Study of MDX-1411 Given Every 14 Days With Pre-medications to Subjects With Clear Cell Kidney Cancer.
- Conditions
- Kidney Cancer
- Registration Number
- NCT00656734
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
To determine the highest and safest tolerated dose of MDX-1411 for the treatment of clear cell renal cell carcinoma (Kidney cancer).
- Detailed Description
Subjects will be assigned one dose upon enrollment and will continue with the same dose throughout the study. The maximum duration for the study is two and a half years for a total of 17 cycles.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 27
- Histologically confirmed diagnosis of RCC with clear cell component
- Measurable disease
- Treated with up to 6 prior systemic therapies for advanced/recurrent disease or have become intolerant to a systemic therapy
- Subjects with treated brain metastases must be without magnetic resonance imaging (MRI) evidence of progression for at least 8 weeks and off steroids for at least 4 weeks to be eligible
- At least 28 days since the last chemotherapy
- At least 28 days before the first dose of MDX 1411 since any major surgery
- ECOG performance status 0-2
- No known positivity for human immunodeficiency virus (HIV), Hep B or C
- Previous treatment with any other anti-CD70 antibody
- Active infection requiring i.v systemic therapy within 28 days before first dose
- Evidence of bleeding diathesis or coagulopathy
- Active autoimmune disease requiring immunosuppressive therapy
- Known current drug or alcohol abuse
- Any underlying medical condition which will make the administration of MDX 1411 hazardous
- Psychiatric illness or social situation that would preclude study compliance
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Determine the safety profile of MDX 1411 duration of study Determine the maximum tolerated dose of MDX 1411 duration of study
- Secondary Outcome Measures
Name Time Method Determine the best overall response rate (BORR) Day 38-42 of each cycle
Trial Locations
- Locations (7)
Beth Israel Deaconness Medical Center
🇺🇸Boston, Massachusetts, United States
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Nevada Cancer Institute
🇺🇸Las Vegas, Nevada, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
Cleveland Clinic Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
Providence Portland Medical Center
🇺🇸Portland, Oregon, United States
Beth Israel Deaconness Medical Center🇺🇸Boston, Massachusetts, United States