Melanoma Clinical Trial
Official title:
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
| Verified date | April 2023 |
| Source | Bristol-Myers Squibb |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | June 24, 2026 |
| Est. primary completion date | June 24, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Local Institution - 0001 | Berlin | |
| Germany | Local Institution - 0020 | Essen | North Rhine-Westphalia |
| Spain | Local Institution - 0002 | Sevilla |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
Germany, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Proportion of Participants That Prefer Nivolumab SC at the First Assessment of Patient Preference Using Patient Experience and Preference Questionnaire (PEPQ) (Question 1) | Up to 24 hours after first full dose at Cycle 4, Day 1 (98 Days) | ||
| Secondary | Number of Participants with Adverse Events (AEs) | Up to 100 days following last dose of nivolumab (Up to Day 465) | ||
| Secondary | Proportion of Participants That Prefer Nivolumab SC at the Second Assessment of Patient Preference Using PEPQ (Question 1) | Up to 24 hours after fourth full dose at Cycle 5, Day 15 (140 Days) |
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