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
Completed
- Conditions
- Squamous Cell Carcinoma of the Head and Neck
- Registration Number
- NCT05123950
- Lead Sponsor
- Bristol-Myers Squibb
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 304
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).
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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: 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: 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
Name Time Method 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
Trial Locations
- Locations (1)
Medical Data Analytics
🇺🇸Parsippany, New Jersey, United States