Study of Autologous Tumor Infiltrating Lymphocytes in Patients With Solid Tumors

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.

Conditions

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

Interventions

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.

BIOLOGICAL

Lifileucel

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.

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 after tumor resection and will continue every 3 weeks or every 6 weeks 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 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.

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 starting NMA-LD and will continue every 4 weeks for up to 2 years.

DRUG

Nivolumab-relatlimab

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.

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.

Sponsors & Collaborators

• Iovance Biotherapeutics, Inc.

  lead INDUSTRY

Principal Investigators

• Iovance Biotherapeutics Medical Monitor · Iovance Biotherapeutics

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-05-07

Primary Completion

2026-02-20

Completion

2026-02-20

FDA Drug

Yes

Countries

• United States
• Canada
• Germany
• Greece
• Spain
• Switzerland
• United Kingdom

Study Locations