A Phase 3 Randomized, Double-blind, Multi-center Study of Adjuvant Nivolumab Versus Placebo in Subjects With High Risk Invasive Urothelial Carcinoma (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

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to determine the effectiveness and safety of Nivolumab compared to placebo in participants who have undergone radical surgery for invasive urothelial cancer.

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

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