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

Completed · Phase 1

Conditions studied: Melanoma

In brief

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.

Key facts

Study ID

NCT03980314

Run by

Bristol-Myers Squibb

People needed

261

Starts

2019-06-24

Expected to finish

2023-11-06

Last updated by the study team

2023-12-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Local Institution - 0006 — Hartford, Connecticut, United States
• Local Institution - 0008 — Minneapolis, Minnesota, United States
• Local Institution - 0035 — Charlotte, North Carolina, United States
• Local Institution - 0043 — Pittsburgh, Pennsylvania, United States
• Local Institution - 0046 — Buenos Aires, Argentina
• Local Institution - 0001 — Wollstonecraft, New South Wales, Australia
• Local Institution - 0036 — Ijuí, Rio Grande do Sul, Brazil
• Local Institution - 0037 — Porto Alegre, Rio Grande do Sul, Brazil
• Local Institution - 0039 — Barretos, São Paulo, Brazil
• Local Institution - 0038 — Cerqueira César, São Paulo, Brazil
• Local Institution - 0040 — São José do Rio Preto, São Paulo, Brazil
• Local Institution - 0041 — Rio de Janeiro, Brazil
• Local Institution - 0013 — Edmonton, Canada
• Local Institution - 0024 — Independencia, Santiago Metropolitan, Chile
• Local Institution - 0045 — Santiago, Santiago Metropolitan, Chile
• Local Institution - 0023 — Santiago, Santiago Metropolitan, Chile
• Local Institution - 0022 — Santiago, Chile
• Local Institution - 0009 — Marseille, France
• Local Institution - 0010 — Nantes, France
• Local Institution - 0011 — Paris, France
• Local Institution - 0018 — Wilton, CORK, Ireland
• Local Institution - 0032 — Dublin, Ireland
• Local Institution - 0014 — Bergamo, Italy
• Local Institution - 0015 — Padova, Italy
• Local Institution - 0016 — Siena, Italy

Full record on ClinicalTrials.gov

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