Status:
COMPLETED
Comparison of Ipilimumab Manufactured by 2 Different Processes in Participants With Advanced Melanoma
Lead Sponsor:
Bristol-Myers Squibb
Collaborating Sponsors:
Medarex
Conditions:
Advanced Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this clinical research study is to compare pharmacokinetics of ipilimumab manufactured by two different processes
Eligibility Criteria
Inclusion
- Histologic diagnosis of malignant melanoma
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Measurable/evaluable disease per modified World Health Organization (mWHO) criteria
Exclusion
- Active Brain Metastasis
- Primary ocular or mucosal melanoma
- Prior Autoimmune disease
- Inadequate hematologic, hepatic or renal function
- Use of immunosuppressants
- Prior treatment with a CD137 agonist or cytotoxic T lymphocyte antigen 4 (CTLA-4) inhibitor
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT00920907
Start Date
August 1 2009
End Date
October 1 2012
Last Update
June 20 2014
Active Locations (7)
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1
The Angeles Clinic & Research Inst.
Los Angeles, California, United States, 90025
2
California Pacific Medical Center
San Francisco, California, United States, 94115
3
H Lee Moffitt Cancer Center
Tampa, Florida, United States, 33612-9416
4
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 11065