Squamous Cell Carcinoma of the Head and Neck
Conditions
Keywords
Metastatic, Nivolumab, Recurrent, SCCHN, Treatment patterns, Outcomes
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).
Interventions
None listed
Sponsors
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distribution of clinical outcomes of 1L R/M SCCHN participants treated with nivolumab: Progression free survival | Up to approximately 36 months | — |
| 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 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 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 clinical outcomes of 1L R/M SCCHN participants treated with nivolumab: Response to therapy | At Baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of time to event endpoints of OS, PFS, and DOR between Cohort 1- Augment and Cohort 1 | Up to approximately 36 months |
| Comparison of patient demographics, clinical characteristics, and treatment patterns between the Cohort 1- Augment and Cohort 1 | At Baseline |
Countries
United States
Outcome results
None listed