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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 belowSelect...
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.
Select...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 7 years total duration
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 years total duration
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 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
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%
Pneumothorax
5%
Malnutrition, Hypercalcemia and Weakness
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
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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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have received treatment for cancer that has spread.I have at least one tumor that can be surgically removed for treatment.My tumor has a BRAF V600 mutation and I've only had immune therapy before surgery.I have brain metastases that haven't been treated and are causing symptoms.I have undergone more than one treatment for my condition.My organs are functioning well.My cancer originates from the eye (melanoma).I am mostly active and my doctor believes I have more than 6 months to live.I am over 70 and have discussed joining the trial with the medical team.I do not have any serious illnesses that would make joining this study risky for me.I haven't had another cancer in the past 3 years, or if I did, it was treated over a year ago and is not likely to come back.I have at least one tumor that can be measured after surgery.My melanoma is at an advanced stage and cannot be surgically removed.You have a weakened immune system from a medical condition like SCID or AIDS.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A
- Group 2: Arm B
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
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