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  • NCT05496192

Not Yet Recruiting

A Study of Nivolumab Intravenous (IV) to Subcutaneous (SC) Switch in Adjuvant Melanoma and Bladder Cancer - CA209-6L6

Opdateret: 22 marts, 2023   |   ClinicalTrials.gov

Udskriftsvenligt sammendrag

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VÆLG SPROG

Forsøgsdetaljer

  • Phase 2

    Fase

  • Køn

  • 18+

    Aldersinterval

  • 3

    Beliggenhed(er)

  • Not Yet Recruiting

Behandlingsmuligheder

Forsøgsgrene
TILDELT INTERVENTION
Experimental: Nivolumab IV followed by Nivolumab SC
Drug: Nivolumab/rHuPH20 Drug: Nivolumab

Primære egnethedskriterier

Inclusion Criteria: - Participant must have Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. - Participants must be eligible for adjuvant therapy for melanoma or muscle-invasive Urothelial Carcinoma (UC) originating from the bladder. - All participants must have disease-free status (DFS) documented by a complete physical examination and imaging studies within 4 weeks prior to treatment assignment. Exclusion Criteria: - History of ocular or uveal or mucosal melanoma. - Upper tract UC (ureter, renal pelvis), non-muscle-invasive UC. - Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to treatment assignment. - Untreated/unresected Central Nervous System (CNS) or leptomeningeal metastases. Other protocol-defined inclusion/exclusion criteria 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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