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:

286

Study ID:

NCT05297565

Recruitment Status:

Recruiting

Sponsor:

Bristol-Myers Squibb

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 46 Locations for this study

See Locations Near You

UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco California, 94158, United States
Mayo Clinic Florida
Jacksonville Florida, 32224, United States More Info
Roxana Dronca, Site 0049
Contact
507-284-2511
Ft. Wayne Medical Oncology and Hematology
Fort Wayne Indiana, 46804, United States More Info
Sunil Babu, Site 0004
Contact
260-436-0800
St. Lukes University Health Network
Philadelphia Pennsylvania, 19107, United States
University of Tennessee Medical Center
Knoxville Tennessee, 37920, United States More Info
NEIL E. FAULKNER, Site 0044
Contact
Local Institution - 0038
Coffs Harbour New South Wales, 2450, Australia More Info
Site 0038
Contact
Local Institution - 0008
Bendigo Victoria, 3550, Australia More Info
Site 0008
Contact
Local Institution - 0017
Box Hill Victoria, 3128, Australia
Local Institution - 0019
Brasschaat , 2930, Belgium
Local Institution - 0029
Gent , 9000, Belgium More Info
Site 0029
Contact
Local Institution - 0028
Woluwe Saint-Lambert , 1200, Belgium
Local Institution - 0013
Yvoir , 5530, Belgium
Local Institution - 0021
Edmonton Alberta, T6G 1, Canada
Local Institution - 0046
Hamilton Ontario, L8V 5, Canada
Local Institution - 0048
Ottawa Ontario, K1H 8, Canada
Local Institution - 0007
Bordeaux , 33075, France
Local Institution - 0025
Nantes , 44093, France
Local Institution - 0039
Nice , 06200, France
Local Institution - 0027
Pierre Benite , 69495, France
Local Institution - 0014
Erlangen Bayern, 91054, Germany
Local Institution - 0010
Buxtehude Niedersachsen, 21614, Germany
Local Institution - 0006
Luebeck Schleswig-Holstein, 23538, Germany
Local Institution - 0023
Dresden , 01307, Germany
Local Institution - 0050
Erfurt , 99089, Germany
Local Institution - 0024
Hamburg , 20246, Germany
Local Institution - 0041
Homburg , 66421, Germany
Local Institution - 0012
Bari , 70124, Italy
Local Institution - 0011
Genova , 16132, Italy
Local Institution - 0016
Milano , 20141, Italy More Info
Site 0016
Contact
Local Institution - 0015
Napoli , 80131, Italy More Info
Site 0015
Contact
Local Institution - 0009
Pisa , 56126, Italy
Local Institution - 0034
Opole Opolskie, 45-06, Poland More Info
Site 0034
Contact
Local Institution - 0045
Brzozow , 36-20, Poland
Local Institution - 0036
Bydgoszcz , 85-79, Poland More Info
Site 0036
Contact
Local Institution - 0035
Gdansk , 80-95, Poland
Local Institution - 0022
Poznan , 60-78, Poland
Local Institution - 0026
Barcelona , 08003, Spain More Info
Site 0026
Contact
Local Institution - 0001
Barcelona , 8036, Spain
Local Institution - 0002
Madrid , 28036, Spain More Info
Site 0002
Contact
Local Institution - 0043
Madrid , 28050, Spain More Info
Site 0043
Contact
Local Institution - 0005
Sevilla , 41009, Spain More Info
Site 0005
Contact
Local Institution - 0030
Valencia , 46014, Spain More Info
Site 0030
Contact
Local Institution - 0047
Zaragoza , 50009, Spain
Local Institution - 0040
Leicester Leicestershire, LE1 5, United Kingdom More Info
Site 0040
Contact
Local Institution - 0018
Guildford Surrey, GU2 7, United Kingdom More Info
Site 0018
Contact
Local Institution - 0031
Leeds , LS7 4, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 3

Estimated Enrollment:

286

Study ID:

NCT05297565

Recruitment Status:

Recruiting

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.