Clinical trial NCT03153085 (phase 2, status: completed)
Conditions: melanoma stage iii, melanoma stage iv
ICD codes: C43.0, C43.31, D03.9, C43.51, C43.9, D03.0, C43.4, C43.0, C43.31, D03.9, C43.51, C43.9, D03.0, C43.4
Drugs: ipilimumab
SMILES: COC1=CC=CC=C1OCC(O)CO
Eligibility criteria:

        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
             document.

        Exclusion Criteria:

          -  Patients who were previously treated with ipilimumab by intravenous infusion.

          -  Patients receiving chemotherapy or molecularly targeted drug or anti-PD-1 antibody
             treatment or radiotherapy or immunotherapy within 4 weeks prior to initiating study
             treatment.

          -  Patients with a history of Grade 4 adverse events caused by chemotherapy, molecularly
             targeted drug, anti-PD-1 antibody treatment, radiotherapy or immunotherapy conducted
             more than 4 weeks prior to TBI-1401(HF10) treatment, or presence of such adverse
             events of Grade 2 or greater, except alopecia and adverse events controlled by a
             treatment.

          -  Patients receiving anti-herpes medication within 1 week prior to initiating
             TBI-1401(HF10) administration, except local treatment such as ointment.

          -  Patients with a history of significant tumor bleeding, or coagulation or bleeding
             disorders.

          -  Patients with target tumors that could potentially invade a major vascular structure
             (e.g., innominate artery, carotid artery), based on unequivocal imaging findings.

          -  Patients with Grade 2 or greater neurologic abnormalities (CTCAE version 4.0),
             including Grade 2 or greater peripheral neuropathy caused by previous treatments.

          -  Patients with clinically evident Human Immunodeficiency Virus (HIV), Hepatitis B Virus
             (HBV), Hepatitis C virus (HCV), or Epstein-Barr virus (EBV) infection.

          -  Patients requiring systemic glucocorticoid (except 10 mg/day/body prednisolone or
             less) or immunosuppressive therapy because of the presence or history of autoimmune
             disease (e.g., Crohn's disease, ulcerative colitis) or other diseases.

          -  Concurrent use of any other investigational agents within 4 weeks prior to initiating
             study treatment.

          -  Patients with active CNS metastases or carcinomatous meningitis, except patients with
             CNS lesions that have been treated and have no evidence of progression in the brain on
             CT/MRI for ≥ 3 months.

          -  Pregnant or breastfeeding women (excluding the case in which breastfeeding is
             discontinued and will not resume it); women desiring to become pregnant within the
             timeframe of the study are also excluded.

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             study requirements, as determined by the investigator.