Phase 3 Trial in Subjects With Metastatic Melanoma Comparing 3 mg/kg Ipilimumab Versus 10 mg/kg Ipilimumab

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: Melanoma

Treatments: Biological: Ipilimumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01515189

2011-004029-28 (EudraCT Number)

CA184-169

Details and patient eligibility

About

The purpose of this study is to determine whether giving Ipilimumab at a dose of 10mg/kg will extend the lives of subjects with unresectable or metastatic melanoma more than giving Ipilimumab at a dose of 3 mg/kg

Enrollment: 831 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

• Unresectable Stage III or Stage IV melanoma
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

• Brain metastases with symptoms or requiring treatment
• History of autoimmune disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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831 participants in 2 patient groups

Arm 1: Ipilimumab (3 mg/kg)

Experimental group

Description:

Ipilimumab 3 mg/kg solution intravenously once every 3 weeks for 4 doses; option for Re-induction, until disease progression or unacceptable toxicity

Treatment:

Biological: Ipilimumab

Arm 2: Ipilimumab (10 mg/kg)

Experimental group

Description:

Ipilimumab 10 mg/kg solution intravenously once every 3 weeks for 4 doses; option for Re-induction, until disease progression or unacceptable toxicity

Treatment:

Biological: Ipilimumab