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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2012-10-31

Brief Summary

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

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Detailed Description

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Conditions

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Advanced Melanoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A

Group Type ACTIVE_COMPARATOR

Ipilimumab

Intervention Type DRUG

Solution, intravenous, 10mg/kg, every 3 weeks in the induction phase, up to 4 doses in the induction phase, 48 weeks

Carboplatin

Intervention Type DRUG

Solution, intravenous, Area Under the Concentration Time Curve=6, every 3 weeks in the induction phase, up to 8 doses in the induction phase, 48 weeks

Paclitaxel

Intervention Type DRUG

Solution, intravenous, 175 mg/m2, every 3 weeks in the induction phase, up to 8 doses in the induction phase, 48 weeks

Arm B

Group Type ACTIVE_COMPARATOR

Ipilimumab

Intervention Type DRUG

Solution, intravenous, 10mg/kg, every 3 weeks in the induction phase, up to 4 doses in the induction phase, 48 weeks

Dacarbazine

Intervention Type DRUG

Solution, intravenous, 850 mg/m2, every 3 weeks in the induction phase, up to 8 doses in the induction phase, 48 weeks

Arm C

Group Type ACTIVE_COMPARATOR

Ipilimumab

Intervention Type DRUG

Solution, intravenous, 10mg/kg, every 3 weeks in the induction phase, up to 4 doses in the induction phase, 48 weeks

Interventions

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Ipilimumab

Solution, intravenous, 10mg/kg, every 3 weeks in the induction phase, up to 4 doses in the induction phase, 48 weeks

Intervention Type DRUG

Carboplatin

Solution, intravenous, Area Under the Concentration Time Curve=6, every 3 weeks in the induction phase, up to 8 doses in the induction phase, 48 weeks

Intervention Type DRUG

Paclitaxel

Solution, intravenous, 175 mg/m2, every 3 weeks in the induction phase, up to 8 doses in the induction phase, 48 weeks

Intervention Type DRUG

Dacarbazine

Solution, intravenous, 850 mg/m2, every 3 weeks in the induction phase, up to 8 doses in the induction phase, 48 weeks

Intervention Type DRUG

Other Intervention Names

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BMS-734016 MDX-010 BMY-26575 PARAPLATIN TAXOL BMS-181339

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No