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Multiple Ascending Dose (MDX1105-01) (Anti-PDL1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00729664
Recruitment Status : Completed
First Posted : August 7, 2008
Last Update Posted : September 7, 2015
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cancer, Multiple Indications Biological: Anti-PDL-1 antibody Phase 1

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 periods: Screening (up to 28 days), Treatment (up to 16 six-week cycles), and Follow-up (up to 6 months).

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 281 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Multidose Study of BMS-936559 (MDX-1105) Administered Every 14 Days in Subjects With Selected Advanced or Recurrent Solid Tumors
Study Start Date : February 2009
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015
Arms and Interventions
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Arm Intervention/treatment
Experimental: Anti-PDL-1 antibody (Arm 1)
BMS-936559 (MDX-1105)
 Biological: Anti-PDL-1 antibody
Solution, Intravenous, 0.1 mg/kg, Every 14 days, 3 doses per each cycle of 42 days, 16 cycles/48 doses depending on response
Other Names:
  • BMS-936559
  • MDX 1105
Experimental: Anti-PDL-1 antibody (Arm 2)
BMS-936559 (MDX-1105)
 Biological: Anti-PDL-1 antibody
Solution, Intravenous, 0.3 mg/kg, Every 14 days, 3 doses per each cycle of 42 days, 16 cycles/48 doses depending on response
Other Names:
  • BMS-936559
  • MDX 1105
Experimental: Anti-PDL-1 antibody (Arm 3)
BMS-936559 (MDX-1105)
 Biological: Anti-PDL-1 antibody
Solution, Intravenous, 1 mg/kg, Every 14 days, 3 doses per each cycle of 42 days, 16 cycles/48 doses depending on response
Other Names:
  • BMS-936559
  • MDX 1105
Experimental: Anti-PDL-1 antibody (Arm 4)
BMS-936559 (MDX-1105)
 Biological: Anti-PDL-1 antibody
Solution, Intravenous, 3 mg/kg, Every 14 days, 3 doses per each cycle of 42 days, 16 cycles/48 doses depending on response
Other Names:
  • BMS-936559
  • MDX 1105
Experimental: Anti-PDL-1 antibody (Arm 5)
BMS-936559 (MDX-1105)
 Biological: Anti-PDL-1 antibody
Solution, Intravenous, 10 mg/kg, Every 14 days, 3 doses per each cycle of 42 days, 16 cycles/48 doses depending on response
Other Names:
  • BMS-936559
  • MDX 1105


Outcome Measures
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Primary Outcome Measures :
  1. Safety, maximum tolerated dose (MTD) and dose-limiting toxicity(DLT)of MDX-1105 [ Time Frame: Weekly ]
  2. Safety, maximum tolerated dose (MTD) and dose-limiting toxicity(DLT)of MDX-1105 [ Time Frame: Bi-weekly ]

Secondary Outcome Measures :
  1. Preliminary efficacy in solid tumors on the basis of objective responses [ Time Frame: Day 42 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00729664


Locations
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United States, California
The Angeles Clinic & Research Institute
Los Angeles, California, United States, 90025
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, Illinois
University Of Chicago
Chicago, Illinois, United States, 60637
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21231
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
United States, Ohio
University Of Cincinnati
Cincinnati, Ohio, United States, 45267
Ohio State University
Columbus, Ohio, United States, 43210
United States, Texas
Oncology Consultants, Pa
Houston, Texas, United States, 77024
The University Of Texas
Houston, Texas, United States, 77030
United States, Washington
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00729664    
Other Study ID Numbers: CA210-001
MDX1105-01 ( Other Identifier: BMS )
First Posted: August 7, 2008    Key Record Dates
Last Update Posted: September 7, 2015
Last Verified: September 2015
Additional relevant MeSH terms:
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Atezolizumab
BMS-936559
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Immunologic Factors
 Physiological Effects of Drugs
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Antineoplastic Agents