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CAR T-cell Therapy

Lifileucel + Chemo for Melanoma

Phase 2

Recruiting

Led By Muhammad Umair Mushtaq

Research Sponsored by University of Kansas Medical Center

Eligibility Criteria Checklist

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

Must have

At least one resectable lesion (or aggregate of lesions resected) of a minimum 1.5 cm in diameter post-resection to generate TIL; surgical removal with minimal morbidity (defined as any procedure for which expected hospitalization is ≤ 3 days)

Patients with unresectable or metastatic melanoma (stage IIIc or stage IV)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from start of treatment to death due to any cause, up to 2 years

Awards & highlights

Study Summary

This trial tests if Lifileucel and chemo can help treat unresectable/metastatic melanoma. Lifileucel are specialized immune cells grown in a lab from a patient's tumor then infused back.

Who is the study for?

This trial is for adults with unresectable or metastatic melanoma who have progressed after 1-3 systemic therapies, including a PD-1 inhibitor. If they have a BRAF V600 mutation, they must have had BRAF/MEK inhibitors. They need at least one measurable lesion and good organ function. Exclusions include primary immunodeficiency, severe lung function impairment, untreated brain metastases, certain heart conditions, pregnancy/breastfeeding, and recent other cancers.Check my eligibility

What is being tested?

The trial tests Lifileucel (T cells from the patient's tumor) combined with reduced doses of Fludarabine and Cyclophosphamide for lymphodepletion plus Interleukin-2 in patients with advanced melanoma. It aims to see if this approach helps the immune system attack the cancer more effectively.See study design

What are the potential side effects?

Potential side effects may include reactions related to immune cell infusion such as fever or chills; effects from chemotherapy like nausea or low blood counts; hormonal imbalances managed by replacement therapy; and general symptoms like fatigue.

Eligibility Criteria

Inclusion Criteria

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

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I have a tumor that can be surgically removed and is at least 1.5 cm big.

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My melanoma cannot be removed by surgery and is advanced.

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I've had 1-3 treatments for my cancer, including one targeting PD-1, and if applicable, a BRAF inhibitor.

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I am fully active or can carry out light work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from start of treatment to death due to any cause, up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from start of treatment to death due to any cause, up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from start of treatment to death due to any cause, up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of total T-cell receptor (TCR) populations shared between the TIL product and peripheral blood mononuclear cells (PBMCs)

Secondary outcome measures

Length of hospital stay

Overall response rate

Overall survival

+4 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (Lifileucel)Experimental Treatment9 Interventions

Lifileucel (LN-144) is an autologous Tumor Infiltrating Lymphocytes (TIL) cell therapy. A tumor sample is resected from each patient for lifileucel manufacturing. Patients then receive the lifileucel regimen which consists of a reduced dose non-myeloablative lymphodepletion, lifileucel infusion followed by interleukin-2.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 2

~1700

Cyclophosphamide

1995

Completed Phase 3

~3770

Echocardiography

2013

Completed Phase 4

~11670

Fludarabine

2012

Completed Phase 3

~1100

Interleukin-2

1994

Completed Phase 3

~700

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Kansas Medical CenterLead Sponsor

463 Previous Clinical Trials

169,258 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,672 Previous Clinical Trials

40,926,429 Total Patients Enrolled

4 Trials studying Cutaneous Melanoma

198 Patients Enrolled for Cutaneous Melanoma

Iovance Biotherapeutics, Inc.Industry Sponsor

20 Previous Clinical Trials

1,684 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are octogenarians eligible for entry into this research?

"This trial is recruiting patients over the age of 18 and under 70 years old."

Answered by AI

Are there any opportunities for participants to join the clinical trial at this time?

"Per the information on clinicaltrials.gov, enrollment for this trial has closed. This experiment was first made available on November 27th 2023 and had its last update also recorded then; however, there are still 773 other medical studies open to prospective participants at present."

Answered by AI

Has the Food and Drug Administration granted authorization for Lifileucel to be used as a therapeutic option?

"Lifileucel has some safety data from a Phase 2 trial, but no efficacy information is available yet. Therefore, we assign it a score of two on the risk scale."

Answered by AI