Melanoma Clinical Trial

A Study to Compare Nivolumab Administered Subcutaneously vs Intravenous in Melanoma Participants Following Complete Resection

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.

View Eligibility Criteria

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

Study is for people with:

Melanoma

Phase:

Phase 3

Estimated Enrollment:

14

Study ID:

NCT05297565

Recruitment Status:

Completed

Sponsor:

Bristol-Myers Squibb

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There are 16 Locations for this study

See Locations Near You

Local Institution - 0004
Fort Wayne Indiana, 46804, United States
Local Institution - 0044
Knoxville Tennessee, 37920, United States
Local Institution - 0038
Coffs Harbour New South Wales, 2450, Australia
Local Institution - 0003
Wollongong New South Wales, 2500, Australia
Local Institution - 0008
Bendigo Victoria, 3550, Australia
Local Institution - 0029
Gent , 9000, Belgium
Local Institution - 0016
Milano , 20141, Italy
Local Institution - 0015
Napoli , 80131, Italy
Local Institution - 0034
Opole Opolskie, 45-06, Poland
Local Institution - 0036
Bydgoszcz , 85-79, Poland
Local Institution - 0026
Barcelona , 08003, Spain
Local Institution - 0002
Madrid , 28036, Spain
Local Institution - 0043
Madrid , 28050, Spain
Local Institution - 0005
Sevilla , 41009, Spain
Local Institution - 0030
Valencia , 46014, Spain
Local Institution - 0040
Leicester Leicestershire, LE1 5, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 3

Estimated Enrollment:

14

Study ID:

NCT05297565

Recruitment Status:

Completed

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

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