TIL Therapy + Pembrolizumab for Skin Cancer
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you cannot have had chemotherapy or radiotherapy within 4 weeks before starting the trial, and you should not be on systemic corticosteroids or other immunosuppressive medications within 14 days before the study drug administration.
What data supports the effectiveness of the drug pembrolizumab for skin cancer?
Is TIL Therapy + Pembrolizumab safe for humans?
Pembrolizumab, also known as Keytruda, has been shown to be generally safe in humans, with common side effects including fatigue, rash, itching, and diarrhea. Less common side effects can include thyroid issues, inflammation of the colon (colitis), liver inflammation (hepatitis), and lung inflammation (pneumonitis).36789
How is the TIL Therapy + Pembrolizumab treatment for skin cancer different from other treatments?
This treatment combines lifileucel, a one-time cell therapy using a patient's own immune cells, with pembrolizumab, a drug that helps the immune system attack cancer by blocking a protein called PD-1. This combination is unique because it uses both personalized cell therapy and a checkpoint inhibitor to enhance the body's ability to fight skin cancer.1371011
What is the purpose of this trial?
This phase I/II trial tests the safety and side effects of LN-144 (Lifileucel) and pembrolizumab in treating patients with stage IIIB-D or stage IV melanoma that has spread to nearby tissue or lymph nodes. Biological therapies, such as LN-144 (Lifileucel), use substances made from living organisms that may attack specific tumor cells and stop them from growing or kill them. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving lifileucel and pembrolizumab may make the tumor smaller.
Research Team
Richard C Wu, M.D. Ph.D.
Principal Investigator
Ohio State University Comprehensive Cancer Center
Eligibility Criteria
Adults aged 18-75 with Stage IIIB-D or IV melanoma, accessible for tumor removal and no prior treatments. Must have good performance status, life expectancy over 3 months, and adequate organ function. Women must not be pregnant/breastfeeding; participants need to use contraception.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Neoadjuvant Treatment
Participants receive pembrolizumab, cyclophosphamide, fludarabine, and lifileucel, followed by surgery
Maintenance
Participants receive pembrolizumab every 6 weeks for up to 1 year
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Lifileucel
- Pembrolizumab
Lifileucel is already approved in United States for the following indications:
- 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
Find a Clinic Near You
Who Is Running the Clinical Trial?
Richard Wu
Lead Sponsor
Iovance Biotherapeutics, Inc.
Industry Sponsor