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Study of LN-145, Autologous Tumor Infiltrating Lymphocytes in the Treatment of Patients With Cervical Carcinoma

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ClinicalTrials.gov Identifier: NCT03108495
Recruitment Status : Recruiting
First Posted : April 11, 2017
Last Update Posted : December 6, 2018
Sponsor:
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, metastatic, or persistent cervical carcinoma

Condition or disease Intervention/treatment Phase
Cervical Carcinoma 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, metastatic, or persistent cervical carcinoma. 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.

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 Using Autologous Tumor Infiltrating Lymphocytes (LN-145) in Patients With Recurrent, Metastatic or Persistent Cervical Carcinoma
Actual Study Start Date : June 22, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : June 2024

Arm Intervention/treatment
Experimental: Single Arm
After NMA lymphodepletion, patients are infused with their autologous TIL (LN-145) followed by IL-2 administration
Biological: LN-145
A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes.
Other Name: TIL, autologous tumor infiltrating lymphocytes




Primary Outcome Measures :
  1. Objective Response Rate [ Time Frame: 6 months ]
    To evaluate the efficacy of LN-145 in patients with recurrent, metastatic, or persistent cervical carcinoma 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. Adverse Events [ Time Frame: 24 months from infusion of LN-145 ]
    To characterize the safety profile of LN-145 in patients with recurrent, metastatic, or persistent cervical carcinoma

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

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

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

  5. Overall Survival [ Time Frame: Up to 60 months ]
    To evaluate overall survival (OS) in patients with recurrent, metastatic, or persistent cervical carcinoma



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

To be eligible for the study, patients must meet ALL of the following criteria prior to enrollment in the study:

  1. Must be ≥ 18 years of age at the time of consent.
  2. Must have recurrent, metastatic, or persistent squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix that is not amenable to curative treatment with surgery and/or radiation therapy and for which no other therapies are expected to have significant benefit, in the opinion of the Investigator.
  3. Must have at least 1 lesion that is resectable for TIL generation. The resected TIL generating lesion(s) should yield at least 1.5 cm in diameter post-resection of tumor tissue. Following resection for TIL generation, must have a remaining measurable target lesion as defined by RECIST v1.1
  4. Must have had at least 1 and no more than 3 prior systemic chemotherapeutic treatments (such as carboplatin/cisplatin, paclitaxel, and bevacizumab except where there are contraindications) for cervical carcinoma. Patients must have progressive disease while receiving or after the completion of the most recent prior treatment.
  5. Any prior therapy directed at the malignant tumor must be discontinued at least 28 days prior to tumor resection. Radiation therapy may have been received up to 28 days prior to tumor resection for lesions not expected to be used for TIL generation or target lesions.
  6. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  7. Patients must be seronegative for the human immunodeficiency virus (HIV). Patients with positive serology 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.
  8. 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:

  1. Patients who have received an organ allograft or prior cell transfer therapy except for prior LN-145 therapy.
  2. Patients who are on a systemic steroid therapy > 10 mg of prednisone daily or other steroid equivalent.
  3. Patients who currently have prior therapy-related toxicities greater than Grade 1 according to NCI-CTCAE v4.03; except for peripheral neuropathy, alopecia, or vitiligo prior to enrollment/resection.
  4. Patients who have a contraindication to or history of hypersensitivity reaction to any component or excipients of the TIL therapy and the other study drugs.
  5. Patients with active systemic infections, coagulation disorders or other active major medical illnesses of the cardiovascular, respiratory, or immune system.
  6. Patients with symptomatic and/or untreated brain metastases (of any size and any number).
  7. Patients who have any form of primary or acquired immunodeficiency syndrome, such as severe combined immunodeficiency disease or acquired immune deficiency 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 forced expiratory volume in 1 second (FEV1) of less than or equal to 60% of predicted normal.
  11. Patients who have received a live or attenuated vaccine within 28 days of the NMA-LD regimen.
  12. Patients whose cancer requires immediate treatment or who would otherwise suffer a disadvantage by participating in this study.
  13. Patients who have received prior treatment with immunotherapy (eg, anti-PD-1 anti-PD-L1, or anti-CTLA4 antibodies)

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 ClinicalTrials.gov identifier (NCT number): NCT03108495


Contacts
Contact: Iovance Biotherapeutics Clinical Inquiries 650-260-7120 Clinical.Inquiries@iovance.com
Contact: Iovance Biotherapeutics Clinical Inquiries 866-565-4410 Clinical.Inquiries@iovance.com

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

Responsible Party: Iovance Biotherapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03108495     History of Changes
Other Study ID Numbers: C-145-04
2016-003447-11 ( EudraCT Number )
First Posted: April 11, 2017    Key Record Dates
Last Update Posted: December 6, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Iovance Biotherapeutics, Inc.:
LN-145
Cell Therapy
Autologous Adoptive Cell Transfer
Autologous Adoptive Cell Therapy
Cellular Immuno-therapy
Tumor Infiltrating Lymphocytes
TIL
IL-2

Additional relevant MeSH terms:
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms