Iovance Biotherapeutics, Inc.
Lifileucel (LN-144/145) (+pembrolizumab)
LN-144 (Lifileucel)/LN-145 is an adoptive cell transfer therapy that utilizes an autologous TIL manufacturing process
To evaluate the efficacy of autologous TIL LN-144 (Lifileucel)/LN-145 in combination with pembrolizumab in MM, HNSCC, or NSCLC patients or TIL LN-145 as a single therapy in relapsed or refractory (r/r) NSCLC patients, who have previously progressed on or after treatment with CPIs, as determined by objective response rate (ORR), using the Response Evaluation Criteria in Solid Tumors (RECIST 1.1), as assessed by Investigator.
-Must have a confirmed diagnosis of malignancy of their receptive histologies: unresectable or metastatic melanoma (Cohort 1A), advanced recurrent or metastatic squamous cell carcinoma of the head and neck (Cohort 2A), or Stage III or Stage IV non-small cell lung cancer (Cohorts 3A and 3B).
-Cohorts 1A, 2A, and 3A only: If previously treated, patients must have progressed on or after most recent therapy. Cohorts 1A, 2A, and 3A may have received up to 3 prior systemic anticancer therapies
-Cohort 3B only: Patients with Stage III or Stage IV NSCLC who have previously received systemic therapy with CPIs (eg, anti-PD-1/anti-PD-L1) as part of ≤ 3 prior lines of systemic therapy. Patients must have radiographically confirmed progression on or after most recent therapy.
-Must have at least 1 resectable lesion
-Must have a remaining measurable disease as defined by RECIST 1.1 following tumor resection
-Must be ≥18 years at the time of consent.
-Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and an estimated life expectancy of ≥ 3 months
-Patient of childbearing potential or those with partners of childbearing potential must be willing to practice an approved method of birth control during treatment and for 12 months after recieving all protocol-related therapy.
-Patients with melanoma of uveal/ocular origin.
-Patients who have received an organ allograft or prior cell transfer therapy that included a nonmyeloablative or myeloablative chemotherapy regimen within the past 20 years.
-Patients with symptomatic and/or untreated brain metastases
-Patients who are on a systemic steroid therapy within 21 days of enrollment.
-Patients who are pregnant or breastfeeding.
-Patients who have an active medical illness(es), which in the opinion of the Investigator, would pose increased risks for study participation
-Patients may not have active or prior documented autoimmune or inflammatory disorders
-Patients who have received a live or attenuated vaccination within 28 days prior to the start of treatment
-Patients who have any form of primary immunodeficiency
-Patients with a history of hypersensitivity to any component of the study drugs
-Patients who have a left ventricular ejection fraction (LVEF) > 45% or who are New York Heart Association Class II or higher
-Patients who have obstructive or restrictive pulmonary disease and have a documented FEV1 ≤ 60% of predicted normal
-Patients who have had another primary malignancy within the previous 3 years
-Participation in another clinical study with an investigational product within 21 days of the initiation of treatment.