Multiple Ascending Dose (MDX1105-01)



Status:Completed
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:February 2009
End Date:July 2015

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A Phase 1, Multidose Study of BMS-936559 (MDX-1105) Administered Every 14 Days in Subjects With Selected Advanced or Recurrent Solid Tumors

Collection of survival data, evaluation of PDL-1 expression in tumors, and evaluation of
PD-L1 receptor occupancy in peripheral blood has been added.

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)
We found this trial at
11
sites
5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
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Chicago, IL
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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Atlanta, GA
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3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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Baltimore, MD
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666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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Buffalo, NY
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2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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Cincinnati, OH
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Columbus, OH
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Houston, Texas 77030
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Houston, TX
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Houston, Texas 77203
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Houston, TX
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Los Angeles, California 90025
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Los Angeles, CA
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Rochester, Minnesota 55905
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Rochester, MN
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Seattle, Washington 98109
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Seattle, WA
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