C-145-03 (CLINICAL TRIAL IN RECURRENT AND/OR METASTATIC SQUAMOUS CELL CARCIOMA OF THE HEAD AND NECK)

Immunotherapy For Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck (HNSCC)

What is an immuno-therapy?

Immuno-therapies are a relatively recent development that are sometimes used in the treatment of cancer. They may work by attacking the cancer cells directly, or by activating a patient’s own immune system to mount an effective attack against the cancer.

WHAT ARE TUMOR INFILTRATING LYMPHOCYTES AND HOW DO THEY WORK?

The TUMOR INFILTRATING LYMPHOCYTE (TIL) therapy being studied in this trial is an investigational immunotherapy named LN-145.

TIL are derived from a patient’s own immune cells called lymphocytes, and specifically T lymphocytes that can recognize and potentially kill the patient’s own cancer cells. Some of these cells naturally travel to, and penetrate existing cancerous tumors, and are then referred to as TUMOR INFILTRATING LYMPHOCYTES (TIL). However, for various reasons the immune-suppressive environment of the cancerous tumors limits their number and activity which diminishes their ability to effectively attack the cancer.

The TIL therapy under investigation in this clinical trial (LN-145) is derived through isolation of a patient’s own naturally occurring TIL from a sample of cancerous tumor removed from the patient. After TIL are extracted from the tumor, they are multiplied in a laboratory until billions of TIL are obtained. Prior to receipt of TIL, patients receive a pre-conditioning therapy to reduce the immune suppressive environment of cancer that remains in the patient. The expanded TIL are then administered via intravenous infusion back to the patient as LN-145 (TIL therapy), with the intention that the TIL will target and infiltrate cancer in the patient and attack the cancer in greater number. Patients receive up to 6 doses of interleukin 2 (IL-2) immediately following TIL infusion to support growth and activation of the TIL in the patient, and to augment the anti-cancer activity of the TIL therapy.

OVERVIEW OF TIL THERAPY PROCEDURE

  1. Tumor is surgically isolated from patient.
  2. Tumor sample is shipped to the GMP facility where TIL are isolated and multiplied to generate billions of TIL over three weeks.
  3. Patient initiates a week of pre-conditioning therapy to prepare to receive TIL.
  4. TIL product is administered as a one-time therapy followed by up to 6 doses of IL-2 to support growth and activation of the TIL therapy inside the patient.

TIL Therapy has been Studied in Patients Since 1988

WHAT CLINICAL RESULTS HAVE BEEN OBSERVED WITH TIL THERAPIES AS A CANCER TREATMENT?

TIL therapy is based on an adoptive cell therapy regimen that was developed at the National Cancer Institute (NCI) and which is currently being applied at a small selection of leading cancer centers around the world. So far, most of the data on TIL therapy has been obtained from studies in metastatic melanoma, a form of aggressive skin cancer, as well as cervical cancer.

Recent data from two trials at the NCI in patients with metastatic melanoma confirmed TIL treatment was associated with high, durable objective responses. In a 93 patient Phase 2 trial, the objective response rate (ORR) was 56%.1  Another trial of 101 patients observed complete responses (CR, total elimination of detectable tumors) in 24% of patients, some of whom were free of disease for more than four years. 2

Research data from three publications has shown a predictive value for TIL with an association between improved patient survival and tumors with higher TIL levels. This includes tumors with weak or no expression of HPV3 and those which were HPV positive.4-5

CLINICAL TRIAL OVERVIEW

C-145-03 is a Phase 2 clinical trial, enrolling patients with recurrent and/or metastatic HNSCC that have received at least one prior treatment with systemic immunotherapy and/or chemotherapeutic treatment.

The clinical trial is designed to determine if Iovance investigational TIL therapy (LN-145) is safe and effective for the treatment of recurrent and/or metastatic HNSCC (helps patients live longer and/or slow down cancer progression).

There are several objectives to the trial, some of which aim to determine:

  • Whether LN-145 reduces or slows the progression of the HNSCC.
  • Whether LN-145 eliminates all detectable HNSCC.
  • Whether treatment with LN-145 extends the life of a patient without their cancer worsening.

LN-145 is an investigational therapy that is being tested in clinical studies and has not been approved by the FDA or any other agency for any indication. A clinical trial is designed to explore efficacy and safety of experimental therapies. You should talk to your doctor about the benefits and risks of participating in this trial.

 

YOU MAY QUALIFY FOR THE TRIAL IF:

  • You have been diagnosed with recurrent and/or metastatic HNSCC
  • Your cancer progressed during or following previous therapy
  • You have received prior immunotherapy and/or chemotherapy
  • You are at least 18 years old

 

If you satisfy these key eligibility criteria, you may be eligible to participate in this clinical trial.  There are other additional eligibility criteria that can only be assessed by a trial physician.

To talk with somebody and to learn more about the trial, please call: 1-866-565-4410

Further details for healthcare providers can be accessed below:
https://clinicaltrials.gov/ct2/show/NCT03083873

Trial Sites Currently Enrolling Patients

City State Institution
Morristown New Jersey Atlantic Health
Louisville Kentucky Univ. of Louisville
Pittsburgh Pennsylvania UPMC
Portland Oregon Providence Cancer Center
Tampa Florida Moffitt
Detroit Michigan Karmanos
Chicago Illinois Northwestern
La Jolla California UCSD
Los Angeles California USC
New Orleans Louisiana LSU

1 Rosenberg, S.A., et al. Durable Complete Responses in Heavily Pretreated Patients with Metastatic Melanoma Using T-Cell TransferImmunotherapy. Clinical Cancer Research, 17(13), 4550-4557.

2 Goff, S.L. et al. Randomized, Prospective Evaluation Comparing Intensity of Lymphodepletion Before Adoptive Transfer of Tumor-Infiltrating Lymphocytes for Patients with Metastatic Melanoma. Journal of Clinical Oncology, 2016; 34(20), 2389-2397.

3 Kong CS, Narasimhan B, Cao H, Kwok S, Erickson JP, Koong A, et al. The relationship between human papillomavirus status and other molecular prognostic markers in head and neck squamous cell carcinomas. Int J Radiat Oncol Biol Phys. 2009;74(2):553-61.

4 Wansom D, Light E, Worden F, Prince M, Urba S, Chepeha DB, et al. Correlation of cellular immunity with human papillomavirus 16 status and outcome in patients with advanced oropharyngeal cancer. Arch Otolaryngol Head Neck Surg. 2010;136(12):1267-73.

5 Ward MJ, Thirdborough SM, Mellows T, Riley C, Harris S, Suchak K, et al. Tumour infiltrating lymphocytes predict for outcome in HPV-positive oropharyngeal cancer. Br J Cancer. 2014;110(2):489-500.