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

This study is currently recruiting participants.
Verified October 2017 by Iovance Biotherapeutics, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03108495
First Posted: April 11, 2017
Last Update Posted: October 31, 2017
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.
Information provided by (Responsible Party):
Iovance Biotherapeutics, Inc.
  Purpose
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 Intervention Phase
Cervical Carcinoma Biological: LN-145 Phase 2

Study Type: Interventional
Study Design: 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

Further study details as provided by Iovance Biotherapeutics, Inc.:

Primary Outcome Measures:
  • Objective Response Rate [ Time Frame: Up to 24 months ]
    To evaluate the efficacy of LN-145 using objective response rate


Secondary Outcome Measures:
  • Adverse Events [ Time Frame: up to 6 months ]
    Incidence of treatment-emergent AEs (TEAEs), including SAEs, therapy-related AEs, AEs leading to early discontinuation of treatment, withdrawal from study or death

  • Complete Response Rate [ Time Frame: Up to 24 months ]
    To evaluate efficacy parameters such Complete Response (CR) rate

  • Duration of Response [ Time Frame: Up to 24 months ]
    To evaluate efficacy parameters such Duration of Response (DOR)

  • Disease Control Rate [ Time Frame: Up to 24 months ]
    To evaluate efficacy parameters such Disease Control Rate (DCR) rate

  • Progression-Free Survival [ Time Frame: Up to 24 months ]
    To evaluate efficacy parameters such Progression-Free Survival (PFS)

  • Overall Survival [ Time Frame: Up to 24 months ]
    To evaluate efficacy parameters such Overall Survival (OS)


Estimated Enrollment: 47
Actual Study Start Date: June 22, 2017
Estimated Study Completion Date: December 2023
Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Must be greater than 18 years of age at the time of consent.
  • Must have metastatic, recurrent or persistent squamous cell carcinoma, adenosquamous carcinoma or adenocarcinoma of the cervix, which is not amenable to curative treatment with surgery and/or radiation therapy.
  • Must have had at least 1 prior systemic immunotherapy or chemotherapeutic treatment for cervical carcinoma. Patients must have either progressive disease or no response (i.e., no PR or CR) while receiving or after the completion of the most recent prior treatment.
  • Any prior therapy directed at the malignant tumor, including radiation therapy, chemotherapy, biologic/targeted agents and immunologic agents must be discontinued at least 28 days prior to tumor resection.
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Patients must be seronegative for the HIV antibody, hepatitis B antigen, and hepatitis C antibody or antigen.
  • 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 prior cell transfer therapy, which includes non-myeloablative or myeloablative chemotherapy regimen.
  • Patients who are on a systemic steroid therapy (greater than 10 mg of prednisone or equivalent daily).
  • 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.
  • Patients with documented Grade 2 or greater diarrhea or colitis as a result of previous immunotherapy within six months from screening.
  • Patients with history of severe immediate hypersensitivity reaction to cyclophosphamide, fludarabine, IL-2, or aminoglycosides (e.g., gentamicin or streptomycin).
  • 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 (of any size and any number).
  • Have any form of primary immunodeficiency, such as severe combined immunodeficiency disease or acquired immune deficiency syndrome (AIDS).
  • Diagnosis of end-stage renal disorder requiring hemodialysis.
  • Patients who have a left ventricular ejection fraction (LVEF) < 45%.
  • Patients who have a FEV1 (forced expiratory volume in one second) of less than or equal to 60% of normal.
  Contacts and Locations
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

Locations
United States, Florida
Iovance Cervical Investigative Site Recruiting
Miami, Florida, United States, 33136
Iovance Cervical Investigative Site Recruiting
Tampa, Florida, United States, 33612
United States, Illinois
Iovance Cervical Investigative Site Recruiting
Chicago, Illinois, United States, 60637
United States, New York
Iovance Cervical Investigative Site Recruiting
Buffalo, New York, United States, 14263
United States, Ohio
Iovance Cervical Investigative Site Recruiting
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Iovance Cervical Investigative Site Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Sponsors and Collaborators
Iovance Biotherapeutics, Inc.
Investigators
Study Director: Iovance Medical Monitor Iovance Biotherapeutics, Inc.
  More Information

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 Submitted: March 27, 2017
First Posted: April 11, 2017
Last Update Posted: October 31, 2017
Last Verified: October 2017
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