Status:
COMPLETED
Efficacy Study of Ipilimumab Versus Placebo to Prevent Recurrence After Complete Resection of High Risk Stage III Melanoma
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
High Risk Stage III Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of the study is to determine if ipilimumab is effective in preventing or delaying recurrence and prolongs survival after complete resection of high risk stage III melanoma
Eligibility Criteria
Inclusion
- For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
- Age ≥ 18 years
- Complete and adequate resection of Stage III melanoma with histologically confirmed melanoma metastatic to lymph node
- Disease-free
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1
- Randomization within 12 weeks of surgery
Exclusion
- Prior therapy for melanoma except surgery
- Auto-immune disease
Key Trial Info
Start Date :
June 30 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 26 2018
Estimated Enrollment :
1211 Patients enrolled
Trial Details
Trial ID
NCT00636168
Start Date
June 30 2008
End Date
November 26 2018
Last Update
December 17 2019
Active Locations (97)
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1
The Angeles Clinic & Research Institute
Los Angeles, California, United States, 90025
2
Sharp Memorial Hospital
San Diego, California, United States, 92123
3
California Pacific Medical Center
San Francisco, California, United States, 94115
4
North. Cal. Melanoma Center-St. Mary's Medical Center
San Francisco, California, United States, 94117