A Study to Compare Nivolumab Drug Product Process D to Nivolumab Drug Product Process C in Participants With Stage IIIa/b/c/d or Stage IV Melanoma After Complete Resection
NCT ID: NCT03980314
Last Updated: 2023-12-15
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
261 participants
INTERVENTIONAL
2019-06-24
2023-11-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Arm A (Process C)
Nivolumab
Specified dose on specified days
Arm B (Process D)
Nivolumab
Specified dose on specified days
Interventions
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Nivolumab
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Complete resection of Stage III disease that is documented on the surgical and pathology reports or complete resection of Stage IV disease with margins negative for disease that is documented on the pathology report
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
Exclusion Criteria
* Any significant acute or chronic medical illness that is uncontrolled
* History of ocular/uveal melanoma
* Active, known or suspected autoimmune disease
* Systemic treatment with either corticosteroids (\> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement steroid doses \> 10 mg daily prednisone or equivalent, are permitted in the absence of active autoimmune disease.
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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Local Institution - 0006
Hartford, Connecticut, United States
Local Institution - 0008
Minneapolis, Minnesota, United States
Local Institution - 0035
Charlotte, North Carolina, United States
Local Institution - 0043
Pittsburgh, Pennsylvania, United States
Local Institution - 0046
Buenos Aires, , Argentina
Local Institution - 0001
Wollstonecraft, New South Wales, Australia
Local Institution - 0036
Ijuí, Rio Grande do Sul, Brazil
Local Institution - 0037
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution - 0039
Barretos, São Paulo, Brazil
Local Institution - 0038
Cerqueira César, São Paulo, Brazil
Local Institution - 0040
São José do Rio Preto, São Paulo, Brazil
Local Institution - 0041
Rio de Janeiro, , Brazil
Local Institution - 0013
Edmonton, , Canada
Local Institution - 0024
Independencia, Santiago Metropolitan, Chile
Local Institution - 0045
Santiago, Santiago Metropolitan, Chile
Local Institution - 0023
Santiago, Santiago Metropolitan, Chile
Local Institution - 0022
Santiago, , Chile
Local Institution - 0009
Marseille, , France
Local Institution - 0010
Nantes, , France
Local Institution - 0011
Paris, , France
Local Institution - 0018
Wilton, CORK, Ireland
Local Institution - 0032
Dublin, , Ireland
Local Institution - 0014
Bergamo, , Italy
Local Institution - 0015
Padua, , Italy
Local Institution - 0016
Siena, , Italy
Local Institution - 0034
Tlalpan, Mexico City, Mexico
Local Institution - 0033
Monterrey, Nuevo León, Mexico
Local Institution - 0031
San Pedro Garza García, Nuevo León, Mexico
Local Institution - 0005
Auckland, , New Zealand
Local Institution - 0004
Christchurch, , New Zealand
Local Institution - 0003
Wellington, , New Zealand
Local Institution - 0017
Warsaw, , Poland
Local Institution - 0030
Timișoara, , Romania
Local Institution - 0029
Badalona-barcelona, , Spain
Local Institution - 0026
Madrid, , Spain
Local Institution - 0027
Madrid, , Spain
Local Institution - 0028
Málaga, , Spain
Countries
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Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
FDA Safety Alerts and Recalls
Other Identifiers
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2018-002993-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA209-8FC
Identifier Type: -
Identifier Source: org_study_id