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)

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
  • Age: Between 18 - 100 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1) Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (= 17 years of age)/Lansky Performance Score = 80% (12 to 16 years of age, inclusive). 2) 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 (8th edition) at study entry that has been completely surgically resected within 12 weeks prior to randomization.

You may not be eligible for this study if the following are true:

  • 1) Use of an investigational agent or an investigational device within 28 days before randomization. 2) Female patients who are pregnant or lactating, who plan to get pregnant, or who have a positive serum or urine pregnancy test. 3) History of ocular/uveal melanoma or mucosal melanoma. 4) Active, known or suspected autoimmune disease. Patients with Type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.

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