Phase 3 randomized study for high risk recurrence Melanoma

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)

  • Clinical Trial Information

    Trial Contact: Frankos, Marie; Donaldson, Karin M; Grofsik, Kiera; Caldwell, Chloe M

  • IRB No: S20.157.09

    Protocol Abbrev: PIVOT-12

    Principal Investigator: Sajeve Samuel Thomas, MD

    Phase: Drug: Phase III

    Age Group: Adult

    Secondary Protocol No: 20-214-29/CA045-022

    Treatment: Biological: Bempegaldesleukin Biological: Nivolumab

    Therapies Involved: Oncology: Adjuvant ID: NCT04410445

  • Objective

    The primary objective is to compare the efficacy, as measured by RFS by BICR, of bempegaldesleukin plus nivolumab versus nivolumab in patients with completely resected Stage IIIA (LN metastasis > 1 mm), Stage IIIB/C/D, or Stage IV (AJCC 8th edition) cutaneous melanoma with NED who are at high risk for recurrence

  • Key Eligibility

    Inclusion Criteria:
    •  Male or female patients, age 12 years or older at the time of signing the informed consent form (age 18 years or older where local regulations or institutional policies do not allow for patients < 18 years of age to participate).
    •  Histologically confirmed Stage IIIA (LN metastasis > 1 mm), IIIB/C/D, or IV (M1a/b/c/d) cutaneous melanoma by AJCC (8th edition) at study entry that has been completely surgically resected within 12 weeks prior to randomization.
    •  Tumor tissue from biopsy or resected disease must be provided to central laboratory for PD-L1 status analysis. Must have PD-L1 expression classification for stratification purposes.
    •  Disease-free status documented by a complete physical examination and imaging studies within 28 days prior to randomization.