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A Study of Nivolumab Plus NKTR-214 vs Nivolumab Alone vs Standard of Care in Participants With Bladder Cancer That Has Invaded the Muscle Wall of the Bladder and Who Cannot Get Cisplatin, a Type of Medicine Given to Treat Bladder Cancer. - CA045-009

Actualizada: 16 enero, 2020   |   ClinicalTrials.gov

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Detalles del estudio

  • Phase 3

    Fase

  • Géneros

  • 18+

    Rango de edad

  • Not Yet Recruiting

Opciones de tratamiento

Brazos del estudio
INTERVENCIÓN ASIGNADA
Experimental: Combination
Biological: Nivolumab Biological: NKTR-214 Procedure: Radical cystectomy (RC)
Experimental: Monotherapy
Procedure: Radical cystectomy (RC) Biological: Nivolumab
Other: Standard-of-care
Procedure: Radical cystectomy (RC)

Criterios clave de elegibilidad

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - MIBC, clinical stage T2-T4a, N0, M0, diagnosed at transurethral resection of bladder tumor (TURBT) and confirmed by radiographic imaging. - Must be deemed eligible for Radical Cystectomy (RC) by urologist, and must agree to undergo RC. For arms A and B, participants must agree to undergo RC after completion of neoadjuvant therapy. - Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 - Cisplatin-ineligible participants will be defined by any one of the following criteria: i) Impaired renal function (glomerular filtration rate [GFR] ≥ 30 but < 60 mL/min) ii) GFR should be assessed by direct measurement (ie, creatinine clearance) or, if not available, by calculation from serum/plasma creatinine (Cockcroft-Gault formula) iii) Common Terminology Criteria for Adverse Events (CTCAE) version 5, ≥ Grade 2 hearing loss (assessed per local SOC). iv) CTCAE version 5, ≥ Grade 2 peripheral neuropathy. - Documented Left Ventricular Ejection Fraction (LVEF) more than 45% Exclusion Criteria: - Clinical evidence of pathologic lymph node (LN) or metastatic bladder cancer. - Prior systemic therapy, radiation therapy, or surgery for bladder cancer other than TURBT or biopsies is not permitted. Prior Bacillus Calmette-Guerin (BCG) or other intravesicular treatment of non-muscle invasive bladder cancer (NMIBC) is permitted if completed at least 6 weeks prior to initiating study treatment. - Evidence of urothelial carcinoma (UC) in upper urinary tracts (ureters or renal pelvis) or history of previous MIBC or urothelial carcinoma not confined to the bladder. Other protocol defined inclusion/exclusion criteria could 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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