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Recruiting

Observational Study of Nivolumab in Patients in Germany With Squamous Cell Carcinoma of the Head and Neck Progressing on or After Platinum-Based Therapy - CA209-99K

Actualizada: 14 diciembre, 2020   |   ClinicalTrials.gov

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Detalles del ensayo

  • Género(s)

  • 18+

    Rango de edad

  • 1

    Ubicación(es)

  • Recruiting

Opciones de tratamiento

Brazos del estudio
INTERVENCIÓN ASIGNADA
Cohort 2: Nivolumab
SCCHN patients in Germany
Otros: Non-Interventional

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

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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