LITT and Pembrolizumab in Recurrent Brain Metastasis

Inclusion Criteria

• •1. Histologic confirmation of primary cancer approved by the FDA for treatment with an immune-checkpoint inhibitor
• •2. 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.
• •3. KPS ≥ 70.
• •4. 18 years or older.
• •5. Adequate bone marrow and organ function as defined below:
• •1. ANC ≥ 1,500/mcL
• •2. Platelets ≥ 100,000/mcL
• •3. Hemoglobin ≥ 9 g/dL or ≥ 5.6 mmol/L (transfusion is allowed)
• •4. Serum creatinine ≤ 1.5 x IULN OR creatinine clearance by Cockcroft-Gault ≥ 60 mL/min for patients with serum creatinine \> 1.5 x IULN
• •5. 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
• •6. Candidate for pembrolizumab treatment.
• •7. Candidate for LITT treatment:
• •1. Metastatic lesions individually measuring 3.5 cm or less
• •2. Only lesions that are growing or new will be treated with LITT
• •3. Five (5) or less target metastatic lesions that are new or growing
• •4. Lesions accessible with a laser probe as determined by the neurosurgeon performing the procedure
• •5. Patient able to undergo MRI scans (no incompatible MRI hardware, etc.)
• •8. A diagnostic contrast-enhanced MRI of the brain must be performed preoperatively, within 30 days prior to study enrollment.
• •9. Participants of childbearing age must use effective contraception:
• •a) Women of childbearing potential (WOCBP) must be using a highly effective method of contraception to avoid pregnancy throughout the study and for at least 24 weeks after the last dose of study drug to minimize the risk of pregnancy. Prior to study enrollment, women of childbearing potential must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy. Refer to Section 9.3 for guidance on highly effective contraceptive methods.
• •i) WOCBP include any woman who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or oophorectomy) or who is not post-menopausal. Post-menopause is defined as:
• •(1) Amenorrhea that has lasted for ≥ 12 consecutive months without another cause, or (2) For women with irregular menstrual periods who are taking hormone replacement therapy (HRT), a documented serum follicle-stimulating hormone (FSH) level of greater than 35 mIU/mL.
• •b) Males with female partners of childbearing potential must agree to use physician-approved contraceptive methods (e.g., abstinence, condoms, vasectomy) throughout the study and should avoid conceiving children for 24 weeks following the last dose of study drug.
• •10\. Ability of the patient to understand and willingness to sign an IRB approved written informed consent document.
• •11\. Steroid dose equivalent to dexamethasone dose of ≤ 6mg daily at the time of enrollment.