Blood-brain Barrier (BBB) Opening Using Exablate Focused Ultrasound With Standard of Care Treatment of NSCLC Brain Mets
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-100
SponsorInSightec
About this trial
The purpose of this study is to evaluate the safety and efficacy of targeted blood brain barrier opening with Exablate Model 4000 Type 2.0/2.1 for the treatment of NSCLC brain metastases in patients who are undergoing planned FDA approved, on-label systemic therapy utilizing immune checkpoint inhibitors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participant is ≥ 18 years of age
The participant provides written informed consent for the trial
Participant is willing to comply with all study procedures for the duration of the study
Participant has a Karnofsky Performance Status ≥ 70% and/or ECOG 0-2
Disqualifiers
Participant has evidence of acute intracranial hemorrhage
Participant at risk for spontaneous intracranial hemorrhage (e.g., history of metastatic melanoma or other tissue histology).
Participant has signs and symptoms of increased intracranial pressure or symptomatic mass effect, midline shift or evidence of subfalcine, uncal or tonsillar herniation.
Participant receiving Bevacizumab (Avastin) therapy, or other drugs with a proclivity for causing bleeding.
Trial design
Design model
Parallel
Treatments tested in this trial
Blood Brain Barrier Opening - Oncology
DeviceBBB opening via Exablate Type 2 system with microbubble resonators on the day of ICI infusion to treat brain metastases.
Pembrolizumab
DrugPembrolizumab infusion
Atezolizumab
DrugAtezolizumab infusion
Cemiplimab
DrugCemiplimab infusion
Nivolumab
DrugNivolumab infusion
Iptilimumab
DrugIptilimumab infusion
Treatment groups
96 Participants
are divided into 2 treatment groupsGroup A: ICI Systemic Therapy with Exablate BBBOExperimental treatment 6 interventions
Group B: Control Arm (ICI Systemic Therapy on-label use only)Active comparator 5 interventions
Trial outcomes
Primary outcomes
1
Adverse events
Adverse events \[ Time Frame: Through study completion, up to 6 months\]. All adverse events and/or Serious Adverse Events will be documented and reported according to CTCAE criteria.
Time frame
up to 6 months2
tumor lesion(s) on the MRI images
Efficacy will be determined by the response of the tumor lesion(s) compared to baseline. Tumor lesions on the MRI images (units: mm) will be measured every three weeks up to six months.
Time frame
up to 6 monthsSecondary outcomes
1
evaluation of Neuro Oncology Brain Mets (RANO-BM) response
The evaluation of the percentages of subjects that achieved the stable disease (SD), partial response (PR) as the best objective response using the response assessment in Neuro Oncology Brain Mets (RANO-BM) response criteria measured at baseline and every 3 weeks during each treatment cycle to up to 6 months of therapy.
Time frame
up to 6 months2
Time to response for brain metastases by treatment arm [applicable to the completed stage 1a only]
The time to achieve a confirmed complete response or partial response for brain metastases by treatment arm as assessed using the RANO-BM criteria evaluated every 3 weeks up to 6 months during treatment cycles.
Time frame
up to 6 monthsOther outcomes
1
Patient reported quality of life measurement questionnaires
patient reported health and quality of life questionnaire completed every 3 weeks up to 6 months during treatment cycle.
Time frame
up to 6 months2
Measurement of BBB Opening
Measurement of blood brain barrier opening (BBBO) assessment of post-sonication contrast-enhanced MR imaging evaluated every 3 weeks up to 6 months in comparison with pre-sonication imaging.
Time frame
up to 6 months Source ClinicalTrials.gov