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

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Collaborator: Medarex
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Dacarbazine; Ipilimumab; Paclitaxel

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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