- LITT and Pembrolizumab in Recurrent Brain Metastasis (TORCH)
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.Location: University of Florida, Gainesville, Fla.
- Laser Interstitial Thermotherapy (LITT) Combined With Checkpoint Inhibitor for Recurrent GBM (rGBM)
The purpose of this study is to test the side effects and efficacy of using Laser Interstitial Thermotherapy (LITT) combined with Pembrolizumab. LITT is a minimally invasive surgical technique that uses a laser to heat brain tumors.Pembrolizumab is an investigational (experimental) drug that works by helping participants’ immune system work correctly to detect and fight cancer cells. Pembrolizumab is experimental because it is not approved by the Food and Drug Administration (FDA), for this use, though it is approved to treat other cancers.
Primary Outcome Measures
A. Phase I endpoint: Optimal timing of LITT with pembrolizumab [ Time Frame: Up to 24 months after beginning Pembrolizumab ]
Optimal timing of LITT with pembrolizumab
B. Phase II endpoint: Tumor Response [ Time Frame: Up to 24 months after beginning Pembrolizumab ]
Response rates for the Phase II component will be calculated and compared to historical controls using chi-square tests or Fishers exact tests.
Secondary Outcome Measures
A. Progression free survival (PFS) [ Time Frame: Up to 24 months after beginning Pembrolizumab ]
PFS, defined as time from diagnosis to documented progression
B. Overall survival (OS) [ Time Frame: Up to 24 months after beginning Pembrolizumab ]
OS, defined as time from diagnosis to death
C. The proportion of patients who achieve progression free survival at 6 months (PFS6) [ Time Frame: Up to 6 months after diagnosis ]
PFS6, Proportion of patients who do not progress at 6 months
D. The proportion of patients who achieve progression free survival at 12 months (PFS12) [ Time Frame: Up to 12 months after diagnosis ]
PFS12, Proportion of patients who do not progress at 12 months
E. The proportion of patients who achieve progression free survival at 24 months (PFS24) [ Time Frame: Up to 24 months after diagnosis ]
PFS24, Proportion of patients who do not progress at 24 months
Location: University Hospitals, Cleveland, Ohio