- - Patients with unresectable stage III or stage IV cutaneous melanoma, as per American
Joint Committee on Cancer (AJCC) (Version 8) staging system (must have been
histologically confirmed at least once during course of disease).
metastatic tumor of unknown primary site and histology of melanoma are eligible.
- - Patients must be primary refractory or non-responding to anti-PD-1 therapy (either as
monotherapy or in combination with Ipilimumab)
- Measurable disease by computer tomography (CT) or Magnetic resonance imaging (MRI) per
immune-related response evaluation criteria in solid tumors (irRECIST) 1.1 criteria,
with longest diameter for non-nodal lesions ≥ 10 mm and ≥ 15 mm in short axis for
- At least one tumor site (either primary site or metastasis) must be accessible for
sequential biopsies and patient must consent to the 2 mandatory biopsies.
requirement is not applicable for continuous dosing schedules and may be waived by the
sponsor in other individual cases.
- Patients who achieved a CR or PR, during or after prior anti-PD-1 mono- or
anti-CTLA-4/anti-PD-1 combination therapy
- Patients with symptomatic brain metastases/central nervous system (CNS) involvement
- Patients with inadequate organ function
- Therapy with agents known to prolong the QT interval and increase the risk for
Torsades de Pointes