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Sponsored by: |
Bristol-Myers Squibb |
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Information provided by: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT00162123 |
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.
Condition | Intervention | Phase |
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Melanoma |
Drug: Ipilimumab |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety Study |
Official Title: | 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. |
Estimated Enrollment: | 207 |
Study Start Date: | May 2006 |
Estimated Study Completion Date: | March 2011 |
Estimated Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental |
Drug: Ipilimumab
Intravenous Solution, Intravenous, 3 or 10 mg/kg, One dose every 3 weeks or every 3 months, until patient discontinuation from any study Phase or withdrawal of consent
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B: Experimental |
Drug: Ipilimumab
Intravenous Solution, Intravenous, 0.3, 3 or 10 mg/kg, One Dose every 3 weeks or every 3 months, until patient discontinuation from any study Phase or withdrawal of consent or no intervention
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C: No Intervention
Until withdrawal of consent or study closure
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email: | Clinical.Trials@bms.com | |
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time. |
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Responsible Party: | Bristol-Myers Squibb ( Study Director ) |
Study ID Numbers: | CA184-025 |
Study First Received: | September 9, 2005 |
Last Updated: | January 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00162123 |
Health Authority: | United States: Food and Drug Administration |
ipilimumab previously treated |
Neuroectodermal Tumors Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Neuroepithelioma |
Nevus Neuroendocrine Tumors Melanoma |
Neoplasms Neoplasms by Histologic Type Neoplasms, Nerve Tissue Nevi and Melanomas |