MelanomaNCT02050594
Ipilimumab 12-month Intensive Pharmacovigilance Protocol
An observational study of Melanoma, run by Bristol-Myers Squibb at 1 site in Venezuela.
Trial summary
The primary objective of the protocol is to identify and describe observed adverse events (AEs) while on treatment with Ipilimumab for advanced melanoma in Venezuela during the study period Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- Ipilimumab
- How many people
- 6 participants
- Where
- 1 siteVenezuela
- Study dates
- Feb 2014to Feb 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: Bristol Myers de Venezuela S.A.C. has in place a Customer Model registry, which tracks every Ipilimumab prescription in Venezuela. Therefore, any oncologist who treats a patient with Ipilimumab will be identified by BMS. Use of this registry will ensure all patients who are infused with Ipilimumab are included in this study
Who may be able to join
- Age of 18 years or older on date of first dose of Ipilimumab
- Subjects who received at least 1 dose of Ipilimumab for the treatment of unresectable, recurrent or metastatic melanoma in Venezuela
Who cannot join
- Subjects who received Ipilimumab as part of a clinical trial
- Subjects who received Ipilimumab for any indication other than local approval (ie, unresectable or metastatic melanoma)
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective of the protocol is to identify and describe observed adverse events (AEs) while on treatment with Ipilimumab for advanced melanoma in Venezuela during the study period
- Conditions
- Melanoma
- Being tested
- Ipilimumab
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IpilimumabDrug
Also called Yervoy
| Study group | Role | What they receive |
|---|---|---|
| Melanoma patients on Ipilimumab | All unresectable, recurrent or metastatic melanoma patients Receives: Drug: Ipilimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Descriptive statistics of observed adverse events (AEs) while on treatment with Ipilimumab for advanced melanoma in Venezuela
Measured: Up to 12 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2014 (estimated)
- Study startFeb 2014
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- JSS Medical Research Inc.
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02050594
- Sponsor's protocol ID
- CA184-366
- Status last verified
- Jul 2015
- First submitted
- 14 Jan 2014
- Last updated
- 7 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ipilimumab 12-month Intensive Pharmacovigilance Protocol
- ClinicalTrials.gov ID
- NCT02050594
- Acronym / sponsor ID
- CA184-366
- Conditions
- Melanoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Collaborators
- JSS Medical Research Inc.
- Study start
- Feb 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 31 Jan 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.
The primary objective of the protocol is to identify and describe observed adverse events (AEs) while on treatment with Ipilimumab for advanced melanoma in Venezuela during the study period
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Melanoma patients on Ipilimumab | – | Drug: IpilimumabAll unresectable, recurrent or metastatic melanoma patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Bristol Myers de Venezuela S.A.C. has in place a Customer Model registry, which tracks every Ipilimumab prescription in Venezuela. Therefore, any oncologist who treats a patient with Ipilimumab will be identified by BMS. Use of this registry will ensure all patients who are infused with Ipilimumab are included in this study
Key inclusion criteria (2 listed)
- Age of 18 years or older on date of first dose of Ipilimumab
- Subjects who received at least 1 dose of Ipilimumab for the treatment of unresectable, recurrent or metastatic melanoma in Venezuela
Key exclusion criteria (2 listed)
- Subjects who received Ipilimumab as part of a clinical trial
- Subjects who received Ipilimumab for any indication other than local approval (ie, unresectable or metastatic melanoma)
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 |
|---|---|---|
| IpilimumabAlso: Yervoy | Drug | Melanoma patients on Ipilimumab |
Primary outcome
Descriptive statistics of observed adverse events (AEs) while on treatment with Ipilimumab for advanced melanoma in Venezuela
Time frame: Up to 12 months of treatment
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 7 Jul 2015.
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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 Melanoma, run by Bristol-Myers Squibb at 1 site in Venezuela.
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 2 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 7 Jul 2015. 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 Venezuela. 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?
Descriptive statistics of observed adverse events (AEs) while on treatment with Ipilimumab for advanced melanoma in Venezuela (time frame: Up to 12 months of treatment). 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 7 Jul 2015.