Immunotherapy + Adoptive Cell Therapy for Melanoma

Recruiting in Palo Alto (17 mi)

Overseen byAmod Sarnaik, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?Purpose of this Pilot Study: The investigators want to study the safety, side effects, and benefits of tumor infiltrating lymphocytes (TILs), when they are given with the drug ipilimumab. Ipilimumab is a type of immunotherapy - a drug that is used to boost the ability of the immune system to fight cancer, infection, and other diseases.

Eligibility Criteria

This trial is for adults with stage III or IV melanoma that hasn't spread to more than three areas in the brain. They can't have had ipilimumab before but may have had other treatments. Participants need good organ function and performance status, not be pregnant, agree to use contraception, and cannot have certain medical conditions or a history of severe autoimmune disease.

Inclusion Criteria

I do not have serious heart rhythm problems.

All laboratory and imaging studies must be completed and satisfactory within 30 days of signing the consent document, with specific exceptions

My tumor may have a BRAF mutation, and I haven't been treated with ipilimumab.

+10 more

Exclusion Criteria

My brain scans show no growth in my cancer 90 days after treatment for more than 3 or larger than 1 cm brain tumors.

I am taking immunosuppressive drugs for an autoimmune disease.

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

+11 more

Participant Groups

The study tests combining TIL (a type of white blood cell) therapy with ipilimumab (an immunotherapy drug), along with lymphodepletion (lowering white blood cells), high dose IL-2 (a substance that activates immune cells), and adoptive cell transfer to see if this approach is safe and effective against melanoma.

1Treatment groups

Experimental Treatment

Group I: Combination TherapyExperimental Treatment7 Interventions

The combination of ipilimumab followed by lymphodepletion with chemotherapy, TIL infusion, and high dose IL-2.