Focused Ultrasound + Immunotherapy for Brain Cancer

Recruiting in Palo Alto (17 mi)

+7 other locations

Overseen byManmeet Ahluwalia, MD, MBA

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: InSightec

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the safety and efficacy of targeted blood brain barrier disruption with Exablate Model 4000 Type 2.0/2.1 for the treatment of NSCLC brain metastases in patients who are undergoing planned pembrolizumab monotherapy.

Eligibility Criteria

Adults with non-small cell lung cancer (NSCLC) brain metastases, not pregnant, willing to use contraception and comply with study procedures. Must have EGFR/ALK-negative tumors, measurable untreated brain metastasis accessible by MRI, good performance status (Karnofsky ≥70% or ECOG 0-2), and prescribed pembrolizumab. Excludes those with bleeding risks, certain infections like hepatitis/HIV/TB, severe medical disorders, known allergies to trial substances, contraindications to MRI/gadolinium-DTPA or pembrolizumab.

Inclusion Criteria

I am not pregnant and will use effective birth control during and 4 months after the study.

Participant is willing to comply with all study procedures for the duration of the study

I can take care of myself and perform normal activities.

See 6 more

Exclusion Criteria

I am allergic or cannot take pembrolizumab due to severe reactions.

I have not received a live vaccine in the last 28 days.

I have an autoimmune disease treated in the last 2 years or currently have pneumonitis.

See 20 more

Treatment Details

Interventions

Exablate Model 4000 Type 2.0/2.1 (Focused Ultrasound)
Pembrolizumab (Monoclonal Antibodies)

Trial OverviewThe trial is testing the safety and effectiveness of disrupting the blood-brain barrier using Exablate Focused Ultrasound in combination with standard pembrolizumab therapy for treating NSCLC brain metastases. The goal is to see if this approach can improve treatment outcomes.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Pembrolizumab with Exablate BBBDExperimental Treatment2 Interventions

Using Exablate Model 4000 Type 2 for the treatment of NSCLC brain metastases in subjects who are undergoing planned pembrolizumab monotherapy.

Group II: Control Arm (Pembrolizumab only)Active Control1 Intervention

subjects will undergo planned pembrolizumab monotherapy.

Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:

🇺🇸 Approved in United States as KEYTRUDA for: