An Investigational Immuno-Therapy Safety and Efficacy Study of Multiple Administration Regimens for Nivolumab Plus Ipilimumab in Subjects With Renal Cell Carcinoma
NCT ID: NCT03029780
Last Updated: 2022-06-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
104 participants
INTERVENTIONAL
2017-02-16
2021-06-15
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
NONE
Study Groups
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Co-Administration
Nivolumab and Ipilimumab Co-Administration
Opdivo
Specified dose on specified days
Yervoy
Specified dose on specified days
Sequential Administration
Nivolumab and Ipilimumab Sequential Administration
Opdivo
Specified dose on specified days
Yervoy
Specified dose on specified days
Interventions
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Opdivo
Specified dose on specified days
Yervoy
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must have full activity or, if limited, must be able to walk and carry out light activities such as light house work or office work
* Must have at least 1 lesion with measurable disease
Exclusion Criteria
* Subjects who received prior therapy with checkpoint inhibitor
* Subjects with active, known or suspected 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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Cancer Specialists of North FL
Jacksonville, Florida, United States
University Of Iowa Hospitals And Clinics
Iowa City, Iowa, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
Local Institution
Pittsburgh, Pennsylvania, United States
Local Institution
Waratah, New South Wales, Australia
Local Institution
Westmead, New South Wales, Australia
Local Institution
Herston, Queensland, Australia
Local Institution
Elizabeth Vale, South Australia, Australia
Local Institution
Malvern, Victoria, Australia
Centro Internacional de Estudios Clinicos
Recoleta, Santiago de Chile, Chile
Fundacion Arturo Lopez Perez
Santiago, Santiago Metropolitan, Chile
Countries
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References
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Menzies AM, Salman P, Frontera OA, Pook D, Hocking CM, Zakharia Y, Gurney H, Gedye C, Goh JC, Telivala B, Grob JJ, Lebbe C, de la Cruz Merino L, Machet L, Neidhardt EM, Qureshi A, Hosein F, Hamuro L, Simsek B, Amin A. Administration of nivolumab plus ipilimumab: Infusion of the fixed-ratio combination versus sequential infusions in two randomized controlled trials of metastatic melanoma (CheckMate 742) and renal cell carcinoma (CheckMate 800). Cancer. 2025 Jul 15;131(14):e35962. doi: 10.1002/cncr.35962.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
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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CA209-800
Identifier Type: -
Identifier Source: org_study_id
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