Status:
COMPLETED
A Study of MDX-1106 in Patients With Selected Refractory or Relapsed Malignancies
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Carcinoma, Non-Small-Cell Lung
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
To evaluate the safety, tolerability, efficacy, and pharmacokinetics of MDX-1106 when administered to patients with advanced non-small cell lung cancer, colorectal cancer, malignant melanoma, clear ce...
Detailed Description
Six patients enrolled at each dose level of 0.3, 1.0, 3.0 and 10mg/kg; the remaining 10 to 15 patients may subsequently be enrolled at a dose at or below the maximum tolerated dose (MTD) during the do...
Eligibility Criteria
Inclusion
- Relapsed/refractory non-small cell lung cancer, colorectal adenocarcinoma, malignant melanoma, renal (clear) cell carcinoma, or hormone-refractory prostate adenocarcinoma
- Prior treatment must have been completed at least 4 weeks prior to enrollment
- No untreated primary or metastatic brain or meningeal tumors
- ECOG PS 0 or 1
- Meet all screening laboratory values
Exclusion
- History of severe hypersensitivity reactions to other monoclonal antibodies
- Active autoimmune disease or a documented history of autoimmune disease
- Prior therapy with an anti-PD-1 or anti-CTLA-4 antibody
- Active infection
- Concurrent medical condition requiring the use of immunosuppressive medications
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT00441337
Start Date
August 1 2006
End Date
November 1 2009
Last Update
February 20 2015
Active Locations (4)
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1
Johns Hopkins Unv., School of Medicine
Baltimore, Maryland, United States, 21231
2
Henry Ford Health System
Detroit, Michigan, United States, 48202
3
Washington University School of Medicine - Barnes Jewish Hospital
St Louis, Missouri, United States, 63110
4
Carolina BioOncology Institute, PLLC
Huntersville, North Carolina, United States, 28078