Lifileucel for Skin Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test a new treatment called lifileucel for individuals with advanced melanoma, a type of skin cancer that has spread or cannot be removed. Researchers seek to determine how effectively lifileucel slows or stops the cancer after other treatments have failed. This trial suits those diagnosed with Stage IIIC, IIID, or IV melanoma who have not responded to treatments like immunotherapy. As a Phase 2 trial, it measures lifileucel's effectiveness in an initial, smaller group, offering a chance to benefit from a promising new treatment.
Do I need to stop my current medications to join the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
Is there any evidence suggesting that lifileucel is likely to be safe for humans?
Research shows that lifileucel is generally well-tolerated by patients with advanced melanoma. Studies have found that this treatment can provide long-lasting benefits in fighting cancer. The FDA has already approved lifileucel for melanoma that has spread or cannot be removed by surgery, indicating its safety for similar conditions.
In previous research, patients who received lifileucel experienced some side effects, but these were manageable. Common side effects included tiredness, fever, and chills, which are typical with cell therapies. While serious side effects can occur, they are less common, and healthcare teams are prepared to handle them.
Overall, lifileucel has demonstrated a promising safety record in patients who have tried other treatments without success. This information may help in deciding if joining this clinical trial is right for you.12345Why do researchers think this study treatment might be promising?
Lifileucel is unique because it uses tumor-infiltrating lymphocytes (TILs) to fight skin cancer. Unlike traditional treatments like chemotherapy or targeted therapies that attack cancer cells directly, Lifileucel harnesses the body's own immune cells to target and destroy the cancer. This approach can potentially offer a more personalized and effective treatment by amplifying the body's natural defenses against the tumor. Researchers are excited because Lifileucel could provide an option for patients whose cancers have not responded to existing treatments, offering new hope in the fight against skin cancer.
What evidence suggests that lifileucel might be an effective treatment for advanced melanoma?
Research has shown that lifileucel, a treatment for advanced melanoma, delivers promising results. In one study, 31.4% of patients experienced a significant reduction in tumor size. Another study found that 79.3% of patients saw tumor shrinkage, with some showing further improvement over time. Lifileucel achieved a confirmed response rate of 65.2%, with some patients' tumors completely disappearing. The treatment offers lasting benefits, with some patients living longer. This suggests that lifileucel may be effective for those with advanced melanoma who have already tried other treatments.12346
Are You a Good Fit for This Trial?
Adults with advanced melanoma who've had disease progression after anti-PD-(L)1 treatment or BRAF inhibitors (if applicable), have a resectable lesion for TIL generation, good organ function, and an ECOG status of 0 or 1. They must not have untreated brain metastases, uveal/ocular melanoma, severe illnesses, immunodeficiency, recent malignancies, active uveitis requiring treatment.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive lifileucel treatment regimen for advanced melanoma
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Lifileucel
Trial Overview
The trial is testing Lifileucel (Tumor-infiltrating Lymphocytes - TIL) in adults with advanced melanoma that has progressed despite previous treatments. It's an open-label Phase 2 study where all participants receive the experimental therapy.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Lifileucel
Find a Clinic Near You
Who Is Running the Clinical Trial?
Iovance Biotherapeutics, Inc.
Lead Sponsor
Citations
Long-Term Efficacy and Safety of Lifileucel Tumor ...
In the registrational C-144-01 study, patients who received lifileucel had an objective response rate (ORR) of 31.4%. ... We report 5-year ...
Long-Term Efficacy and Safety of Lifileucel Tumor ...
Overall, 79.3% of patients had tumor burden reduction; 16 had deepened responses with four converting from PR to CR > 1 year after lifileucel ...
Efficacy and safety of lifileucel, an autologous tumor- ...
Confirmed ORR was 65.2% (15/23), including 30.4% (7/23) CR, 34.8% (8/23) PR, and 26.1% (6/23) SD. Median time to initial response was 2.6 months. All evaluable ...
Efficacy and safety of lifileucel, an autologous tumor- ...
Confirmed ORR was 63.6% (14/22), including 22.7% (5/22) CR and 40.9% (9/22) PR; 6 pts (27.3%) had SD. Median time to initial response was 2.5 months. All ...
Lifileucel Shows Durable 5-Year Benefit in Advanced ...
The data showed that one-time lifileucel therapy produced durable responses, with a 5-year overall survival rate of 19.7%. 1 Notably, after the ...
AMTAGVI (Lifileucel) Learn about AMTAGVI (Lifileucel)
AMTAGVI® is the first and only FDA-approved one-time T cell therapy treatment for people with previously treated melanoma that has spread or cannot be removed ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.