NCT04187872

LITT and Pembrolizumab in Recurrent Brain Metastasis

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• 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

Interventions

Type	Name	Description
COMBINATION_PRODUCT	LITT + Pembrolizumab	Each patient will undergo brain biopsy and laser interstitial thermotherapy (LITT). As soon as possible, no later than two weeks after LITT, pembrolizumab will be administered via infusion and continue q3wks for up to two years.

Timeline

• Start date: 2020-01-10
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2019-12-05
• Last updated: 2023-12-27

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study