A Companion Study for Patients Enrolled in Prior/Parent Ipilimumab Studies

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Trial phase: 
Phase III
Recruitment status: 
Recruiting

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.

Background information
Trial ID: 
NCT00162123
Other unique IDs: 
CA184-025
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.

Detailed description: 

 

Number to be enrolled: 
207 patients
Clinical information
Age groups: 
Adult
Senior
Gender: 
Both
Eligibility criteria: 

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

Study design: 
Treatment
Open Label
Parallel Assignment
Safety Study
Non-Randomized
Uncontrolled
Interventions: 
Ipilimumab
Conditions treated: 
Melanoma
Outcome measurements: 

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 ]

Funding
Funding types: 
INDUSTRY
Sponsor: 
Bristol-Myers Squibb
Dates
Date the data was first received: 
Fri, 2005-09-09
Trial start date: 
Mon, 2006-05-01
Trial completion date: 
Tue, 2011-03-01
Trial last updated: 
Wed, 2009-05-20