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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Advanced Melanoma

Treatments: Drug: Paclitaxel; Drug: Carboplatin; Drug: Dacarbazine; Drug: Ipilimumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00796991

CA184-078

Details and patient eligibility

About

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

Enrollment: 72 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 3 patient groups

Arm A

Active Comparator group

Treatment:

Drug: Ipilimumab

Drug: Carboplatin

Drug: Paclitaxel

Arm B

Active Comparator group

Treatment:

Drug: Ipilimumab

Drug: Dacarbazine

Arm C

Active Comparator group

Treatment:

Drug: Ipilimumab