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

NCT05123950 | Completed

• 1 other identifier: CA209-8HX
• Study Type: observational
• Target: 304
• Locations: 1 country
• Sites: 1

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).

Conditions

Squamous Cell Carcinoma of the Head and Neck

Keywords

Metastatic; Nivolumab; Recurrent; SCCHN; Treatment patterns; Outcomes

Outcome Measures

Primary Outcomes (45)

• 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 Outcomes (2)

• 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

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Medical Data Analytics

Parsippany, New Jersey, 07054, United States

Location

Related Links

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

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Neoplasm Metastasis; Recurrence

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2021
• First Posted: November 17, 2021
• Study Start: January 1, 2019
• Primary Completion: March 19, 2021
• Study Completion: March 19, 2021
• Last Updated: November 17, 2021

Record last verified: 2021-11

Locations

US (1)