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Site for A Phase III, Randomized, Open-label Study of Adjuvant Immunotherapy with Bempegaldesleukin Combined with Nivolumab Versus Nivolumab After Complete Resection of Melanoma in Participants at High Risk for Recurrence (PIVOT-12)

This study is to compare the efficacy, as measured by recurrence-free survival (RFS) by a blinded independent central review (BICR) of bempegaldesleukin plus nivolumab versus nivolumab in patients with completely resected Stage IIIa, Stage IIIb/c/d, or Stage IV no evidence of disease (NED) cutaneous melanoma who are at high risk for recurrence.
Irina Geier at or 717-531-4300
18 year(s) or older
This study is NOT accepting healthy volunteers
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Inclusion Criteria:
Prior treated central nervous system (CNS) metastases must have magnetic resonance imaging (MRI) evidence of no recurrence for at least 4 weeks after treatment
Male or female patients age 12 years or older at the time of signing the informed consent form (ICF) (age 18 years or older where local regulations or institutional policies do not allow for patients < 18 years of age to participate).
Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Histologically confirmed Stage IIIA (LN metastasis > 1 mm [i.e., at least one LN metastasis measuring > 1 mm at greatest diameter]), IIIB/C/D, or IV (M1a/b/c/d) cutaneous melanoma by AJCC
Tumor tissue from biopsy or resected disease must be provided to central laboratory for PD-L1 status analysis
Exclusion Criteria:
Use of an investigational agent or an investigational device within 28 days before randomization
History of ocular/uveal melanoma or mucosal melanoma
Conditions requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization
Prior therapy for melanoma
History of leptomeningeal disease
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Hershey, PA