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TIL Therapy + Pembrolizumab for Skin Cancer
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2024 Phase 2 trial • 57 Patients • NCT03004183Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Treatment (pembrolizumab, lifileucel)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
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."
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."
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."
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."
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."
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."
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"
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