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Recruiting

A Study to Compare Nivolumab Administered Subcutaneously vs Intravenous in Melanoma Participants Following Complete Resection - CA209-6GE

Updated: 10 May, 2022   |   ClinicalTrials.gov

Print Friendly Summary

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Trial Details

  • Phase 3

    Phase

  • Gender(s)

  • 18+

    Age Range

  • 1

    Location(s)

  • Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: Part 1 Arm A: Subcutaneous Nivolumab
Biological: Nivolumab/rHuPH20
Active Comparator: Part 1 Arm B: Intravenous Nivolumab
Biological: Nivolumab
Experimental: Part 2: Subcutaneous Nivolumab
Biological: Nivolumab/rHuPH20

Key Eligibility Criteria

Inclusion Criteria: - Stage IIIA/B/C/D or Stage IV melanoma and have histologically confirmed melanoma that is completely surgically resected (free of disease) with negative margins - Complete resection performed within 12 weeks prior to randomization or treatment assignment - Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 Exclusion Criteria: - History of uveal or mucosal melanoma - Untreated/unresected CNS metastases or leptomeningeal metastases - Active, known or suspected autoimmune disease - Serious or uncontrolled medical disorder 4 weeks prior to screening - Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to randomization or treatment assignment. Participants with history of prior early stage basal/squamous cell skin cancer or non-invasive or in situ cancers that have undergone definitive treatment at any time are eligible - Prior immunotherapy treatments for any prior malignancies are not permitted 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