Study of Ipilimumab (MDX-010) Monotherapy in Patients With Previously Treated Unresectable Stage III or IV Melanoma

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Melanoma

Treatments: Drug: Ipilimumab; Drug: ipilimumab (MDX-010, BMS-734016)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00289640

CA184-022

Details and patient eligibility

About

The purpose of this clinical research study is to compare the best overall response rate (BORR)(as per modified WHO criteria) in patients with previously treated, therapy-refractory, or -intolerant, Stage III (unresectable) or Stage IV melanoma receiving ipilimumab doses of 0.3, 3, and 10 mg/kg. The safety of this product will also be evaluated.

Enrollment: 210 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Patients with previously treated, therapy-refractory or -intolerant, Stage III (unresectable) or Stage IV melanoma

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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210 participants in 3 patient groups

1

Experimental group

Treatment:

Drug: ipilimumab (MDX-010, BMS-734016)

2

Experimental group

Treatment:

Drug: Ipilimumab

Drug: Ipilimumab

3

Experimental group

Treatment:

Drug: Ipilimumab

Drug: Ipilimumab