NCT03645928

Study of Autologous Tumor Infiltrating Lymphocytes in Patients With Solid Tumors

A Phase 2, Multicenter Study of Autologous Tumor Infiltrating Lymphocytes (LN 144/LN-145/LN-145-S1) in Patients With Solid Tumors

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 245 (estimated)
• Sponsor: Iovance Biotherapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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 (NMA) lymphodepletion regimen, followed by infusion of autologous TIL followed by the administration of aldesleukin. 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.

Conditions

• Metastatic Melanoma
• Squamous Cell Carcinoma of the Head and Neck
• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Lifileucel	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 Lifileucel followed by aldesleukin administration. Lifileucel will be administered to patients once (on Day 0) during the study.
BIOLOGICAL	LN-145	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.
DRUG	Pembrolizumab	Humanized antibody. Pembrolizumab will be administered following tumor resection and will continue every 3 weeks or every 6 weeks thereafter for up to 2 years.
BIOLOGICAL	LN-145-S1	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-S1) followed by aldesleukin administration. TIL will be administered to patients once (on Day 0) during the study.
DRUG	Ipilimumab	Monoclonal antibody Ipilimumab will be administered as a single dose prior to tumor resection.
DRUG	Nivolumab	Monoclonal antibody Nivolumab will be administered once prior to tumor resection. The second dose will be administered prior to TIL administration and dosing will continue every 4 weeks for up to 2 years.
DRUG	Nivolumab-relatlimab	Nivolumab-relatlimab will be administered following tumor resection and will continue every 4 weeks thereafter for up to 2 years.
DRUG	Cisplatin	Cisplatin administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles.
DRUG	Carboplatin	Carboplatin administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles.
DRUG	Paclitaxel	Paclitaxel administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles.
DRUG	Nab-Paclitaxel	Nab-Paclitaxel administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles.
DRUG	Pemetrexed	Pemetrexed administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles. Optional continuation maintenance every 3 weeks, if applicable.

Timeline

• Start date: 2019-05-07
• Primary completion: 2029-08-09
• Completion: 2029-08-09
• First posted: 2018-08-24
• Last updated: 2025-06-19

Locations

45 sites across 8 countries: United States, Canada, France, Germany, Greece, Spain, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study