Squamous Cell Carcinoma of the Head and NeckVOLUME-PRONCT05068609
A Study of Nivolumab in Participants With Squamous Cell Carcinoma of the Head & Neck (SCCHN) - Patient Reported Outcomes (PRO)
An observational study of Squamous Cell Carcinoma of the Head and Neck, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma of the Head and Neck
- What is being tested?
- Nivolumab
- How many people
- 509 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Aug 2020to 18 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Diagnosis of recurrent/metastatic squamous cell carcinoma of the head and neck (SCCHN)
- Age ≥18 years at time of nivolumab treatment initiation
- Investigator has decided that nivolumab is appropriate therapy and the participant had received at least one administration of nivolumab for the treatment of recurrent/metastatic SCCHN prior to enrolment in the study
- Charts/records include treatment start date of nivolumab
- Provide consent and is willing to self-complete on-site patient reported outcomes (PROs) on at least one occasion
Who cannot join
- Currently enrolled in an interventional clinical trial for their SCCHN
- Received systemic treatment for any other primary cancer within 6 months of study enrolment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nivolumab in the Real World in Patients With Squamous Cell Carcinoma of the Head & Neck (SCCHN) - Patient Reported Outcomes (PRO)
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.
Read the detailed description
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.
- Being tested
- Nivolumab
- Keywords
- BMS-936558, Health Related Quality of Life, Metastatic, Nivolumab, Opdivo®, Patient Reported Outcomes, Recurrent, Squamous Cell Carcinoma of the Head and Neck, VOLUME-PRO
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Neoplasm Metastasis, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabBiological
Also called Opdivo®, BMS-936558
Participants in this study are being treated with nivolumab for SCCHN
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Participants with squamous cell carcinoma of the head and neck (SCCHN) treated with nivolumab Receives: Biological: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: At enrollment
Distribution of demographic characteristics of R/M SCCHN participants treated with nivolumab: Sex
Measured: At enrollment
Distribution of demographic characteristics of R/M SCCHN participants treated with nivolumab: Race/ethnicity
Measured: At enrollment
Distribution of demographic characteristics of R/M SCCHN participants treated with nivolumab: Smoking status
Measured: At enrollment
Distribution of clinical characteristics of R/M SCCHN participants treated with nivolumab: Primary tumor location
Measured: At enrollment
Distribution of clinical characteristics of R/M SCCHN participants treated with nivolumab: Metastasis locations
Measured: At enrollment
Distribution of clinical characteristics of R/M SCCHN participants treated with nivolumab: Histology
Measured: At enrollment
Distribution of clinical characteristics of R/M SCCHN participants treated with nivolumab: Date of diagnosis of R/M SCCHN
Measured: At enrollment
Distribution of clinical characteristics of R/M SCCHN participants treated with nivolumab: Stage at locally advanced/metastatic SCCHN diagnosis
Measured: At enrollment
Distribution of patterns of use of nivolumab treatment in participants with R/M SCCHN: Duration of nivolumab therapy
Measured: Up to 8 weeks following enrollment
Distribution of patterns of use of nivolumab treatment in participants with R/M SCCHN: Drug discontinuation
Measured: Up to 8 weeks following enrollment
Distribution of doses of nivolumab therapy in participants with R/M SCCHN
Measured: Up to 8 weeks following enrollment
Distribution of subsequent treatment in participants discontinuing nivolumab
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: At enrollment, Up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2021
- Study start13 Aug 2020
- Primary completion18 Oct 2021
- Study completion18 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Carcinoma of the Head and NeckStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 509 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05068609
- Sponsor's protocol ID
- CA209-7F9
- Acronym
- VOLUME-PRO
- Status last verified
- May 2022
- First submitted
- 8 Sep 2021
- Last updated
- 5 May 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nivolumab in the Real World in Patients With Squamous Cell Carcinoma of the Head & Neck (SCCHN) - Patient Reported Outcomes (PRO)
