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Nektar Therapeutics 20-214-29/CA045-022/PIVOT12

Trial Overview

Official Title

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)

Study Purpose

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.

Diagnosis

Melanoma in patients at high risk for recurrence

Eligibility

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.

Intervention

  • 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

Key Participation Requirements
Gender
Male or Female
Age
19 years and older
Enrollment Status
Recruiting
Phase
Phase III
Methodist Health System Trial Code
20-214-29/CA045-022/PIVOT12
Related Specialties