A Phase 3, Randomized, Double-blind Trial of Nivolumab in Combination With Intravesical BCG Versus Standard of Care BCG Alone in Participants With High-risk Non-muscle Invasive Bladder Cancer That Is Persistent or Recurrent After Treatment With BCG

TerminadoFase 3ClinicalTrials.gov

ID: NCT04149574Tipo: INTERVENTIONALInicio: 15 de ene de 2020Fin estimado: 31 de oct de 2023

Traducción no disponible, mostrando original

Resumen

A study comparing nivolumab and bacterial drugs given to help the body's immune system in the bladder versus bacterial drugs alone in high risk bladder cancer participants.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Persistent or recurrent disease ≤ 24 months of last BCG dose, but not classified as BCG unresponsive
Histologically confirmed persistent or recurrent high-risk non-muscle-invasive urothelial carcinoma (UC)
Treated with at least 1 adequate course of induction BCG therapy (at least 5 out of 6 doses)
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2

Criterios de exclusión

Previous or concurrent muscle invasive, locally advanced, or disseminated/metastatic UC
UC in the upper genitourinary tract (kidneys, renal collecting systems, ureters) within 24 months of enrollment
UC and/or CIS in the prostatic urethra within 12 months of enrollment

Intervenciones

drug

nivolumab

Specified Dose on Specified Days

other

Placebo

Specified Dose on Specified Days

biological

Bacillus Calmette-Guérin (BCG)

Specified Dose on Specified Days

Ubicaciones

Local Institution - 0009

Caba, Buenos Aires, Argentina

Local Institution - 0088

Capital Federal, Buenos Aires, Argentina

Local Institution - 0016

Ciudad Autonoma Beunos Aires, Buenos Aires, Argentina

Local Institution - 0081

Mar del Plata, Buenos Aires, Argentina

Local Institution - 0008

Viedma, Río Negro Province, Argentina

Local Institution - 0080

Buenos Aires, Argentina

Local Institution - 0107

Córdoba, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

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