A Study of Nivolumab Intravenous (IV) to Subcutaneous (SC) Switch in Adjuvant Melanoma and Bladder Cancer
Megadott ok: Replaced it with another clinical trial
Key facts
- Where
- Berlin és Essen, NémetországSee the 2 sites
- Phase
- 2. fázis
Where in Németország
- BerlinBerlin, NémetországNo longer taking part
- EssenEssen, NémetországNo longer taking part
Trial details
- Who runs it
- Bristol-Myers Squibb
- Trial code
- NCT05496192
- Record updated
- 2023. április 14.
- Original description
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.Read full original descriptionShow less
A Phase II Study of Adjuvant Nivolumab Switch From Intravenous (IV) to Subcutaneous (SC) Use in Participants With Resected Stage III or Stage IV Melanoma or High Risk Invasive Urothelial Carcinoma Originating in the Bladder
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.
Inclusion: 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: History of ocular or uveal or mucosal melanoma; Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to treatment assignment; Upper tract UC (ureter, renal pelvis), non-muscle-invasive UC; Untreated/unresected Central Nervous System (CNS) or leptomeningeal metastases; Other protocol-defined inclusion/exclusion criteria apply.