Status:
COMPLETED
A Companion Study for Patients Enrolled in Prior/Parent Ipilimumab Studies
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 stu...
Eligibility Criteria
Inclusion
- For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
- Key Inclusion Criteria
- Diagnosis of advanced melanoma
- Prior treatment in a prespecified prior/parent ipilimumab study
- Men and women 18 years of age and older
- First Reinduction:
- 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
- Key Exclusion Criteria
- Prior treatment with a CD137 agonist or a cytotoxic T-lymphocyte antigen 4 inhibitor or agonist, other than ipilimumab
- Primary ocular or mucosal melanoma
Exclusion
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
248 Patients enrolled
Trial Details
Trial ID
NCT00162123
Start Date
May 1 2006
End Date
April 1 2014
Last Update
July 27 2016
Active Locations (58)
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1
University Of Arizona Cancer Center
Tucson, Arizona, United States, 85719
2
Wilshire Oncology Medical Group Inc
Laverne, California, United States, 91750
3
The Angeles Clinic & Research Inst.
Los Angeles, California, United States, 90025
4
Usc/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033