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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2
-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
Washington University School of Medicine
St Louis, Missouri, United States
Intracranial Progression-free Survival
* The PFS time will be calculated as the duration of time from the date of first dose of study treatment to the date of earliest intracranial progression or death, whichever occurs first. * Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).
Time frame: At 6 months (up to 184 days)
Overall Survival
-Defined as the duration of time from the date of first dose of study treatment to death from any cause.
Time frame: At 6 months (up to 184 days)
Best Intracranial Response Rate
* Defined as the percentage of patients with a confirmed intracranial complete or partial response * Using modified RANO criteria
Time frame: Until disease progression or death whichever comes first (median follow-up 53 days (full range 15-91 days))
Best Extracranial Response Rate
* Defined as the percentage of patients with a confirmed extracranial complete or partial response * Using modified RANO criteria
Time frame: Until disease progression or death whichever comes first (median follow-up 53 days (full range 15-91 days))
Extracranial Progression-free Survival
* Defined as the duration of time from the date of first dose of study treatment to the date of earliest extracranial progression or death, whichever occurs first. Patients who neither progress nor die by the data cutoff date will be censored at the last follow up. * Using modified RANO criteria
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Time frame: At 6 months
Safety of the Treatment Regimen as Measured by Number of Participants With Treatment-related Grade 3 or Greater Adverse Events
-The descriptions and grading scales found in CTCAE version 5.0.
Time frame: Through 100 days after completion of treatment (median follow-up 107.5 days, full range (25 days-190 days)
Safety of the Treatment Regimen as Measured by Number of Participants With Discontinuations Due to Treatment Related Adverse Events.
-The descriptions and grading scales found in CTCAE version 5.0.
Time frame: Through 100 days after completion of treatment (median follow-up 107.5 days, full range (25 days-190 days)