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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2012-10-31

Brief Summary

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

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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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Ipilimumab (Process B)

Reference

Group Type EXPERIMENTAL

Ipilimumab

Intervention Type BIOLOGICAL

Solution, Intravenous, 10 mg/kg, Every 3 weeks (up to 4 doses) in induction phase, every 12 weeks in maintenance phase, 48 weeks

Ipilimumab (Process C)

Test

Group Type EXPERIMENTAL

Ipilimumab

Intervention Type BIOLOGICAL

Solution, Intravenous, 10 mg/kg, Every 3 weeks (up to 4 doses) in induction phase, every 12 weeks in maintenance phase, 48 weeks

Interventions

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Ipilimumab

Solution, Intravenous, 10 mg/kg, Every 3 weeks (up to 4 doses) in induction phase, every 12 weeks in maintenance phase, 48 weeks

Intervention Type BIOLOGICAL

Other Intervention Names

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BMS-734016 MDX010

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No