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CAR T-cell Therapy
TIL Therapy + Pembrolizumab for Skin Cancer
Phase 1
Waitlist Available
Led By Richard C Wu, M.D. Ph.D.
Research Sponsored by Richard Wu
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have an ECOG performance status of 0 or 1 and an estimated life expectancy of >= 3 months
Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is testing the safety and side effects of two different treatments for melanoma that has spread to nearby tissue or lymph nodes.
Who is the study for?
Adults aged 18-75 with Stage IIIB-D or IV melanoma, accessible for tumor removal and no prior treatments. Must have good performance status, life expectancy over 3 months, and adequate organ function. Women must not be pregnant/breastfeeding; participants need to use contraception.Check my eligibility
What is being tested?
The trial is testing LN-144 (Lifileucel) combined with pembrolizumab against advanced melanoma. Lifileucel uses living organism substances to target cancer cells while pembrolizumab boosts the immune system's response to cancer.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system attacking normal organs (autoimmunity), infusion-related reactions, fatigue, possible impact on fertility, and increased risk of infections due to immune modulation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can care for myself and doctors expect me to live 3 months or more.
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I have another cancer type, but it won't affect this trial's treatment.
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I have a tumor in my lymph node that can be measured and accessed for treatment.
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My cancer may or may not have a BRAF V600 mutation.
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I understand the study's requirements, have given my consent in writing, and agree to follow the study rules and visit the site as needed.
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I have been treated for herpes simplex virus.
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I had EBV or CMV but currently have no symptoms and low viral levels.
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I have not received any previous treatments for my condition.
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I can undergo an ultrasound for my lymph nodes and have confirmed melanoma metastases there within the last 28 days.
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My heart function is classified as class 2B or better according to NYHA.
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My melanoma is advanced (Stage IIIB-D or IV) and can be measured in my lymph nodes.
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I am using or willing to use effective birth control during and after the study.
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I am between 18 and 75 years old.
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My organ and bone marrow functions are within normal ranges.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility of neoadjuvant administration of MK-3475 and LN-144/Lifileucel in 3 stage IIIB-D melanoma patients (Phase 1)
Incidence of grade >= 3 treatment-emergent adverse events (both immune and non-immune related) (Phase 2)
Secondary outcome measures
Overall objective response rate
Relapse-free survival (RFS) rate
Other outcome measures
Changes in the patients' health-related quality of life
Doses of the infused TIL with respect to response and 24-month relapse-free survival
Immune correlates (as described above) with respect to response and 24-month relapse free survival, of the TIL/LN-144 + pembrolizumab neoadjuvant therapy
+2 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%
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
1Treatment groups
Experimental Treatment
Group I: Treatment (pembrolizumab, lifileucel)Experimental Treatment5 Interventions
Patients receive pembrolizumab IV on day -14, cyclophosphamide IV QD on days -7 to -6, fludarabine IV over 30 minutes QD on days -5 to -1, and lifileucel IV infusion on day 0. Patients also receive pembrolizumab IV on day 28 and 70, and undergo surgery on day 80.
