Study of the Effectiveness and Safety of Acasunlimab Alone or With Pembrolizumab in treating Advanced Melanoma of the Skin That Has Returned After or did not respond to Cancer Immunotherapy (ABBIL1TY MELANOMA-07)

Other illness

• Subjects with newly identified or known unstable or symptomatic central nervous system metastases or history of carcinomatous meningitis.

Other

• Subjects with non-cutaneous or acral melanoma.

• Subjects ≥ 18 years of age with histologically or cytologically confirmed diagnosis of relapsed/refractory, locally advanced unresectable (Stage IIIB, IIIC, or IIID) or metastatic (Stage IV) cutaneous melanoma.
• Subject must have radiographic progression on or following ≥ 1 prior systemic therapy according to local and international guidelines, including a programmed cell death protein 1 blocking antibody (anti-PD-1) treatment or combination treatment containing an anti-PD-1.
• Subject must have received a minimum of 2 cycles of an approved anti PD-1 as monotherapy or combination therapy, containing an anti-PD-1.
• Neoadjuvant and/or adjuvant systemic therapy count as the first line of prior systemic therapy if there is documented disease progression ≤ 6 months after completion of therapy.
• Subjects with a BRAF V600 mutation should have received prior BRAF-directed therapy (with or without a MEK inhibitor) prior to enrollment in the study, unless deemed not clinically indicated by the Investigator due to concurrent medical condition or prior toxicity.
• Subject has an Eastern Cooperative Oncology Group performance status of 0 or 1 within 7 days prior to Cycle 1 Day 1.