An Open-Label Phase 1b Clinical Study of Intravenous CAVATAK® (Coxsackievirus A21, CVA21), in Combination With Ipilimumab in Subjects With Uveal Melanoma Metastatic to Liver (VLA-024 CLEVER)
This is an open-label Phase 1b clinical study of ipilimumab in combination with intravenous CVA21 in subjects who have uveal melanoma metastatic to liver.
• Histologic or cytologically confirmed diagnosis of uveal melanoma with measurable disease (based on RECIST 1.1 criteria) in the liver (by CT, PET/CT or MRI) at the time of screening.
• Patients that have had prior treatment must show disease progression during or following the last treatment according to RECIST 1.1 criteria.
• Men and women ≥ 18 years of age.
• The subject has a life expectancy of greater than 12 weeks.
• The subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
• Adequate organ function as defined by and obtained within 28 days of starting treatment:
‣ Absolute neutrophil count ≥ 1,500 /mcl
⁃ WBC ≥ 3.0 x 10e9/L
⁃ Platelets ≥ 100,000 /mcl
⁃ Hemoglobin ≥ 9 g/dL
⁃ Creatinine ≤ 1.5 x ULN
⁃ Albumin \> 3 g/dL
⁃ Total bilirubin ≤ 1.5 x ULN or direct bilirubin ≤ ULN for subjects with total bilirubin \> 1.5 x ULN
⁃ AST and ALT ≤ 5 x ULN
⁃ INR or PT ≤ 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT and PTT are within therapeutic range of intended use of anticoagulants.
⁃ aPTT ≤ 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT and PTT are within therapeutic range of intended use of anticoagulants.
• Prior therapy with an immune checkpoint inhibitor therapy is allowable. A 6-week washout period will be required for those with prior PD-1 or PD-L1 treatment.
• Female subjects of child-bearing potential must have a negative urine pregnancy test within 72 hours prior to receiving the first dose of study medication. If a urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
• Female and Male subjects of childbearing potential must be willing to use an adequate method of contraception, starting with the first dose of study drug through 4 weeks after the last dose of study drug. Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
⁃ The subject is capable of understanding and complying with protocol requirements.
⁃ The subject or the subject's legally acceptable representative provides written, informed consent prior to the initiation of any study procedures.