LN-144 + Pembrolizumab for Melanoma
Trial Summary
Do I need to stop my current medications to join the trial?
The trial requires a washout period of at least 21 days from any prior anti-cancer therapies before starting the new treatment. However, it does not specify if you need to stop other medications, so it's best to discuss your current medications with the trial team.
What data supports the effectiveness of the drug LN-144 + Pembrolizumab for treating melanoma?
Research shows that pembrolizumab, a part of this treatment, has strong antitumor effects and is safe for patients with advanced melanoma, including those with aggressive forms. It has been effective in patients who did not respond to other treatments, providing long-term disease control for some.12345
Is the combination of LN-144 and Pembrolizumab safe for treating melanoma?
What makes the treatment LN-144 + Pembrolizumab unique for melanoma?
LN-144 (Lifileucel) is a type of cell therapy that uses a patient's own immune cells to fight cancer, which is different from traditional drugs like pembrolizumab that block proteins to boost the immune response. This combination aims to enhance the body's ability to attack melanoma by using both personalized cell therapy and immune checkpoint inhibition.134810
What is the purpose of this trial?
The purpose of this study is to evaluate the efficacy of adjuvant adoptive cell therapy (ACT) via infusion of LN-144 (autologous TIL) followed by interleukin-2 (IL-2) after a nonmyeloablative lymphodepletion (NMA-LD) preparative regimen, followed by Pembrolizumab.
Research Team
James Isaacs, MD
Principal Investigator
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Eligibility Criteria
This trial is for adults over 18 with high-risk Stage III melanoma that can be surgically removed. They should have a life expectancy of at least 3 months, good performance status (able to carry out daily activities), and no prior immunotherapy. Participants need one tumor lesion suitable for TIL harvesting and adequate organ function. Those who've had recent cancer treatments must wait at least 21 days before joining.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Harvest and Production
Surgical resection of tumor tissue to provide autologous tissue for LN-144 production at a GMP facility
Nonmyeloablative Lymphodepletion
A 5-day nonmyeloablative lymphodepletion (NMA-LD) preparative regimen
Treatment
Infusion of LN-144 product followed by administration of IV interleukin-2 (IL-2) for ≤ 6 doses and pembrolizumab every 3 weeks for up to 1 year
Follow-up
Participants are monitored for safety and effectiveness after treatment, including relapse-free survival and overall survival
Treatment Details
Interventions
- LN-144
- Pembrolizumab
LN-144 is already approved in United States for the following indications:
- Advanced unresectable or metastatic melanoma who progressed on or after prior anti–PD-1/L1 therapy and targeted therapy
Find a Clinic Near You
Who Is Running the Clinical Trial?
James Isaacs, MD
Lead Sponsor
Iovance Biotherapeutics, Inc.
Industry Sponsor