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  • NCT03873402

Active, Not Recruiting

An Immunotherapy Study of Nivolumab Plus Ipilimumab Versus Nivolumab Alone in Participants With Advanced Kidney Cancer - CA209-8Y8

Opdateret: 10 marts, 2025   |   ClinicalTrials.gov

Udskriftsvenligt sammendrag

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VÆLG SPROG

Forsøgsdetaljer

  • Phase 3

    Fase

  • Køn

  • 18+

    Aldersinterval

  • Active, Not Recruiting

Behandlingsmuligheder

Forsøgsgrene
TILDELT INTERVENTION
Experimental: Nivolumab + ipilimumab
Biological: Nivolumab, Ipilimumab
Experimental: Nivolumab + ipilimumab placebo
Other: Ipilimumab placebo

Primære egnethedskriterier

For more information regarding Bristol Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Histological confirmation of renal carcinoma with clear cell component including participants who may have sarcomatoid features. - Advanced (not amenable to curative surgery or radiation therapy) renal cell carcinoma (RCC) or metastatic RCC (mRCC). - Measurable disease by CT or MRI per RECIST 1.1 criteria. - No prior systemic therapy for RCC - Must be intermediate or poor risk as per International Metastatic RCC Database Consortium (IMDC). Exclusion Criteria: - Any active central nervous system (CNS) metastases. - Active, known, or suspected autoimmune disease. - Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4 antibody, or any other agents specifically targeting T-cell co-stimulation or checkpoint pathways Other protocol defined inclusion/exclusion criteria could apply

Hvis du vil rapportere en bivirkning, kan du indberette direkte til Lægemiddelstyrelsen via hjemmesiden www.meldenbivirkning.dk
Vi anbefaler at du også kontakter BMS for at rapportere bivirkninger.
Bivirkninger og andre rapporterbare begivenheder er defineret her
Rapporter bivirkninger eller klager over produktkvalitet: Medicinsk information

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