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New treatment option for Melanoma
Official title A Phase 2 Trial for Metastatic Melanoma Using Adoptive Cell Therapy With Tumor Infiltrating Lymphocytes Plus IL-2 Either Alone or Following the Administration of Pembrolizumab
ClinicalTrials.gov ID: NCT02621021
What this study is testing
What is young TIL?
young TIL is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for melanoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Background: Cell therapy is an experimental cancer therapy. It takes young tumor infiltrating lymphocytes (Young TIL) cells from a person s tumors and grows them in a lab.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 72
You may be able to join if
- 1. Measurable metastatic melanoma with at least one lesion that is resectable for TIL generation.
- Confirmation of diagnosis of metastatic melanoma by the Laboratory of Pathology of NCI.
- Patients must have received at least one prior therapy for metastatic melanoma.
- Patients with 3 or fewer brain metastases that are less than 1 cm in diameter and asymptomatic are eligible. Lesions that have been treated with...
- Greater than or equal to 18 years and less than or equal to 72 years.
You likely can't join if
- Individuals of child-bearing potential who are pregnant or nursing because of the potentially dangerous effects of the treatment on the fetus or...
- Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease).
- Concurrent opportunistic infections (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who...
- Active systemic infections requiring anti-infective treatment, coagulation disorders or any other active major medical illnesses.
- History of major organ autoimmune disease
- Concurrent systemic steroid therapy.
See the full eligibility criteria
- 1. Measurable metastatic melanoma with at least one lesion that is resectable for TIL generation.
- Confirmation of diagnosis of metastatic melanoma by the Laboratory of Pathology of NCI.
- Patients must have received at least one prior therapy for metastatic melanoma.
- Patients with 3 or fewer brain metastases that are less than 1 cm in diameter and asymptomatic are eligible. Lesions that have been treated with stereotactic radiosurgery must be clinically stable for 1 month after...
- Greater than or equal to 18 years and less than or equal to 72 years.
- All participants must sign a written informed consent.
- All participants must be willing to sign a durable power of attorney
- Clinical performance status of ECOG 0 or 1.
- Patients of both sexes must be willing to practice birth control from the time of enrollment on this study and for up to four months after treatment.
- Serology:
- Seronegative for HIV antibody. (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who are HIV seropositive can have decreased immune-competence and thus are less...
- Seronegative for hepatitis B antigen, and seronegative for hepatitis C antibody. If hepatitis C antibody test is positive, then patient must be tested for the presence of antigen by RT-PCR and be HCV RNA negative.
- Individuals of child-bearing potential must be willing to undergo a pregnancy test prior to the start of treatment because of the potentially dangerous effects of the treatment on the fetus.
- Individuals of child-bearing potential (IOCBP) must agree to use highly effective contraception (hormonal, intrauterine device [IUD, abstinence, surgical sterilization starting at the time of study entry, for the...
- Nursing participants must be willing to discontinue nursing from study treatment initiation through 4 months after the last dose of the study drug(s).
- Hematology
- Absolute neutrophil count greater than 1000/mm3 without the support of filgrastim
- WBC greater than or equal to 2500/mm3
- Platelet count greater than or equal to 800,000/mm3
- Hemoglobin \> 8.0 g/dl
- Chemistry:
- Serum ALT/AST less than or equal to 2.5 times ULN
- Serum Creatinine less than or equal to 1.6 mg/dl
- Total bilirubin less than or equal to 1.5 mg/dl, except in patients with Gilbert's Syndrome who must have a total bilirubin less than 3.0 mg/dL.
- Patients must have completed any prior systemic therapy at the time of enrollment.
- Patients must demonstrate progressive disease at the time of treatment. (Note: Patients who have received tyrosine kinase inhibitors (e.g. vemurafinib) may be treated if they present with stable disease at the time of...
- Patients must be co-enrolled in protocol 03-C-0277.
- Individuals of child-bearing potential who are pregnant or nursing because of the potentially dangerous effects of the treatment on the fetus or infant.
- Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease).
- Concurrent opportunistic infections (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune competence may be less responsive to the...
- Active systemic infections requiring anti-infective treatment, coagulation disorders or any other active major medical illnesses.
- History of major organ autoimmune disease
- Concurrent systemic steroid therapy.
- History of severe immediate hypersensitivity reaction to any of the agents used in this study.
- Grade 3 or 4 major organ Immune-related Adverse Events (IRAEs) clinically attributed to anti PD-1/PD-L1 monotherapy. Previously screened participants that experience these IRAEs after resection for creation of TIL are...
- History of coronary revascularization or ischemic symptoms.
- For select patients with a clinical history prompting cardiac evaluation: last LVEF less than or equal to 45%
- For select patients with a clinical history prompting pulmonary evaluation: known FEV1 less than or equal to 50%.
- Patients who are receiving any other investigational agents.
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 72 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.