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New treatment option for Metastatic Uveal Melanoma
Official title Phase 2 Combination of Melphalan/HDS Via PHP + Tebentafusp in Treating Metastatic Uveal Melanoma
ClinicalTrials.gov ID: NCT07276386
What this study is testing
What is Melphalan/HDS (Percutaneous Hepatic Perfusion)?
Melphalan/HDS (Percutaneous Hepatic Perfusion) is an investigational medicine, being studied as a potential treatment for metastatic 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
- This Phase 2 study evaluates the efficacy and safety of sequential treatment with percutaneous hepatic perfusion (PHP) using melphalan/HDS followed by tebentafusp in patients with metastatic uveal melanoma (mUM) with isolated liver metastases. The rationale is that PHP enhances antigen release and immunomodulation, potentially sensitizing tumors to tebentafusp in HLA-A\ 02:01-positive patients.
- Phase 2: a mid-size study of how well it works
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 is ≥18 years of age on the day of signing informed consent.
- ECOG performance status of 0 or 1.
- Histologically or cytologically confirmed liver metastasis of uveal melanoma.
- HLA-A\ 02:01 positive status.
- Measurable disease by computed tomography (CT) per RECIST 1.1 with at least one target lesion identified in the liver.
You likely can't join if
- Life expectancy of less than 6 months.
- More than 50% of the liver volume replaced by tumor as measured by MRI.
- Extrahepatic disease as measured by CT of thorax abdomen and pelvis. (See inclusion criteria #10 above for limited treatable extrahepatic disease.)
- History of congestive heart failure, active cardiac conditions, including unstable coronary syndromes (unstable or severe angina, recent myocardial...
- History or evidence of clinically significant pulmonary disease e.g. severe COPD that precludes the use of general anesthesia.
- Patients who are unable to undergo general anesthesia for any reason.
See the full eligibility criteria
- Patient is ≥18 years of age on the day of signing informed consent.
- ECOG performance status of 0 or 1.
- Histologically or cytologically confirmed liver metastasis of uveal melanoma.
- HLA-A\ 02:01 positive status.
- Measurable disease by computed tomography (CT) per RECIST 1.1 with at least one target lesion identified in the liver.
- Patient deemed suitable for PHP and tebentafusp.
- Female patient of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to receiving the first treatment. If the urine test is positive or cannot be confirmed as negative, a...
- Female patients of childbearing potential must be willing to use an adequate method of contraception, for the course of the study through 150 days after the last dose of study medication. Note: Abstinence is acceptable...
- Male patients of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study therapy through 150 days after the last dose of study therapy. Abstinence is...
- Limited extrahepatic disease would be allowed initially, that can be treated with stereotactic body radiation therapy (SBRT) or surgical resection prior to the start of tebentafusp. This concept is similar to the FOCUS...
- Ability to provide and understand written informed consent prior to any study procedures.
- Life expectancy of less than 6 months.
- More than 50% of the liver volume replaced by tumor as measured by MRI.
- Extrahepatic disease as measured by CT of thorax abdomen and pelvis. (See inclusion criteria #10 above for limited treatable extrahepatic disease.)
- History of congestive heart failure, active cardiac conditions, including unstable coronary syndromes (unstable or severe angina, recent myocardial infarction), significant arrhythmias and severe valvular disease that...
- History or evidence of clinically significant pulmonary disease e.g. severe COPD that precludes the use of general anesthesia.
- Patients who are unable to undergo general anesthesia for any reason.
- Reduced renal function defined as Serum Creatinine \>=1.5xULN or Creatinine Clearance \< 40 mL/min, calculated using the Cockcroft and Gault formula.
- Reduced hepatic function (defined as AST, ALT, bilirubin\>2.5\ ULN and PT-INR\>1.5) or medical history of liver cirrhosis (Child-Pugh Class B or C) or evidence of portal hypertension by history, endoscopy or radiology.
- Hemoglobin \<90 g/L or platelets \<100x109/L or neutrophils \<1.5x109/L.
- Use of live vaccines four weeks before the last study treatment.
- History of severe reactions to melphalan, heparin or iodine contrast. Iodine contrast reaction history patients permitted if patient will be treated with pre-meds, or if still problematic, treating physician may switch...
- Known human immunodeficiency virus (HIV) infection, acquired immunodeficiency syndrome (AIDS), hepatitis B or hepatitis C.
- Active autoimmune disease or a documented history of autoimmune disease requiring active systemic immunosuppressive treatment. Type-1 diabetes, atopic dermatitis, and hypothyroidism are exceptions to this.
- A condition requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids...
- Concomitant therapy with any other anti-cancer therapy, concurrent medical conditions requiring use of immunosuppressive medications (other than physiologic (i.e., \>10 mg) doses of steroids or as specified in exclusion...
- Has a known additional malignancy that is progressing or requires active treatment.
- Pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 150 days after the last dose of study drug.
- A history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not...
- Previous treatment with PHP or tebentafusp.
The study team makes the final eligibility decision.
Where it's taking place
- Tampa, Florida, 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tampa, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
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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.