Lifileucel for Endometrial Cancer

Recruiting at 6 trial locations

Overseen By Iovance Biotherapeutics Study Team

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Iovance Biotherapeutics, Inc.

Must not be taking: Systemic steroids

Disqualifiers: Brain metastases, Organ transplant, Immunodeficiency, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6-8 weeks

60 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on systemic steroid therapy greater than 10 mg/day prednisone or equivalent, you may not be eligible to participate.

Research Team

Iovance Biotherapeutics Study Team

Principal Investigator

Iovance Biotherapeutics

Eligibility Criteria

This trial is for adults with advanced endometrial cancer who've had prior treatments, including platinum-based chemo and anti-PD-1/PD-L1 therapy. They should be in good physical condition (ECOG 0 or 1), have a life expectancy over 6 months, at least one resectable lesion for TIL generation, and adequate organ function. Women of childbearing age must use effective birth control.

Inclusion Criteria

I have been diagnosed with endometrial carcinoma, not uterine sarcoma.

I've had up to 3 treatments for my cancer, but only one was chemotherapy.

My cancer progressed after treatments with platinum chemotherapy and anti-PD-1/PD-L1.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive lifileucel (Tumor-infiltrating Lymphocytes) for advanced endometrial cancer

6-8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 5 years

Treatment Details

Interventions

• Lifileucel

Trial Overview The study tests the effectiveness and safety of Lifileucel treatment in participants with previously treated endometrial cancer. It focuses on those whose disease progressed after standard therapies like chemotherapy and immunotherapy.

Participant Groups

Group I: Patients with Endometrial Cancer Experimental Treatment 1 Intervention

Lifileucel is already approved in United States for the following indications:

Approved in United States as Lifileucel for:

• Unresectable or metastatic melanoma in adults who have previously been treated with a PD-1 inhibitor and, if BRAF-positive, a BRAF inhibitor with or without a MEK inhibitor

Who Is Running the Clinical Trial?

Iovance Biotherapeutics, Inc.

Lead Sponsor

Trials

26

Recruited

1,800+