| A Companion Study for Patients Enrolled in Prior/Parent Ipilimumab Studies |
| A Multi-Center, Open-Label, Phase II Study of Ipilimumab (MDX-010 Extended-Treatment Monotherapy or Follow-up for Patients Previously Enrolled in Ipilimumab (MDX-010) Protocols. |
The purpose of this study is to evaluate the continued use of ipilimumab in patients who had clinical benefit in a prior/parent study and are now eligible to receive either Re-Induction at the time of disease progression or to continue Maintenance treatment. In addition, this study will also continue to follow patients that have had ipilimumab but who are not eligible for Maintenance or Re-Induction therapy. |
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| Phase II, Phase III |
| Interventional |
| Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety Study |
| To monitor safety of ipilimumab by evaluating the frequency of adverse events and laboratory abnormalities with corresponding severity. [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ] |
Estimate overall survival from the first dose [ Time Frame: At the end of the study ] [ Designated as safety issue: No ]
Estimate survival rate from the first dose [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Monitor Immune Breakthrough Events [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ] |
| Melanoma |
| Drug: Ipilimumab |
|
BMS Clinical Trials Disclosure 
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm  |
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| Recruiting |
| 207 |
| May 2006 |
| March 2011 |
Inclusion Criteria:
- Diagnosis of advanced melanoma
- Prior treatment in a prior/parent ipilimumab study
- Men and women >=18 years of age (or, >=16, if allowable per local regulatory authority)
Exclusion Criteria:
- Prior treatment with a CD137 agonist or CTLA-4 inhibitor or agonist, except for ipilimumab
- Primary ocular or mucosal melanoma
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| Both |
| 18 Years and older |
| No |
| Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email: |
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Clinical.Trials@bms.com |
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| Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time. |
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| United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Czech Republic, Denmark, France, Germany, Israel, Italy, Norway, Peru, Poland, Russian Federation, South Africa, Spain, Sweden, Ukraine |
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| NCT00162123 |
| CA184-025 |
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| Bristol-Myers Squibb |
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| Study Director: |
Bristol-Myers Squibb |
Bristol-Myers Squibb |
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| Bristol-Myers Squibb |
| August 2008 |
| September 9, 2005 |
| September 4, 2008 |