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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Advanced Melanoma

Treatments: Biological: Ipilimumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00920907

CA184-087

Details and patient eligibility

About

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

Enrollment: 99 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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99 participants in 2 patient groups

Ipilimumab (Process B)

Experimental group

Description:

Reference

Treatment:

Biological: Ipilimumab

Ipilimumab (Process C)

Experimental group

Description:

Test

Treatment:

Biological: Ipilimumab