Vemurafenib + ACT + IL-2 for Melanoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the effects of a new combination treatment for melanoma, a type of skin cancer. The treatment involves vemurafenib, a drug, combined with a special immune cell therapy called Adoptive Cell Therapy (ACT). The focus is on individuals with advanced melanoma that cannot be surgically removed and has specific genetic mutations (B-RAF V600E, D, or K). Participants should have ongoing melanoma despite previous surgeries and may have up to three small untreated brain metastases. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group of people.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. However, if you are on chronic immunosuppressive steroids or medications for autoimmune diseases, you may not be eligible to participate.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that the combination of vemurafenib, ACT with TIL infusion, and high-dose interleukin-2 (IL-2) is generally safe for people. Each component of this treatment has undergone safety studies in humans.
Vemurafenib has proven effective and safe for patients with advanced skin cancer (metastatic melanoma), with no new safety issues over long-term use. One study showed it remained safe for a large group of patients over two years.
ACT with TIL infusion has been reviewed and found to have manageable side effects for patients with advanced melanoma. A review of several studies found it safe when used with high-dose IL-2.
High-dose IL-2 has shown safety for carefully chosen melanoma patients, even those with cancer spread to the brain. It can be used safely if other treatments do not work.
Overall, research suggests that this combination treatment should be well-tolerated in humans. However, individual responses can vary, so discussing potential risks with healthcare providers is important.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the combination therapy of vemurafenib, ACT with TIL infusion, and IL-2 for melanoma because it represents a powerful integration of targeted therapy and immunotherapy. Unlike standard treatments such as single-agent chemotherapy or immune checkpoint inhibitors like pembrolizumab, this regimen uses vemurafenib to target the specific BRAF mutation found in many melanoma patients, which can help shrink tumors. Additionally, the use of Tumor Infiltrating Lymphocytes (TIL) in Adoptive Cell Therapy enhances the body's immune response by expanding the patient's own immune cells to attack cancer more effectively. Finally, high-dose IL-2 boosts the immune system, enhancing the effectiveness of the treatment. This multi-faceted approach offers a promising new avenue for patients who may not respond to existing therapies.
What evidence suggests that this trial's treatments could be effective for melanoma?
Research shows that vemurafenib can extend the lives of melanoma patients with the BRAF V600E mutation. It controls the disease in 79% of patients and reduces tumors in more than half of those treated. In this trial, participants will receive a combination therapy that includes vemurafenib, lymphodepletion, ACT (Adoptive Cell Therapy) using TIL (Tumor Infiltrating Lymphocytes), and high-dose interleukin-2 (IL-2). Studies have shown that ACT is effective for melanoma, with up to 50% of patients responding well. High-dose IL-2 has been used for advanced melanoma, with some patients experiencing positive results and even complete tumor disappearance. These treatments work together to enhance the body's immune system to fight melanoma more effectively. Overall, they aim to improve outcomes for patients with advanced melanoma.56789
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