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LITT and Pembrolizumab in Recurrent Brain Metastasis — TORCH  

Hepatocellular Carcinoma Clinical Trial

Official title:
Recurrent Brain Metastasis Immune Effects and RespOnse to Laser Interstitial ThermotHerapy (LITT) and Pembrolizumab in Combination (TORCH)

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

  • Brain Metastases, Adult
  • Brain Neoplasms
  • Carcinoma
  • Carcinoma, Merkel Cell
  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma, Squamous Cell
  • Cervical Cancer
  • Classical Hodgkin Lymphoma
  • Esophageal Cancer
  • Gastric Cancer
  • Head and Neck Squamous Cell Cancer
  • Hepatocellular Carcinoma
  • Lymphoma
  • Melanoma
  • Merkel Cell Carcinoma
  • Microsatellite Instability
  • Microsatellite Instability-High Cancer
  • Neoplasm Metastasis
  • Neoplasms, Squamous Cell
  • Non-small Cell Lung Carcinoma (NSCLC)
  • Primary Mediastinal Large B-Cell Lymphoma
  • Renal Cell Carcinoma (RCC)
  • Small Cell Lung Carcinoma
  • Small-cell Lung Cancer
  • Urothelial Carcinoma
Clinical Trial Details
NCT number NCT04187872
Study type Interventional
Source University of Florida
Contact
Status Terminated
Phase Phase 1
Start date January 10, 2020
Completion date December 1, 2023
View Details
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