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Active, Not Recruiting

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 - CA209-8FC

Updated: 12 May, 2022   |   ClinicalTrials.gov

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Trial Details

  • Phase 1

    Phase

  • Gender(s)

  • 18+

    Age Range

  • Active, Not Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Active Comparator: Arm A (Process C)
Drug: Nivolumab
Experimental: Arm B (Process D)
Drug: Nivolumab

Key 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

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Have questions? Live support is available 24/7 - Call 855-907-3286 or email clinical.trials@bms.com

Have questions? Live support is available 24/7 -
Call 855-907-3286 or email clinical.trials@bms.com