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Ícono de BMS, estudio Activo, no reclutando

Active, Not Recruiting

ID del estudio CA209-99K  |   NCT03114163

Observational Study of Nivolumab in Patients in Germany With Squamous Cell Carcinoma of the Head and Neck Progressing on or After Platinum-Based Therapy

Ícono de advertencia
Lo sentimos, este estudio ya no acepta nuevos participantes, pero aún está en curso.
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Resumen

  • Ícono de género masculino y femenino
  • 18+
  • Ícono de BMS, estudio Activo, no reclutando
    Active, Not Recruiting

Descripción general

This is an observational study in adult patients in Germany diagnosed with SCCHN progressing on or after platinum-based therapy, who start a new systemic therapy with nivolumab for the first time, and are treated within the market authorization approval. Patients are to be enrolled into the study no earlier than the decision to initiate treatment with nivolumab and no later than the first dose of nivolumab treatment.

Criterios clave de elegibilidad

Inclusion Criteria: 1. Adult patients (at least 18 years of age at time of treatment decision) - Diagnosis of SCCHN and patients are progressing on or after platinum-based therapy - Diagnosis of SCCHN has been confirmed by histology or cytology (either at initial diagnosis or any time later during the course of the disease) - Treatment decision to initiate a treatment with nivolumab for the first time for the treatment of SCCHN (according to the label approved in Germany) has already been taken 2. Patients who provided informed consent to participate in the study Exclusion Criteria: 1. Patients with a current primary diagnosis of a cancer other than SCCHN, ie, a cancer other than SCCHN that requires systemic or other treatment, or has not been treated curatively (as per discretion of the investigator) 2. Patients previously treated with nivolumab and/or ipilimumab, an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways (applicable for any indication) 3. Patients currently included in an interventional clinical trial for their SCCHN. Patients who have completed their participation in an interventional trial; or who are not receiving study drug anymore and who are only followed-up for OS can be enrolled

Opciones de tratamiento

Brazos del estudio

INTERVENCIÓN ASIGNADA

Brazos del estudio

Cohort 2: Nivolumab

INTERVENCIÓN ASIGNADA

Brazos del estudio

SCCHN patients in Germany

INTERVENCIÓN ASIGNADA

We strongly recommend you contact BMS to report Side Effects (Adverse Events)
Side Effects (Adverse Events) and other reportable events are defined here
Report Side Effects (Adverse Events) or Product Quality Complaints: Medical Information

Recomendamos encarecidamente que se comunique con BMS para informar los efectos secundarios (eventos adversos)
Los efectos secundarios (eventos adversos) y otros eventos reportables se definen aquí
Informe de efectos secundarios (eventos adversos) o quejas sobre la calidad del producto: información médica

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Llame 855-907-3286 o Envíenos un correo electrónico