Actively Recruiting
Phase 2 Sequential Treatment With Melphalan/HDS Via Percutaneous Hepatic Perfusion Followed by Tebentafusp in the Treatment of Metastatic Uveal Melanoma
Led by H. Lee Moffitt Cancer Center and Research Institute · Updated on 2026-03-31
18
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
H
H. Lee Moffitt Cancer Center and Research Institute
Lead Sponsor
D
Delcath Systems Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of a sequential treatment approach for patients with metastatic uveal melanoma that has spread only to the liver. This Phase 2 study focuses on patients who are positive for HLA-A*02:01 and aims to see if percutaneous hepatic perfusion (PHP) with melphalan/HDS followed by tebentafusp can improve outcomes by enhancing tumor antigen release and immune response. The study is led by the H. Lee Moffitt Cancer Center and Research Institute. Participants will first receive two PHP treatments delivering melphalan/HDS directly to the liver through a catheter, spaced 6 to 8 weeks apart. After these treatments, tebentafusp will be started within 6 weeks and given weekly for one year. If the disease progresses during tebentafusp treatment, up to four additional PHP procedures may be administered as part of standard care. The melphalan dose is based on ideal body weight, and tebentafusp dosing begins with increasing amounts before settling into a weekly routine. Throughout the study, participants will undergo regular assessments to track disease progression using imaging and clinical evaluations. The primary measure is progression-free survival over up to 24 months. Secondary measures include response rates, clinical benefit, liver-specific progression, overall survival, and time and duration of response. Safety monitoring and follow-up will continue as scheduled to understand the treatment effects and tolerability over time. Total participation may last up to two years depending on individual patient response and treatment course.
CONDITIONS
Brief Title
Phase 2 Combination of Melphalan/HDS Via PHP + Tebentafusp in Treating Metastatic Uveal Melanoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is 18 years of age or older at the time of signing informed consent
- ECOG performance status of 0 or 1
- Histologically or cytologically confirmed liver metastasis of uveal melanoma
- Positive for HLA-A*02:01 status
- Measurable liver disease by CT scan per RECIST 1.1 with at least one target lesion
- Suitable candidate for percutaneous hepatic perfusion and tebentafusp treatment
- Female patients of childbearing potential must have a negative pregnancy test within 72 hours before first treatment and agree to use contraception during the study and for 150 days after last dose
- Male patients of childbearing potential must agree to use contraception during the study and for 150 days after last dose
- Limited extrahepatic disease treatable by stereotactic body radiation therapy or surgery before tebentafusp
- Ability to provide and understand written informed consent
You will not qualify if you...
- Life expectancy less than 6 months
- More than 50% of liver volume replaced by tumor as measured by MRI
- Extrahepatic disease not treatable by allowed methods
- History of congestive heart failure or active serious cardiac conditions preventing general anesthesia
- History or evidence of severe pulmonary disease preventing general anesthesia
- Unable to undergo general anesthesia for any reason
- Reduced kidney function with serum creatinine ≥1.5 times upper limit or creatinine clearance <40 mL/min
- Reduced liver function defined by elevated liver enzymes or clotting times, liver cirrhosis (Child-Pugh B or C), or portal hypertension
- Low blood counts: hemoglobin <90 g/L, platelets <100x10^9/L, or neutrophils <1.5x10^9/L
- Use of live vaccines within four weeks before last study treatment
- History of severe allergic reactions to melphalan, heparin, or iodine contrast (with conditions for exceptions)
- Known HIV, AIDS, hepatitis B, or hepatitis C infection
- Active autoimmune disease requiring systemic immunosuppressive treatment (except type-1 diabetes, atopic dermatitis, hypothyroidism)
- Recent systemic corticosteroids or immunosuppressive treatment within 14 days prior to study drug (with exceptions)
- Concurrent anti-cancer or investigational treatments
- Known progressing additional malignancy
- Pregnant, breastfeeding, or planning pregnancy during study and 150 days after
- Any condition or treatment interfering with study participation or results
- Previous treatment with PHP or tebentafusp
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 1 year (PHP procedures plus weekly tebentafusp dosing)
Participants undergo two percutaneous hepatic perfusion (PHP) procedures with melphalan/HDS spaced 6-8 weeks apart, followed by weekly tebentafusp infusions for one year. Additional PHP procedures may be performed if disease progression occurs while on tebentafusp.
2 PHP procedures spaced 6-8 weeks apart, then weekly visits for tebentafusp infusions for up to 1 year
Trial Site Locations
Total: 1 location
1
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
Research Team
D
Deanryan De Aquino
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here