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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: 15 November, 2019   |   ClinicalTrials.gov

Print Friendly Summary

CONSIDERING THIS TRIAL?
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Use the Study Participant's Guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.

Trial Details

  • Phase 1/Phase 2

    Phase

  • Gender(s)

  • 18+

    Age Range

  • 25

    Location(s)

  • Recruiting

Treatment Options

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

Key Eligibility Criteria

Inclusion Criteria: - Late Stage melanoma that is completely surgically resected and pathologically absent - Participants must not have received anti-cancer therapy greater than equal to (>=) 6 months prior to randomization - Imaging studies to include Computed tomography (CT), Magnetic resonance imaging (MRI), positron emission tomography (PET) scans that show no clinically detectable nodes on imaging Exclusion Criteria: - Participants must not have a history of ocular/uveal melanoma - Participants with active, known, or suspected autoimmune disease(s) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll - Participants must not have prior malignancy active within the previous 3 years except for locally curable cancers - Participants must not have a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of study drug administration. - Participants must not have had prior therapy for melanoma except surgery, for the melanoma lesion(s) adjuvant radiation therapy after neurosurgical resection for CNS lesions and except for participants who received prior adjuvant interferon therapy - Treatment directed against the resected melanoma that is administered after complete resection other than adjuvant radiation

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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