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

Squamous Cell Carcinoma of the Head and Neck Clinical Trial

Official title:

Treatment Patterns and Clinical Outcomes in First Line Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (1L R/M SCCHN) Patients in Europe

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05123950
• Other study ID #: CA209-8HX
• Status: Completed
• Start date: January 1, 2019
• Est. completion date: March 19, 2021

Study information

• Verified date: November 2021
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 304
• Est. completion date: March 19, 2021
• Est. primary completion date: March 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Squamous Cell Carcinoma of Head and Neck
• Squamous Cell Carcinoma of the Head and Neck

Locations

Country	Name	City	State
United States	Medical Data Analytics	Parsippany	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Distribution of demographic characteristics of 1L R/M SCCHN participants treated with nivolumab: Height		At Baseline
Primary	Distribution of demographic characteristics of 1L R/M SCCHN participants treated with nivolumab: Weight		At Baseline
Primary	Distribution of demographic characteristics of 1L R/M SCCHN participants treated with nivolumab: Body surface area (BSA)		At Baseline
Primary	Distribution of demographic characteristics of 1L R/M SCCHN participants treated with nivolumab: Health insurance coverage		At Baseline
Primary	Distribution of demographic characteristics of 1L R/M SCCHN participants treated with nivolumab: Tobacco use		At Baseline
Primary	Distribution of demographic characteristics of 1L R/M SCCHN participants treated with nivolumab: Patient comorbidities		At Baseline
Primary	Distribution of demographic characteristics of 1L R/M SCCHN participants treated with nivolumab: Alcohol use		At Baseline
Primary	Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Human papillomavirus(HPV) p -16 status		At Baseline
Primary	Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Date of early stage diagnosis		At Baseline
Primary	Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Receive a platinum-based agent for early stage diagnosis		At Baseline
Primary	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
Primary	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
Primary	Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Date of R/M SCCHN diagnosis		At Baseline
Primary	Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Specialty of diagnosing physician		At Baseline
Primary	Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Primary site of SCCHN at R/M diagnosis		At Baseline
Primary	Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Clinical stage at R/M diagnosis		At Baseline
Primary	Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Primary tumor stage at R/M diagnosis		At Baseline
Primary	Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Lymph node involvement at R/M diagnosis		At Baseline
Primary	Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Metastasis at R/M diagnosis		At Baseline
Primary	Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Histologic tumor grade at R/M diagnosis		At Baseline
Primary	Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Overall prognosis at R/M diagnosis		At Baseline
Primary	Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Platinum-based grouping		At Baseline
Primary	Distribution of diagnostic procedures of 1L R/M SCCHN participants treated with nivolumab		At Baseline
Primary	Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: First (second, third+) Line of therapy (LOT)		At Baseline
Primary	Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Duration of LOT		At Baseline
Primary	Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Administration form		At Baseline
Primary	Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Dose		At Baseline
Primary	Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Dose changes		At Baseline
Primary	Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Frequency of treatment regimen		At Baseline
Primary	Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Schedule of agent administration		At Baseline
Primary	Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Number of planned cycles		At Baseline
Primary	Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Number of completed cycles		At Baseline
Primary	Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Reasons for prescribing therapy		At Baseline
Primary	Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Reasons for discontinuing therapy		At Baseline
Primary	Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Dose delays		At Baseline
Primary	Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Radiation performed for R/M disease		At Baseline
Primary	Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Surgical procedures performed for R/M disease		At Baseline
Primary	Distribution of adverse events of 1L R/M SCCHN participants treated with nivolumab		At Baseline
Primary	Distribution of adverse events of 1L R/M SCCHN participants treated with nivolumab: Action taken		At Baseline
Primary	Distribution of adverse events of 1L R/M SCCHN participants treated with nivolumab: Resolution		At Baseline
Primary	Distribution of clinical outcomes of 1L R/M SCCHN participants treated with nivolumab: Response to therapy		At Baseline
Primary	Distribution of clinical outcomes of 1L R/M SCCHN participants treated with nivolumab: Duration of response		Up to approximately 36 months
Primary	Distribution of clinical outcomes of 1L R/M SCCHN participants treated with nivolumab: Overall survival		Up to approximately 36 months
Primary	Distribution of clinical outcomes of 1L R/M SCCHN participants treated with nivolumab: Progression free survival		Up to approximately 36 months
Secondary	Comparison of patient demographics, clinical characteristics, and treatment patterns between the Cohort 1- Augment and Cohort 1		At Baseline
Secondary	Comparison of time to event endpoints of OS, PFS, and DOR between Cohort 1- Augment and Cohort 1		Up to approximately 36 months

External Links

•   BMS Clinical Trial Information
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