A Study to Compare Nivolumab Administered Subcutaneously vs Intravenous in Melanoma Participants Following Complete Resection

Completed · Phase 3

Conditions studied: Melanoma

In brief

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.

Key facts

Study ID

NCT05297565

Run by

Bristol-Myers Squibb

People needed

14

Starts

2022-08-02

Expected to finish

2024-02-08

Last updated by the study team

2025-02-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Local Institution - 0004 — Fort Wayne, Indiana, United States
• Local Institution - 0044 — Knoxville, Tennessee, United States
• Local Institution - 0038 — Coffs Harbour, New South Wales, Australia
• Local Institution - 0003 — Wollongong, New South Wales, Australia
• Local Institution - 0008 — Bendigo, Victoria, Australia
• Local Institution - 0029 — Ghent, Belgium
• Local Institution - 0016 — Milan, Italy
• Local Institution - 0015 — Naples, Italy
• Local Institution - 0034 — Opole, Opole Voivodeship, Poland
• Local Institution - 0036 — Bydgoszcz, Poland
• Local Institution - 0026 — Barcelona, Spain
• Local Institution - 0002 — Madrid, Spain
• Local Institution - 0043 — Madrid, Spain
• Local Institution - 0005 — Seville, Spain
• Local Institution - 0030 — Valencia, Spain
• Local Institution - 0040 — Leicester, Leicestershire, United Kingdom

Full record on ClinicalTrials.gov

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