Bladder Cancer Clinical Trial
A Study of Nivolumab Intravenous (IV) to Subcutaneous (SC) Switch in Adjuvant Melanoma and Bladder Cancer
Summary
The purpose of this study is to evaluate the switch from Nivolumab Intravenous (IV) infusions to Nivolumab Subcutaneous (SC) administration in participants with resected Stage IIIA/B/C/D or Stage IV melanoma or resected invasive Urothelial Carcinoma (UC) originating in the bladder who have high risk of recurrence.
Eligibility Criteria
Inclusion Criteria:
Participant must have Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
Participants must be eligible for adjuvant therapy for melanoma or muscle-invasive Urothelial Carcinoma (UC) originating from the bladder.
All participants must have disease-free status (DFS) documented by a complete physical examination and imaging studies within 4 weeks prior to treatment assignment.
Exclusion Criteria:
History of ocular or uveal or mucosal melanoma.
Upper tract UC (ureter, renal pelvis), non-muscle-invasive UC.
Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to treatment assignment.
Untreated/unresected Central Nervous System (CNS) or leptomeningeal metastases.
Other protocol-defined inclusion/exclusion criteria apply
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There are 3 Locations for this study
Essen North Rhine-Westphalia, 45136, Germany
Berlin , 10117, Germany
Sevilla , 41013, Spain
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