Pembrolizumab, Standard Chemotherapy, Tumor Infiltrating Lymphocytes, and High- or Low-Dose Aldesleukin in Treating Patients With Metastatic Melanoma

Inclusion Criteria

• TURNSTILE I - SCREENING:
• Patients must have metastatic melanoma or stage III in-transit, subcutaneous, or regional nodal disease
• Patients must have a lesion amenable to resection for the generation of TIL on MD Anderson protocol 2004-0069
• Patients must receive a magnetic resonance imaging (MRI)/computed tomography (CT)/positron emission tomography (PET) of the brain within 6 months of signing informed consent; if new central nervous system (CNS) lesions are present, patient must have definitive treatment (including surgery or radiation); principal investigator (PI) or his designee should make final determination regarding enrollment
• Clinical performance status of Eastern Cooperative Oncology Group (ECOG) 0 - 1 within 30 days of signing informed consent
• Patients previously treated with immunotherapy, targeted therapy, or no therapy (treatment naive) will be eligible
• Patients receiving cytotoxic agents will be evaluated by the PI or his designee for eligibility suitability
• Patients with a negative pregnancy test (urine or serum) must be documented within 14 days of screening for women of childbearing potential (WOCBP); a WOCBP has not undergone a hysterectomy or who has not been naturally postmenopausal for at least 12 consecutive months (i.e. who has not had menses at any time in the preceding 12 consecutive months)
• TURNSTILE II - TREATMENT:
• Patients must sign the treatment consent document before Turnstile II screening procedures; before the treatment starts and at each visit, the patient will be asked to complete two quality of life questionnaires; It should take about 15 minutes to complete the questionnaires (Functional Assessment of Cancer Therapy General [FACT-G], FACT-Melanoma); patients must fulfill all of the following criteria to be eligible for Turnstile II of the study
• Patients must have adequate TIL that were previously harvested and then cryopreserved on MD Anderson Cancer Center (MDACC) protocol 2004-0069
• Patients who have had prior therapy (BRAF inhibitors, ipilimumab, anti PD-1 antibody or anti PD-L1 antibody) or treatment naive patients are eligible as long as toxicity from therapy is grade = 1 cm and must be amenable to undergoing serial biopsies through the course of therapy; this lesion must not be documented as one of the target lesions
• Patients may have central nervous system (CNS) metastases which have been treated and are radiographically stable for at least 4 weeks
• Patients of both genders must practice birth control for four months after receiving the preparative regimen (lymphodepletion) and continue to practice birth control throughout the study; patients must have a documented negative pregnancy test (urine or serum) for women who have menstruated in the past 12 months and without sterilization surgery
• Unless surgically sterile by bilateral tubal ligation or vasectomy of partner(s), or if the patient is post-menopausal, the patient agrees to continue to use a barrier method of contraception throughout the study such as: condom, diaphragm, hormonal, intrauterine device (IUD), or sponge plus spermicide; abstinence is an acceptable form of birth control
• Pregnancy testing will be performed within 14 days of screening for women of childbearing potential (WOCBP); a WOCBP has not undergone a hysterectomy or who has not been naturally postmenopausal for at least 12 consecutive months (i.e. who has not had menses at any time in the preceding 12 consecutive months)
• Clinical performance status of ECOG 0-1 within 30 days of signing informed consent
• A stress cardiac test (stress thallium, stress multi-gated acquisition scan [MUGA], dobutamine echocardiogram or other stress test that will rule out cardiac ischemia) within 1 month of lymphodepletion
• 12-lead electrocardiogram (EKG) showing no active ischemia and corrected QT (QTc) interval less than 480 msec
• Pulmonary function tests (forced expiratory volume in 1 second [FEV1] > 65% or forced vital capac