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Study of Autologous Tumor Infiltrating Lymphocytes (LN-145) In Combo With Durvalumab in Non-Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT03419559
Recruitment Status : Recruiting
First Posted : February 2, 2018
Last Update Posted : December 10, 2018
Sponsor:
Information provided by (Responsible Party):
Iovance Biotherapeutics, Inc.

Brief Summary:
This study is a Phase 2, open-label, multicenter study evaluating adoptive cell therapy (ACT) with autologous TIL therapy (LN-145) in combination with Anti-PD-L1 inhibitor durvalumab.

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Biological: LN-145 Drug: Durvalumab 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. The 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study to Assess the Efficacy and Safety of Autologous Tumor Infiltrating Lymphocytes (LN-145) In Combination With Anti-PD-L1 Inhibitor Durvalumab (MEDI4736) in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
Actual Study Start Date : February 28, 2018
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Durvalumab

Arm Intervention/treatment
Experimental: LN-145 in combination with durvalumab
After nonmyeloablative (NMA) lymphodepletion, patients are infused with their autologous TIL (LN-145) followed by IL-2 administration.
Biological: LN-145
adoptive cell therapy (ACT) with autologous TIL therapy
Other Name: TIL, autologous tumor infiltrating lymphocytes

Drug: Durvalumab
PD-L1 antagonist monoclonal antibody
Other Name: MEDI4736




Primary Outcome Measures :
  1. Objective Response Rate [ Time Frame: A maximum of 24 months ]
    To evaluate efficacy using the objective response rate (ORR)

  2. ≥ Grade 3 Treatment-Emergent Adverse Event [ Time Frame: A maximum of 24 months ]
    To evaluate the safety as measured by any ≥ Grade 3 treatment-emergent adverse event (TEAE) rate


Secondary Outcome Measures :
  1. Duration of Response [ Time Frame: A maximum of 24 months ]
    To further evaluate efficacy such as the duration of response (DOR)

  2. Progression Free Survival [ Time Frame: A maximum of 24 months ]
    To further evaluate efficacy such as progression free survival (PFS)

  3. Overall Survival [ Time Frame: A minimum of 5 years ]
    To further evaluate efficacy such as overall survival (OS)



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

Inclusion Criteria:

  • Confirmed diagnosis of Stage III or Stage IV NSCLC and progressed after ≤ 3 lines of prior systemic therapy in the locally advanced or metastatic setting
  • Have at least 1 lesion resectable for TIL generation
  • Measurable disease as defined by RECIST v1.1
  • Male or female, ≥ 18 years of age
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and estimated life expectancy of ≥ 3 months
  • Adequate bone marrow function at screening
  • Adequate organ function at screening
  • A washout period from prior anticancer therapy(ies) of a minimum duration is required prior to first study treatment
  • Recovered from all prior anticancer therapy-related AEs to Grade 1 or less (per CTCAE v4.03) prior to enrollment
  • Female patients of childbearing potential and male patients with partners of childbearing potential patient must agree to use contraception while on study and during the timeframes as specified following the last dose of study drug(s) received, or until the first dose of the subsequent anticancer therapy, whichever is longer
  • Evidence of postmenopausal status or negative urine or serum pregnancy test for female premenopausal patients

Exclusion Criteria:

  • History of other malignancies, except for the following: adequately treated nonmelanoma skin cancer, curatively treated in-situ cancer of the cervix, curatively-treated thyroid cancer, or other solid tumors curatively treated with no evidence of disease for ≥ 3 years
  • Patients who have received prior cell therapy
  • Patients who have received prior checkpoint inhibitors: such as anti-PD-1, anti-PD-L1 inhibitors, and durvalumab
  • Active or prior documented autoimmune or inflammatory disorders
  • History of primary or acquired immunodeficiency syndrome, history of allogeneic organ transplant that requires therapeutic immunosuppression
  • Received live or attenuated vaccination within 28 days prior to the start of NMA-LD
  • Patients with a history of hypersensitivity to any component of the study drugs
  • Mean QT interval ≥ 470 msec
  • Patients who have a left ventricular ejection fraction (LVEF) of < 45% or who are New York Heart Association (NYHA) Class 2 or higher
  • Serious illnesses or medical conditions, which would pose increased risk for study participation and/or compliance with the protocol
  • Patients who have obstructive or restrictive pulmonary disease and have a documented FEV1 (forced expiratory volume in 1 second) of ≤ 60%
  • Active central nervous system metastases and/or leptomeningeal disease
  • Female patients who are pregnant or breastfeeding
  • Active infection including tuberculosis (TB), hepatitis B, hepatitis C, or HIV
  • Current or prior use of immunosuppressive medication within 28 days before the first dose of study treatment, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid

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): NCT03419559


Contacts
Contact: Iovance Biotherapeutics Clinical Inquiries 866-565-4410 clinical.inquiries@iovance.com

Locations
United States, California
University of California San Diego, Moores Cancer Center Recruiting
La Jolla, California, United States, 92093
University of California, Los Angeles, Santa Monica Hematology/Oncology Recruiting
Los Angeles, California, United States, 90095
United States, Kentucky
University of Louisville James Graham Brown Cancer Center Recruiting
Louisville, Kentucky, United States, 40202
United States, Michigan
Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
United States, New Jersey
Morristown Medical Center Atlantic Hematology Oncology Recruiting
Morristown, New Jersey, United States, 07960
United States, Oregon
Providence Cancer Center Oncology and Hematology Care Clinic Active, not recruiting
Portland, Oregon, United States, 97213
United States, Pennsylvania
UPMC Cancer Center Recruiting
Pittsburgh, Pennsylvania, United States, 15232
United States, Tennessee
Vanderbilt University Recruiting
Nashville, Tennessee, United States, 37232
United States, Washington
University of Washington Medical Center Recruiting
Seattle, Washington, United States, 98195-0001
Sponsors and Collaborators
Iovance Biotherapeutics, Inc.
Investigators
Study Director: Iovance Medical Monitor Iovance Biotherapeutics, Inc.

Responsible Party: Iovance Biotherapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03419559     History of Changes
Other Study ID Numbers: IOV-LUN-201
First Posted: February 2, 2018    Key Record Dates
Last Update Posted: December 10, 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
Cellular Immuno-therapy
TIL
IL-2
Durvalumab

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs