LITT and Pembrolizumab in Recurrent Brain Metastasis (TORCH)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04187872|
Recruitment Status : Recruiting
First Posted : December 5, 2019
Last Update Posted : September 16, 2020
|Condition or disease||Intervention/treatment||Phase|
|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||Combination Product: LITT + Pembrolizumab||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Recurrent Brain Metastasis Immune Effects and RespOnse to Laser Interstitial ThermotHerapy (LITT) and Pembrolizumab in Combination (TORCH)|
|Actual Study Start Date :||January 10, 2020|
|Estimated Primary Completion Date :||January 2022|
|Estimated Study Completion Date :||October 2023|
Experimental: Patients with Recurrent Brain Metastes
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 SRS treatment will receive LITT per standard of care in combination with Pembrolizumab 200mg IV every 3 weeks (+/-3 days) up to 2 years.
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.
- Immune Effect of LITT plus pembrolizumab [ Time Frame: From first dose pembro through 30 days after administration of pembro ]Immune profile of peripheral blood mononuclear cells (PBMCs) as measured by RNA sequencing; analysis will be performed through serial blood draws and will compare each analysis to the patient's baseline prior to treatment.
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]) of LITT plus pembrolizumab [ Time Frame: From first dose pembro to 30 days post final pembro dose ]Adverse events will be collected for each patient from the first dose of pembrolizumab until end of the study treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04187872
|Contact: Annie Allen||352-294-8836||Anne.Allen@neurosurgery.ufl.edu|
|United States, Florida|
|McKnight Brain Institute of the University of Florida||Recruiting|
|Gainesville, Florida, United States, 32611|
|Principal Investigator:||Maryam Rahman, MD||University of Florida|
|Principal Investigator:||David Tran, PhD||University of Florida|