Focused Ultrasound and Pembrolizumab in Metastatic Breast Cancer

Phase 1

Terminated

• Conditions: Breast Cancer
• Interventions: Drug: Pembrolizumab; Device: High-intensity focused ultrasound (HIFU)

• Registration Number: NCT03237572
• Lead Sponsor: Patrick Dillon, MD

Brief Summary

This pilot study evaluates the use of high-intensity focused ultrasound (HIFU) combined with pembrolizumab in patients with metastatic breast cancer. One-half of participants will be randomized to receive the first dose of pembrolizumab after HIFU and one-half of participants will be randomized to receive their first dose of pembrolizumab before HIFU.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-07-31
• Study First Submitted QC: 2017-07-31
• Study First Posted: 2017-08-02
• Study Start: 2017-09-25
• Primary Completion: 2022-06-01
• Study Completion: 2022-06-17
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-07
• Last Update Posted: 2022-09-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm B: 1st dose of pembrolizumab before HIFU	High-intensity focused ultrasound (HIFU)	Pembrolizumab (200 mg) intravenously, days 1, 22, 43, 64, followed by day 1 of each ensuing 3 -week cycle. Focused ultrasound tumor ablation day 15. High-intensity focused ultrasound ablation will target 50% of the tumor, up to 3 cubic centimeters.
Arm A: 1st dose of pembrolizumab after HIFU	High-intensity focused ultrasound (HIFU)	Pembrolizumab (200 mg) administered intravenously, days 22, 43, 64, followed by day 1 of each ensuing 3 -week cycle. Focused ultrasound tumor ablation day 15. High-intensity focused ultrasound ablation will target 50% of the tumor, up to 3 cubic centimeters.
Arm A: 1st dose of pembrolizumab after HIFU	Pembrolizumab	Pembrolizumab (200 mg) administered intravenously, days 22, 43, 64, followed by day 1 of each ensuing 3 -week cycle. Focused ultrasound tumor ablation day 15. High-intensity focused ultrasound ablation will target 50% of the tumor, up to 3 cubic centimeters.
Arm B: 1st dose of pembrolizumab before HIFU	Pembrolizumab	Pembrolizumab (200 mg) intravenously, days 1, 22, 43, 64, followed by day 1 of each ensuing 3 -week cycle. Focused ultrasound tumor ablation day 15. High-intensity focused ultrasound ablation will target 50% of the tumor, up to 3 cubic centimeters.

Primary Outcome Measures

Name	Time	Method
Change in tumor infiltrating lymphocytes	baseline and week 4	Change in proportion of CD8+ tumor infiltrating lymphocytes (ration CD8+/CD4+) in the primary ablation zone

Secondary Outcome Measures

Name	Time	Method
Adverse event profile of pembrolizumab and HIFU	From date of randomization through 30 days following cessation of treatment	Toxicities from the combination of pembrolizumab and HIFU

Trial Locations

Locations (1)

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States