MAINTENANCE: Patients receive pembrolizumab IV every 6 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine
2012
Completed Phase 3
~1100
Cyclophosphamide
1995
Completed Phase 3
~3780
Therapeutic Conventional Surgery
2005
Completed Phase 3
~9850
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
Richard WuLead Sponsor
Iovance Biotherapeutics, Inc.Industry Sponsor
20 Previous Clinical Trials
1,694 Total Patients Enrolled
9 Trials studying Melanoma
957 Patients Enrolled for Melanoma
Richard C Wu, M.D. Ph.D.Principal InvestigatorOhio State University Comprehensive Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My lung function test shows less than 60% of the normal breathing capacity.I can care for myself and doctors expect me to live 3 months or more.I have a tumor in my lymph node that can be measured and accessed for treatment.I am an adult under legal guardianship or trusteeship.I have another cancer type, but it won't affect this trial's treatment.My cancer may or may not have a BRAF V600 mutation.I have been treated for herpes simplex virus.You have tested positive for HTLV1/HTLV2 or syphilis.I have not been treated with drugs targeting immune system pathways.I have not received any previous treatments for my condition.I have a serious illness that requires specific treatment.I had EBV or CMV but currently have no symptoms and low viral levels.I have a chronic condition like IBD or celiac disease that causes diarrhea.I can undergo an ultrasound for my lymph nodes and have confirmed melanoma metastases there within the last 28 days.I have had another type of cancer in the last 3 years.I do not have an active HIV infection.My heart function is classified as class 2B or better according to NYHA.My melanoma is advanced (Stage IIIB-D or IV) and can be measured in my lymph nodes.I have not had any infections, including COVID-19, in the last 30 days.I have a chronic autoimmune disease, but it's either active vitiligo, a history of vitiligo, or psoriasis.I am using or willing to use effective birth control during and after the study.I understand the study's requirements, have given my consent in writing, and agree to follow the study rules and visit the site as needed.I have or had lung inflammation treated with steroids.I am between 18 and 75 years old.You have an ongoing infection with CMV or EBV based on blood tests.You have had a bad reaction to certain drugs or their ingredients in the past.I have been diagnosed with eye melanoma.I haven't had chemotherapy or radiotherapy in the last 4 weeks.I cannot take medications that increase blood pressure.You have an active Hepatitis B or Hepatitis C infection based on blood tests.I have a severe, worsening heart condition.Women who could become pregnant must have a recent test to check if they are pregnant before joining the study.I haven't taken steroids or immunosuppressants in the last 14 days.My organ and bone marrow functions are within normal ranges.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (pembrolizumab, lifileucel)
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.
Has Pembrolizumab obtained clearance from the FDA?
"The safety of Pembrolizumab is estimated to be a 1, as this Phase 1 trial contains limited information on its efficacy and safety."
Answered by AI
Are there any previous data sets that have evaluated the efficacy of Pembrolizumab?
"At present, 1817 clinical trials are researching Pembrolizumab. Of those active investigations, 281 have entered Phase 3 testing. While the majority of these studies take place in Philadelphia, Pennsylvania, globally 63417 sites are running research with this medication."
Answered by AI
What is the current cohort size for this medical experiment?
"Affirmative. Clinicaltrials.gov attests to the fact that this clinical trial is actively seeking participants, having been initially posted on July 1st 2022 and most recently updated on October 24th 2022. The study requires 15 patients from one centre."
Answered by AI
Is the age restriction of this trial under 55 years old?
"To participate in this trial, applicants must be over the age of consent and below 75. There are 395 studies available to individuals under 18 years old and 2389 trials for those above 65."
Answered by AI
In what ways has Pembrolizumab been found to be beneficial for patients?
"Pembrolizumab is typically prescribed for lymphoma and non-Hodgkin's disease. Additionally, this medication may be beneficial in the treatment of malignant melanomas, recurrent cervical cancer, and leukemia."
Answered by AI
Would it be feasible to partake in this research study at present?
"Right, the information available on clinicaltrials.gov attests that this trial is actively recruiting candidates. The research was initially made public on July 1st 2022 and has been edited as recently as October 24th 2022. A total of 15 participants need to be enrolled at a single site for the study's completion."
Answered by AI
Are there any criteria for participating in this medical experiment?
"This medical trial is enrolling 15 participants aged 18-75 with cutaneous melanoma. In order to be eligible, no prior therapies are permitted and all applicants must have received pathology confirmation of their condition in the 28 days before commencing treatment. Additionally, those with BRAF V600E/K mutations and past or concurrent malignancies that don't interfere the safety evaluations can qualify for entry. Furthermore, it's important that patients possess an ECOG performance score of 0-1 as well as estimated life expectancy greater than three months; they must also demonstrate measurable disease across primary sites (20mm CXR scan minimum) plus a"
Answered by AI
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