Advanced MelanomaNCT02224768
YERVOY® Risk Minimization Tool Effectiveness Evaluation Survey
An observational study of Advanced Melanoma, run by Bristol-Myers Squibb at 2 sites in 2 countries.
Trial summary
To evaluate the effectiveness of the YERVOY® educational Risk Minimization (RM) tools in terms of awareness about these tools, their utilization, knowledge and comprehension of Immune Related Adverse Reaction (irAR)s, and appropriate behavior by Healthcare Professional (HCP)s and patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Melanoma
- What is being tested?
- Ipilimumab
- How many people
- 158 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jul 2015to Nov 2015
- 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: HCPs and Patients in EU member states where YERVOY has been marked for atleast six months
Who may be able to join
- HCP experienced in the treatment of patients with the research compound and patients that have received at least one dose
Who cannot join
None listed.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United Kingdom1 site
Local Institution
St Ives, Cambridgeshire, PE27 5BZ
About this study
Official title: YERVOY Risk Minimisation Tool Evaluation Survey
To evaluate the effectiveness of the YERVOY® educational Risk Minimization (RM) tools in terms of awareness about these tools, their utilization, knowledge and comprehension of Immune Related Adverse Reaction (irAR)s, and appropriate behavior by Healthcare Professional (HCP)s and patients
Read the detailed description
A total sample size of 160 to 200 HCPs and 160 to 200 patients
- Conditions
- Advanced Melanoma
- Being tested
- Ipilimumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IpilimumabDrug
| Study group | Role | What they receive |
|---|---|---|
| HCP and Patient inclusion | HCP inclusion - HCP Experience with treatment of patients with study compound who have been exposed to risk minimization tools
Patient inclusion - Patients treated with study compound as per label who have been exposed to the risk minimization materials Receives: Drug: Ipilimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of YERVOY HCPs that are aware of the existence of the risk communications tools and how the tools were accessed (i.e. paper or electronic versions)
Distribution metrics and awareness of the tools from responses through the survey will be analysed and descriptive statistics will be used within the different participant groups
Measured: 6 months
Questionnaire: "Who uses the RM communication tools, how, when they are used and how often they are used"
Web downloads metrics will be collected and the usage of tools from responses in the survey will be analysed, and descriptive statistics will be used within the participant groups
Measured: 6 months
Level of knowledge and comprehension of the key elements of important identified risks associated with YERVOY treatment based on the scores obtained from the Questionnaire Surveys
Knowledge and comprehension in HCPs and patients, the knowledge surveys will provide the following data
- Total number of responses to the question including the proportions of correct answers to questions where appropriate
- Number or frequency and proportion of response options selected
- Percentage of responses/total responses per option
- Mean value and standard deviation (for appropriate questions)
From the obtained data, Acceptable levels of correct responses will be determined, post data analysis, reporting and discussion with EMA, to set baseline levels for potential future evaluations and then the scores will be assessed
Measured: 6 months
HCP and patient behaviours via behavioural questions and scenarios based on the scores obtained from the Questionnaire Surveys
For determining appropriate behaviours in HCPs and patients, ideal expected behaviours will be mapped to the ideal care pathway from the Failure Modes and Effects Analysis (FMEA) as described in the RMP. The metrics will show:
- Total of number of participants answering the question.
- Proportions of participants providing correct answers (to identify knowledge and comprehension)
- Proportion of participants showing expected (ideal) behaviour - i.e. correct answers to individual questions.
- Proportion of participants showing non-ideal behaviour - i.e. partially correct or incorrect answers to individual questions.
Analysis will examine knowledge, comprehension and behaviours for different participant types (HCP, Hospital type and Country)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2014 (estimated)
- Study startJul 2015
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced MelanomaStudies 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
- Cross-sectional
- Enrolment
- 158 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
- NCT02224768
- Sponsor's protocol ID
- CA184-242
- Status last verified
- Dec 2015
- First submitted
- 20 Mar 2014
- Last updated
- 21 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- YERVOY Risk Minimisation Tool Evaluation Survey
- ClinicalTrials.gov ID
- NCT02224768
- Acronym / sponsor ID
- CA184-242
- Conditions
- Advanced Melanoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Jul 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 25 Aug 2014 (estimated)
- 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.
