LITT and Pembrolizumab in Recurrent Brain Metastasis

Phase 1

Terminated

• Conditions: Renal Cell Carcinoma (RCC); Small-cell Lung Cancer; Microsatellite Instability-High Cancer; Gastric Cancer; Cervical Cancer; Primary Mediastinal Large B-Cell Lymphoma; Merkel Cell Carcinoma; Classical Hodgkin Lymphoma; Urothelial Carcinoma; Hepatocellular Carcinoma
• Interventions: Combination Product: LITT + Pembrolizumab

• Registration Number: NCT04187872
• Lead Sponsor: University of Florida

Brief Summary

This is an open-label, historically controlled pilot study investigating the immune effect of Laser Interstitial ThermotHerapy (LITT)+ pembrolizumab in adult patients with a primary cancer approved by the FDA for treatment with an immune-checkpoint inhibitor who have recurrent brain metastasis after prior stereotactic radiosurgery (SRS).

Detailed Description

Adult patients with a primary cancer approved by the FDA for treatment with an immune-checkpoint inhibitor who have recurrent brain metastasis that have failed stereotactic radiosurgery treatment will be screened. They will sign consent and complete screening procedures. Each patient will be scheduled to undergo biopsy and LITT treatment. Within two weeks of surgery, patients will begin receiving pembrolizumab every three weeks. Pembrolizumab infusions will continue until brain met recurrence per RANO for Brain Mets or up to two years, whichever comes first. Blood samples will be collected for immune monitoring. Tumor tissue will be collected for immune and genomic studies. Approximately 21 patients will be enrolled to accrue 15 evaluable subjects. Patients will be followed for survival data for one year or until death, whichever comes first.

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: 2019-12-03
• Study First Submitted QC: 2019-12-03
• Study First Posted: 2019-12-05
• Study Start: 2020-01-10
• Status Verified: 2023-12
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-01
• Last Update Submitted: 2023-12-20
• Last Update Posted: 2023-12-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with Recurrent Brain Metastes	LITT + Pembrolizumab	Adult patients with a primary cancer approved by the FDA for treatment with an immune-checkpoint inhibitor who have recurrent brain metastasis that have failed SRS treatment will receive LITT per standard of care in combination with Pembrolizumab 200mg IV every 3 weeks (+/-3 days) up to 2 years.

Primary Outcome Measures

Name	Time	Method
Immune Effect of LITT plus pembrolizumab	From first dose pembro through 30 days after administration of pembro	Immune profile of peripheral blood mononuclear cells (PBMCs) as measured by RNA sequencing; analysis will be performed through serial blood draws and will compare each analysis to the patient's baseline prior to treatment.

Secondary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]) of LITT plus pembrolizumab	From first dose pembro to 30 days post final pembro dose	Adverse events will be collected for each patient from the first dose of pembrolizumab until end of the study treatment.

Trial Locations

Locations (2)

McKnight Brain Institute of the University of Florida; 🇺🇸 Gainesville, Florida, United States

University of Florida Health; 🇺🇸 Jacksonville, Florida, United States