NCT05297565
Recruiting
March 28, 2022
May 16, 2022
Brief summary:
The purpose of this study is to compare the drug levels of nivolumab administered subcutaneously versus intravenous administration in participants with melanoma following complete resection.
N/A
Arm | Intervention/treatment |
---|---|
Experimental: Part 1 Arm A: Subcutaneous Nivolumab |
Biological: Nivolumab/rHuPH20 Specified dose on specified days |
Experimental: Part 2: Subcutaneous Nivolumab |
Biological: Nivolumab/rHuPH20 Specified dose on specified days |
Active Comparator: Part 1 Arm B: Intravenous Nivolumab |
Biological: Nivolumab Specified dose on specified days |
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
Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT # and Site #.
United States, Indiana
Ft. Wayne Medical Oncology and Hematology
Fort Wayne
Spain
Local Institution - 0001
Barcelona
Bristol-Myers Squibb
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb