A Study to Compare Nivolumab Administered Subcutaneously vs Intravenous in Melanoma Participants Following Complete Resection
About the study
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION 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
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
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Melanoma
Age (in years)
18+
Phase
Phase 3
Participants needed
14
Est. Completion Date
Feb 28, 2024
Treatment type
Interventional
Sponsor
Bristol-Myers Squibb
ClinicalTrials.gov identifier
NCT05297565
Study number
CA2096GE
Understanding Clinical Trials
Get answers to your questions about clinical trials.What is a clinical research?What does taking part in clinical trials involve?What should I ask the trial doctor?