Estudio de fase 3, aleatorizado, doble ciego, multicéntrico, de nivolumab adyuvante versus placebo en participantes con carcinoma urotelial invasivo de alto riesgo (CheckMate 274: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 274)

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT02632409Tipo: INTERVENTIONALInicio: 22 de mar de 2016Fin estimado: 27 de may de 2027

Resumen

El propósito de este estudio es determinar la eficacia y seguridad de nivolumab comparado con placebo en participantes que se han sometido a cirugía radical por cáncer urotelial invasivo.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Must have had invasive urothelial cancer at high risk of recurrence originating in the bladder, ureter, or renal pelvis
Must have had radical surgical resection (e.g. radical cystectomy), performed within the last 120 days
Must have disease free status as determined by imaging within 4 weeks of dosing
Tumor tissue must be provided for biomarker analysis
Patients who have not received prior neoadjuvant cisplatin chemotherapy must be ineligible for or refuse cisplatin-based adjuvant chemotherapy

Criterios de exclusión

Partial bladder or partial kidney removal (eg, partial cystectomy or partial nephrectomy)
Secondary Treatment (eg, adjuvant systemic chemotherapy for bladder cancer) following surgical removal of bladder cancer
Subjects with active, known or suspected autoimmune disease
Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured
Condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 day of study drug administration
Positive test for hepatitis B virus surface antigen (HBV s Ag) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection

Intervenciones

biological

Nivolumab

other

Placebo

Ubicaciones

Local Institution - 0021

Berazategui, Buenos Aires, Argentina

Local Institution - 0090

Capital Federal, Buenos Aires, Argentina

Local Institution - 0089

Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina

Local Institution - 0022

Ciudad Autónoma de BuenosAires, Buenos Aires, Argentina

Local Institution - 0020

San Miguel de Tucumán, Tucumán Province, Argentina

Local Institution - 0102

Viedma, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

ColaboradorOno Pharmaceutical Co. Ltd

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

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