Vemurafenib + ACT + IL-2 for Melanoma
What You Need to Know Before You Apply
What is the purpose of this trial?
The purpose of this study is to find out more about the effects of an investigational combination of medicines, which includes special immune cells (T-cells).A T-cell is a type of lymphocyte, or white blood cell. Lymphocytes are a kind of white blood cell that protect the body from viral infections, help other cells fight bacterial and fungal infections, produce antibodies, fight cancers, and coordinate the activities of other cells in the immune system.
Who Is on the Research Team?
Amod Sarnaik, M.D.
Principal Investigator
H. Lee Moffitt Cancer Center and Research Institute
Are You a Good Fit for This Trial?
This trial is for adults with stage III or IV melanoma that can't be removed by surgery. They should have good physical health, a specific type of mutation in their cancer (B-RAF V600), and no serious heart rhythm problems. Pregnant women, those with significant psychiatric illness, certain brain metastases, previous BRAF inhibitor treatment, or active infections are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive vemurafenib for about three weeks while T-cells are being grown in the lab, followed by lymphodepletion with chemotherapy, TIL infusion, and high dose IL-2
Follow-up
Participants are monitored for safety and effectiveness after treatment, with evaluations at month 12
Extension
Participants may continue vemurafenib treatment for up to two years
What Are the Treatments Tested in This Trial?
Interventions
- ACT with TIL Infusion
- High Dose Interleukin-2 (IL-2)
- Lymphodepletion
- Vemurafenib
Find a Clinic Near You
Who Is Running the Clinical Trial?
H. Lee Moffitt Cancer Center and Research Institute
Lead Sponsor