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CAR T-cell Therapy
Tumor Infiltrating Lymphocyte Therapy for Cancer
Phase 2
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
Must have a confirmed diagnosis of malignancy of their receptive histologies: unresectable or metastatic melanoma Stage IIIC to IV (Cohorts 1A, 1B and 1C), advanced, recurrent or metastatic HNSCC (Cohort 2A), or Stage III or Stage IV non-small cell lung cancer (Cohorts 3A, 3B, and 3C)
Must have progressed on or after most recent therapy and must not have received CPIs as part of one of the counted lines of prior therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 60 months
Awards & highlights
Study Summary
This trial is testing a new cancer treatment involving the transfer of immune cells. It is open-label, meaning that participants and doctors will know which treatment is being given. The study will enroll patients at multiple centers.
Who is the study for?
This trial is for adults with certain solid tumors like melanoma, head and neck squamous cell carcinoma (HNSCC), or non-small cell lung cancer (NSCLC) that can be surgically removed. They should have a good performance status, measurable disease after surgery, and not be on high-dose steroids. Some cohorts require prior treatments with specific drugs. Pregnant women, those with brain metastases or autoimmune diseases needing treatment are excluded.Check my eligibility
What is being tested?
The study tests TIL therapy using LN-145/Lifileucel alone or combined with checkpoint inhibitors like Ipilimumab, Nivolumab, or Pembrolizumab in patients who've had different levels of previous treatments. It's an open-label Phase 2 trial where everyone gets the experimental therapy without being compared to a control group.See study design
What are the potential side effects?
Possible side effects include reactions related to immune system activation such as inflammation in various organs including the lungs (pneumonitis), fatigue, skin rash, hormonal gland issues (endocrinopathies), infusion-related reactions and potential worsening of pre-existing autoimmune conditions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with a specific stage of melanoma, head and neck cancer, or non-small cell lung cancer.
Select...
My cancer has worsened after my last treatment and I haven't had CPIs in my previous treatments.
Select...
My cancer has worsened despite my last treatment.
Select...
I still have visible cancer after surgery.
Select...
I am mostly active and my doctors expect me to live 6 months or more.
Select...
I have at least one tumor that can be surgically removed.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 60 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 60 months
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
Safety Profile Measured by Grade ≥3 TEAEs
Secondary outcome measures
Complete Response Rate
Disease Control Rate
Duration of Response
+2 moreTrial Design
7Treatment groups
Experimental Treatment
Group I: Cohort 3CExperimental Treatment3 Interventions
LN-145 therapy in combination with ipilimumab and nivolumab in patients with Stage III or Stage IV NSCLC who have previously received 1 line of CPI monotherapy. No other systemic therapy for metastatic disease is allowed. Prior chemoradiation and/or chemotherapy in the adjuvant and/or neo-adjuvant settings are allowed.
Group II: Cohort 3BExperimental Treatment1 Intervention
LN-145 therapy as a single agent in patients with Stage III or Stage IV NSCLC, who have previously received 1-3 lines of prior systemic therapy. Patients with known oncogene drivers (eg, EGFR, ALK, ROS) who have mutations that are sensitive to targeted therapies are not required to have received prior systemic therapy with CPIs.
Group III: Cohort 3AExperimental Treatment2 Interventions
LN-145 therapy in combination with pembrolizumab in patients with locally advanced or metastatic (Stage III or Stage IV) non-small-cell lung cancer (NSCLC) with ≤ 3 prior lines of systemic therapy, excluding CPIs, or ≤ 4 lines if 2 or more of the lines are TKI therapy for those with tumors that harbored actionable mutations (eg, EGFR, ALK, ROS).
Group IV: Cohort 2AExperimental Treatment2 Interventions
LN-145 therapy in combination with pembrolizumab in patients with advanced, recurrent, or metastatic HNSCC, with ≤ 3 prior lines of systemic therapy, excluding CPIs.
Group V: Cohort 1CExperimental Treatment1 Intervention
LN-144 Generation 3 (Gen 3) therapy as a single agent in patients with Stage IIIC or Stage IV unresectable or metastatic melanoma, who have previously received systemic therapy with a PD-1 blocking antibody. If the tumor is BRAF V600 mutation positive, patients must have received BRAF inhibitor with or without a MEK inhibitor.
