Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of the study is to capture the utilization of nivolumab among participants with squamous cell carcinoma of the head and neck (SCCHN) since its approval, and to describe the health related quality of life (HRQoL) among participants treated with nivolumab in a real-world setting.
This is a phase 4 prospective chart review study with patient reported outcome (PRO) administration. The study population consists of participants diagnosed with squamous cell carcinoma of the head and neck (SCCHN) and are being treated with nivolumab. Eligible participants will be enrolled and observed from enrollment up to eight weeks. Demographic and clinical characteristics will be collected at enrollment. PROs will be administered at enrollment and again at a follow-up standard of care visit approximately eight weeks after enrollment.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Participants with squamous cell carcinoma of the head and neck (SCCHN) treated with nivolumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nivolumab | Biological | Participants in this study are being treated with nivolumab for SCCHN |
|
| Measure | Description | Time Frame |
|---|---|---|
| Distribution of demographic characteristics of R/M SCCHN participants treated with nivolumab: Month and year of birth | Recurrent/Metastatic (R/M) Squamous Cell Carcinoma of the Head & Neck (SCCHN) | At enrollment |
| Distribution of demographic characteristics of R/M SCCHN participants treated with nivolumab: Sex | At enrollment | |
| Distribution of demographic characteristics of R/M SCCHN participants treated with nivolumab: Race/ethnicity | At enrollment | |
| Distribution of demographic characteristics of R/M SCCHN participants treated with nivolumab: Smoking status | At enrollment | |
| Distribution of clinical characteristics of R/M SCCHN participants treated with nivolumab: Primary tumor location | At enrollment | |
| Distribution of clinical characteristics of R/M SCCHN participants treated with nivolumab: Metastasis locations | At enrollment | |
| Distribution of clinical characteristics of R/M SCCHN participants treated with nivolumab: Histology | At enrollment | |
| Distribution of clinical characteristics of R/M SCCHN participants treated with nivolumab: Date of diagnosis of R/M SCCHN | At enrollment | |
| Distribution of clinical characteristics of R/M SCCHN participants treated with nivolumab: Stage at locally advanced/metastatic SCCHN diagnosis |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
The population for this study will be approximately 50 adult participants, with a diagnosis of recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) currently being treated with nivolumab in the United Kingdom, Switzerland, Spain, or Canada. The study population will include participants with available data from medical records at enrollment who are willing to complete patient reported outcome (PRO) assessments.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Mount Laurel | New Jersey | 08054 | United States |
Not provided
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| Investigator Inquiry Form | View source |
| FDA Safety Alerts and Recalls |
Not provided
Not provided
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
Not provided
Not provided
Not provided
Not provided
Not provided
| At enrollment |
| Distribution of patterns of use of nivolumab treatment in participants with R/M SCCHN: Duration of nivolumab therapy | Up to 8 weeks following enrollment |
| Distribution of patterns of use of nivolumab treatment in participants with R/M SCCHN: Drug discontinuation | Up to 8 weeks following enrollment |
| Distribution of doses of nivolumab therapy in participants with R/M SCCHN | Up to 8 weeks following enrollment |
| Distribution of subsequent treatment in participants discontinuing nivolumab | Up to 8 weeks following enrollment |
| Distribution of patient reported health-related quality of life (HRQoL) measures through European Organisation for Research and Treatment of Cancer Quality of Life- Core Questionnaire in participants treated with nivolumab for R/M SCCHN | At enrollment, Up to 8 weeks |
| Distribution of patient reported HRQoL measures through EQ-5D-5L in participants treated with nivolumab for R/M SCCHN | At enrollment, Up to 8 weeks |
| Distribution of patient reported HRQoL measures through European Organisation for Research and Treatment of Cancer Head and Neck Cancer Module in participants treated with nivolumab for R/M SCCHN | At enrollment, Up to 8 weeks |
| Distribution of patient reported HRQoL measures through CTSQ in participants treated with nivolumab for R/M SCCHN | Cancer Therapy Satisfaction Questionnaire (CTSQ) | At enrollment, Up to 8 weeks |
| Distribution of patient reported HRQoL measures through WPAI:GH in participants treated with nivolumab for R/M SCCHN | Work Productivity and Activity Impairment Questionnaire: General Health (WPAI:GH) | At enrollment, Up to 8 weeks |
| BMS Clinical Trial Patient Recruiting | View source |
| 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 |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |