Vemurafenib + ACT + IL-2 for Melanoma

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Must not be taking: Immunosuppressants, Steroids

Disqualifiers: Infections, Autoimmune diseases, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 3 weeks for initial vemurafenib, followed by additional treatment phases

17 Participants Needed

Trial Summary

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.

Research Team

Amod Sarnaik, M.D.

Principal Investigator

H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria

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

I tested positive for Epstein-Barr Virus antibodies.

My largest cancer lesion is bigger than 1 cm or I have more than 3 lesions, but my brain scans show no worsening after treatment.

I am a woman who can have children and have a negative pregnancy test.

Exclusion Criteria

I have not had cancer other than melanoma in the last 2 years.

I have up to 3 untreated brain tumors, with at least one larger than 1 cm or causing swelling.

I do not have any active infections needing IV antibiotics or major illnesses affecting my heart, lungs, or immune system.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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

3 weeks for initial vemurafenib, followed by additional treatment phases

Follow-up

Participants are monitored for safety and effectiveness after treatment, with evaluations at month 12

12 months

Extension

Participants may continue vemurafenib treatment for up to two years

Up to 24 months

Treatment Details

Interventions

• ACT with TIL Infusion
• High Dose Interleukin-2 (IL-2)
• Lymphodepletion
• Vemurafenib

Trial Overview The study tests a combination therapy for advanced melanoma involving lymphodepletion (weakening the immune system), T-cell infusion (ACT with TIL), high-dose IL-2 to boost immunity, and Vemurafenib targeting cancer cells. It aims to see how well these treatments work together.

Participant Groups

Group I: Combination Therapy Experimental Treatment 4 Interventions

Combination Chemotherapy and Immunotherapy. The combination of vemurafenib followed by lymphodepletion with chemotherapy, Adoptive Cell Therapy (ACT) with Tumor Infiltrating Lymphocytes (TIL) infusion, and High Dose Interleukin-2 (IL-2).

Who Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials

576

Recruited

145,000+