Eine nationale, prospektive, nicht-interventionelle Studie (NIS) mit Nivolumab (BMS-936558) bei Patienten mit Plattenepithelkarzinomen im Kopf-Hals-Bereich, die eine Tumorprogressionwährend oder nach einer platinbasierten Therapie aufweisen

A national, prospective, non-interventional study (NIS) of Nivolumab (bms-936558) in patients with squamous cell carcinoma of the head and neck (SCCHN) progressing on or after platinumbased Therapy

Study Design: This is a German, nationwide, prospective, observational, multicenter study in adult patients 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. It is mandatory that the treating physician’s decision to start treatment with nivolumab for SCCHN was taken independently and before the decision to invite the patient to participate in the study. Physicians will be asked to enroll eligible patients consecutively until the maximum inclusion threshold (maximum number of patients to be included into the study) is reached. The enrollment period is anticipated to last approximately 2 years at study level. Patients will be followed for 5 years from Day 0 (ie, treatment initiation).

Study Population:

Inclusion Criteria

  •  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

  •  Patients who provided informed consent to participate in the study

Exclusion Criteria

  • 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)

  •  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)

  •  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


The primary objective of this study is to estimate overall survival (OS) in adult patients with squamous cell carcinoma of the head and neck (SCCHN) progressing on or after platinum-based therapy initiating nivolumab for the first time, in real-life conditions in Germany, over a 5-year follow-up period.

The secondary objectives of this study are, among adult patients with SCCHN progressing on or after platinum-based therapy initiating nivolumab for the first time, in real-life conditions in Germany:

  • to estimate OS, calculated from the date of initiating treatment with nivolumab, according to the other subgroups of interest

  • to estimate intermediate endpoints, including progression-free survival (PFS); response rates duration of response, overall and according to subgroups of interest, and treatment characteristics

  • to describe socio-demographic, clinical characteristics, and treatment characteristics of patients overall, and according to other subgroups of interest

  • to describe management of patients, treatment patterns, and variation in treatment patterns over a 5-year period (ie, dosing, regimen, indication, treatment rationale, treatment duration, and management and characteristics of treatment-related adverse events [AEs] such as median time to onset, median time to resolution, grade at onset) overall, and according to other subgroups of interest

  • to describe the incidence, severity, and management of following types of AEs to estimate toxicity:

  • Select AEs (immune-related pneumonitis, immune-related colitis, immune-related hepatitis, immune-related

  • nephritis/renal dysfunction, immune-related endocrinopathies [hyperthyroidism, hypothyroidism, adrenal

  • insufficiency, hypophysitis, diabetes mellitus], and immune-related rash)

  • other immune-related AEs (severe infusion reactions, uveitis, pancreatitis, demyelination, Guillain-Barre

  • Syndrome, myasthenic syndrome, encephalitis, and toxic epidermal necrolysis)

  • other treatment-related AEs

  • to describe patient-reported outcomes and health-related quality-of-life of patients 

Status: Aktiv

Beginn der Rekrutierung: 10.01.2018

Zentrum im UCT Universitätsklinikum Frankfurt
Prüfer: PD Dr. med. P. Balermpas
Atefeh Nateghian
Margarita Diaz Maguina
Universitätsklinikum Frankfurt/Main
Zentrum für Radiologie und Strahlentherapie
Theodor-Stern Kai
760590 Frankfurt am Main
Tel: +49 (0)69 6301-4655/ 3742
E-Mail: studien-strahlen@kgu.de

Ansprechpartner Leiter der klinischen Prüfung
Daniela Waldenberger, PhD
Bristol-Myers Squibb GmbH & Co. KGaA
Arnulfstrasse 29, D-80636 München