Phase 3
N=14
A Study to Compare Nivolumab Administered Subcutaneously vs Intravenous in Melanoma Participants Following Complete Resection
Melanoma
Bottom Line
View on ClinicalTrials.gov: NCT05297565 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcome: Primary: Number of Participants With Adverse Events — 6; 8; 0; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Nivolumab/rHuPH20 (Biological); Nivolumab (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bristol-Myers Squibb
- Primary completion
- Feb 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events |
6; 8; 0; 2; 0; 0 | — |
| PRIMARY Number of Participants With Serious Adverse Events |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Treatment Related Adverse Events |
6; 8; 0; 2; 0; 0 | — |
| PRIMARY Number of Participants With Treatment Related Serious Adverse Events |
0; 0; 0; 0; 0; 0 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05297565). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.