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Active, Not Recruiting

A Study of Nivolumab Combined With Cabozantinib Compared to Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma - CA209-9ER

Oppdatert: 12 januar, 2024   |   ClinicalTrials.gov

Utskriftsvennlig Sammendrag

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Vis detaljer

  • Phase 3

    Fase

  • Kjønn

  • 18+

    Aldersgruppe

  • Active, Not Recruiting

Behandlingsalternativer

Studiearmer
TILDELT INTERVENSJON
Experimental: Doublet
Drug: Cabozantinib Biological: Nivolumab
Active Comparator: Monotherapy
Drug: Sunitinib
Experimental: Triplet
Biological: Ipilimumab

Nøkkelkriterier for kvalifikasjon

For more information regarding Bristol Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Histological confirmation of RCC with a clear-cell component, including participants who may also have sarcomatoid features - Advanced (not amenable to curative surgery or radiation therapy) or metastatic (AJCC Stage IV) RCC - No prior systemic therapy for RCC with the following exception: i) One prior adjuvant or neoadjuvant therapy for completely resectable RCC if such therapy did not include an agent that targets VEGF or VEGF receptors and if recurrence occurred at least 6 months after the last dose of adjuvant or neoadjuvant therapy Exclusion Criteria: - Any active CNS metastases - Any active, known or suspected autoimmune disease - Any condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization Other protocol defined inclusion/exclusion criteria could apply

Vi anbefaler at du kontakter BMS for å rapportere bivirkninger.
Bivirkninger (uønskede hendelser) og andre rapporterbare hendelser er definert her
For å rapportere bivirkninger (uønskede hendelser) eller reklamere på et legemiddel: Medisinsk informasjon

MLTNO2000046