Study of LN-145, Autologous Tumor Infiltrating Lymphocytes in the Treatment of Patients With Cervical Carcinoma
NCT ID: NCT03108495
Last Updated: 2025-09-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
210 participants
INTERVENTIONAL
2017-06-22
2025-08-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Cohort 1 LN-145 monotherapy
Post-NMA lymphodepletion, patients are infused with their autologous TIL (LN-145) followed by IL-2 administration.
LN-145
A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes.
Cohort 2 LN-145 monotherapy
Patients previously treated with an antiprogrammed cell death protein-1 (PD-1) or anti-programmed death-ligand 1 (PD-L1) checkpoint inhibitor: Post-NMA lymphodepletion, patients are infused with their autologous TIL (LN-145) followed by IL-2 administration.
LN-145
A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes.
Cohort 3 - Combination Arm (TIL + Pembrolizumab) - US Only
Patients will be administered with pembrolizumab, followed by NMA lymphodepletion, then infused with their autologous TIL (LN-145) followed by pembrolizumab every 3 or 6 weeks post IL-2 administration up to 24 months.
LN-145 + pembrolizumab
A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. The first dose of anti-PD-1 immunotherapy will be administered following tumor resection.
Cohort 4 - Non-enrolling Cohort
Cohort includes patient population not meeting inclusion criteria in cohort 1 and 2. Post-NMA lymphodepletion, patients are infused with their autologous TIL (LN-145) followed by IL-2 administration.
LN-145
A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes.
Cohort 5 Retreatment Cohort
Patients who have been previously treated with LN-145 may be given a second treatment with TIL.
LN-145
A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes.
Interventions
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LN-145
A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes.
LN-145 + pembrolizumab
A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. The first dose of anti-PD-1 immunotherapy will be administered following tumor resection.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Must be ≥ 18 years of age at the time of consent. Enrollment of patients \> 70 years of age may be allowed after consultation with the Medical Monitor.
2. Must have recurrent, metastatic, or persistent squamous cell carcinoma (SCC), adenosquamous carcinoma (ASC), or adenocarcinoma (AC) of the cervix that is not amenable to curative treatment with surgery and/or radiation therapy.
3. At least one resectable lesion (or aggregate of lesions resected) of a minimum 1.5 cm in diameter post-resection to generate TIL; surgical removal with minimal morbidity (defined as any procedure for which expected hospitalization is ≤ 3 days)
4. At least one measurable target lesion, as defined by RECIST v1.1.
5. Cohort 1 and Cohort 2: Progression during or following at least one, but no more than three, prior systemic chemotherapeutic treatments for recurrent, metastatic, or persistent cervical carcinoma
* A line of systemic therapy is defined as any chemotherapy or multiple-agent chemotherapy regimen that was administered for recurrent, metastatic, or persistent SCC, ASC, or AC of the cervix.
* A bevacizumab and chemotherapy combination is encouraged as a prior line of treatment.
* Neither chemoradiation, nor chemotherapy in the neoadjuvant or adjuvant settings are considered as a prior line of systemic therapy.
Cohort 2: Must also have previously received treatment with a checkpoint inhibitor (ie, PD-1, PD-L1\]) in the setting of recurrent, metastatic, or persistent disease either as monotherapy or in combination (eg, in combination with chemotherapy or another immune agent)
Cohort 3 (United States only): Must have not received any therapies other than prior chemoradiation or surgery for loco-regional disease
6. Any prior therapy directed at the malignant tumor, including chemotherapy, biologic/targeted agents, and immunologic agents must be discontinued at least 28 days prior to tumor resection.
7. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
8. Must have adequate organ function.
9. Patient has no evidence of any active viral, bacterial, or fungal infection requiring ongoing systemic treatment. Patients must be seronegative for the human immunodeficiency virus (HIV). Patients with acute or chronic hepatitis infections may be enrolled if the viral load by nucleic acid amplification test (NAAT) is undetectable with/without active treatment
10. Patients of childbearing potential must be willing to take the appropriate precaution to avoid pregnancy for the duration of the study and practice an approved, highly effective method of birth control during treatment and for 12 months after receiving the last protocol-related therapy.
11. Prior to study Enrollment (tumor resection), patient must have documentation of radiological disease progression after the most recent therapy
Exclusion Criteria
1. Patients who have received an organ allograft or prior cell transfer therapy except for prior LN-145 therapy in the setting of re-treatment only.
2. Patients who require ongoing systemic steroid therapy (\> 10 mg/day of prednisone or other steroid equivalent dose).
3. Patients who currently have prior therapy-related toxicities Grade \> 1 according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0; except for peripheral neuropathy, alopecia, or vitiligo prior to Enrollment (tumor resection).
4. . Patients who have a history of hypersensitivity to any component or excipient of LN-145 or other study drugs:
• NMA-LD preparative regimen (cyclophosphamide, mesna, and fludarabine)
5. Patients who have active systemic infections, coagulation disorders, or other active major medical illness(es) of the cardiovascular, respiratory, or immune system, including evidence in the medical history of urinary tract obstruction, a positive cardiac stress test, myocardial infarction, cardiac arrhythmia, obstructive or restrictive pulmonary disease, or other conditions that in the opinion of the Investigator would increase the risk of participation.
