TIL + Pembrolizumab for Melanoma
Trial Summary
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that patients must have completed any prior systemic therapy at the time of enrollment, which might imply stopping certain treatments. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the treatment TIL + Pembrolizumab for Melanoma?
Research shows that tumor-infiltrating lymphocytes (TILs) and pembrolizumab, a drug that blocks a protein called PD-1, can help the immune system fight cancer. While studies specifically on melanoma are limited, similar treatments have shown promise in other cancers, suggesting potential benefits for melanoma as well.12345
Is the combination of TIL and Pembrolizumab safe for humans?
Pembrolizumab, also known as KEYTRUDA, has been shown to have a generally acceptable safety profile in various studies, including those for melanoma and multiple myeloma. Some side effects have been reported, such as diarrhea and lung inflammation, but they were manageable and resolved without lasting effects.34678
How is the TIL + Pembrolizumab treatment for melanoma different from other treatments?
The TIL + Pembrolizumab treatment is unique because it combines tumor-infiltrating lymphocytes (TIL), which are immune cells extracted from the patient's own tumor, with pembrolizumab, a drug that helps the immune system attack cancer cells. This combination aims to enhance the body's immune response against melanoma, offering a novel approach compared to standard treatments that typically involve only drugs like pembrolizumab.478910
What is the purpose of this trial?
Background:Cell therapy is an experimental cancer therapy. It takes young tumor infiltrating lymphocytes (Young TIL) cells from a person s tumors and grows them in a lab. Then they are returned to the person. Researchers think adding the drug pembrolizumab might make the therapy more effective.Objective:To test if adding pembrolizumab to cell therapy is safe and effective to shrink melanoma tumors.Eligibility:People ages 18-72 years with metastatic melanoma OF THE SKINDesign:Participants will be screened with:Physical examCT, MRI, or PET scansX-raysHeart and lung function tests if indicatedBlood and urine testsBefore treatment, participants will have:A piece of tumor taken from a biopsy or during surgery in order to grow TIL cellsLeukapheresis: Blood flows through a needle in one arm and into a machine that removes white blood cells.The rest of the blood returns through a needle in the other arm.An IV catheter placed in the chest for getting TIL cells, aldesleukin, and pembrolizumab (if assigned)Participants will stay in the hospital for treatment. This includes:Daily chemotherapy for 1 weekFor some participants, pembrolizumab infusion 1 day after chemotherapyTIL cell infusion 2-4 days after chemotherapy, then aldesleukin infusion every 8 hours for up to 12 dosesFilgrastim injections to help restore your blood countsRecovery for 1-3 weeksAfter treatment, participants will:Take an antibiotic and an antiviral for at least 6 months, as applicableIf assigned, have pembrolizumab treatment every 3 weeks for 3 more doses. They may have another round.Have 2-day follow-up visits every 1-3 months for 1 year and then every 6 months
Research Team
Stephanie L Goff, M.D.
Principal Investigator
National Cancer Institute (NCI)
Eligibility Criteria
Adults aged 18-70 with metastatic melanoma of the skin, who have had at least one prior treatment. Eligible participants may have up to three small, stable brain tumors and must practice birth control. Excluded are those with severe allergies, immune deficiencies, active infections or major illnesses, pregnant or breastfeeding women, and anyone on systemic steroids.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a non-myeloablative lymphodepleting regimen, TIL infusion, and high-dose IL-2. Some participants also receive pembrolizumab.
Recovery
Participants recover from treatment and receive supportive care including filgrastim injections.
Follow-up
Participants are monitored for safety and effectiveness after treatment, with pembrolizumab administered every 3 weeks for 3 more doses if applicable.
Long-term Follow-up
Participants continue to be monitored for progression-free survival and overall survival.
Treatment Details
Interventions
- Pembrolizumab
- Young TIL
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor