E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Advanced or metastatic solid tumors |
Tumores sólidos avanzados o metastásicos |
|
E.1.1.1 | Medical condition in easily understood language |
Advanced Cancer |
Cánceres avanzados |
|
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 | 10061873 |
E.1.2 | Term | Non-small cell lung cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10051971 |
E.1.2 | Term | Pancreatic adenocarcinoma |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
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 | 10075566 |
E.1.2 | Term | Triple negative breast cancer |
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 whether an investigational combination immuno-therapy of nivolumab and daratumumab is safe and effective in the treatment of advanced or metastatic solid tumors. |
El objetivo de este ensayo es determinar si la combinación de dos inmunoterápicos, nivolumab y daratumumab es segura y eficaz en el tratamiento de tumores sólidos avanzados o metastásicos |
|
E.2.2 | Secondary objectives of the trial |
-To evaluate the objective response rate (ORR) of nivolumab combined with daratumumab in participants with advanced or metastatic tumors in each cohort. - To assess progression free survival (PFS) of nivolumab combined with daratumumab in participants with advanced or metastatic tumors in each cohort. -To characterize the pharmacokinetics of nivolumab and daratumumab in participants with advanced or metastatic tumors. -To characterize the immunogenicity of nivolumab and daratumumab in participants with advanced or metastatic tumors |
- Evaluar la tasa de respuestas objetivas (TRO) de nivolumab combinado con daratumumab en participantes con tumores avanzados o metastásicos en cada cohorte. - Evaluar la supervivencia libre de progresión (SLP) de nivolumab combinado con daratumumab en participantes con tumores avanzados o metastásicos en cada cohorte. - Caracterizar la farmacocinética de nivolumab y daratumumab en participantes con tumores avanzados o metastásicos. - Caracterizar la inmunogenicidad de nivolumab y daratumumab en participantes con tumores avanzados o metastásicos |
|
E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
see protocol section 9.8.1: Additional Research Collection |
Ver la sección del protocolo 9.8.1: recogida adicional para investigación |
|
E.3 | Principal inclusion criteria |
- Patients must have metastatic or advanced solid tumors. - Women with histologically or cytologically confirmed triple negative breast carcinoma. - Participants with histologically confirmed pancreatic adenocarcinoma. - Participants must have histologic or cytologic confirmation of Non Small Cell Lung Cancer (NSCLC). |
- Pacientes con tumores sólidos avanzados o metastásicos - Mujeres con carcinoma de mama triple negativo confirmado citológica o histológicamente - Participantes con adenocarcinoma pancreático histológicamente confirmado - Los pacientes deben tener la confirmación histológica o citológica de Cáncer de pulmón no microcítico (CPNM) |
|
E.4 | Principal exclusion criteria |
-Active brain metastases or leptomeningeal metastases. - Any serious or uncontrolled medical disorder. - Prior malignancy active within the previous 3 years. |
- Metástasis cerebrales activas o leptomeningeas. - Cualquier alteración médica grave o no controlada - Cualquier otra malignidad activa dentro de los 3 años anteriores |
|
E.5 End points |
E.5.1 | Primary end point(s) |
-Incidence of adverse events (AE) [ Time Frame: Up to 2.5 years - Incidence of serious adverse events (SAE) [ Time Frame: Up to 2.5 years -Grade of laboratory abnormalities. [ Time Frame: Up to 2.5 years ] |
- Incidencia de acontecimientos adversos (AA) [hasta 2,5 años] - Incidencia de acontecimientos adversos graves (AAG) [hasta 2,5 años] - Grado de anomalías de laboratorio específicas [hasta 2,5 años] |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
-Incidence of adverse events (AE) [ Time Frame: Up to 2.5 years - Incidence of serious adverse events (SAE) [ Time Frame: Up to 2.5 years -Grade of laboratory abnormalities. [ Time Frame: Up to 2.5 years ] |
- Incidencia de acontecimientos adversos (AA) [hasta 2,5 años] - Incidencia de acontecimientos adversos graves (AAG) [hasta 2,5 años] - Grado de anomalías de laboratorio específicas [hasta 2,5 años] |
|
E.5.2 | Secondary end point(s) |
-Objective Response rate (ORR) [ Time Frame: Up to 3 years ] • Progression Free Survival (PFS) [ Time Frame: Up to 3 years ] • Anti-Drug Antibodies (ADA) positivity [ Time Frame: Up to 2.5 years ] • Area under the concentration-time curve (AUC) [ Time Frame: Up to 2.5 years ] • Minimum observed concentration (Cmin) [ Time Frame: Up to 2.5 years ] |
- Tasa de Respuesta objetiva (TRO) [hasta 3 años] - Supervivencia libre de progresión (SLP) [hasta 3 años] - Positividad para anticuerpos anti-medicamento [hasta 2,5 años] - Área bajo la curva concentración-tiempo (AUC) [hasta 2,5 años] - Concentración mínima observada (Cmin) [hasta 2,5 años] |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
-Objective Response rate (ORR) [ Time Frame: Up to 3 years ] • Progression Free Survival (PFS) [ Time Frame: Up to 3 years ] • Anti-Drug Antibodies (ADA) positivity [ Time Frame: Up to 2.5 years ] • Area under the concentration-time curve (AUC) [ Time Frame: Up to 2.5 years ] • Minimum observed concentration (Cmin) [ Time Frame: Up to 2.5 years ] |
- Tasa de Respuesta objetiva (TRO) [hasta 3 años] - Supervivencia libre de progresión (SLP) [hasta 3 años] - Positividad para anticuerpos anti-medicamento [hasta 2,5 años] - Área bajo la curva concentración-tiempo (AUC) [hasta 2,5 años] - Concentración mínima observada (Cmin) [hasta 2,5 años] |
|
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 | Yes |
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 |
Evaluaciones de biomarcadores, evaluaciones de resultados de la investigación, evaluaciones de inmunogenicidad |
|
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 |
|
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 | 12 |
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 |
Canada |
France |
Germany |
Italy |
Spain |
Switzerland |
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
|
End of trial is defined as the last visit or scheduled procedure shown in the Schedule of Activities for the last participant. |
El final del ensayob se define como la última visita o procedimiento programad demostrado en la programación de actividades para el último participante. |
|
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 | 0 |
E.8.9.1 | In the Member State concerned days | |
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 | 5 |