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

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

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).

Study Overview

• Status: Completed
• Conditions: Squamous Cell Carcinoma of the Head and Neck

• Study Type: Observational
• Enrollment (Actual): 304

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Parsippany, New Jersey, United States, 07054
      • Medical Data Analytics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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).

Description

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).

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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		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

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): March 19, 2021
• Study Completion (Actual): March 19, 2021

Study Registration Dates

• First Submitted: October 19, 2021
• First Submitted That Met QC Criteria: November 15, 2021
• First Posted (Actual): November 17, 2021

Study Record Updates

• Last Update Posted (Actual): November 17, 2021
• Last Update Submitted That Met QC Criteria: November 15, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Nivolumab; Outcomes; Metastatic; Recurrent; SCCHN; Treatment patterns
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Head and Neck Neoplasms; Neoplasms, Squamous Cell; Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
• Other Study ID Numbers: CA209-8HX

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No