Trial Information

Summary: A Single Arm Study of Ipilimumab Monotherapy in Patients With Previously Treated Unresectable Stage III or IV Melanoma

The purpose of this clinical research study is to evaluate the Best Overall Response Rate (BORR), (as per modified WHO criteria) in patients with previously treated melanoma-Stage III (unresectable) or Stage IV melanoma receiving 10 mg/kg of ipilimumab. The safety of this product will also be evaluated.

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study

Further study details as provided by Bristol-Myers Squibb:
Primary Outcomes: Evaluate BORR in patients with previously treated Stage III (unresectable) or Stage IV melanoma receiving ipilimumab.
Secondary Outcomes: estimate disease control rate; estimate progression free survival rate at Week 12; estimate PFS; estimate overall survival; estimate survival rate at one year; estimate duration of BOR; evaluate proportion of patients whose duration of response is >=24 weeks; estimate time to BOR; evaluate safety profile of ipilimumab during the induction and maintenance phases; evaluate health-related quality of life; obtain PK sample for population PK analysis
Expected Total Enrollment: 150

Study start: March 2006

Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both

Inclusion Criteria:

• Patients with previously treated Stage III (unresectable)or Stage IV melanoma

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Trial listings updated: June 1, 2008 at 5:46:05 AM