Group VI: Cohort 1BExperimental Treatment1 Intervention
LN-145-S1 therapy as a single agent in patients with Stage IIIC or Stage IV unresectable or metastatic melanoma, who have previously received systemic therapy with a PD-1 blocking antibody. If the tumor is proto-oncogene B-Raf (BRAF) V600 mutation positive, patients must have received a BRAF inhibitor with or without a mitogen-activated extracellular signal-related kinase (MEK) inhibitor.
Group VII: Cohort 1AExperimental Treatment2 Interventions
LN-144 therapy in combination with pembrolizumab in patients with Stage IIIC to IV unresectable or metastatic melanoma with ≤ 3 prior lines of systemic therapy, excluding checkpoint inhibitors (CPI).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ipilimumab
2014
Completed Phase 3
~2620
LN-145
2017
Completed Phase 2
~70
Pembrolizumab
2017
Completed Phase 2
~2010
LN-145-S1
2017
Completed Phase 2
~70
Nivolumab
2014
Completed Phase 3
~4750
Find a Location
Who is running the clinical trial?
Iovance Biotherapeutics, Inc.Lead Sponsor
20 Previous Clinical Trials
1,518 Total Patients Enrolled
10 Trials studying Melanoma
959 Patients Enrolled for Melanoma
Iovance Biotherapeutics Medical MonitorStudy DirectorIovance Biotherapeutics
3 Previous Clinical Trials
312 Total Patients Enrolled
1 Trials studying Melanoma
178 Patients Enrolled for Melanoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have brain metastases that have not been treated and are causing symptoms.I am on low-dose steroids for adrenal insufficiency or not on steroids above 10 mg/day.My melanoma originates from the eye.I have no history of autoimmune disorders needing treatment.I have been diagnosed with a specific stage of melanoma, head and neck cancer, or non-small cell lung cancer.I have had another type of cancer in the last 3 years.My cancer has worsened after my last treatment and I haven't had CPIs in my previous treatments.My cancer has worsened despite my last treatment.I still have visible cancer after surgery.I am at least 18 years old, or at least 12 for certain study groups.I have not received a live vaccine in the last 28 days.I am mostly active and my doctors expect me to live 6 months or more.I have at least one tumor that can be surgically removed.My heart's pumping ability is below normal, or I have moderate to severe heart problems.I have had an organ transplant or cell therapy in the last 20 years, but not TIL for this study.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1C
- Group 2: Cohort 1B
- Group 3: Cohort 2A
- Group 4: Cohort 3C
- Group 5: Cohort 1A
- Group 6: Cohort 3A
- Group 7: Cohort 3B
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
On how many different websites can I find information about this topic?
"This trial is taking place at 23 different locations, some of which include Henry Ford Health System in Detroit, Georgetown University Medical Center in Washington, and the University of Louisville."
Answered by AI
Are people currently being recruited for this experiment?
"Yes, the information on clinicaltrials.gov points out that this trial is currently searching for participants. The study was originally posted on 5/7/2019 and was most recently updated on 6/13/2022. The study is recruiting for 178 patients between 23 sites."
Answered by AI
What are the goals that this research is hoping to achieve?
"The aim of this study, which will last for up to 60 months, is to measure the safety profile of Grade ≥3 TEAEs. Other metrics used to gauge success include Duration of Response, Progression-Free Survival, and Overall Survival."
Answered by AI
How many participants are being sought for this research project?
"The total number of patients required to run this clinical trial is 178. The sponsor, Iovance Biotherapeutics Inc., will be carrying out the study at Henry Ford Health System in Detroit, Michigan and Georgetown University Medical Center in Washington, District of Columbia among other locations."
Answered by AI
Has the United States Food and Drug Administration cleared this cell-based therapy?
"While there is some data gathered on Lifileucel's safety, its efficacy has not been clinically proven yet. Consequently, it received a score of 2."
Answered by AI
What are the primary benefits of Lifileucel?
"Lifileucel is a common treatment for unresectable melanoma. This immunotherapy can also be useful in treating microsatellite instability high, squamous cell carcinoma, and patients with a high risk of cancer recurrence."
Answered by AI
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