Status:
COMPLETED
A Study to Compare Nivolumab Administered Subcutaneously vs Intravenous in Melanoma Participants Following Complete Resection
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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
- 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
- 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
Key Trial Info
Start Date :
August 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 8 2024
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT05297565
Start Date
August 2 2022
End Date
February 8 2024
Last Update
February 27 2025
Active Locations (16)
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1
Local Institution - 0004
Fort Wayne, Indiana, United States, 46804
2
Local Institution - 0044
Knoxville, Tennessee, United States, 37920
3
Local Institution - 0038
Coffs Harbour, New South Wales, Australia, 2450
4
Local Institution - 0003
Wollongong, New South Wales, Australia, 2500