Drug-Drug Interaction - 3 Arm - Carboplatin/Paclitaxel, Dacarbazine

Completed · Phase 1

Conditions studied: Advanced Melanoma

In brief

The purpose of this clinical research study is to learn the pharmacokinetics of Ipilimumab when combined with Paclitaxel/Carboplatin or Dacarbazine

Key facts

Study ID

NCT00796991

Run by

Bristol-Myers Squibb

People needed

72

Starts

2009-02-01

Expected to finish

2012-10-01

Last updated by the study team

2014-01-06

Who can join

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

You may qualify if…

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

You may not qualify if…

• Evidence of active brain metastases
• Prior treatment with anti-cytotoxic lymphocyte antigen 4 (CTLA-4) or anti-CD137 (type of tumor necrosis factor) antibody
• Total Bilirubin greater than (>) 1.5 * upper limit of normal (ULN) and aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 * upper limit of normal (ULN)
• Prior Autoimmune disease
• Use of immunosuppressing therapies

Where it is running

• The Angeles Clinic & Research Inst. — Los Angeles, California, United States
• H Lee Moffit Cancer Cnt And Res Inst — Tampa, Florida, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Blumenthal Cancer Center, Carolinas Medical Center — Charlotte, North Carolina, United States

Full record on ClinicalTrials.gov

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