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.

CompletadoFase 2ClinicalTrials.gov

ID: NCT00162123Tipo: INTERVENTIONALInicio: 1 de may de 2006Fin estimado: 1 de abr de 2014

Traducción no disponible, mostrando original

Resumen

The purpose of this study was to evaluate the continued use of ipilimumab in patients who had reinduction at the time of disease progression or to continue maintenance treatment. In addition, this study will continue to follow patients who have taken ipilimumab, but who are not eligible for maintenance or reinduction therapy.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

First Reinduction:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Diagnosis of advanced melanoma
Prior treatment in a prespecified prior/parent ipilimumab study
Men and women 18 years of age and older
No unacceptable toxicity (except select reversible immune-related adverse events) requiring ipilimumab discontinuation
Had experienced documented progressive disease after expanded clinical benefit
Extended Maintenance
Received ipilimumab at any dose in a parent study
Achieved expanded clinical benefit at the time of entry to current study
Follow-up:
Received ipilimumab at any dose in a closing parent study
Deemed ineligible for reinduction or extended maintenance treatment or refused treatment as reinduction or extended maintenance at the time of screening in the current study, but consented to follow-up

Criterios de exclusión

Prior treatment with a CD137 agonist or a cytotoxic T-lymphocyte antigen 4 inhibitor or agonist, other than ipilimumab
Primary ocular or mucosal melanoma

Intervenciones

drug

Ipilimumab

Intravenous solution, 0.3, 3, or 10 mg/kg; 1 dose every 3 weeks or every 3 months until patient discontinuation

Ubicaciones

Local Institution

Buenos Aires, Buenos Aires, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

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