A Study of Combination with TBI-1401(HF10) and Ipilimumab in Japanese Patients with Unresectable or Metastatic Melanoma

Inclusion Criteria: * Patients with histologically confirmed Stage IIIB, IIIC or IV unresectable or metastatic melanoma except uveal melanoma, who must have a history of treatment (chemotherapy, molecular targeted therapy, or anti PD-1 antibody therapy). * Patients must have measurable non-visceral lesion(s) that are evaluable by the modified World Health Organization (mWHO) criteria and immune-related response criteria (irRC). * Patients must be ≥ 20 years of age. * Patients must have a life expectancy ≥ 24 weeks. * Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. * Patients must have adequate organ function, defined as * Total bilirubin levels ≤ 1.5 x upper limit of normal \[ULN\] (except for patients with Gilbert's Syndrome, who must have a total bilirubin of less than 3.0 mg/dL) * AST/ALT levels ≤ 2.5 x ULN, or ≤ 5 x ULN if liver metastases are present. * Creatinine ≤ 1.5 x ULN or creatinine clearance (calculated) ≥ 60 mL/min/1.73 m\^2 for patients with creatinine \> 1.5 x ULN. * Absolute neutrophil count ≥1,500/µL and * Platelet count ≥ 75,000/ µL * Men and women of childbearing potential must agree to use adequate contraception from the time of consent through 30 days after final study treatment. * Females of childbearing potential must have a negative urine or serum pregnancy test within 1 week prior to start of treatment. * Patients must be able to understand and willing to sign a written informed consent do…