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
Study Details
Study Description
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).
Condition or Disease | Intervention/Treatment | Phase |
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Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Cohort 1 Participants diagnosed with R/M SCCHN between 01-Jan-2014 and 31-Dec-2016 |
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Cohort 1- Augment Participants newly initiating 1L treatment for R/M SCCHN between 01-Jun-2017 and 01-Jun-2018 |
Outcome Measures
Primary Outcome Measures
- Distribution of demographic characteristics of 1L R/M SCCHN participants treated with nivolumab: Age [At Baseline]
Recurrent/Metastatic (R/M) Squamous Cell Carcinoma of the Head & Neck (SCCHN)
- Distribution of demographic characteristics of 1L R/M SCCHN participants treated with nivolumab: Height [At Baseline]
- Distribution of demographic characteristics of 1L R/M SCCHN participants treated with nivolumab: Weight [At Baseline]
- Distribution of demographic characteristics of 1L R/M SCCHN participants treated with nivolumab: Body surface area (BSA) [At Baseline]
- Distribution of demographic characteristics of 1L R/M SCCHN participants treated with nivolumab: Health insurance coverage [At Baseline]
- Distribution of demographic characteristics of 1L R/M SCCHN participants treated with nivolumab: Tobacco use [At Baseline]
- Distribution of demographic characteristics of 1L R/M SCCHN participants treated with nivolumab: Patient comorbidities [At Baseline]
- Distribution of demographic characteristics of 1L R/M SCCHN participants treated with nivolumab: Alcohol use [At Baseline]
- Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Human papillomavirus(HPV) p -16 status [At Baseline]
- Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Date of early stage diagnosis [At Baseline]
- Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Receive a platinum-based agent for early stage diagnosis [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 [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 [At Baseline]
- Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Date of R/M SCCHN diagnosis [At Baseline]
- Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Specialty of diagnosing physician [At Baseline]
- Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Primary site of SCCHN at R/M diagnosis [At Baseline]
- Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Clinical stage at R/M diagnosis [At Baseline]
- Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Primary tumor stage at R/M diagnosis [At Baseline]
- Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Lymph node involvement at R/M diagnosis [At Baseline]
- Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Metastasis at R/M diagnosis [At Baseline]
- Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Histologic tumor grade at R/M diagnosis [At Baseline]
- Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Overall prognosis at R/M diagnosis [At Baseline]
- Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Platinum-based grouping [At Baseline]
- Distribution of diagnostic procedures of 1L R/M SCCHN participants treated with nivolumab [At Baseline]
- Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: First (second, third+) Line of therapy (LOT) [At Baseline]
- Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Duration of LOT [At Baseline]
- Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Administration form [At Baseline]
- Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Dose [At Baseline]
- Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Dose changes [At Baseline]
- Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Frequency of treatment regimen [At Baseline]
- Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Schedule of agent administration [At Baseline]
- Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Number of planned cycles [At Baseline]
- Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Number of completed cycles [At Baseline]
- Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Reasons for prescribing therapy [At Baseline]
- Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Reasons for discontinuing therapy [At Baseline]
- Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Dose delays [At Baseline]
- Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Radiation performed for R/M disease [At Baseline]
- Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Surgical procedures performed for R/M disease [At Baseline]
- Distribution of adverse events of 1L R/M SCCHN participants treated with nivolumab [At Baseline]
- Distribution of adverse events of 1L R/M SCCHN participants treated with nivolumab: Action taken [At Baseline]
- Distribution of adverse events of 1L R/M SCCHN participants treated with nivolumab: Resolution [At Baseline]
- Distribution of clinical outcomes of 1L R/M SCCHN participants treated with nivolumab: Response to therapy [At Baseline]
- Distribution of clinical outcomes of 1L R/M SCCHN participants treated with nivolumab: Duration of response [Up to approximately 36 months]
- Distribution of clinical outcomes of 1L R/M SCCHN participants treated with nivolumab: Overall survival [Up to approximately 36 months]
- Distribution of clinical outcomes of 1L R/M SCCHN participants treated with nivolumab: Progression free survival [Up to approximately 36 months]
Secondary Outcome Measures
- Comparison of patient demographics, clinical characteristics, and treatment patterns between the Cohort 1- Augment and Cohort 1 [At Baseline]
- Comparison of time to event endpoints of OS, PFS, and DOR between Cohort 1- Augment and Cohort 1 [Up to approximately 36 months]
Eligibility Criteria
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:
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Adults18 years or older
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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.
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Prescribed 1L treatment for R/M SCCHN
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Treatment history and response available for medical chart abstraction from date of diagnosis until death or the end of the study in living participants
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Have available for review one month of follow-up data available post initiation of 1L R/M SCCHN therapy
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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:
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Adults 18 years or older
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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.
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Prescribed 1L treatment for R/M SCCHN
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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
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Have available for review one month of follow-up data post initiation of 1L R/M SCCHN therapy
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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:
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Were enrolled in a cancer treatment-related clinical trial since the diagnosis of R/M SCCHN
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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).
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Medical Data Analytics | Parsippany | New Jersey | United States | 07054 |
Sponsors and Collaborators
- Bristol-Myers Squibb
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- CA209-8HX