A Phase 2 interventional study of Lifileucel and LN-145 in Metastatic Melanoma, Squamous Cell Carcinoma of the Head and Neck and Non-small Cell Lung Cancer, sponsored by Iovance Biotherapeutics, Inc.. Terminated at 34 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-15.
Sponsored by Iovance Biotherapeutics, Inc. · Phase 2, Interventional, and Treatment
A prospective, open-label, multi-cohort, non-randomized, multicenter Phase 2 study evaluating adoptive cell therapy (ACT) with TIL [LN-144/LN-145 (lifileucel)] in combination with immune checkpoint inhibitors or TIL [LN-144/LN-145 (lifileucel) and LN-145-S1] as a single agent therapy.
TIL [LN-144/LN-145 (lifileucel) and LN-145-S1] is an adoptive cell transfer therapy that utilizes an autologous TIL for the treatment of patients with unresectable or metastatic melanoma; advanced, recurrent, or metastatic squamous cell carcinoma of the head and neck; and locally advanced or metastatic non-small-cell lung cancer. The adoptive cell transfer therapy used in this study involves patients receiving a nonmyeloablative lymphodepletion (NMA-LD) regimen, followed by autologous TIL infusion , then aldesleukin administration. Patients in Cohorts 1A, 1D, 2A, 3A, 3C, 3D, and 3E will receive TIL plus immune checkpoint inhibitors. Patients in Cohorts 1B, 1C, and 3B will receive autologous TIL as a single therapy.
3,006 studies on the registry are indexed under Melanoma; 519 are open to participants now.
This study's enrollment of 225 is above the median of 38 across 2,350 interventional studies indexed under Melanoma.
Browse Melanoma studies →Iovance Biotherapeutics, Inc. is the lead sponsor of 16 studies on the registry; 8 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria
Lifileucel (LN-144) regimen in combination with pembrolizumab in patients with Stage IIIC to IV unresectable or metastatic melanoma with ≤ 3 prior lines of systemic therapy, excluding immune checkpoint inhibitors (ICI).
Biological: Lifileucel · Drug: Pembrolizumab
LN-145-S1 regimen in patients with Stage IIIC or Stage IV unresectable or metastatic melanoma, who have previously received systemic therapy with a PD-1 blocking antibody. If the tumor is proto-oncogene B-Raf (BRAF) V600 mutation positive, patients must have received a BRAF inhibitor with or without a mitogen-activated extracellular signal-related kinase (MEK) inhibitor.
Biological: LN-145-S1
Lifileucel (LN-144 Generation 3 \[Gen 3\]) regimen in patients with Stage IIIC or Stage IV unresectable or metastatic melanoma, who have previously received systemic therapy with a PD-1 blocking antibody. If the tumor is BRAF V600 mutation positive, patients must have received BRAF inhibitor with or without a MEK inhibitor.
Biological: Lifileucel
Lifileucel (LN-145) regimen in combination with pembrolizumab in patients with advanced, recurrent, or metastatic HNSCC, with ≤ 3 prior lines of systemic therapy, excluding ICIs.
Biological: Lifileucel · Biological: LN-145 · Drug: Pembrolizumab
Lifileucel (LN-145) regimen in combination with pembrolizumab in patients with locally advanced or metastatic (Stage III or Stage IV) non-small-cell lung cancer (NSCLC) with ≤ 3 prior lines of systemic therapy, excluding ICIs, or ≤ 4 lines if 2 or more of the lines are tyrosine kinase inhibitor (TKI) therapy for those with tumors that harbored actionable mutations (eg, EGFR, ALK, ROS).
Biological: Lifileucel · Biological: LN-145 · Drug: Pembrolizumab
Lifileucel (LN-145) regimen ent in patients with Stage III or Stage IV NSCLC, who have previously received 1-3 lines of prior systemic therapy. Patients with known oncogene drivers (eg, EGFR, ALK, ROS) who have mutations that are sensitive to targeted therapies are not required to have received prior systemic therapy with ICIs.
Biological: Lifileucel · Biological: LN-145
Lifileucel (LN-145) regimen in combination with ipilimumab and nivolumab in patients with Stage III or Stage IV NSCLC who have previously received 1 line of ICI monotherapy. No other systemic therapy for metastatic disease is allowed. Prior chemoradiation and/or chemotherapy in the adjuvant and/or neo-adjuvant settings are allowed.
Biological: Lifileucel · Biological: LN-145 · Drug: Ipilimumab · Drug: Nivolumab
Lifileucel regimen in combination with pembrolizumab with or without pemetrexed, given after tumor resection then 4 cycles of frontline platinum doublet chemotherapy plus pembrolizumab, in patients with Stage IV NSCLC without EGFR, ALK, or ROS1 driver mutations, who have had no prior therapy for advanced disease.
