Melanoma Clinical Trial
— CheckMate-6GEOfficial title:
A Phase 3, Open Label, Randomized, Non-Inferiority Pharmacokinetic Study of Nivolumab Subcutaneous (Nivo SC) Versus Intravenous (Nivo IV) Administration in Participants With Stage IIIA/B/C/D or Stage IV Adjuvant Melanoma Following Complete Resection
| Verified date | February 2024 |
| Source | Bristol-Myers Squibb |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to assess the safety and tolerability of subcutaneous nivolumab vs intravenous nivolumab in participants with completely resected Stage IIIA/B/C/D or Stage IV melanoma.
| Status | Completed |
| Enrollment | 14 |
| Est. completion date | February 8, 2024 |
| Est. primary completion date | February 8, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Stage IIIA/B/C/D or Stage IV melanoma and have histologically confirmed melanoma that is completely surgically resected (free of disease) with negative margins - Complete resection performed within 12 weeks prior to randomization or treatment assignment - Eastern Cooperative Oncology Group (ECOG) performance status of = 1 Exclusion Criteria: - History of uveal or mucosal melanoma - Untreated/unresected CNS metastases or leptomeningeal metastases - Active, known or suspected autoimmune disease - Serious or uncontrolled medical disorder 4 weeks prior to screening - Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to randomization or treatment assignment. Participants with history of prior early stage basal/squamous cell skin cancer or non-invasive or in situ cancers that have undergone definitive treatment at any time are eligible - Prior immunotherapy treatments for any prior malignancies are not permitted Other protocol-defined inclusion/exclusion criteria apply |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Local Institution - 0008 | Bendigo | Victoria |
| Australia | Local Institution - 0038 | Coffs Harbour | New South Wales |
| Australia | Local Institution - 0003 | Wollongong | New South Wales |
| Belgium | Local Institution - 0029 | Gent | |
| Italy | Local Institution - 0016 | Milano | |
| Italy | Local Institution - 0015 | Napoli | |
| Poland | Local Institution - 0036 | Bydgoszcz | |
| Poland | Local Institution - 0034 | Opole | Opolskie |
| Spain | Local Institution - 0026 | Barcelona | |
| Spain | Local Institution - 0002 | Madrid | |
| Spain | Local Institution - 0043 | Madrid | |
| Spain | Local Institution - 0005 | Sevilla | |
| Spain | Local Institution - 0030 | Valencia | |
| United Kingdom | Local Institution - 0040 | Leicester | Leicestershire |
| United States | Local Institution - 0004 | Fort Wayne | Indiana |
| United States | Local Institution - 0044 | Knoxville | Tennessee |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
United States, Australia, Belgium, Italy, Poland, Spain, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of participants with adverse events (AEs) | Up to 15 months | ||
| Primary | Number of participants with serious adverse events (SAEs) | Up to 15 months | ||
| Primary | Number of participants with treatment-related AEs | Up to 15 months | ||
| Primary | Number of participants with treatment-related SAEs | Up to 15 months |
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