- ClinicalTrials.gov ID
- NCT05068609
- Acronym / sponsor ID
- VOLUME-PRO / CA209-7F9
- Keywords
- BMS-936558, Health Related Quality of Life, Metastatic, Nivolumab, Opdivo®, Patient Reported Outcomes, Recurrent, Squamous Cell Carcinoma of the Head and Neck
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 509 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 13 Aug 2020 (actual)
- Primary completion
- 18 Oct 2021 (actual)
- Study completion
- 18 Oct 2021 (actual)
- First posted
- 6 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Biological: NivolumabParticipants with squamous cell carcinoma of the head and neck (SCCHN) treated with nivolumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- Diagnosis of recurrent/metastatic squamous cell carcinoma of the head and neck (SCCHN)
- Age ≥18 years at time of nivolumab treatment initiation
- Investigator has decided that nivolumab is appropriate therapy and the participant had received at least one administration of nivolumab for the treatment of recurrent/metastatic SCCHN prior to enrolment in the study
- Charts/records include treatment start date of nivolumab
- Provide consent and is willing to self-complete on-site patient reported outcomes (PROs) on at least one occasion
Key exclusion criteria (2 listed)
- Currently enrolled in an interventional clinical trial for their SCCHN
- Received systemic treatment for any other primary cancer within 6 months of study enrolment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NivolumabAlso: Opdivo®, BMS-936558Participants in this study are being treated with nivolumab for SCCHN | Biological | Cohort 1 |
Primary outcome
Distribution of demographic characteristics of R/M SCCHN participants treated with nivolumab: Month and year of birth
Time frame: At enrollment
Recurrent/Metastatic (R/M) Squamous Cell Carcinoma of the Head \& Neck (SCCHN)
Distribution of demographic characteristics of R/M SCCHN participants treated with nivolumab: Sex
Time frame: At enrollment
Distribution of demographic characteristics of R/M SCCHN participants treated with nivolumab: Race/ethnicity
Time frame: At enrollment
Distribution of demographic characteristics of R/M SCCHN participants treated with nivolumab: Smoking status
Time frame: At enrollment
Distribution of clinical characteristics of R/M SCCHN participants treated with nivolumab: Primary tumor location
Time frame: At enrollment
Distribution of clinical characteristics of R/M SCCHN participants treated with nivolumab: Metastasis locations
Time frame: At enrollment
Distribution of clinical characteristics of R/M SCCHN participants treated with nivolumab: Histology
Time frame: At enrollment
Distribution of clinical characteristics of R/M SCCHN participants treated with nivolumab: Date of diagnosis of R/M SCCHN
Time frame: At enrollment
Distribution of clinical characteristics of R/M SCCHN participants treated with nivolumab: Stage at locally advanced/metastatic SCCHN diagnosis
Time frame: At enrollment
Distribution of patterns of use of nivolumab treatment in participants with R/M SCCHN: Duration of nivolumab therapy
Time frame: Up to 8 weeks following enrollment
Distribution of patterns of use of nivolumab treatment in participants with R/M SCCHN: Drug discontinuation
Time frame: Up to 8 weeks following enrollment
Distribution of doses of nivolumab therapy in participants with R/M SCCHN
Time frame: Up to 8 weeks following enrollment
Distribution of subsequent treatment in participants discontinuing nivolumab
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At enrollment, Up to 8 weeks
Distribution of patient reported HRQoL measures through CTSQ in participants treated with nivolumab for R/M SCCHN
Time frame: At enrollment, Up to 8 weeks
Cancer Therapy Satisfaction Questionnaire (CTSQ)
Distribution of patient reported HRQoL measures through WPAI:GH in participants treated with nivolumab for R/M SCCHN
Time frame: At enrollment, Up to 8 weeks
Work Productivity and Activity Impairment Questionnaire: General Health (WPAI:GH)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2022.
- BMS Clinical Trial InformationLink provided by the sponsor.
- Investigator Inquiry FormLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Squamous Cell Carcinoma of the Head and Neck, run by Bristol-Myers Squibb at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distribution of demographic characteristics of R/M SCCHN participants treated with nivolumab: Month and year of birth (time frame: At enrollment). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2022.