Study Stopped
Sponsor terminated
LITT and Pembrolizumab in Recurrent Brain Metastasis
TORCH
Recurrent Brain Metastasis Immune Effects and RespOnse to Laser Interstitial ThermotHerapy (LITT) and Pembrolizumab in Combination (TORCH)
2 other identifiers
interventional
10
1 country
2
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jan 2020
Longer than P75 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 3, 2019
CompletedFirst Posted
Study publicly available on registry
December 5, 2019
CompletedStudy Start
First participant enrolled
January 10, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedDecember 27, 2023
December 1, 2023
3.9 years
December 3, 2019
December 20, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Immune Effect of LITT plus pembrolizumab
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.
From first dose pembro through 30 days after administration of pembro
Secondary Outcomes (1)
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]) of LITT plus pembrolizumab
From first dose pembro to 30 days post final pembro dose
Study Arms (1)
Patients with Recurrent Brain Metastes
EXPERIMENTALAdult 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Histologic confirmation of primary cancer approved by the FDA for treatment with an immune-checkpoint inhibitor
- At least one metastatic lesion has had prior SRS. Each patient's scan must be reviewed by a neurosurgeon or radiation oncologist prior to enrollment.
- KPS ≥ 70.
- years or older.
- Adequate bone marrow and organ function as defined below:
- ANC ≥ 1,500/mcL
- Platelets ≥ 100,000/mcL
- Hemoglobin ≥ 9 g/dL or ≥ 5.6 mmol/L (transfusion is allowed)
- Serum creatinine ≤ 1.5 x IULN OR creatinine clearance by Cockcroft-Gault ≥ 60 mL/min for patients with serum creatinine \> 1.5 x IULN
- Serum total bilirubin ≤ 1.5 x IULN OR direct bilirubin ≤ IULN for patients with total bilirubin
- i) 1.5 x IULN f) AST (SGOT) and ALT (SGPT) ≤ 3 x IULN
- Candidate for pembrolizumab treatment.
- Candidate for LITT treatment:
- Metastatic lesions individually measuring 3.5 cm or less
- Only lesions that are growing or new will be treated with LITT
- +11 more criteria
You may not qualify if:
- Actively participating in another clinical trial on active study treatment; follow-up or observational status is acceptable if more than 2 weeks since last study treatment.
- History of immunodeficiency or is receiving any form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment (with the exception of daily dexamethasone ≤ 6 mg).
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection that will no resolve prior to delivery of treatment (LITT), symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled hypertension, or psychiatric illness/social situations that would limit compliance with study requirements.
- History of active autoimmune disease requiring systemic treatment within the past 2 years (i.e. with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. (Note that prior autoimmune diseases at Grade 1 or 2 per CTCAE v. 4.0 - in the last 2 years that were deemed related to prior use of immunotherapy, will be allowed under this protocol, provided that continuation or subsequent resumption of immunotherapy, regardless of whether systemic treatment had been given, did not result in worsening of signs and symptoms of the aforementioned autoimmune diseases).
- Pneumonitis within the past 3 years (Note that patients with a history of pneumonitis in the past 3 years that was not aggravated by immunotherapy including immune checkpoint inhibitors or that has clinically resolved or improved and has not recurred or progressed clinically with subsequent immunotherapy including immune checkpoint inhibitors are eligible to participate in the study).
- Pregnant and/or breastfeeding. Women of childbearing potential must have a negative serum or urine pregnancy test at screening.
- Females or males of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 24 weeks after the last dose of study drug.
- Known active hepatitis B (e.g., HBsAg reactive) or hepatitis C (e.g., HCV RNA \[qualitative\] is detected) infection.
- Known history of active TB (bacillus tuberculosis).
- Known history of HIV (HIV 1/2 antibodies).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Floridalead
- Monteris Medicalcollaborator
Study Sites (2)
McKnight Brain Institute of the University of Florida
Gainesville, Florida, 32611, United States
University of Florida Health
Jacksonville, Florida, 32209, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maryam Rahman, MD
University of Florida
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 3, 2019
First Posted
December 5, 2019
Study Start
January 10, 2020
Primary Completion
December 1, 2023
Study Completion
December 1, 2023
Last Updated
December 27, 2023
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will not share