Study of Autologous Tumor Infiltrating Lymphocytes in Patients With Solid Tumors



Status:Recruiting
Conditions:Lung Cancer, Skin Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 70
Updated:3/21/2019
Start Date:March 2019
End Date:December 2024
Contact:Iovance Biotherapeutics Study Team
Email:Clinical.Inquiries@iovance.com
Phone:866-565-4410

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

A prospective, open-label, multi-cohort, non-randomized, multicenter Phase 2 study evaluating
adoptive cell therapy (ACT) with TIL LN-144 (Lifileucel)/LN-145 in combination with
pembrolizumab. TIL as a single-therapy will be evaluated with LN-145 only.

LN-144 (Lifileucel)/LN-145 is an adoptive cell transfer therapy that utilizes an autologous
TIL manufacturing process for the treatment of patients with advanced unresectable or
metastatic melanoma, advanced squamous cell carcinoma of the head and neck, and non-small
cell lung cancer. The adoptive cell transfer therapy used in this study involves patients
receiving a nonmyeloablative (NMA) lymphocyte depleting preparative regimen, followed by
infusion of autologous TIL followed by the administration of a regimen of IL-2. Patients in
Cohort 1 and 2 will receive TIL plus pembrolizumab, and patients in Cohort 3 will receive TIL
as a single therapy.

Inclusion Criteria

- Patients must be ≥18 years and ≤70 years of age at the time of consent. Enrollment of
patients >70 years of age may be allowed.

- Must have a histologically confirmed unresectable or metastatic melanoma (Cohort 1),
recurrent or metastatic squamous cell carcinoma of the head and neck (HPV-positive or
HPV-negative) (Cohort 2), or recurrent or metastatic non-small cell lung cancer
(Cohort 3).

- Cohort 1 and Cohort 2 only: must have not received prior immunotherapy, including
checkpoint inhibitors (eg, anti-PD-1/anti-PD-L1 and/or anti-CTLA-4). With the excluded
prior therapies cited, patients may have received from 1 to 3 prior systemic
anticancer therapies.

- Cohort 3 only: Patients with Stage III or Stage IV NSCLC (squamous, nonsquamous,
adenocarcinoma, or large cell carcinoma) who have received from 1 to 3 prior systemic
anticancer therapies, including checkpoint inhibitors (eg, anti-PD-1/anti-PD-L1) in
the locally advanced or metastatic setting.

- Must have remaining measurable disease as defined by RECIST 1.1 following tumor
resection

- Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

- Childbearing potential or their partners of childbearing potential must be willing to
practice an approved method of birth control

- Must have adequate organ function.

- Must be seronegative for the human immunodeficiency virus (HIV).

- Must have provided written authorization for use and disclosure of protected health
information.

Exclusion Criteria

- Patients with melanoma of uveal/ocular origin.

- Patients who have received an organ allograft or prior cell transfer therapy that
included a nonmyeloablative or myeloablative chemotherapy regimen.

- Patients with symptomatic and/or untreated brain metastases

- Patients who are on a systemic steroid therapy at a dose of >10mg of prednisone or
equivalent a day. Short course of higher-dose steroid therapy is allowed.

- Patients who are pregnant or breastfeeding.

- Patients who have an active medical illness(es), which in the opinion of the
Investigator, would pose increased risks for study participation

- Patients may not have active or prior documented autoimmune or inflammatory disorders

- Patients who have any form of primary immunodeficiency

- Patients with a history of hypersensitivity to any component of the study drugs

- Patients who have obstructive or restrictive pulmonary disease

- Patients who have had another primary malignancy within the previous 3 years

- Participation in another clinical study with an investigational product within 21 days
of the initiation of nonmyeloablative lymphodepletion (NMA-LD) treatment.
We found this trial at
8
sites
Detroit, Michigan 48201
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Los Angeles, California 90033
213) 740-2311
University of Southern California The University of Southern California is one of the world’s leading...
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Los Angeles, CA
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Los Angeles, California 90095
310-825-4321
University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
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Los Angeles, CA
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Barcelona,
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500 S Preston St
Louisville, Kentucky
(502) 852-5555
University of Louisville The University of Louisville is a state supported research university located in...
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Louisville, KY
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Miami Beach, Florida 33140
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Miami Beach, FL
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New Haven, Connecticut 6520
(203) 432-4771
Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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New Haven, CT
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Orlando, Florida 32806
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Orlando, FL
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