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

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About the study

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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:


  1. Histologically confirmed stage IIIa/b/c/d or stage IV melanoma
  2. 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
  3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

EXCLUSION CRITERIA

Exclusion Criteria:


  1. Prior malignancy active within the previous 3 years, except for locally curable cancers that have been apparently cured
  2. Any significant acute or chronic medical illness that is uncontrolled
  3. History of ocular/uveal melanoma
  4. Active, known or suspected autoimmune disease
  5. 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


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Study Locations

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How to Apply


Contact the study center to learn if this study is a good match for you.

Study’s details


Contition
Melanoma
Age (in years)
18+
Phase
Phase 1
Participants needed
261
Est. Completion Date
Oct 31, 2023
Treatment type
Interventional

Sponsor
Bristol-Myers Squibb
ClinicalTrials.gov identifier
NCT03980314
Study number
CA209-8FC

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