Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
281 participants
INTERVENTIONAL
2009-02-28
2015-07-31
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Anti-PDL-1 antibody (Arm 1)
BMS-936559 (MDX-1105)
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
Anti-PDL-1 antibody (Arm 2)
BMS-936559 (MDX-1105)
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
Anti-PDL-1 antibody (Arm 3)
BMS-936559 (MDX-1105)
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
Anti-PDL-1 antibody (Arm 4)
BMS-936559 (MDX-1105)
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
Anti-PDL-1 antibody (Arm 5)
BMS-936559 (MDX-1105)
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
Interventions
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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
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
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
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
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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The Angeles Clinic & Research Institute
Los Angeles, California, United States
Emory University
Atlanta, Georgia, United States
University Of Chicago
Chicago, Illinois, United States
Johns Hopkins University
Baltimore, Maryland, United States
Mayo Clinic
Rochester, Minnesota, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
University Of Cincinnati
Cincinnati, Ohio, United States
Ohio State University
Columbus, Ohio, United States
Oncology Consultants, Pa
Houston, Texas, United States
The University Of Texas
Houston, Texas, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
Countries
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References
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Brahmer JR, Tykodi SS, Chow LQ, Hwu WJ, Topalian SL, Hwu P, Drake CG, Camacho LH, Kauh J, Odunsi K, Pitot HC, Hamid O, Bhatia S, Martins R, Eaton K, Chen S, Salay TM, Alaparthy S, Grosso JF, Korman AJ, Parker SM, Agrawal S, Goldberg SM, Pardoll DM, Gupta A, Wigginton JM. Safety and activity of anti-PD-L1 antibody in patients with advanced cancer. N Engl J Med. 2012 Jun 28;366(26):2455-65. doi: 10.1056/NEJMoa1200694. Epub 2012 Jun 2.
Related Links
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BMS clinical trial educational resource
Investigator Inquiry form
Other Identifiers
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MDX1105-01
Identifier Type: OTHER
Identifier Source: secondary_id
CA210-001
Identifier Type: -
Identifier Source: org_study_id
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