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CAR T-cell Therapy

Lifileucel + Pembrolizumab for Melanoma

Phase 3
Recruiting
Research Sponsored by Iovance Biotherapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant is assessed as having at least one resectable lesion (or aggregate lesions) for lifileucel generation.
In the investigator's assessment, the participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and an estimated life expectancy of > 6 months.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 years total duration
Awards & highlights

Study Summary

This trial tests a combo therapy for advanced melanoma, with an option for participants to switch to a different therapy if needed.

Who is the study for?
This trial is for adults with untreated, unresectable or metastatic melanoma. They must have at least one lesion suitable for treatment creation, measurable disease, good organ function, and be willing to use effective birth control. Those over 70 may join after extra review. Exclusions include eye-origin melanoma, untreated brain metastases, more than one prior therapy line or any prior therapy for metastatic disease.Check my eligibility
What is being tested?
The study compares the effectiveness of a new combination treatment (Lifileucel plus Pembrolizumab) against Pembrolizumab alone in advanced melanoma patients. Participants are randomly assigned to either group and those on just Pembrolizumab can switch to Lifileucel if their disease progresses.See study design
What are the potential side effects?
Potential side effects may include immune system reactions that could affect various organs, infusion-related responses similar to allergic reactions, tiredness, issues with digestion and blood cells as well as an increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have at least one tumor that can be surgically removed for treatment.
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I am mostly active and my doctor believes I have more than 6 months to live.
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I have at least one tumor that can be measured after surgery.
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My melanoma is at an advanced stage and cannot be surgically removed.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 years total duration
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 years total duration for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective Response Rate and Progression Free Survival
Secondary outcome measures
Adverse Events
Complete Response Rate, Duration of Response and Event Free Survival
Objective Response Rate, Progression Free Survival, Complete Response Rate, Duration of Responses, Event Free Survival and PFS2
+1 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm AExperimental Treatment1 Intervention
Lifileucel plus Pembrolizumab
Group II: Arm BActive Control1 Intervention
Pembrolizumab alone with Optional Crossover Period

Find a Location

Who is running the clinical trial?

Iovance Biotherapeutics, Inc.Lead Sponsor
20 Previous Clinical Trials
1,026 Total Patients Enrolled
9 Trials studying Melanoma
289 Patients Enrolled for Melanoma
Iovance Biotherapeutics Study TeamStudy DirectorIovance Biotherapeutics
2 Previous Clinical Trials
223 Total Patients Enrolled
1 Trials studying Melanoma
53 Patients Enrolled for Melanoma

Media Library

Lifileucel (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05727904 — Phase 3
Melanoma Research Study Groups: Arm A, Arm B
Melanoma Clinical Trial 2023: Lifileucel Highlights & Side Effects. Trial Name: NCT05727904 — Phase 3
Lifileucel (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05727904 — Phase 3

Frequently Asked Questions

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

Does this experiment allow for enrollment from elderly individuals?

"This clinical trial admits participants aged between 18 years and 70 years old, in accordance with the set inclusion criteria."

Answered by AI

Are there any potential dangers associated with Arm A?

"Our experts at Power gave Arm A a score of 3 in terms of safety due to the amount of clinical data demonstrating its efficacy and multiple sets of evidence validating its safety."

Answered by AI

What is the upper limit of participants enrolled in this scientific investigation?

"Affirmative. Per the information hosted on clinicaltrials.gov, this research study is currently in progress and was initially posted on March 30th 2023. Its last modification happened April 27th of the same year and it requires 670 participants to be enrolled at a single site."

Answered by AI

Is there still capacity for new enrollees in this research study?

"Per the most recent update on clinicaltrials.gov, this clinical trial is actively searching for eligible candidates. The study was initially posted on March 30th 2023 and experienced a revision as recently as April 27th of that same year."

Answered by AI

What are the qualifications for participants of this research experiment?

"This clinical trial seeks 670 individuals, ranging from 18 to 70 years old, that have been diagnosed with melanoma. In order to qualify for the study they must also meet the following requirements: show a measurable disease as outlined in RECIST 1.1 post-surgery treatment; possess sufficient organ functionality; have Stage IIIC, IIID or IV unresectable metastatic melanoma; be of ECOG performance status 0 or 1 and expectancy of more than 6 months life span; demonstrate at least one resectable lesion suitable for lifileucel generation and if applicable employ an approved birth control method. Those over seventy"

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study to Investigate Lifileucel Regimen Plus Pembrolizumab Compared With Pembrolizumab Alone in Participants With Untreated Advanced Melanoma.
2023. "Study to Investigate Lifileucel Regimen Plus Pembrolizumab Compared With Pembrolizumab Alone in Participants With Untreated Advanced Melanoma.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05727904.
~447 spots leftby Mar 2028
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