Clinical trial NCT05123950: A Study of Treatment Patterns and Clinical Outcomes in First Line Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (1L R/M SCCHN) Participants in Europe
Official title: Treatment Patterns and Clinical Outcomes in First Line Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (1L R/M SCCHN) Patients in Europe
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Squamous Cell Carcinoma of the Head and Neck
Keywords: Metastatic
Nivolumab
Recurrent
SCCHN
Treatment patterns
Outcomes
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2021-11-17
Enrollment: 304
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A population of participants diagnosed with Recurrent/Metastatic Squamous cell carcinoma of the head and neck (R/M SCCHN) and treated with 1L therapy in two cohorts based on time period of initiating 1L treatment. Patients will be enrolled from France (FR), Germany (DE), and the United Kingdom (UK).

Brief summary: The purpose of this observational study is to collect real-world data that describes treatment patterns and clinical outcomes in participants with first line recurrent/metastatic squamous cell carcinoma of the head \& neck (1L R/M SCCHN).


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

Inclusion Criteria:

Participants are included in Cohort 1 - Augment if they meet the following criteria:

* Adults18 years or older
* Diagnosis of histologically confirmed R/M SCCHN, from any of the following primary sites only: oral cavity, oropharynx, hypopharynx, and larynx between 01-Jun-2017 and 31-June-2018.
* Prescribed 1L treatment for R/M SCCHN
* Treatment history and response available for medical chart abstraction from date of diagnosis until death or the end of the study in living participants
* Have available for review one month of follow-up data available post initiation of 1L R/M SCCHN therapy
* Informed consent form (ICF) signature/collection of living participants, as required by country regulation and local ethics committees

Participants are included in Cohort 1 if they meet the following criteria:

* Adults 18 years or older
* Diagnosis of histologically confirmed R/M SCCHN, from any of the following primary sites only: oral cavity, oropharynx, hypopharynx and larynx between 01-Jan-2014 and 31-Dec-2016.
* Prescribed 1L treatment for R/M SCCHN
* Treatment history and response available for medical chart abstraction from the date of diagnosis until death or the end of the study in living participants
* Have available for review one month of follow-up data post initiation of 1L R/M SCCHN therapy
* Informed consent form (ICF) signature/collection of living participants, as required by country regulation and local ethics committees

Exclusion Criteria:

Participants were excluded from either cohort if they meet the following criteria:

* Were enrolled in a cancer treatment-related clinical trial since the diagnosis of R/M SCCHN
* Recurrent or metastatic carcinoma of the nasopharynx, squamous cell carcinoma of unknown primary site, squamous cell carcinoma that originated from the skin and salivary gland or non-squamous histologies (e.g., mucosal melanoma).

Primary outcomes:
measure: Distribution of demographic characteristics of 1L R/M SCCHN participants treated with nivolumab: Age
timeFrame: At Baseline
measure: Distribution of demographic characteristics of 1L R/M SCCHN participants treated with nivolumab: Height
timeFrame: At Baseline
measure: Distribution of demographic characteristics of 1L R/M SCCHN participants treated with nivolumab: Weight
timeFrame: At Baseline
measure: Distribution of demographic characteristics of 1L R/M SCCHN participants treated with nivolumab: Body surface area (BSA)
timeFrame: At Baseline
measure: Distribution of demographic characteristics of 1L R/M SCCHN participants treated with nivolumab: Health insurance coverage
timeFrame: At Baseline
measure: Distribution of demographic characteristics of 1L R/M SCCHN participants treated with nivolumab: Tobacco use
timeFrame: At Baseline
measure: Distribution of demographic characteristics of 1L R/M SCCHN participants treated with nivolumab: Patient comorbidities
timeFrame: At Baseline
measure: Distribution of demographic characteristics of 1L R/M SCCHN participants treated with nivolumab: Alcohol use
timeFrame: At Baseline
measure: Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Human papillomavirus(HPV) p -16 status
timeFrame: At Baseline
measure: Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Date of early stage diagnosis
timeFrame: At Baseline
measure: Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Receive a platinum-based agent for early stage diagnosis
timeFrame: At Baseline
measure: Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Receive radiation within 6 months prior to early stage diagnosis
timeFrame: At Baseline
measure: Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Undergo related surgeries within 6 months prior to early stage diagnosis
timeFrame: At Baseline
measure: Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Date of R/M SCCHN diagnosis
timeFrame: At Baseline
measure: Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Specialty of diagnosing physician
timeFrame: At Baseline
measure: Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Primary site of SCCHN at R/M diagnosis
timeFrame: At Baseline
measure: Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Clinical stage at R/M diagnosis
timeFrame: At Baseline
measure: Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Primary tumor stage at R/M diagnosis
timeFrame: At Baseline
measure: Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Lymph node involvement at R/M diagnosis
timeFrame: At Baseline
measure: Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Metastasis at R/M diagnosis
timeFrame: At Baseline
measure: Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Histologic tumor grade at R/M diagnosis
timeFrame: At Baseline
measure: Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Overall prognosis at R/M diagnosis
timeFrame: At Baseline
measure: Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Platinum-based grouping
timeFrame: At Baseline
measure: Distribution of diagnostic procedures of 1L R/M SCCHN participants treated with nivolumab
timeFrame: At Baseline
measure: Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: First (second, third+) Line of therapy (LOT)
timeFrame: At Baseline
measure: Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Duration of LOT
timeFrame: At Baseline
measure: Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Administration form
timeFrame: At Baseline
measure: Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Dose
timeFrame: At Baseline
measure: Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Dose changes
timeFrame: At Baseline
measure: Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Frequency of treatment regimen
timeFrame: At Baseline
measure: Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Schedule of agent administration
timeFrame: At Baseline
measure: Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Number of planned cycles
timeFrame: At Baseline
measure: Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Number of completed cycles
timeFrame: At Baseline
measure: Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Reasons for prescribing therapy
timeFrame: At Baseline
measure: Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Reasons for discontinuing therapy
timeFrame: At Baseline
measure: Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Dose delays
timeFrame: At Baseline
measure: Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Radiation performed for R/M disease
timeFrame: At Baseline
measure: Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Surgical procedures performed for R/M disease
timeFrame: At Baseline
measure: Distribution of adverse events of 1L R/M SCCHN participants treated with nivolumab
timeFrame: At Baseline
measure: Distribution of adverse events of 1L R/M SCCHN participants treated with nivolumab: Action taken
timeFrame: At Baseline
measure: Distribution of adverse events of 1L R/M SCCHN participants treated with nivolumab: Resolution
timeFrame: At Baseline
measure: Distribution of clinical outcomes of 1L R/M SCCHN participants treated with nivolumab: Response to therapy
timeFrame: At Baseline
measure: Distribution of clinical outcomes of 1L R/M SCCHN participants treated with nivolumab: Duration of response
timeFrame: Up to approximately 36 months
measure: Distribution of clinical outcomes of 1L R/M SCCHN participants treated with nivolumab: Overall survival
timeFrame: Up to approximately 36 months
measure: Distribution of clinical outcomes of 1L R/M SCCHN participants treated with nivolumab: Progression free survival
timeFrame: Up to approximately 36 months
Secondary outcomes:
measure: Comparison of patient demographics, clinical characteristics, and treatment patterns between the Cohort 1- Augment and Cohort 1
timeFrame: At Baseline
measure: Comparison of time to event endpoints of OS, PFS, and DOR between Cohort 1- Augment and Cohort 1
timeFrame: Up to approximately 36 months
Other outcomes:
Locations:
city: Parsippany
country: United States
facility: Medical Data Analytics
state: New Jersey
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: