Neoadj Admin Autologous Tumor Infiltrating Lymphocytes & Pembrolizumab for Treatment of Adv Melan… (NCT05176470) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Neoadj Admin Autologous Tumor Infiltrating Lymphocytes & Pembrolizumab for Treatment of Adv Melanoma Patients
United States2 participantsStarted 2022-07-01
Plain-language summary
This phase I/II trial tests the safety and side effects of LN-144 (Lifileucel) and pembrolizumab in treating patients with stage IIIB-D or stage IV melanoma that has spread to nearby tissue or lymph nodes. Biological therapies, such as LN-144 (Lifileucel), use substances made from living organisms that may attack specific tumor cells and stop them from growing or kill them. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving lifileucel and pembrolizumab may make the tumor smaller.
Who can participate
Age range18 Years – 75 Years
SexALL
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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 curre…
What they're measuring
1
Feasibility of neoadjuvant administration of MK-3475 and LN-144/Lifileucel in 3 stage IIIB-D melanoma patients (Phase 1)
Timeframe: Up to 2 years
2
Incidence of grade >= 3 treatment-emergent adverse events (both immune and non-immune related) (Phase 2)