Active, Not Recruiting
An Investigational Immuno-therapy Study of Nivolumab, Compared to Placebo, in Patients With Bladder or Upper Urinary Tract Cancer, Following Surgery to Remove the Cancer - CA209-274
Oppdatert:
2 januar, 2024
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ClinicalTrials.gov
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Aldersgruppe
Active, Not Recruiting
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - 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 Exclusion Criteria: - 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
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Bivirkninger (uønskede hendelser) og andre rapporterbare hendelser er definert her
For å rapportere bivirkninger (uønskede hendelser) eller reklamere på et legemiddel: Medisinsk informasjon
MLTNO2000046