Your session is about to expire
← 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Participant Drop Out Rate
Percentage of Participants With Overall Response (OR)
Secondary outcome measures
Number of Participants With Progression Free Survival (PFS)
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
~3100
Find a Location
Who is running the clinical trial?
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
543 Previous Clinical Trials
135,465 Total Patients Enrolled
43 Trials studying Melanoma
3,201 Patients Enrolled for Melanoma
Amod Sarnaik, M.D.Principal InvestigatorH. Lee Moffitt Cancer Center and Research Institute
3 Previous Clinical Trials
43 Total Patients Enrolled
3 Trials studying Melanoma
43 Patients Enrolled for Melanoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had cancer other than melanoma in the last 2 years.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.I have up to 3 untreated brain tumors, with at least one larger than 1 cm or causing swelling.I have advanced melanoma that cannot be surgically removed and am considered a good candidate for a specific type of immunotherapy.My tumor has a specific B-RAF mutation.I may or may not have received treatment for my advanced cancer.I have up to 3 small brain tumors (less than 1 cm) without swelling, confirmed by a brain scan.I do not have any active infections needing IV antibiotics or major illnesses affecting my heart, lungs, or immune system.I have tested positive for HIV, Hepatitis B or C, HTLV I/II, or syphilis.I have more than 3 untreated brain metastases or swelling around the tumor.I agree to use two forms of birth control while on Vemurafenib and for 6 months after.I am a male agreeing to use two forms of birth control with my partner during and 6 months after Vemurafenib treatment.You have a serious mental health condition.I still have visible cancer after surgery to remove some of it for treatment.I have congenital long QT syndrome.My brain scans show no growth in cancer after treatment for more than 3 months.My heart's electrical activity is normal, with no history of long QT syndrome.I have had treatment for up to 3 brain metastases.I cannot swallow pills.My kidney, liver, and blood functions are all within normal ranges.I have been treated with a BRAF inhibitor before.You won't be excluded from the study just because you have allergies to antibiotics.I am fully active or restricted in physically strenuous activity but can do light work.I am unable to understand and agree to the study's details.I do not have serious heart rhythm problems.I have an autoimmune disease and take medication to suppress my immune system.I need to take steroids every day for my immune system.
Research Study Groups:
This trial has the following groups:- Group 1: Combination Therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger