for HCC must be completed at least 4 weeks prior to the baseline scan. -Child-Pugh Class A -Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1. |
- Confirmación histológica de carcinoma hepatocelular no elegible para tratamientos quirúrgicos y/o locorregionales, o enfermedad progresiva después de tratamientos quirúrgicos y/o locoregionales - El tratamiento locorregional para el CHC debe haberse terminado al menos 4 semanas antes del estudio de imagen basal - Estado cirrótico de Child-Pugh Clase A -Estado funcional (EF) del Eastern Cooperative Oncology Group (ECOG) de 0 o 1. |
|
E.4 | Principal exclusion criteria |
-Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC -Prior liver transplant -Active, known, or suspected autoimmune disease |
- CHC fibrolamelar, CHC sarcomatoide o tumor mixto colangiocarcinoma-CHC conocidos - Trasplante hepático previo -Enfermedad autoinmunitaria activa, conocida o sospechada |
|
E.5 End points |
E.5.1 | Primary end point(s) |
-Time To Progression (TTP) -Overall Survival (OS) |
-Tiempo hasta la progresión (THP) -Supervivencia global (SG) |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
-Time To Progression (TTP):Approximately 18 months -Overall Survival (OS): Approximately 33 months |
-Tiempo hasta la progresión (THP aproximadamente hasta 18 meses -Supervivencia global (SG) aproximadamente hasta 33 meses |
|
E.5.2 | Secondary end point(s) |
-Overall Response Rate (ORR) -Progression-Free Survival (PFS) -PD-L1 expression |
-- Tasa de respuestas objetivas (TRO) - Supervivencia libre de progresión (SLP) - Expresión de PD-L1 en el tumor |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
-Overall Response Rate (ORR):Approximately 33 months -Progression-Free Survival (PFS):Approximately 33 months -PD-L1 expression:Approximately 33 months |
- Tasa de respuestas objetivas (TRO), apróximadamente 33 meses - Supervivencia libre de progresión (SLP), apróximasdamete 33 meses - Expresión de PD-L1 en el tumor, apróximadamente 33 meses |
|
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 | 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 |
Outcomes Research Assessments, Immunogenicity Assessments |
Evaluaciones de investigación de resultados, evaluaciones de inmunogenicidad |
|
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
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 | Yes |
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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
|
E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 4 |
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 | 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 |
Australia |
Austria |
Belgium |
Canada |
Czech Republic |
Denmark |
Finland |
France |
Germany |
Hong Kong |
Israel |
Italy |
Japan |
Korea, Republic of |
Poland |
Singapore |
Spain |
Sweden |
Switzerland |
Taiwan |
United Kingdom |
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
|
Last follow-up visit of the last subject |
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 | 7 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | 15 |
E.8.9.2 | In all countries concerned by the trial years | 7 |
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 | 13 |