Study of MDX-010 in Subjects With Unresectable Stage III or Stage IV Malignant Melanoma
This is a Phase I, open-label, multicenter, pharmacokinetic study of MDX-010 in up to 90 evaluable subjects with surgically unresectable malignant melanoma.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-Label Pharmacokinetic and Safety Study of MDX-010 in Subjects With Unresectable Stage III or Stage IV Malignant Melanoma|
- To determine the safety and pharmacokinetic profile of single and multiple doses of MDX-010. [ Time Frame: up to approximately 1 year ] [ Designated as safety issue: Yes ]
- Determine the clinical activity profile of single and multiple doses of MDX-010 [ Time Frame: up to aproximately one year. ] [ Designated as safety issue: No ]
|Study Start Date:||July 2003|
|Study Completion Date:||June 2007|
|Primary Completion Date:||October 2005 (Final data collection date for primary outcome measure)|
Group A: Six to 12 subjects will be treated with transfectoma-derived MDX-010 at 2.8 or 5 mg/kg/dose, or with hybridoma-derived MDX-010 at 3 mg/kg/dose administered on Days 1, 57, and 85. The 2.8, 3, and 5 mg/kg dosage cohorts may be initiated concurrently. Additionally, 6 subjects per cohort will receive single doses of transfectoma-derived MDX-010 at 7.5, 10, 15, and 20 mg/kg.
Dose escalation from the 5 mg/kg cohort to the 7.5 mg/kg cohort will depend on the safety profile following a single dose of 5 mg/kg. Once all subjects are enrolled in the 5 mg/kg cohort and 4 weeks have elapsed since the sixth subject in the cohort has received the first infusion, dose escalation to the 7.5 mg/kg cohort may occur if ≤1 DLT has occurred in the 5 mg/kg cohort. Dose escalation to the 10 mg/kg cohort may occur 4 weeks after the sixth subject in the 7.5 mg/kg/dose cohort has received the first infusion (with ≤1 DLT). Dose escalation to the 15 and 20 mg/kg cohorts may occur 4 weeks after the sixth subject in the previous cohort has received the first infusion (with ≤1 DLT). Up to six additional subjects may be enrolled in the MTD dose cohort or in the 20 mg/kg dose cohort if MTD is not attained.
Group B: If single-dose administration of MDX-010 at 10 mg/kg is well tolerated (≤1 DLT in the cohort in Group A), then an additional 12 to 20 subjects will be enrolled and treated with MDX-010 at 10 mg/kg/dose administered on Days 1, 22, 43, and 64.
Subjects who respond to therapy will be followed until disease progression or a maximum of approximately 1 year. Subjects with a response of SD ≥ 3 months, PR, or CR to their initial treatment cycle who subsequently relapse may be eligible for retreatment with the same regimen or an alternate regimen considered to be more effective at the time of retreatment.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00729950
|United States, Arizona|
|Arizona Cancer Center|
|Tucson, Arizona, United States, 85724-5024|
|United States, California|
|USC/Norris Comprehensive Cancer Center|
|Los Angeles, California, United States, 90033|
|United States, North Carolina|
|Piedmont Oncology Specialists|
|Charlotte, North Carolina, United States, 28207|
|United States, Oregon|
|Providence Portland Medical Center|
|Portland, Oregon, United States, 97213|
|Study Director:||Bristol-Myers Squibb||Bristol-Myers Squibb|