A Study of MDX-1106 in Patients With Selected Refractory or Relapsed Malignancies
NCT ID: NCT00441337
Last Updated: 2015-02-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
39 participants
INTERVENTIONAL
2006-08-31
2009-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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0.3 mg/kg MDX-1106 drug
0.3 milligrams (mg) MDX-1106 drug (nivolumab) per kilogram (kg) of body weight (mg/kg) was administered in a single intravenous (IV) infusion. If criteria were met, 2 additional doses could be administered (1 every 4 weeks).
MDX-1106
patients will receive a single dose of MDX-1106 as a 60 minute infusion.
1 mg/kg MDX-1106 drug
1 mg MDX-1106 drug (nivolumab) per kg of body weight (mg/kg) was administered in a single IV infusion. If criteria were met, 2 additional doses could be administered (1 every 4 weeks).
MDX-1106
patients will receive a single dose of MDX-1106 as a 60 minute infusion.
3 mg/kg MDX-1106 drug
3 mgs MDX-1106 drug (nivolumab) per kg of body weight (mg/kg) was administered in a single IV infusion. If criteria were met, 2 additional doses could be administered (1 every 4 weeks).
MDX-1106
patients will receive a single dose of MDX-1106 as a 60 minute infusion.
10 mg/kg MDX-1106 drug
10 mgs MDX-1106 drug (nivolumab) per kg of body weight (mg/kg) was administered in a single IV infusion. If criteria were met, 2 additional doses could be administered (1 every 4 weeks).
MDX-1106
patients will receive a single dose of MDX-1106 as a 60 minute infusion.
Interventions
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MDX-1106
patients will receive a single dose of MDX-1106 as a 60 minute infusion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Prior treatment must have been completed at least 4 weeks prior to enrollment
* No untreated primary or metastatic brain or meningeal tumors
* ECOG PS 0 or 1
* Meet all screening laboratory values
Exclusion Criteria
* Active autoimmune disease or a documented history of autoimmune disease
* Prior therapy with an anti-PD-1 or anti-CTLA-4 antibody
* Active infection
* Concurrent medical condition requiring the use of immunosuppressive medications
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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Johns Hopkins Unv., School of Medicine
Baltimore, Maryland, United States
Henry Ford Health System
Detroit, Michigan, United States
Washington University School of Medicine - Barnes Jewish Hospital
St Louis, Missouri, United States
Carolina BioOncology Institute, PLLC
Huntersville, North Carolina, United States
Countries
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References
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George S, Pili R, Carducci MA, Kim JJ. Role of immunotherapy for renal cell cancer in 2011. J Natl Compr Canc Netw. 2011 Sep 1;9(9):1011-8. doi: 10.6004/jnccn.2011.0085.
Other Identifiers
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MDX1106-01
Identifier Type: OTHER
Identifier Source: secondary_id
CA209-001 ST
Identifier Type: -
Identifier Source: org_study_id
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