study to compare adjuvant immunotherapy of bempegaldesleukin combined with nivolumab versus nivolumab after complete resection of melanoma in patients at high risk for recurrence

Conditions: Melanoma; Melanoma Stage III; Melanoma Stage IV; Melanoma (Skin)

Summary: the main purpose of this study is to compare the efficacy of bempegaldesleukin plus nivolumab versus nivolumab in patients with completely resected stage iiia/b/c/d, or stage iv cutaneous melanoma who are at high risk for recurrence.

the main purpose of this study is to compare the efficacy, as measured by recurrence-free survival (rfs) by blinded independent central review (bicr), of bempegaldesleukin plus nivolumab versus nivolumab in patients with completely resected stage iiia (lymph node \[ln\] metastasis \> 1 mm), stage iiib/c/d, or stage iv (american joint committee on cancer \[ajcc\] 8th edition) cutaneous melanoma with no evidence of disease (ned) who are at high risk for recurrence.

Eligibility criteria:
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, countries, and/or institutional policies do not allow for patients \< 18 years of age (adolescents) to participate). in regions where adolescents are not allowed to participate in the study due to age restrictions, enrolled patients must be ≥ 18 years of age. * 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 available 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. exclusion criteria: * history of ocular/uveal melanoma or mucosal melanoma. * active, known or suspected autoimmune disease. patients with type i diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll. * conditions requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization. inhaled or topical steroids, and adrenal replacement steroid doses \> 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease. * prior therapy for melanoma except surgery for the melanoma lesion(s) and/or adjuvant radiation therapy for central nervous system lesions. * prior therapy with interferon, talimogene laherparepvec (imylgic®), interleukin-2 (il-2) directed therapy, anti-pd-1, anti-pd-l1, anti-pd-l2, anti-cd137, or anti-cytotoxic t lymphocyte-associated protein 4 antibody (including ipilimumab or any other antibody or drug specifically targeting t cell co-stimulation or checkpoint pathways). * prior malignancy active within the previous 3 years except for locally potentially curable cancers that have been apparently cured.

Keywords: cd122-biased agonist cd122-biased cytokine il-2 receptor agonist nktr-214 bempegaldesleukin il-2 immunotherapy bempeg nivolumab opdivo® nivo adjuvant skin cancer resectable melanoma high risk of recurrence melanoma post resection checkpoint inhibitor