← Back to Search

Cell Therapy

Vemurafenib + ACT + IL-2 for Melanoma

Phase 2

Waitlist Available

Led By Amod Sarnaik, M.D.

Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must have a positive screening Epstein-Barr Virus (EBV) antibody titre on screening test

Tumor must have a B-RAF V600E, D or K mutation by pyrosequencing, Cobas assay, or equivalent

Must not have

Patients with ≤ 3 untreated CNS metastases but with at least one lesion >1 cm or peri-tumoral edema

Patients with active systemic infections requiring intravenous antibiotics, coagulation disorders or other major medical illness of the cardiovascular, respiratory or immune system

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will test the effects of an investigational combination of medicines, which includes special immune cells (T-cells), on people with cancer.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include reactions from weakening the immune system like infections; fatigue from high-dose IL-2; skin issues, joint pain and heart risks from Vemurafenib; plus general risks associated with receiving new immune cells.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I tested positive for Epstein-Barr Virus antibodies.

Select...

My tumor has a specific B-RAF mutation.

Select...

I still have visible cancer after surgery to remove some of it for treatment.

Select...

My heart's electrical activity is normal, with no history of long QT syndrome.

Select...

I am fully active or restricted in physically strenuous activity but can do light work.

Select...

I do not have serious heart rhythm problems.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Select...

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

Select...

I have tested positive for HIV, Hepatitis B or C, HTLV I/II, or syphilis.

Select...

I have more than 3 untreated brain metastases or swelling around the tumor.

Select...

I have congenital long QT syndrome.

Select...

My brain scans show no growth in cancer after treatment for more than 3 months.

Select...

I cannot swallow pills.

Select...

I have been treated with a BRAF inhibitor before.

Select...

I am unable to understand and agree to the study's details.

Select...

I have an autoimmune disease and take medication to suppress my immune system.

Select...

I need to take steroids every day for my immune system.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of Participant Drop Out Rate

Percentage of Participants With Overall Response (OR)

Secondary study objectives

Number of Participants With Progression Free Survival (PFS)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Combination TherapyExperimental Treatment4 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).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Vemurafenib

2015

Completed Phase 3

~3550

0 / 17Eligibility criteria met