A Study of Nivolumab Intravenous (IV) to Subcutaneous (SC) Switch in Adjuvant Melanoma and Bladder Cancer
NCT ID: NCT05496192
Last Updated: 2023-04-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2023-05-31
2026-06-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Nivolumab IV followed by Nivolumab SC
Nivolumab/rHuPH20
Specified dose on specified days
Nivolumab
Specified dose on specified days
Interventions
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Nivolumab/rHuPH20
Specified dose on specified days
Nivolumab
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 0020
Essen, North Rhine-Westphalia, Germany
Local Institution - 0001
Berlin, , Germany
Local Institution - 0002
Seville, , Spain
Countries
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Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
FDA Safety Alerts and Recalls
Other Identifiers
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2022-000294-67
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1273-4725
Identifier Type: REGISTRY
Identifier Source: secondary_id
CA209-6L6
Identifier Type: -
Identifier Source: org_study_id
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