Clinical trial NCT06481592: A Study of Lifileucel (Tumor-infiltrating Lymphocytes) in Adults With Advanced Endometrial Cancer.
Official title: A Phase 2, Multicenter, Open-label Study of Lifileucel (Tumor-infiltrating Lymphocytes [TIL]) in Participants With Previously Treated Advanced Endometrial Cancer.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Endometrial Cancer
Keywords: Tumor Infiltrating Lymphocytes
TIL
Endometrial Cancer
Endometrial
Cell Therapy
Cellular Immunotherapy
IL-2
Non-myeloablative lymphodepletion (NMALD)
Lead sponsor: Iovance Biotherapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2024-07-01
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the efficacy and safety of the lifileucel regimen in participants with previously treated endometrial cancer.

Detailed description: The study will enroll participants with advanced endometrial cancer who previously received treatment with platinum-based chemotherapy and an anti-programmed cell death protein-1 (PD-1)/programmed death ligand 1 (PD-L1) agent in a recurrent or advanced setting, either sequentially or in combination.

Eligibility criteria: Inclusion Criteria:

1. Participants must have a histologically confirmed diagnosis of endometrial carcinoma. All histologies, including carcinosarcoma, will be allowed. Uterine sarcoma will not be allowed.
2. Participants who have received the following previous therapy:

   * Up to 3 lines of systemic therapy with no more than 1 line of chemotherapy for recurrent, metastatic, or primary unresectable disease. Prior hormonal therapy is allowed and do not count as prior lines of therapy.
   * Participants have progressed on or after platinum-based chemotherapy and anti-PD-1/PD-L1 therapy. Platinum-based chemotherapy and anti-PD-1/PD-L1 therapy may have been given together or in separate lines of therapy.
   * Participants must have documented radiographic disease progression during or after the last line of therapy.
3. Participants who have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and estimated life expectancy of \>6 months.
4. Participants having at least one resectable lesion and at least one measurable lesion, following resection of the lesion for TIL generation.
5. Participants who have adequate organ function, including adequate cardiopulmonary function.
6. Participants of childbearing potential must be willing to practice an approved method of highly effective birth control during treatment and up to 12 months after the last dose of study intervention.
7. Participants who are \>70 years of age may be allowed to enroll after the investigator discusses with the medical monitor.

Exclusion Criteria:

1. Participants who have symptomatic untreated brain metastases.
2. Participants who have had a history of allogeneic organ transplant or any form of cell therapy involving prior conditioning chemotherapy within the past 20 years.
3. Participants who require systemic steroid therapy \> 10 mg/day prednisone or another steroid equivalent dose.
4. Participants who have any form of primary immunodeficiency.
5. Participants who have another primary malignancy within the previous 3 years.
6. Participants who have received or will receive a live or attenuated vaccination within 28 days prior to the start of the NMALD.

Primary outcomes:
measure: Objective Response Rate
timeFrame: Up to 5 Years
Secondary outcomes:
measure: Complete Response Rate
timeFrame: Up to 5 Years
measure: Duration of Response
timeFrame: Up to 5 Years
measure: Disease Control Rate
timeFrame: Up to 5 Years
measure: Progression-Free Survival
timeFrame: Up to 5 Years
measure: Overall Survival
timeFrame: Up to 5 Years
measure: Adverse Events
timeFrame: Up to 5 Years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Louisville
country: United States
facility: UofL Health - Brown Cancer Center
state: Kentucky
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Hospital
state: Michigan
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: Oklahoma City
country: United States
facility: University of Oklahoma
state: Oklahoma
city: Pittsburgh
country: United States
facility: Allegheny Health
state: Pennsylvania
city: Houston
country: United States
facility: MD Anderson Cancer Center - U of Texas
state: Texas
Study officials:
affiliation: Iovance Biotherapeutics
name: Iovance Biotherapeutics Study Team
role: STUDY_DIRECTOR
References: