Non-Interventional Study (NIS) of Nivolumab With or Without Ipilimumab in Participants With Advanced Kidney Cancer
NCT ID: NCT03455452
Last Updated: 2025-06-25
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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ACTIVE_NOT_RECRUITING
600 participants
OBSERVATIONAL
2018-01-21
2025-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cohort 1: Nivolumab
Participants diagnosed with advanced renal cell carcinoma (RCC) and whose physician has decided to initiate a treatment with Nivolumab for the first time for the treatment of RCC
No interventions assigned to this group
Cohort 2: Nivolumab + Ipilimumab
Participants diagnosed with advanced RCC and whose physician has decided to start a new systemic therapy with nivolumab + ipilimumab for the first time for the treatment of RCC
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
NOTE: Nivolumab with ipilimumab is indicated for the first-line treatment of adult participants with intermediate/poor-risk advanced RCC
Exclusion Criteria
* Previously treated with anti-PD1, anti-programmed death-ligand 1 (anti-PDL1) or anti-CTLA4 therapy
* Currently included in an interventional clinical trial for advanced or RCC. Participants who have completed participation in an interventional trial; or who are not receiving study drug anymore and who are only followed-up for overall survival (OS) can be enrolled
* Pregnant women and participants under guardianship
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 - 0001
Paris, , France
Countries
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References
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Barthelemy P, Albiges L, Escudier B, Narciso B, Bigot P, Chehimi M, Emambux S, Calcagno F, Mouillet G, Eymard JC, Schlurmann F, Bailly S, Garbay D, Berdah JF, Palmaro MB, Goupil MG, Spaeth D, Nere S, Quentric C, Vano YA, Thiery-Vuillemin A. Nivolumab in patients with advanced renal cell carcinoma in France: interim results of the observational, real-world WITNESS study. ESMO Open. 2024 Jul;9(7):103602. doi: 10.1016/j.esmoop.2024.103602. Epub 2024 Jun 18.
Related Links
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BMS Clinical Trial Information
Other Identifiers
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CA209-9GY
Identifier Type: -
Identifier Source: org_study_id
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