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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Participants diagnosed with R/M SCCHN between 01-Jan-2014 and 31-Dec-2016 | ||
| Cohort 1- Augment | Participants newly initiating 1L treatment for R/M SCCHN between 01-Jun-2017 and 01-Jun-2018 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) | At Baseline |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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:
Participants are included in Cohort 1 if they meet the following criteria:
Exclusion Criteria:
Participants were excluded from either cohort if they meet the following criteria:
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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).
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Data Analytics | Parsippany | New Jersey | 07054 | United States |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| Investigator Inquiry Form | View source |
| FDA Safety Alerts and Recalls |
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| 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 |
| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D009362 | Neoplasm Metastasis |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
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