LITT and Pembrolizumab in Recurrent Brain Metastasis
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 15
Summary
- Conditions
- Cervical Cancer
- Brain Metastases, Adult
- Classical Hodgkin Lymphoma
- Primary Mediastinal Large B Cell Lymphoma
- Esophageal Cancer
- Gastric Cancer
- Head and Neck Squamous Cell Cancer
- Urothelial Carcinoma
- Hepatocellular Carcinoma
- Melanoma
- Merkel Cell Carcinoma
- Microsatellite Instability-High Cancer
- Small Cell Lung Cancer
- Non Small Cell Lung Carcinoma NSCLC
- Renal Cell Carcinoma (RCC)
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 100 years
- Gender
- Both males and females
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 schedul...
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.
Tracking Information
- NCT #
- NCT04187872
- Collaborators
- Monteris Medical
- Investigators
- Principal Investigator: Maryam Rahman, MD University of Florida Principal Investigator: David Tran, PhD University of Florida
Get Well Soon