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

Bristol-Myers Squibb304 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

304

Conditions

Squamous Cell Carcinoma of the Head and Neck

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (1)

Medical Data Analytics

Parsippany, New Jersey, United States

Outcomes

Primary Outcomes

Distribution of demographic characteristics of 1L R/M SCCHN participants treated with nivolumab: Age

Recurrent/Metastatic (R/M) Squamous Cell Carcinoma of the Head \& Neck (SCCHN)

Time frame: At Baseline

Distribution of demographic characteristics of 1L R/M SCCHN participants treated with nivolumab: Height

Time frame: At Baseline

Distribution of demographic characteristics of 1L R/M SCCHN participants treated with nivolumab: Weight

Time frame: At Baseline

Distribution of demographic characteristics of 1L R/M SCCHN participants treated with nivolumab: Body surface area (BSA)

Time frame: At Baseline

Distribution of demographic characteristics of 1L R/M SCCHN participants treated with nivolumab: Health insurance coverage

Time frame: At Baseline

Distribution of demographic characteristics of 1L R/M SCCHN participants treated with nivolumab: Tobacco use

Time frame: At Baseline

Distribution of demographic characteristics of 1L R/M SCCHN participants treated with nivolumab: Patient comorbidities

Time frame: At Baseline

Distribution of demographic characteristics of 1L R/M SCCHN participants treated with nivolumab: Alcohol use

Time frame: At Baseline

Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Human papillomavirus(HPV) p -16 status

Time frame: At Baseline

Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Date of early stage diagnosis

Data from ClinicalTrials.gov

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Time frame: At Baseline

Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Receive a platinum-based agent for early stage diagnosis

Time frame: At Baseline

Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Receive radiation within 6 months prior to early stage diagnosis

Time frame: At Baseline

Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Undergo related surgeries within 6 months prior to early stage diagnosis

Time frame: At Baseline

Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Date of R/M SCCHN diagnosis

Time frame: At Baseline

Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Specialty of diagnosing physician

Time frame: At Baseline

Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Primary site of SCCHN at R/M diagnosis

Time frame: At Baseline

Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Clinical stage at R/M diagnosis

Time frame: At Baseline

Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Primary tumor stage at R/M diagnosis

Time frame: At Baseline

Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Lymph node involvement at R/M diagnosis

Time frame: At Baseline

Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Metastasis at R/M diagnosis

Time frame: At Baseline

Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Histologic tumor grade at R/M diagnosis

Time frame: At Baseline

Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Overall prognosis at R/M diagnosis

Time frame: At Baseline

Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Platinum-based grouping

Time frame: At Baseline

Distribution of diagnostic procedures of 1L R/M SCCHN participants treated with nivolumab

Time frame: At Baseline

Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: First (second, third+) Line of therapy (LOT)

Time frame: At Baseline

Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Duration of LOT

Time frame: At Baseline

Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Administration form

Time frame: At Baseline

Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Dose

Time frame: At Baseline

Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Dose changes

Time frame: At Baseline

Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Frequency of treatment regimen

Time frame: At Baseline

Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Schedule of agent administration

Time frame: At Baseline

Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Number of planned cycles

Time frame: At Baseline

Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Number of completed cycles

Time frame: At Baseline

Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Reasons for prescribing therapy

Time frame: At Baseline

Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Reasons for discontinuing therapy

Time frame: At Baseline

Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Dose delays

Time frame: At Baseline

Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Radiation performed for R/M disease

Time frame: At Baseline

Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Surgical procedures performed for R/M disease

Time frame: At Baseline

Distribution of adverse events of 1L R/M SCCHN participants treated with nivolumab

Time frame: At Baseline

Distribution of adverse events of 1L R/M SCCHN participants treated with nivolumab: Action taken

Time frame: At Baseline

Distribution of adverse events of 1L R/M SCCHN participants treated with nivolumab: Resolution

Time frame: At Baseline

Distribution of clinical outcomes of 1L R/M SCCHN participants treated with nivolumab: Response to therapy

Time frame: At Baseline

Distribution of clinical outcomes of 1L R/M SCCHN participants treated with nivolumab: Duration of response

Time frame: Up to approximately 36 months

Distribution of clinical outcomes of 1L R/M SCCHN participants treated with nivolumab: Overall survival

Time frame: Up to approximately 36 months

Distribution of clinical outcomes of 1L R/M SCCHN participants treated with nivolumab: Progression free survival

Time frame: Up to approximately 36 months

Secondary Outcomes

Comparison of patient demographics, clinical characteristics, and treatment patterns between the Cohort 1- Augment and Cohort 1

Time frame: At Baseline

Comparison of time to event endpoints of OS, PFS, and DOR between Cohort 1- Augment and Cohort 1

Time frame: Up to approximately 36 months