Study of Ipilimumab (MDX-010) Monotherapy in Patients With Previously Treated Unresectable Stage III or IV Melanoma
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|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00289640