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Study of LN-145 Autologous Tumor Infiltrating Lymphocytes in the Treatment of Squamous Cell Carcinoma of the Head & Neck

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03083873
Recruitment Status : Recruiting
First Posted : March 20, 2017
Last Update Posted : April 16, 2019
Information provided by (Responsible Party):
Iovance Biotherapeutics, Inc.

Brief Summary:
Prospective, multicenter, single-arm, open label, interventional study evaluating adoptive cell therapy (ACT) with autologous tumor infiltrating lymphocytes (TIL) infusion (LN-145) followed by IL-2 after a non-myeloablative (NMA) lymphodepletion preparative regimen for the treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck

Condition or disease Intervention/treatment Phase
Squamous Cell Carcinoma of the Head and Neck Biological: LN-145 Phase 2

Detailed Description:
LN-145 is an adoptive cell transfer therapy that utilizes an autologous TIL manufacturing process, as originally developed by the NCI, for the treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck. The cell transfer therapy used in this study involves patients receiving a NMA lymphocyte depleting preparative regimen, followed by infusion of autologous TIL followed by the administration of a regimen of IL-2.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 47 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter Study to Evaluate the Efficacy and Safety of Autologous Tumor Infiltrating Lymphocytes (LN-145) for the Treatment of Patients With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck
Actual Study Start Date : January 9, 2017
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Single Arm
LN-145 autologous tumor infiltrating lymphocytes
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 IL-2 administration.
Other Name: TIL, autologous tumor infiltrating lymphocytes

Primary Outcome Measures :
  1. Objective Response Rate [ Time Frame: Up to 24 months ]
    To evaluate the efficacy of LN-145 in patients with recurrent and/or metastatic HNSCC based on the objective response rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by the Investigator

Secondary Outcome Measures :
  1. Duration of Response [ Time Frame: Up to 24 months ]
    To evaluate efficacy parameters such as Duration of Response (DOR) using RECIST v1.1 as assessed by the Investigator

  2. Disease Control Rate [ Time Frame: Up to 24 months ]
    To evaluate efficacy parameters such as Disease Control Rate (DCR) using RECIST v1.1 as assessed by the Investigator

  3. Progression-Free Survival [ Time Frame: Up to 24 months ]
    To evaluate efficacy parameters such as Progression-Free Survival (PFS) using RECIST v1.1 as assessed by the Investigator

  4. Overall Survival [ Time Frame: Up to 36 months ]
    To evaluate Overall Survival (OS) in patients with recurrent and/or metastatic HNSCC

  5. Safety Profile as Assessed by Incidence of Adverse Events [ Time Frame: Up to 24 months ]
    To characterize the safety profile of LN-145 in patients with metastatic and/or recurrent HNSCC

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria

  • Must be greater than 18 years of age at the time of consent.
  • Must have recurrent and/or metastatic, squamous cell carcinoma of the head and neck (both HPV-positive and -negative)
  • Must have at least 1 lesion that is resectable for TIL generation.
  • Must have measurable disease as defined by RECIST v1.1 following the surgical resection.
  • Must have received at least 1 and no more than 3 lines of prior systemic immunotherapy and/or chemotherapeutic treatments for HNSCC.
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Patients must be seronegative for the HIV antibody.
  • Patients seropositive for hepatitis B virus surface antigen (HBsAg), hepatitis B core antibody (anti-HBc), or hepatitis C virus (anti-HCV) indicating acute or chronic infection may be enrolled if the viral load by polymerase chain reaction (PCR) is undetectable with/without active treatment
  • Male and female patients of childbearing potential must be willing to practice an approved method of birth control starting at the time of informed consent and for 1 year after the completion of the study treatment regimen.

Exclusion Criteria:

  • Patients who have received an organ allograft or prior cell transfer therapy, except for prior LN-145.
  • Patients who are on a systemic steroid therapy (greater than 10 mg of prednisone or equivalent). A short course of higher dose steroid therapy is allowed.
  • Patients who currently have prior therapy-related toxicities greater than Grade 1 according to Common Toxicity Criteria for Adverse Events (CTCAE) v4.03; except for neuropathy, dysphagia, alopecia or vitiligo prior to tumor resection.
  • Patients with documented Grade 2 or greater diarrhea or colitis as a result of previous immunotherapy within six months from screening.
  • Patients who have a contraindication to or history of hypersensitivity reaction to cyclophosphamide, mesna, fludarabine, IL-2, antibiotics of the aminoglycoside group, any component of the TIL infusion product formulation including dimethylsulfoxide (DMSO), human serum albumin (HSA), IL-2, and dextran-40.
  • Patients with active systemic infections, coagulation disorders or other active major medical illnesses of the cardiovascular, respiratory or immune system.
  • Patients with symptomatic and/or untreated brain metastases.
  • Have any form of primary or acquired immunodeficiency syndrome, such as severe combined immunodeficiency disease or acquired immune deficiency syndrome (AIDS).
  • Diagnosis of end-stage renal disease requiring hemodialysis.
  • Patients who have a left ventricular ejection fraction (LVEF) < 45% or who are New York Heart Association (NYHA) Class 2 or higher.
  • Patients who have a forced expiratory volume in one second (FEV1) of less than 60% of predicted normal; or walk a distance less than 80% predicted in a 6-minute walk test or demonstrate evidence of hypoxia at any point during the test.
  • Patients who have had another primary malignancy within the previous 3 years.
  • Patients who are pregnant, parturient, or breastfeeding women.
  • Patients who have received a live or attenuated vaccine within 28 days of the NMA-LD regimen.
  • Patients whose cancer requires immediate treatment or who would otherwise suffer a disadvantage by participating in this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03083873

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Contact: Iovance Biotherapeutics Study Team 866-565-4410

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Sponsors and Collaborators
Iovance Biotherapeutics, Inc.
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Study Director: Iovance Biotherapeutics Medical Monitor Iovance Biotherapeutics

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Responsible Party: Iovance Biotherapeutics, Inc. Identifier: NCT03083873     History of Changes
Other Study ID Numbers: C-145-03
2016-003446-86 ( EudraCT Number )
First Posted: March 20, 2017    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Iovance Biotherapeutics, Inc.:
Cell Therapy
Autologous Adoptive Cell Transfer
Autologous Adoptive Cell Therapy
Cellular Immuno-therapy
Tumor Infiltrating Lymphocytes
Additional relevant MeSH terms:
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Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site