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A Study Comparing the Efficacy and Safety of Nivolumab in Combination With Bacillus Calmette-Guerin (BCG) Versus BCG Alone in Participants With High-Risk Non-Muscle Invasive Bladder Cancer (HR NMIBC) - CA209-7G8

Actualizada: 20 noviembre, 2019   |   ClinicalTrials.gov

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Detalles del estudio

  • Phase 3

    Fase

  • Géneros

  • 18+

    Rango de edad

  • 17

    Ubicación (es)

  • Not Yet Recruiting

Opciones de tratamiento

Brazos del estudio
INTERVENCIÓN ASIGNADA
Experimental: Arm A: nivolumab
Drug: nivolumab Biological: Bacillus Calmette-Guérin (BCG)
Placebo Comparator: Arm B: placebo +BCG
Biological: Bacillus Calmette-Guérin (BCG) Other: Placebo

Criterios clave de elegibilidad

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com. Inclusion: - Predominant histologic component (> 50%) must be urothelial (transitional cell) carcinoma - 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) - Sufficient tissue for both biomarker analysis and central pathology review committee (PRC) confirmation of diagnosis - Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2 - Women of child bearing potential (WOCBP) and men with WOCBP partners must agree to follow contraceptive requirements Exclusion Criteria - 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 - Prior surgery (other than transurethral resection of the bladder tumor (TURBT)/biopsies) for bladder cancer; prior radiation therapy, or systemic chemotherapy or immunotherapy for bladder cancer or UC Other inclusion/exclusion criteria apply.

Recomendamos encarecidamente que se comunique con BMS para informar los efectos secundarios (eventos adversos)
Los efectos secundarios (eventos adversos) y otros eventos reportables se definen aquí
Informe de efectos secundarios (eventos adversos) o quejas sobre la calidad del producto: información médica

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Llame 855-907-3286 o Envíenos un correo electrónico