Optune Device - TT Field Plus Nivolumab and Ipilimumab for Melanoma With Brain Metastasis
Condition: Melanoma With Brain Metastasis
MeSH terms: Melanoma; Neoplasm Metastasis; Brain Neoplasms
Intervention: Optune; Nivolumab; Ipilimumab
Intervention description: -Optune is programmed by Novocure to deliver 200 kHz TTFields in two sequential, perpendicular field directions at a maximal intensity of 707mARMS.; -Standard of care; -Standard of care
Intervention MeSH terms: Nivolumab; Ipilimumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II study will evaluate the safety of combining intermediate frequency electric
      field (TT Field) with immunotherapy in melanoma patients with brain metastasis. The data of
      this study will also inform whether this combination will offer advantage in progression free
      survival (PFS) and overall survival.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed melanoma with metastasis to the brain.

          -  Measurable disease defined as lesions that can be accurately measured in at least one
             dimension (longest diameter to be recorded) as ≥ 10 mm with CT scan or MRI, as ≥ 20 mm
             by chest x-ray, or ≥ 10 mm with calipers by clinical exam.

          -  Candidate for treatment with immunotherapy.

          -  At least 18 years of age.

          -  Normal bone marrow and organ function as defined below:

               -  Absolute neutrophil count ≥ 1,500/mcl

               -  Platelets ≥ 100,000/mcl

               -  Total bilirubin ≤ 1.5 x IULN

               -  AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN

               -  Creatinine ≤ IULN OR creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with
                  creatinine levels above institutional normal

          -  Women of childbearing potential and men must agree to use adequate contraception
             (hormonal or barrier method of birth control, abstinence) prior to study entry and for
             the duration of study participation, including at least 5 months (for women of
             childbearing potential) and at least 7 months (for men) after last dose of study drug.
             Should a woman become pregnant or suspect she is pregnant while participating in this
             study, she must inform her treating physician immediately.

          -  Ability to understand and willingness to sign an IRB approved written informed consent
             document (or that of legally authorized representative, if applicable).

        Exclusion Criteria:

          -  Received treatment in the metastatic setting

          -  Treated with whole brain radiation Receiving targeted therapy or on immunosuppressive
             agents (dexamethasone> 4mg/day) within 1 week of therapy.

          -  A history of other malignancy ≤ 5 years previous with the exception of basal cell or
             squamous cell carcinoma of the skin which were treated with local resection only or
             carcinoma in situ of the cervix.

          -  Currently receiving any other investigational agents.

          -  A history of allergic reactions attributed to compounds of similar chemical or
             biologic composition to nivolumab, ipilimumab, or other agents used in the study.

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac
             arrhythmia.

          -  History of pre-existing immunodeficiency disorder or autoimmune condition requiring
             immunosuppressive therapy. This includes inflammatory bowel disease, ulcerative
             colitis, Crohn's disease, systemic vasculitis, scleroderma, psoriasis, multiple
             sclerosis, hemolytic anemia, immune-mediated thrombocytopenia, rheumatoid arthritis,
             systemic lupus erythematosus, Sjögren's syndrome, sarcoidosis, or other rheumatologic
             disease or any other medical condition or use of medication which might make it
             difficult for the patient to complete the full course of treatments or to generate an
             immune response to vaccines.

          -  Known sensitivity to conductive hydrogels.

          -  Skull defects such as missing bone or bullet fragments.

          -  Implanted pacemaker, programmable shunts, defibrillator, deep brain stimulator, vagus
             nerve stimulator, and other implanted electronic devices in the brain or spinal cord.

          -  Pregnant and/or breastfeeding. Women of childbearing potential must have a negative
             pregnancy test within 14 days of study entry.

          -  Known HIV-positivity on combination antiretroviral therapy because of the potential
             for pharmacokinetic interactions with nivolumab and/or ipilimumab. In addition, these
             patients are at increased risk of lethal infections when treated with
             marrow-suppressive therapy. Appropriate studies will be undertaken in patients
             receiving combination antiretroviral therapy when indicated.