Lifileucel for Endometrial Cancer

Recruiting at 11 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called lifileucel, a type of immunotherapy, to evaluate its effectiveness and safety for individuals with endometrial cancer who have previously tried other treatments. Endometrial cancer affects the lining of the uterus, and the trial seeks participants who have undergone at least one, but no more than four, prior therapies, including specific chemotherapy and immunotherapy treatments. Individuals who have experienced tumor growth despite stable disease or who discontinued their last treatment due to side effects might be suitable candidates for this trial. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

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.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that lifileucel has been tested in patients with advanced cancers, such as non-small cell lung cancer (NSCLC). In these studies, lifileucel helped shrink tumors in 25.6% of patients and temporarily halted disease progression in 71.8% of patients. These results are promising.

Regarding safety, side effects were reported but were similar to those expected from treatments that do not completely destroy bone marrow, which is part of the immune system. Lifileucel is still under investigation for endometrial cancer, so its safety for this type of cancer remains under evaluation.

Overall, previous studies suggest that lifileucel can be tolerated by some patients, but side effects may occur, as with most cancer treatments. Prospective trial participants should carefully consider these potential risks and benefits. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Lifileucel is unique because it uses a groundbreaking approach called tumor-infiltrating lymphocyte (TIL) therapy, which harnesses the power of a patient's own immune cells to fight endometrial cancer. Unlike traditional treatments like surgery, radiation, or chemotherapy, which can have widespread effects on the body, Lifileucel specifically targets cancer cells by enhancing the body's natural immune response. Researchers are excited about Lifileucel because it offers a personalized treatment option with the potential for fewer side effects and improved outcomes for patients with endometrial cancer.

What evidence suggests that lifileucel might be an effective treatment for endometrial cancer?

Research has shown that lifileucel, a therapy using tumor-infiltrating lymphocytes (TILs), holds potential for treating various cancers. Although not yet approved for endometrial cancer, it has produced positive results in other cancers, such as melanoma. TIL therapy uses a patient's own immune cells to combat cancer. Early studies suggest this method might also be effective for endometrial cancer. Therefore, this trial examines whether lifileucel can benefit people with this type of cancer. ^{1 2 6 7 8}

Who Is on the Research Team?

Iovance Biotherapeutics Study Team

Principal Investigator

Iovance Biotherapeutics

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06481592

NCT06481592 | A Study of Lifileucel (Tumor-infiltrating ... The purpose of this study is to investigate the efficacy and safety of the lifileucel regimen in participants with previously treated endometrial cancer.

2. gynecologiconcology-online.net gynecologiconcology-online.net/article/S0090-8258(25)00337-3/fulltext

A phase II, multicenter, open-label study of lifileucel (tumor- ... Lifileucel, a tumor-infiltrating lymphocyte (TIL) therapy, has demonstrated clinical responses across anti-PD-(L)1 responsive solid tumor types such as melanoma ...

3. iovance.com iovance.com/clinical-trials/end-201/

END-201 Study Overview Lifileucel is investigational and not approved by any regulatory agency for use in endometrial cancer. Its safety and efficacy in endometrial cancer are still ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0147027225000790

Current perspectives on Lifileucel tumor-infiltrating ... The article explores various mechanisms of TIL treatment, analyzes the clinical data supporting the effectiveness of Lifileucel, and assesses its possible ...

5. mdpi.com mdpi.com/1422-0067/26/15/7151

Feasibility of Manufacturing and Antitumor Activity of TIL for ... Lifileucel, a tumor-infiltrating lymphocyte (TIL) cell therapy approved for advanced melanoma, demonstrates promise for treating other solid tumors, ...

6. targetedonc.com targetedonc.com/view/til-cell-therapy-lifileucel-makes-efficacy-safety-gains-in-advanced-nsclc

TIL Cell Therapy Lifileucel Makes Efficacy, Safety Gains in ... Lifileucel shows a 25.6% objective response rate and 71.8% disease control rate in advanced nonsquamous NSCLC patients, indicating promising ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40454684/

Long-term Efficacy and Safety of Lifileucel Tumor ... Median overall survival (OS) was 13.9 months, with 5-year OS of 19.7%. Adverse events were consistent with nonmyeloablative lymphodepletion and ...

8. theglobeandmail.com theglobeandmail.com/investing/markets/stocks/IOVA/pressreleases/35743891/iovance-biotherapeutics-advances-in-endometrial-cancer-treatment-with-lifileucel-study/

Iovance Biotherapeutics Advances in Endometrial Cancer ... ' The study aims to assess the efficacy and safety of the lifileucel regimen in patients with advanced endometrial cancer who have undergone ...