Study of Ipilimumab (MDX-010) Monotherapy in Patients With Previously Treated Unresectable Stage III or IV Melanoma
|ClinicalTrials.gov Identifier: NCT00289640|
Recruitment Status : Completed
First Posted : February 10, 2006
Last Update Posted : March 2, 2010
|Condition or disease||Intervention/treatment||Phase|
|Melanoma||Drug: ipilimumab (MDX-010, BMS-734016) Drug: Ipilimumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||210 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Randomized, Double-Blind, Multi-center, Phase II Fixed Dose Study of Multiple Doses of Ipilimumab (MDX-010) Monotherapy in Patients With Previously Treated Unresectable Stage III or IV Melanoma|
|Study Start Date :||April 2006|
|Actual Primary Completion Date :||July 2007|
|Actual Study Completion Date :||July 2007|
Drug: ipilimumab (MDX-010, BMS-734016)
IV solution, IV, 0.3mg/kg, Q 3 wks for 12 wks then Q 12 wks, 48+ weeks depending on response.
IV solution, IV, 3 mg/kg, Q 3 wks for 12 wks then Q 12 wks, 48+ weeks depending on response.
IV solution, IV, 10 mg/kg, Q 3 wks for 12 wks then Q 12 wks, 48+ weeks depending on response.
- estimate BORR 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.
- estimate progression free survival rate at Week 12 assessment and other timepoints
- estimate disease control rate at various time points
- estimate overall survival
- estimate survival rate at one year
- evaluate health-related quality of life
- obtain pharmacokinetic samples for population PK analysis
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00289640
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