Biological: Lifileucel · Biological: LN-145 · Drug: Pembrolizumab · Drug: Cisplatin · Drug: Carboplatin · Drug: Paclitaxel · Drug: Nab paclitaxel · Drug: Pemetrexed
Lifileucel regimen in combination with pembrolizumab with or without pemetrexed, given after 4 cycles of frontline platinum doublet chemotherapy plus pembrolizumab with tumor resection between any 2 cycles, in patients with Stage IV NSCLC without EGFR, ALK, or ROS1 driver mutations.
Biological: Lifileucel · Biological: LN-145 · Drug: Pembrolizumab · Drug: Cisplatin · Drug: Carboplatin · Drug: Paclitaxel · Drug: Nab paclitaxel · Drug: Pemetrexed
Lifileucel (LN-144) regimen in combination with nivolumab-relatlimab in patients with Stage IIIC to IV unresectable or metastatic (advanced) melanoma who have had no prior therapy for advanced disease.
Biological: Lifileucel · Drug: Nivolumab-relatlimab
A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor-infiltrating lymphocytes (TIL). After NMA-LD, patients receive lifileucel, followed by aldesleukin administration. Lifileucel will be administered to patients once (on Day 0) during the study.
Also known as: LN-144, TIL, autologous tumor-infiltrating lymphocytes
A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After NMA lymphodepletion, patients are infused with their autologous TIL (LN-145) followed by aldesleukin administration. TIL will be administered to patients once (on Day 0) during the study.
Also known as: TIL, autologous tumor infiltrating lymphocytes
Humanized antibody. Pembrolizumab will be administered after tumor resection and will continue every 3 weeks or every 6 weeks for up to 2 years.
Also known as: Keytruda
A tumor sample is resected from each patient and cultured ex vivo to expand the population of TIL, then TIL with high levels of PD-1 surface expression are selected. After NMA-LD, patients receive their autologous PD-1-selected TIL (LN-145-S1), followed by aldesleukin administration. TIL will be administered to patients once (on Day 0) during the study.
Also known as: TIL, autologous tumor-infiltrating lymphocytes, PD-1-selected TIL
Monoclonal antibody Ipilimumab will be administered as a single dose prior to tumor resection.
Also known as: Yervoy
Monoclonal antibody. Nivolumab will be administered once prior to tumor resection. The second dose will be administered prior to starting NMA-LD and will continue every 4 weeks for up to 2 years.
Also known as: Opdivo
Monoclonal antibody (nivolumab) and monoclonal antibody (relatlimab). Nivolumab-relatlimab will be administered after tumor resection and will continue every 4 weeks for up to 2 years.
Also known as: Opdualag
Cisplatin administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles.
Carboplatin administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles.
Paclitaxel administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles.
Nab-Paclitaxel administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles.
Pemetrexed administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles. Optional continuation maintenance every 3 weeks, if applicable.
Objective Response Rate
To evaluate the efficacy of autologous TIL in combination with ICIs in metastatic melanoma, HNSCC, and NSCLC patients and as a single therapy in metastatic melanoma and NSCLC patients as determined by objective response rate (ORR) using the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as assessed by Investigator
Time frame: Up to 60 months
Safety Profile Measured by Grade ≥3 TEAEs
To characterize the safety profile of autologous TIL in combination with ICIs in metastatic melanoma, HNSCC, and NSCLC patients and as a single therapy in metastatic melanoma and NSCLC patients as measured by the incidence of Grade ≥ 3 treatment-emergent adverse events (TEAEs)
Time frame: Up to 60 months
Percentage of patients for whom lifileucel is successfully manufactured and meets release specification
To evaluate the feasibility of producing lifileucel using tumor samples obtained before (Cohort 3D) or during (Cohort 3E) frontline platinum doublet chemotherapy and pembrolizumab in patients with Stage IV NSCLC
Time frame: Up to 60 months
Complete Response Rate
To evaluate efficacy using Complete Response (CR) rate per RECIST 1.1, as assessed by the Investigator
Time frame: Up to 60 months
Duration of Response
To evaluate efficacy using Duration of Response (DOR) per RECIST 1.1, as assessed by the Investigator
Time frame: Up to 60 months
Disease Control Rate
To evaluate efficacy using Disease Control Rate (DCR) per RECIST 1.1, as assessed by the Investigator
Time frame: Up to 60 months
Progression-Free Survival
To evaluate efficacy using Progression-Free Survival (PFS) per RECIST 1.1, as assessed by the Investigator
Time frame: Up to 60 months
Overall Survival
To evaluate efficacy using Overall Survival (OS)
Time frame: Up to 60 months
This study is terminated, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Iovance Biotherapeutics, Inc.