6. Patients with symptomatic and/or untreated brain metastases (of any size and any number)
• Patients with definitively treated brain metastases may be considered for Enrollment, and must be stable for ≥ 14 days prior to beginning the NMA-LD preparative regimen
7. Patients who have any form of primary immunodeficiency (such as severe combined immunodeficiency \[SCID\] or acquired immunodeficiency syndrome \[AIDS\])
8. Patients who have a diagnosis of end-stage renal disorder requiring hemodialysis
9. Patients who have a left ventricular ejection fraction (LVEF) \< 45% or who are New York Heart Association (NYHA) Class 2 or higher.
10. Patients who have a documented forced expiratory volume in 1 second (FEV1) of ≤ 60%
11. Patients who have had another primary malignancy within the previous 3 years (except for curatively treated localized malignancy that has not required treatment for \> 1 year, and in the judgement of the Investigator, does not pose a significant risk of recurrence including, but not limited to, non-melanoma skin cancer or bladder cancer)
12. Patients who are of the following protected classes will be excluded, including:
* Pregnant, parturient, or breastfeeding women
* Persons who are hospitalized without consent or those deprived of liberty because of a judiciary or administrative decision
* Patients with a legal protection measure or a person who cannot express his/her consent
* Patients in emergency situations who cannot consent to the study
13. Patients who have received a live or attenuated vaccine within 28 days prior to beginning the NMA-LD preparative regimen
14. Patients whose cancer requires immediate attention or who would otherwise suffer a disadvantage by participating in this study
15. Cohort 1 and Cohort 3: Patients who have received prior treatment with immunotherapy (eg, PD-1, PD-L1, or anti-cytotoxic T lymphocyte-associated antigen-4 \[CTLA-4\] antibodies)
16. Patients who have Grade ≥ 2 hemorrhage within 14 days prior to Enrollment (tumor resection)
17. Cohort 3: Patients may not have active or prior documented autoimmune or inflammatory disorders (including pneumonitis, inflammatory bowel disease \[eg, colitis or Crohn's disease\], diverticulitis \[with the exception of diverticulosis\], systemic lupus erythematosus, sarcoidosis syndrome, or Wegener syndrome \[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.\]).
18 Years
FEMALE
No
Sponsors
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Iovance Biotherapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Iovance Medical Monitor
Role: STUDY_DIRECTOR
Iovance Biotherapeutics, Inc.
Locations
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St. Joseph's Hospital and Medical Center Center For Women's Health
Phoenix, Arizona, United States
University of Southern California
Los Angeles, California, United States
University of California San Diego
San Diego, California, United States
Sylvester Comprehensive Cancer Center
Miami, Florida, United States
University of Florida Health Cancer Center
Orlando, Florida, United States
University of South Florida H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Augusta University
Augusta, Georgia, United States
University of Chicago
Chicago, Illinois, United States
James Graham Brown Cancer Center
Louisville, Kentucky, United States
LSU Health Sciences Center
New Orleans, Louisiana, United States
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Rutgers University
Newark, New Jersey, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Allegheny Health
Pittsburgh, Pennsylvania, United States
UPMC Cancer Center
Pittsburgh, Pennsylvania, United States
Avera Medical Group Oncology
Sioux Falls, South Dakota, United States
MD Anderson Cancer Center
Houston, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Centre Hospitalier Lyon Sud
Pierre-Bénite, Auvergne-Rhône-Alpes, France
Centre Léon Bérard
Lyon, , France
Gustave Roussy Cancer Campus
Villejuif, , France
Universitätsklinikum Erlangen
Erlangen, Bavaria, Germany
Universitätsklinikum Carl Gustav Carus
Dresden, Saxony, Germany
Istituto Europeo di Oncologia
Miano, Milano, Italy
Academisch Medisch Centrum
Amsterdam, AZ, Netherlands
Clínica Universidad de Navarra
Pamplona, Navarre, Spain
Hospital Universitari Vall d'Hebrón
Barcelona, , Spain
Institut Català d'Oncologia
Barcelona, , Spain
Hospital General Universitario Gregorio Marañon
Madrid, , Spain
Hospital Universitario Madrid Sanchinarro
Madrid, , Spain
Inselspital
Bern, , Switzerland
Centre Hospitalier Universitaire Vaudois Lausanne - Centre Pluridisciplinaire d'Oncologie
Lausanne, , Switzerland
Bristol Haematology and Oncology Centre
Bristol, England, United Kingdom
Sarah Cannon Research Institute London
London, England, United Kingdom
University College London Hospitals NHS Foundation Trust
London, England, United Kingdom
NHS Greater Glasgow and Clyde
Glasgow, Scotland, United Kingdom
Guy's & St.Thomas NHS Foundation Trust
London, , United Kingdom
Countries
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Other Identifiers
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2024-510634-41-00
Identifier Type: CTIS
Identifier Source: secondary_id
C-145-04
Identifier Type: -
Identifier Source: org_study_id
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