A Phase 2, Multicenter Study to Evaluate the Efficacy and Safety Using Autologous Tumor Infiltrating Lymphocytes (LN-145) in Patients with Recurrent, Metastatic, or Persistent Cervical Carcinoma

UVA Tracking #
HSR230095
Principal Investigator
Linda R Duska
Contact
Contact Phone
Official Trial Title
A Phase 2, Multicenter Study to Evaluate the Efficacy and Safety Using Autologous Tumor Infiltrating Lymphocytes (LN-145) in Patients with Recurrent, Metastatic, or Persistent Cervical Carcinoma
Study Description

The University of Virginia is participating a clinical research study for adults ages 18 and over, who have cervical cancer that has come back after treatment (recurrent), has spread to other organs (metastatic) or has not improved (persistent) after the previous treatment. The purpose of this study is to find out:
* If an Investigational Medicinal Product (IMP) called LN-145 (referred to as “investigational product”), autologous tumor-infiltrating lymphocytes (TIL) derived from the patient’s own tumor when given as a single therapy is safe and beneficial in the treatment of patients with cervical cancer when previous treatment has not worked.

Participants in the study will be enrolled into one of the following cohorts:
* Cohort 2: If you have previously received immunotherapy (e.g., PD-1/PD-L1 checkpoint inhibitor such as Nivolumab, Pembrolizumab, Atezolizumab) for your cancer, you will be enrolled in Cohort 2 and you will receive LN-145 therapy. Approximately 75 patients will be enrolled in this cohort.
* Cohort 5 (Retreatment): You may receive a second treatment of LN-145 therapy alone, if needed.
Additional information can be found here: https://clinicaltrials.gov/ct2/show/NCT03108495

Study-related procedures that are being done beyond your standard of care will be provided at no cost to you or your insurance.

Reimbursement:

Local Travel
* Patient Meals, for patients who reside locally and are not required to stay at the site for a full day – up to $30 per day

* Patient Meals, for patients who reside locally and are required to stay at the site for a full day – up to $65 per day

* Local Travel (less than 50 miles away, one way), reimburseable for mileage at the current IRS business mileage rate
* Local travel - taxi, train or bus – up to $90 round trip

Long distance travel – over 50 miles one way

* Mileage reimbursement – IRS Business rate, per mile
* Airfare – will be reimbursed
* Train – will be reimbursed
* Bus fare – will be reimbursed

* Hotel – no maximum rate, need to live 50 miles away one way
* Patient Meals,– up to $65 per day

Contact: uvacancertrials@hscmail.mcc.virginia.edu

Compensation

No Compensation