To evaluate the effectiveness of the YERVOY® educational Risk Minimization (RM) tools in terms of awareness about these tools, their utilization, knowledge and comprehension of Immune Related Adverse Reaction (irAR)s, and appropriate behavior by Healthcare Professional (HCP)s and patients
Detailed description
A total sample size of 160 to 200 HCPs and 160 to 200 patients
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HCP and Patient inclusion | – | Drug: IpilimumabHCP inclusion - HCP Experience with treatment of patients with study compound who have been exposed to risk minimization tools Patient inclusion - Patients treated with study compound as per label who have been exposed to the risk minimization materials |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HCPs and Patients in EU member states where YERVOY has been marked for atleast six months
Key inclusion criteria (1 listed)
- HCP experienced in the treatment of patients with the research compound and patients that have received at least one dose
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Ipilimumab | Drug | HCP and Patient inclusion |
Primary outcome
The proportion of YERVOY HCPs that are aware of the existence of the risk communications tools and how the tools were accessed (i.e. paper or electronic versions)
Time frame: 6 months
Distribution metrics and awareness of the tools from responses through the survey will be analysed and descriptive statistics will be used within the different participant groups
Questionnaire: "Who uses the RM communication tools, how, when they are used and how often they are used"
Time frame: 6 months
Web downloads metrics will be collected and the usage of tools from responses in the survey will be analysed, and descriptive statistics will be used within the participant groups
Level of knowledge and comprehension of the key elements of important identified risks associated with YERVOY treatment based on the scores obtained from the Questionnaire Surveys
Time frame: 6 months
Knowledge and comprehension in HCPs and patients, the knowledge surveys will provide the following data 1. Total number of responses to the question including the proportions of correct answers to questions where appropriate 2. Number or frequency and proportion of response options selected 3. Percentage of responses/total responses per option 4. Mean value and standard deviation (for appropriate questions) From the obtained data, Acceptable levels of correct responses will be determined, post data analysis, reporting and discussion with EMA, to set baseline levels for potential future evaluations and then the scores will be assessed
HCP and patient behaviours via behavioural questions and scenarios based on the scores obtained from the Questionnaire Surveys
Time frame: 6 months
For determining appropriate behaviours in HCPs and patients, ideal expected behaviours will be mapped to the ideal care pathway from the Failure Modes and Effects Analysis (FMEA) as described in the RMP. The metrics will show: 1. Total of number of participants answering the question. 2. Proportions of participants providing correct answers (to identify knowledge and comprehension) 3. Proportion of participants showing expected (ideal) behaviour - i.e. correct answers to individual questions. 4. Proportion of participants showing non-ideal behaviour - i.e. partially correct or incorrect answers to individual questions. Analysis will examine knowledge, comprehension and behaviours for different participant types (HCP, Hospital type and Country)
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 21 Dec 2015.
Related trials for Advanced Melanoma
RecruitingPhase 2
A Study of Navlimetostat (BMS-986504) Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic Solid Tumors With Homozygous MTAP Deletion (MountainTAP-5)
Solid Tumors
RecruitingPhase 2
BiCaZO: A Study Combining Two Immunotherapies (Cabozantinib and Nivolumab) to Treat Patients With Advanced Melanoma or Squamous Cell Head and Neck Cancer, an immunoMATCH Pilot Study
Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
Not yet recruitingPhase 1
SI-B036-ST-101 in Advanced/Metastatic Solid Tumors
Locally Advanced /Metastatic Solid Tumors, Locally Advanced / Metastatic Solid Tumors
Active, not recruitingPhase 2
A Study to Evaluate the Efficacy and Safety of IBI363 Monotherapy Compared to Pembrolizumab in Patients With Unresectable Locally Advanced or Metastatic Mucosal or Acral Melanoma Who Had Not Previously Received Systemic Therapy
Melanoma
RecruitingPhase 1
A Study of BI 3810944 in Patients With Advanced Cancer
Solid Tumours, Melanoma
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
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Melanoma, run by Bristol-Myers Squibb at 2 sites in 2 countries.
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 1 inclusion and 0 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 21 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, United Kingdom. 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?
The proportion of YERVOY HCPs that are aware of the existence of the risk communications tools and how the tools were accessed (i.e. paper or electronic versions) (time frame: 6 months). The study lists 4 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 21 Dec 2015.