Status:
COMPLETED
Multiple Ascending Dose (MDX1105-01)
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Cancer, Multiple Indications
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Collection of survival data, evaluation of PDL-1 expression in tumors, and evaluation of PD-L1 receptor occupancy in peripheral blood has been added.
Detailed Description
This is an open label, multicenter, dose escalation and multidose study of MDX-11-5, a fully human monoclonal IgG4 antibody targeting the Programed Death-Ligand 1 (PD-L1). The study will consist of 3...
Eligibility Criteria
Inclusion
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 1
- The malignancies include relapsed/refractory renal cell carcinoma, non-small cell lung cancer, colorectal adenocarcinoma, malignant melanoma, advanced/metastatic epithelial ovarian cancer, gastric cancer, pancreatic cancer and breastcancer
- Must have measurable disease
Exclusion
- Prior therapy with an anti-PD 1, anti-PDL 1, or anti-Cytotoxic T-Lymphocyte Antigen 4 antibody (or any other agents that target T-cell co-stimulation)
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
281 Patients enrolled
Trial Details
Trial ID
NCT00729664
Start Date
February 1 2009
End Date
July 1 2015
Last Update
September 7 2015
Active Locations (11)
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1
The Angeles Clinic & Research Institute
Los Angeles, California, United States, 90025
2
Emory University
Atlanta, Georgia, United States, 30322
3
University Of Chicago
Chicago, Illinois, United States, 60637
4
Johns Hopkins University
Baltimore, Maryland, United States, 21231