Lifileucel for Metastatic Melanoma

Recruiting in Palo Alto (17 mi)

Overseen by Alexander Shoushtari

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This is an open label study evaluating lifileucel (LN-144) in patients with melanoma brain metastases.

Eligibility Criteria

This trial is for adults with metastatic melanoma that has spread to the brain but isn't causing symptoms. They should have at least one tumor big enough to be removed and used for treatment, be in fairly good health (able to perform daily activities), and not have serious illnesses or conditions that could make participating risky.

Inclusion Criteria

I have melanoma that has spread to my brain but I don't have symptoms.

My blood counts and organ functions are within normal ranges.

I am mostly active and doctors expect me to live for at least 3 more months.

Exclusion Criteria

Pregnant or breastfeeding

Active medical illness(es) that would pose increased risk for protocol participation

I have not received a live vaccine in the last 28 days.

Treatment Details

Interventions

• Lifileucel (LN-144) (CAR T-cell Therapy)

Trial Overview The study is testing Lifileucel (LN-144), a therapy using cells from the patient's own immune system, on patients with melanoma that has spread to their brains. It's an open-label trial, meaning everyone knows they're getting this specific treatment.

Participant Groups

Group I: Participants with Melanoma Brain Metastases Experimental Treatment 1 Intervention

Participants have melanoma brain metastases who will undergo surgical excision to generate LN-144.

Lifileucel (LN-144) is already approved in United States for the following indications:

🇺🇸 Approved in United States as AMTAGVI for:

• Unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation-positive, a BRAF inhibitor with or without a MEK inhibitor

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Memorial Sloan Kettering Cancer Center (All Protocol Activities) New York, NY

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center Lead Sponsor

Iovance Biotherapeutics, Inc. Industry Sponsor

References