Comparison of Ipilimumab Manufactured by 2 Different Processes in Participants With Advanced Melanoma

Completed · Phase 1

Conditions studied: Advanced Melanoma

In brief

The purpose of this clinical research study is to compare pharmacokinetics of ipilimumab manufactured by two different processes

Key facts

Study ID

NCT00920907

Run by

Bristol-Myers Squibb

People needed

99

Starts

2009-08-01

Expected to finish

2012-10-01

Last updated by the study team

2014-06-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologic diagnosis of malignant melanoma
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Measurable/evaluable disease per modified World Health Organization (mWHO) criteria

You may not qualify if…

• 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

Where it is running

• The Angeles Clinic & Research Inst. — Los Angeles, California, United States
• California Pacific Medical Center — San Francisco, California, United States
• H Lee Moffitt Cancer Center — Tampa, Florida, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Carolinas Medical Center — Charlotte, North Carolina, United States
• St Luke'S Hospital And Health Network — Bethlehem, Pennsylvania, United States
• Seattle Cancer Care Alliance — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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