NCT05297565CompletedPhase 3
A Study to Compare Nivolumab Administered Subcutaneously vs Intravenous in Melanoma Participants Following Complete Resection
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
Source: ClinicalTrials.gov · Last updated 27 Feb 2025
Brief summary (registry, in English)
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 (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 14 (actual)
- First submitted
- 17 Mar 2022
- Start date
- 2 Aug 2022
- Primary completion date
- 8 Feb 2024
- Lead sponsor
- Bristol-Myers Squibb
- Diseases
- Melanoma
- NCT number
- NCT05297565
- EudraCT number
- 2021-003208-42
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 14
- From 2 Aug 2022 to the primary completion date, 8 Feb 2024
- 16 sites in 7 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Serious or uncontrolled medical disorder 4 weeks prior to screening
Other illness
- History of uveal or mucosal melanoma
- Active, known or suspected autoimmune disease
- 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
Other
- Untreated/unresected CNS metastases or leptomeningeal metastases
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (16)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.