Clinical trial for Uveal Melanoma
Official title Immune Response to Percutaneous Hepatic Perfusion With Melphalan for Ocular Melanoma Metastatic to the Liver
ClinicalTrials.gov ID: NCT07364474
What this study is testing
What is Melphalan through Percutaneous Hepatic Perfusion?
Melphalan through Percutaneous Hepatic Perfusion is an investigational medicine, being studied as a potential treatment for uveal 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
- The study aims to learn how the liver's immune system responds to a specific chemotherapy delivery method, either alone or with two immune-boosting drugs.
- Who it's for
- People with uveal melanoma (a type of eye cancer) that has spread to the liver.
- What's involved
- Participants will receive melphalan (a chemotherapy drug) through a procedure called Percutaneous Hepatic Perfusion (PHP), which filters blood through the liver. Some may also receive ipilimumab and nivolumab, which are drugs that help the immune system fight cancer.
- Time commitment
- The source text does not specify the duration or visit schedule.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patient has histologically or cytologically confirmed diagnosis of uveal melanoma metastatic to the liver and is determined to be a candidate for...
- In Cohort B only: patient is determined to be a candidate for percutaneous hepatic perfusion with melphalan combined with Ipilimumab and Nivolumab
- The subject has read, signed and dated the Informed Consent Form (ICF), having been advised of the risks and benefits of the trial in a language...
- Age \> 18 years at date of informed consent signature having the ability to comply with the protocol.
- Contrast-enhanced cross-sectional imaging of the abdomen (either CT or MRI) obtained within two months prior to study enrollment
You likely can't join if
- Lesion to undergo biopsy cannot have undergone prior radiation therapy or other locoregional therapy
- Continued adverse events from a previously administered chemotherapeutic agents.
- Treatment with systemic corticosteroids exceeding the equivalent of 10 mg/day of prednisone or other systemic immunosuppressive medications...
- Patients who receive acute, low-dose, systemic corticosteroid medications (e.g., a one-time dose of dexamethasone for nausea) or for prevention of...
- Anticoagulant or anti-platelet medication that cannot be interrupted prior to biopsy
- Pregnant or lactating
See the full eligibility criteria
- Patient has histologically or cytologically confirmed diagnosis of uveal melanoma metastatic to the liver and is determined to be a candidate for percutaneous hepatic perfusion with melphalan
- In Cohort B only: patient is determined to be a candidate for percutaneous hepatic perfusion with melphalan combined with Ipilimumab and Nivolumab
- The subject has read, signed and dated the Informed Consent Form (ICF), having been advised of the risks and benefits of the trial in a language understood by the subject.
- Age \> 18 years at date of informed consent signature having the ability to comply with the protocol.
- Contrast-enhanced cross-sectional imaging of the abdomen (either CT or MRI) obtained within two months prior to study enrollment
- Measurable metastatic disease. Subject must have at least one site of metastatic disease ≥ 1 cm in size and amenable to percutaneous image-guided biopsy
- Life expectancy \> 12 weeks.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Absolute neutrophil count (ANC) \> 1 x 109/L
- Platelets \> 75 x 109/L
- Alanine aminotransferase (ALT) / Aspartate aminotransferase (AST) \< 5 x ULN
- Total bilirubin \<3 mg/dL
- International normalized ratio (INR) \<1.7
- Glomerular filtration rate (GFR) \>30 ml/min
- Lesion to undergo biopsy cannot have undergone prior radiation therapy or other locoregional therapy
- Continued adverse events from a previously administered chemotherapeutic agents. Grade 1 adverse events and ongoing toxicities such as alopecia are exempt
- Treatment with systemic corticosteroids exceeding the equivalent of 10 mg/day of prednisone or other systemic immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide...
- Patients who receive acute, low-dose, systemic corticosteroid medications (e.g., a one-time dose of dexamethasone for nausea) or for prevention of hypersensitivity reactions to contrast agents may be enrolled in the...
- Anticoagulant or anti-platelet medication that cannot be interrupted prior to biopsy
- Pregnant or lactating
- Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicated the use of an investigational drug or...
- Treatment with systemic immunostimulatory agents (including but not limited to interferon(IFN)s, interleukin [IL]-2) within 6 weeks or five half- lives of the drug, whichever was shorter, prior to Day 1.
- Prior treatment with immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies, anti-LAG-3 antibodies, within the past three months.
- Treatment with any investigational systemic medication within at least one month prior to biopsy. If an investigational agent is an immune checkpoint inhibitor, a three-month washout is required.
- Signs or symptoms clinically significant of infection within 2 weeks prior to Day 1.
The study team makes the final eligibility decision.
Where it is enrolling
- Boston, Massachusetts, 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, but 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Boston, Massachusetts, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.