Neoadj Admin Autologous Tumor Infiltrating Lymphocytes & Pembrolizumab for Treatment of Adv Melanoma Patients

Inclusion Criteria

• •Patient must be 18 to 75 years of age
• •Must have a confirmed diagnosis of Stage IIIB-D locally advanced or Stage IV melanoma (American Joint Committee on Cancer \[AJCC\] 8th edition) with measurable disease in the lymph node(s) documented by computed tomography (CT) or ultrasound imaging (\>= 15 mm short axis) or by physical exam. Patients must also have measurable primary site of disease, including cutaneous and/or intransit metastases by imRECIST (\>= 20 mm chest x-ray \[CXR\], \>= 10 mm CT, or \>= 10 mm by exam)
• •No prior therapy is allowed
• •Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and an estimated life expectancy of \>= 3 months in the opinion of the investigator
• •Patients must have at least one easily accessible measurable tumor-involved lymph node(s) documented by CT or ultrasound imaging for TIL harvest
• •Patients must be amenable to have ultrasound examination of measurable lymph node(s) and have pathologic confirmation of melanoma metastases in the lymph node (fine needle aspiration \[FNA\] acceptable) in the 28 days preceding the first administration of the treatment
• •Patients with and without BRAF V600E/K mutations are included.
• •Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
• •Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.
• •Patients with a history of herpes simplex virus (HSV) infection must have been treated. Patients with a history of Epstein-Barr virus (EBV) or cytomegalovirus (CMV) infection must be asymptomatic and have low viral loads
• •Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
• •Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional classification. To be eligible for this trial, patients should be class 2B or better
• •Women must not be pregnant or breast-feeding due to potential harm to an unborn fetus and possible risk of adverse events in nursing infants with the anti-PD-1 regimen(s) being used.
• •* All females of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy.
• •* A female of childbearing potential is defined as any woman, regardless of sexual orientation, or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy, or 3) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding consecutive months)
• •Women of childbearing potential and sexually active males must not conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse from the time of study registration and continuing until at least 5 months after the last dose of anti-PD-1 treatment for female patients and for at least 7 months after the last dose of anti-PD-1 treatment for male patients who are sexually active with a woman of childbearing potential (WOCBP).
• •Patients must have adequate organ and marrow function as defined below at study enrollment and prior to surgical resection. (these labs must be obtained ≤ 4 weeks prior to protocol registration and ≤1 week prior to surgery):
• •Hemoglobin \>= 10 g/dL
• •Neutrophils \>= 1500/ul
• •Leukocytes \>= 3000/ul
• •Lymphocytes \>= 700/ul
• •Blood platelet \>= 100,000/ul
• •Serum creatinine =\< 1.5 x upper limit of normal or creatinine clearance (CrCl) \>= 40 mL/min (if using the Cockcroft-Gault formula)
• •Serum bilirubin =\< 2.0 mg/dL
• •Total bilirubin =\< 1.5 x upper limit of normal (except for patients with Gilbert syndrome, who can have total bilirubin \< 3 mg/dL)
• •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2 x upper limit of normal
• •Lactate dehydrogenase (LDH) =\< 1.5 x upper limit of normal
• •Patients (or legally authorized representative) must have the ability to understand the requirements of the study, have provided written informed consent as evidenced by signature on an informed consent form (ICF) approved by an Institutional Review Board/Independent Ethics Committee (IRB/IEC), and agree to abide by the study restrictions and return to the site for the required assessments, including the RFS Follow-up Period