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| Sponsor: | Bristol-Myers Squibb |
|---|---|
| Information provided by (Responsible Party): | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT00495066 |
Purpose
The primary objective of the study is to provide treatment with Ipilimumab to subjects who have serious or immediately life-threatening unresectable Stage III or Stage IV melanoma, who have no alternative treatment options, and whose physicians believe, based upon available data on benefit and risk, that it is appropriate to administer Ipilimumab for eligible subjects, including those previously enrolled in Ipilimumab studies MDX010-16 or MDX010-20.
| Condition | Intervention |
|---|---|
|
Melanoma |
Drug: Ipilimumab |
| Study Type: | Expanded Access What is Expanded Access? |
| Official Title: | A Multicenter Treatment Protocol for Compassionate Use of Ipilimumab in Subjects With Unresectable Stage III or IV Melanoma |
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Required values for initial laboratory tests:
Exclusion Criteria:
Contacts and Locations| Contact: For participation information at a USA site use a phone number .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. |
| Brazil | |
| Instituto ÉTICA - AMO - Assistência Multidisciplinar em Oncologia | |
| Salvador, Bahia, Brazil, 41950-610 | |
| Contact: Bruno Setenta, Site 134 557130218734 | |
| Instituto do Cancer do Ceara | |
| Fortaleza, Ceara, Brazil, 60930-230 | |
| Contact: Flavio Bitencourt, Site 135 558532884576 | |
| Hospital Sao Lucas das PUCRS | |
| Porto Alegre, Rio Grande do Sul (RS), Brazil, 90610-000 | |
| Contact: Carlos Henrique Escosteguy Barrios, Site 136 555133203039 | |
| Hospital Mae de Deus | |
| Porto Alegre, Rio Grande do Sul (RS), Brazil, 90840440 | |
| Contact: Sergio Jobim de Azevedo, Site 148 555132523930 and 555132523931 | |
| Amaral Carvalho hospital | |
| Jau, Sao Paulo, Brazil, 17210-120 | |
| Contact: Edilaine Sabio, Site 141 551436021399 | |
| Fundacao Pio XI - Hospital De Cancer De Barretos | |
| Barretos, SP, Brazil, 14784-400 | |
| Contact: Sergio Vicente Serrano, Site 144 551733216637 | |
| Hospital Sao Jose - Beneficencia Portuguesa - Oncology Center | |
| Sao Paulo, SP, Brazil, CEP 01321-001 | |
| Contact: Antonio Carlos Buzaid, Site 149 | |
| Hospital A. C. Camargo | |
| Sao Paulo, SP, Brazil, 01509-900 | |
| Contact: Jose Augusto Rinck Junior, Site 142 551121895188 | |
| Instituto Nacional de Cancer - INCA | |
| Rio de Janeiro, Brazil, 20231-050 | |
| Contact: Daniel Herchenhorn, Site 139 552132076567 | |
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT00495066 History of Changes |
| Other Study ID Numbers: | CA184-045 |
| Study First Received: | June 29, 2007 |
| Last Updated: | May 14, 2012 |
| Health Authority: | Canada: Health Canada Argentina: Ministry of Health Brazil: Agencia Nacional de Vigilancia Sanitaria United States: Food and Drug Administration |
|
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas |