A Phase 1, Multidose Study of BMS-936559 (MDX-1105) Administered Every 14 Days in Subjects With Selected Advanced or Recurrent Solid Tumors
18 Years
N/A
Both
Cancer, Multiple Indications
Trial Information
A Phase 1, Multidose Study of BMS-936559 (MDX-1105) Administered Every 14 Days in Subjects With Selected Advanced or Recurrent Solid Tumors
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 periods: Screening (up to 28 days), Treatment (up to 16 six-week
cycles), and Follow-up (up to 6 months).
Inclusion Criteria:
- 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 Criteria:
- 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)
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Safety, maximum tolerated dose (MTD) and dose-limiting toxicity(DLT)of MDX-1105
Outcome Time Frame:
Weekly
Safety Issue:
Yes
Principal Investigator
Bristol-Myers Squibb
Investigator Role:
Study Director
Investigator Affiliation:
Bristol-Myers Squibb
Authority:
United States: Food and Drug Administration
Study ID:
CA210-001
NCT ID:
NCT00729664
Start Date:
April 2009
Completion Date:
December 2013
Related Keywords:
- Cancer, Multiple Indications
Name | Location |
|---|---|
| Johns Hopkins University | Baltimore, Maryland 21205 |
| Roswell Park Cancer Institute | Buffalo, New York 14263 |
| Mayo Clinic | Rochester, Minnesota 55905 |
| Emory University | Atlanta, Georgia 30322 |
| Ohio State University | Columbus, Ohio 43210 |
| The Angeles Clinic & Research Institute | Los Angeles, California 90404 |
| University of Chicago | Chicago, Illinois 60637 |
| Fred Hutchinson Cancer Center | Seattle, Washington 98109 |
| University of Cincinnati | Cincinnati, Ohio 45267-0502 |
| Oncology Consultants, PA | Houston, Texas 77024 |
| The University of Texas | Houston, Texas 77030 |
