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A Phase II Study of High Dose Bolus IL2 in Combination with Low Dose Ipilimumab Followed Sequentially by Nivolumab in Patients with Inoperable Stage III or Stage IV Melanoma Who Have Failed Prior Anti-PD1 Immunotherapy
This is a Phase II study of high dose bolus interleukin-2 (HD IL2) in combination with low dose ipilimumab followed sequentially by nivolumab in patients with advanced inoperable stage III or stage IV melanoma who have failed prior anti-PD1 immunotherapy.
Primary Objective: To determine the response rate (CR+PR) of HD IL2 plus low dose ipilimumab followed sequentially by nivolumab in patients with inoperable stage III or stage IV melanoma who have either failed prior treatment with anti-PD1 immunotherapy (nivolumab or pembrolizumab) or who have demonstrated tumor progression following such therapy. Secondary Objectives: (1) Evaluate the toxicities of the combination in this patient population (CTCAE v.5). (2) Evaluate the progression free survival (PFS) and overall survival (OS). (3) Bank biological specimens for the future testing of laboratory correlative studies within the circulation and the tumor microenvironment (TME) to better understand the impact of HD IL2 in combination with immune checkpoint inhibitors in this setting.
Aldesleukin (Interleukin-2); BMS-936558 (Nivolumab); IL-2 (Interleukin-2); Interleukin-2 (); Ipilimumab (); Nivolumab (Opdivo); Proleukin (Interleukin-2); Yervoy (Ipilimumab)
> Histologically or cytologically confirmed metastatic melanoma. This includes American Joint Committee on Cancer (AJCC) stage IV or advanced/inoperable stage III. This also includes patients with a history of lower stage melanoma and subsequent recurrent metastatic disease that is either locally/regionally advanced/inoperable disease or distant metastases
> Patients who have had systemic therapy for melanoma or radiotherapy within 3 weeks prior to registering on the study or those who have not recovered from adverse events due to agents administered more than 3 weeks earlier. Patients with a history of endocrinopathies (e.g. hypothyroidism, adrenal insufficiency, hypopituitarism) are eligible if they are stable on hormone replacement therapy.