Optune Device - TT Field Plus Nivolumab and Ipilimumab for Melanoma With Brain Metastasis

  • STATUS
    Recruiting
  • End date
    Jul 31, 2027
  • participants needed
    23
  • sponsor
    Washington University School of Medicine
Updated on 25 January 2021

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.

Details
Condition Melanoma With Brain Metastasis
Treatment Ipilimumab, Nivolumab, Optune
Clinical Study IdentifierNCT03903640
SponsorWashington University School of Medicine
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

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, Sjgren'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
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