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

November 15, 2021 updated by: Bristol-Myers Squibb

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
304

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Distribution of demographic characteristics of 1L R/M SCCHN participants treated with nivolumab: Age
Time Frame: At Baseline
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
Time Frame: At Baseline
At Baseline
Distribution of demographic characteristics of 1L R/M SCCHN participants treated with nivolumab: Weight
Time Frame: At Baseline
At Baseline
Distribution of demographic characteristics of 1L R/M SCCHN participants treated with nivolumab: Body surface area (BSA)
Time Frame: At Baseline
At Baseline
Distribution of demographic characteristics of 1L R/M SCCHN participants treated with nivolumab: Health insurance coverage
Time Frame: At Baseline
At Baseline
Distribution of demographic characteristics of 1L R/M SCCHN participants treated with nivolumab: Tobacco use
Time Frame: At Baseline
At Baseline
Distribution of demographic characteristics of 1L R/M SCCHN participants treated with nivolumab: Patient comorbidities
Time Frame: At Baseline
At Baseline
Distribution of demographic characteristics of 1L R/M SCCHN participants treated with nivolumab: Alcohol use
Time Frame: At Baseline
At Baseline
Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Human papillomavirus(HPV) p -16 status
Time Frame: At Baseline
At Baseline
Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Date of early stage diagnosis
Time Frame: At Baseline
At Baseline
Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Receive a platinum-based agent for early stage diagnosis
Time Frame: At Baseline
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
Time Frame: At Baseline
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
Time Frame: At Baseline
At Baseline
Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Date of R/M SCCHN diagnosis
Time Frame: At Baseline
At Baseline
Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Specialty of diagnosing physician
Time Frame: At Baseline
At Baseline
Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Primary site of SCCHN at R/M diagnosis
Time Frame: At Baseline
At Baseline
Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Clinical stage at R/M diagnosis
Time Frame: At Baseline
At Baseline
Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Primary tumor stage at R/M diagnosis
Time Frame: At Baseline
At Baseline
Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Lymph node involvement at R/M diagnosis
Time Frame: At Baseline
At Baseline
Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Metastasis at R/M diagnosis
Time Frame: At Baseline
At Baseline
Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Histologic tumor grade at R/M diagnosis
Time Frame: At Baseline
At Baseline
Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Overall prognosis at R/M diagnosis
Time Frame: At Baseline
At Baseline
Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Platinum-based grouping
Time Frame: At Baseline
At Baseline
Distribution of diagnostic procedures of 1L R/M SCCHN participants treated with nivolumab
Time Frame: At Baseline
At Baseline
Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: First (second, third+) Line of therapy (LOT)
Time Frame: At Baseline
At Baseline
Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Duration of LOT
Time Frame: At Baseline
At Baseline
Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Administration form
Time Frame: At Baseline
At Baseline
Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Dose
Time Frame: At Baseline
At Baseline
Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Dose changes
Time Frame: At Baseline
At Baseline
Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Frequency of treatment regimen
Time Frame: At Baseline
At Baseline
Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Schedule of agent administration
Time Frame: At Baseline
At Baseline
Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Number of planned cycles
Time Frame: At Baseline
At Baseline
Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Number of completed cycles
Time Frame: At Baseline
At Baseline
Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Reasons for prescribing therapy
Time Frame: At Baseline
At Baseline
Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Reasons for discontinuing therapy
Time Frame: At Baseline
At Baseline
Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Dose delays
Time Frame: At Baseline
At Baseline
Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Radiation performed for R/M disease
Time Frame: At Baseline
At Baseline
Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Surgical procedures performed for R/M disease
Time Frame: At Baseline
At Baseline
Distribution of adverse events of 1L R/M SCCHN participants treated with nivolumab
Time Frame: At Baseline
At Baseline
Distribution of adverse events of 1L R/M SCCHN participants treated with nivolumab: Action taken
Time Frame: At Baseline
At Baseline
Distribution of adverse events of 1L R/M SCCHN participants treated with nivolumab: Resolution
Time Frame: At Baseline
At Baseline
Distribution of clinical outcomes of 1L R/M SCCHN participants treated with nivolumab: Response to therapy
Time Frame: At Baseline
At Baseline
Distribution of clinical outcomes of 1L R/M SCCHN participants treated with nivolumab: Duration of response
Time Frame: Up to approximately 36 months
Up to approximately 36 months
Distribution of clinical outcomes of 1L R/M SCCHN participants treated with nivolumab: Overall survival
Time Frame: Up to approximately 36 months
Up to approximately 36 months
Distribution of clinical outcomes of 1L R/M SCCHN participants treated with nivolumab: Progression free survival
Time Frame: Up to approximately 36 months
Up to approximately 36 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Comparison of patient demographics, clinical characteristics, and treatment patterns between the Cohort 1- Augment and Cohort 1
Time Frame: At Baseline
At Baseline
Comparison of time to event endpoints of OS, PFS, and DOR between Cohort 1- Augment and Cohort 1
Time Frame: Up to approximately 36 months
Up to approximately 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 19, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 19, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 19, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 15, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 17, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 17, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 15, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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