Study of MDX-1411 Given Every 14 Days With Pre-medications to Subjects With Clear Cell Kidney Cancer.
Completed · Phase 1
Conditions studied: Kidney Cancer
In brief
To determine the highest and safest tolerated dose of MDX-1411 for the treatment of clear cell renal cell carcinoma (Kidney cancer).
Key facts
- Study ID
- NCT00656734
- Run by
- Bristol-Myers Squibb
- People needed
- 27
- Starts
- 2008-04-01
- Expected to finish
- 2010-06-01
- Last updated by the study team
- 2013-05-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- 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
- Memorial Sloan Kettering Cancer Center — New York, New York, United States
- Montefiore Medical Center — The Bronx, New York, United States
- Cleveland Clinic Taussig Cancer Center — Cleveland, Ohio, United States
- Providence Portland Medical Center — Portland, Oregon, United States
Full record on ClinicalTrials.gov
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