Nektar Therapeutics 20-214-29/CA045-022/PIVOT12
A Phase 3, Randomized, Open-Label Study To Compare Adjuvant Immunotherapy Of Bempegaldesleukin Combined With Nivolumab Versus Nivolumab After Complete Resection Of Melanoma In Patients At High Risk For Recurrence (Pivot 12)
To compare the efficacy of bempegaldesleukin plus nivolumab versus nivolumab in patients with completely resected Stage IIIA cutaneous melanoma with no evidence of disease who are at high risk for recurrence.
DiagnosisMelanoma in patients at high risk for recurrence
Histologically confirmed Stage IIIA, IIIB/C/D, or IV cutaneous melanoma that has been completely surgically resected within 12 weeks prior to randomization.
No ocular/uveal melanoma or mucosal melanoma.
No prior treatment
Patients must sign an approved informed consent and authorization permitting release of personal health information.
- Group 1: Patients in this group will receive bempegaldesleukin plus nivolumab every 3 weeks.
- Group 2: Patients in this group will receive nivolumab monotherapy every 4 weeks.
For more information, visit ClinicalTrials.gov