LITT and Pembrolizumab in Recurrent Brain Metastasis (TORCH)
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- STATUS
- Recruiting
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- End date
- Oct 19, 2025
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- participants needed
- 16
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- sponsor
- University of Florida
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).
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.
Details
| Condition | Melanoma, Non-small Cell Lung Carcinoma (NSCLC), Renal Cell Carcinoma (RCC), Small-cell Lung Cancer, Head and Neck Squamous Cell Cancer, Classical Hodgkin Lymphoma, Primary Mediastinal Large B-Cell Lymphoma, Urothelial Carcinoma, Microsatellite Instability-High Cancer, Gastric Cancer, Esophageal Cancer, Cervical Cancer, Hepatocellular Carcinoma, Merkel Cell Carcinoma, Brain Metastases, Adult |
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| Treatment | LITT + Pembrolizumab |
| Clinical Study Identifier | NCT04187872 |
| Sponsor | University of Florida |
| Last Modified on | 4 October 2022 |
Eligibility
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