Melanoma Clinical Trial

A Study to Compare Nivolumab Drug Product Process D to Nivolumab Drug Product Process C in Participants With Stage IIIa/b/c/d or Stage IV Melanoma After Complete Resection

Summary

The purpose of this study is to compare the drug levels, immunogenicity and safety of Nivolumab Process D to Nivolumab Process C after complete resection of stage IIIa/b/c/d or stage IV melanoma.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Histologically confirmed stage IIIa/b/c/d or stage IV melanoma
Complete resection of Stage III disease that is documented on the surgical and pathology reports or complete resection of Stage IV disease with margins negative for disease that is documented on the pathology report
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

Exclusion Criteria:

Prior malignancy active within the previous 3 years, except for locally curable cancers that have been apparently cured
Any significant acute or chronic medical illness that is uncontrolled
History of ocular/uveal melanoma
Active, known or suspected autoimmune disease
Systemic treatment with either corticosteroids (> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement steroid doses > 10 mg daily prednisone or equivalent, are permitted in the absence of active autoimmune disease.

Other protocol-defined inclusion/exclusion criteria apply

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

261

Study ID:

NCT03980314

Recruitment Status:

Completed

Sponsor:

Bristol-Myers Squibb

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There are 33 Locations for this study

See Locations Near You

Local Institution - 0006
Hartford Connecticut, 06106, United States
Local Institution - 0008
Minneapolis Minnesota, 55407, United States
Local Institution - 0035
Charlotte North Carolina, 28204, United States
Local Institution - 0043
Pittsburgh Pennsylvania, 15213, United States
Local Institution - 0046
Buenos Aires , 1431, Argentina
Local Institution - 0001
Wollstonecraft New South Wales, 2065, Australia
Local Institution - 0036
Ijui RIO Grande DO SUL, 98700, Brazil
Local Institution - 0037
Porto Alegre RIO Grande DO SUL, 90610, Brazil
Local Institution - 0039
Barretos Sao Paulo, 14780, Brazil
Local Institution - 0038
Cerqueira Cesar SAO Paulo, 01246, Brazil
Local Institution - 0040
São José do Rio Preto São Paulo, 15090, Brazil
Local Institution - 0041
Rio de Janeiro , 20230, Brazil
Local Institution - 0013
Edmonton , T6X 1, Canada
Local Institution - 0045
Santiago Metropolitana, 84203, Chile
Local Institution - 0023
Santiago Metropolitana, , Chile
Local Institution - 0024
Independencia Santiago, , Chile
Local Institution - 0022
Santiago , 0, Chile
Local Institution - 0009
Marseille Cedex 5 , 13385, France
Local Institution - 0010
Nantes Cedex 1 , 44093, France
Local Institution - 0011
Paris , 75475, France
Local Institution - 0018
Wilton Cork, T12 D, Ireland
Local Institution - 0032
Dublin , , Ireland
Local Institution - 0014
Bergamo , 24127, Italy
Local Institution - 0015
Padova , 35128, Italy
Local Institution - 0016
Siena , 53100, Italy
Local Institution - 0034
Tlalpan Distrito Federal, 14080, Mexico
Local Institution - 0033
Monterrey Nuevo Leon, 64460, Mexico
Local Institution - 0031
San Pedro Garza Garcia Nuevo LEON, 66278, Mexico
Local Institution - 0005
Auckland , 1023, New Zealand
Local Institution - 0004
Christchurch , 0, New Zealand
Local Institution - 0003
Wellington , 6021, New Zealand
Local Institution - 0017
Warszawa , 02-78, Poland
Local Institution - 0030
Timisoara , 30069, Romania
Local Institution - 0029
Badalona-barcelona , 08916, Spain
Local Institution - 0026
Madrid , 28007, Spain
Local Institution - 0027
Madrid , 28040, Spain
Local Institution - 0028
Malaga , 29010, Spain

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

261

Study ID:

NCT03980314

Recruitment Status:

Completed

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

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