Clinical trial NCT03114163: Observational Study of Nivolumab in Participants in Germany With Squamous Cell Carcinoma of the Head and Neck (SCCHN) Progressing on or After Platinum-Based Therapy
Official title: 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 Platinum-Based Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Head and Neck Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2017-04-14
Enrollment: 485
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will enroll adult participants who are at least 18 years of age at the time of the treatment decision, with the diagnosis of Squamous Cell Carcinoma of the Head and Neck (SCCHN) (either initial diagnosis or during later course histologically or cytologically confirmed). It is mandatory that the physician has already decided to initiate a treatment with nivolumab as 1st line or ≥2nd line therapy for the first time for the treatment of SCCHN, according to the label approved in Germany.

Brief summary: This is a German, observational study in adult participants diagnosed with squamous cell carcinoma of the head and neck (SCCHN) progressing on or after platinum-based therapy, who start a new systemic therapy with nivolumab in 1st line (cohort 2) or ≥2nd line (cohort 1) for the first time, and are treated within the market authorization approval. Participants 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.


Eligibility criteria: For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

- Adult participants (at least 18 years of age at time of treatment decision)

* Diagnosis of Squamous cell carcinoma of the head and neck (SCCHN) and participants are progressing on or after platinum-based therapy, administered for locally advanced, metastatic or recurrent disease (Cohort 2: prior platinum-based therapy was administered for locally advanced disease in the adjuvant or primary setting, e.g. radiotherapy)
* 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

Exclusion Criteria:

* Current primary diagnosis of a cancer other than SCCHN, ie, a cancer other than SCCHN or cancer of unknown primary (CUP-syndrome) that requires systemic or other treatment, or has not been treated curatively (as per discretion of the investigator)
* Previously treated with nivolumab and/or ipilimumab, an anti-PD-1, anti-programmed death ligand 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)
* Currently included in an interventional clinical trial for their SCCHN. Participants who have completed their participation in an interventional trial; or who are not receiving study drug anymore and who are only followed-up for Overall survival (OS) can be enrolled

Primary outcomes:
measure: Overall Survival
timeFrame: Up to 5 years
Secondary outcomes:
measure: Overall Survival
timeFrame: Up to 5 years
measure: Progression-Free Survival (PFS)
timeFrame: Up to 5 years
measure: Time to progression
timeFrame: Up to 5 years
measure: Overall Response Rate (ORR)
timeFrame: Up to 5 years
measure: Best overall response rate (BORR)
timeFrame: Up to 5 years
measure: Best overall response (BOR)
timeFrame: Up to 5 years
measure: Tumor response (Investigator assessed)
timeFrame: Up to 5 years
measure: Time to response (TTR)
timeFrame: Up to 5 years
measure: Duration of response (DOR)
timeFrame: Up to 5 years
measure: Description of socio-demographic characteristics of participants
timeFrame: Up to 5 years
measure: Description of clinical characteristics of participants
timeFrame: Up to 5 years
measure: Description of management of participants with treatment-related adverse events (AEs)
timeFrame: Up to 5 years
measure: Description of incidence of AEs
timeFrame: Up to 5 years
measure: Description of Severity of AEs
timeFrame: Up to 5 years
measure: Description of management of AEs
timeFrame: Up to 5 years
measure: Description of participant-reported outcomes (PROs) and health-related quality-of-life (QoL) of participants using the Functional Assessment of Cancer Therapy - Head & Neck (FACT-H&N) questionnaires
timeFrame: Up to 5 years
measure: Description of participant-reported outcomes (PROs) and health-related quality-of-life (QoL) of participants using European Quality of Life-5 Dimensions (EQ-5D) questionnaires
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: Local Institution - 0001
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: