Metastatic MelanomaMDX010-28NCT00928031
Long-term Data Collection for Subjects in MDX-010 Studies
An observational study of Metastatic Melanoma, run by Bristol-Myers Squibb at 11 sites in United States.
Trial summary
The objective of this study is to collect disease status and overall survival information for all Subjects in MDX-010 studies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Melanoma
- How many people
- 160 participants
- Where
- 11 sitesUnited States
- Study dates
- Jun 2007to Apr 2009
- 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: Subjects who received any dose of ipilimumab (MDX-010) in MDX010-02, MDX010-08, and MDX010-15 and were alive at the time of study completion.
Who may be able to join
- Subjects who were previously enrolled in MDX-010 studies MDX010-02, MDX010-08, or MDX010-15.
- Subjects (or if applicable, next of kin), who are alive at the time of contact must have read, understood, and provided written informed consent and health Insurance Portability and Accountability Act (HIPAA) authorization after the nature of the study has been fully explained.
- For subjects who have died or have been lost to follow-up(the subject status at end of original ipilimumab study), approval from the appropriate site IRB, specifying or limiting appropriate means for obtaining information, must be granted prior to collection of any information.
Who cannot join
None listed.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
St. Francis Research Foundation
Beech Grove, Indiana, 46107
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Carolinas Cancer Care
Charlotte, North Carolina, 28211
Pacific Shores Medical Group
Long Beach, California, 90813
The Angeles Clinic and Research Institute
Los Angeles, California, 90025
USC Norris Cancer Center
Los Angeles, California, 90033
University of Miami Sylvester Cancer Center
Miami, Florida, 33136
NYU Cancer Institute
New York, New York, 10016
Providence Portland Medical Center
Portland, Oregon, 97213
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
Arizona Cancer Center
Tuscon, Arizona, 85724
About this study
Official title: Collection of Long-Term Outcome Data for Subjects Who Have Previously Participated in Selected Ipilimumab (MDX-010) Studies in Metastatic Melanoma
The objective of this study is to collect disease status and overall survival information for all Subjects in MDX-010 studies.
Read the detailed description
This is a multicenter, follow-up study in up to 191 subjects with metastatic melanoma who were previously enrolled and treated in ipilimumab studies MDX010-02, MDX010-08, and MDX010-15. The purpose of this study is to 1) collect the date and cause of death, if known, for all deceased subjects who participated in any of the specified studies; 2) collect the date of progression for subjects who completed the studies with stable disease or better; and 3) prospectively follow all surviving subjects to determine progression-free and overall survival.
- Conditions
- Metastatic Melanoma
- Medical subject headings
- Melanoma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2009 (estimated)
- Study startJun 2007
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic 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
- Retrospective
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Walter Urba, MD PhD, Principal investigator, Providence Health & Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00928031
- Sponsor's protocol ID
- MDX010-28
- Acronym
- MDX010-28
- Status last verified
- Apr 2010
- First submitted
- 24 Jun 2009
- Last updated
- 26 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of Long-Term Outcome Data for Subjects Who Have Previously Participated in Selected Ipilimumab (MDX-010) Studies in Metastatic Melanoma
- ClinicalTrials.gov ID
- NCT00928031
- Acronym / sponsor ID
- MDX010-28 / MDX010-28
- Conditions
- Metastatic Melanoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 25 Jun 2009 (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 objective of this study is to collect disease status and overall survival information for all Subjects in MDX-010 studies.
Detailed description
This is a multicenter, follow-up study in up to 191 subjects with metastatic melanoma who were previously enrolled and treated in ipilimumab studies MDX010-02, MDX010-08, and MDX010-15. The purpose of this study is to 1) collect the date and cause of death, if known, for all deceased subjects who participated in any of the specified studies; 2) collect the date of progression for subjects who completed the studies with stable disease or better; and 3) prospectively follow all surviving subjects to determine progression-free and overall survival.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who received any dose of ipilimumab (MDX-010) in MDX010-02, MDX010-08, and MDX010-15 and were alive at the time of study completion.
Key inclusion criteria (3 listed)
- Subjects who were previously enrolled in MDX-010 studies MDX010-02, MDX010-08, or MDX010-15.
- Subjects (or if applicable, next of kin), who are alive at the time of contact must have read, understood, and provided written informed consent and health Insurance Portability and Accountability Act (HIPAA) authorization after the nature of the study has been fully explained.
- For subjects who have died or have been lost to follow-up(the subject status at end of original ipilimumab study), approval from the appropriate site IRB, specifying or limiting appropriate means for obtaining information, must be granted prior to collection of any information.
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.
Primary outcome
Not reported in the source record.
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 26 Apr 2010.
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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.
Walter Urba, MD PhD principal investigator
Providence Health & Services
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Melanoma, run by Bristol-Myers Squibb at 11 sites 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 3 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 26 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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.
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 26 Apr 2010.