E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Squamous cell carcinoma of the head and neck |
Carcinoma escamoso de cabeza y cuello |
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E.1.1.1 | Medical condition in easily understood language |
Squamous cell carcinoma of the head and neck |
Carcinoma escamoso de cabeza y cuello |
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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 | 16.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10066471 |
E.1.2 | Term | Squamous cell carcinoma of pharynx |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10041857 |
E.1.2 | Term | Squamous cell carcinoma of the oral cavity |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10023856 |
E.1.2 | Term | Laryngeal squamous cell carcinoma |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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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 |
The purpose of this study is to find out whether nivolumab will significantly improve progression-free survival and/or overall survival as compared to therapy of investigator?s choice in patients with recurrent or metastatic head and neck carcinoma. |
El objetivo de este estudio es descubrir si nivolumab mejorará significativamentr la SLP y la SG comparado con el tratamiento de elección por el investigador en sujetos que carcinoma de cabeza y cuello recidivante o metastásico. |
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E.2.2 | Secondary objectives of the trial |
Objective Response Rate |
Tasa de Respuesta Objetiva |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Men and women ? 18 years of age with an ECOG performance status ? 1. - Histologically confirmed recurrent or metastatic HNSCC (oral cavity, pharynx, larynx), stage III/IV and not amenable to local therapy with curative intent (surgery or radiation therapy with or without chemotherapy). - Tumor progression or recurrence within 6 months of last dose of platinum therapy in the adjuvant (ie with radiation after surgery), primary (ie, with radiation), recurrent, or metastatic setting. - Measurable disease by CT or MRI per RECIST 1.1 criteria. |
1)Varones y mujeres ? 18 años con un estado funcional ECOG ? 1. 2)CECC (cavidad oral, faringe, laringe) recidivante o metastásico, confirmado histológicamente, en estadio III/IV y no susceptible de tratamiento local con intención curativa (cirugía o radioterapia con o sin quimioterapia). 3)Progresión o recidiva tumoral dentro del plazo de 6 meses después de la última dosis de tratamiento con platino en el contexto adyuvante (esto es, con radioterapia tras cirugía), primario (esto es, con radioterapia), recurrente o metastásico. 4)Los sujetos deben tener enfermedad medible por TC o RM según los criterios RECIST 1.1. |
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E.4 | Principal exclusion criteria |
- Active brain metastases or leptomeningeal metastases are not allowed. - Histologically confirmed recurrent or metastatic carcinoma of the nasopharynx and salivary gland or nonsquamous histologies - Subjects with active, known or suspected autoimmune disease. |
1)No se permiten las metástasis cerebrales activas o las metástasis leptomeníngeas. 2)No se permiten el carcinoma recurrente o metastásico confirmado histológicamente de la nasofaringe y la glándula salivar o histologías no escamosas (p. ej., melanoma de la mucosa). 5)Sujetos con enfermedad autoinmune activa, conocida o sospechada. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Co-primary endpoints: Progression-Free Survival (PFS) and Overall Survival (OS) |
Variables coprincipales: Supervivencia Libre de Progresión (SLP) y Supervivencia Global (SG) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
For PFS: Starting at week 9 and then every 6 weeks after randomization, until disease progression For OS: Every 3 months during the survival follow-up phase |
PFS: Comenzando en la semana 9 y después cada 6 semanas después de aleatorización, hasta la progresión de la enfermedad. OS: Cada 3 meses durante la fase de seguimiento de la supervivencia |
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E.5.2 | Secondary end point(s) |
Objective Response Rate |
Tasa de Respuesta Objetiva |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Starting at week 9 and then every 6 weeks after randomization, until disease progression or study drug is discontinued (whichever occurs later). |
Comenzando en la semana 9 y después cada 6 semanas después de aleatorización, hasta la progresión de la enfermedad o la interrupción de la medicación del estudio ( lo que ocurra primero). |
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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 | 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 | 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) | 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 | No |
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 | 25 |
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 |
Netherlands |
Argentina |
Germany |
Hong Kong |
Spain |
Switzerland |
United Kingdom |
United States |
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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
|
The study will end when analysis of survival is complete. |
El estudio terminará cuando se complete el análisis de supervivencia. |
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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 | 3 |
E.8.9.1 | In the Member State concerned months | 5 |
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 |