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

Iovance Biotherapeutics, Inc.

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.

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…

Eligibility

Interventions

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.

Summary

Description

Eligibility

Interventions

Locations (45)