Phase 2 Combination of Melphalan/HDS Via PHP + Tebentafusp in Treating Metastatic Uveal Melanoma (NCT07276386)

🧪 Interventions in This Study

• Melphalan/HDS (Percutaneous Hepatic Perfusion) (DRUG)
• Tebentafusp (DRUG)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Patient is ≥18 years of age on the day of signing informed consent.
2. ECOG performance status of 0 or 1.
3. Histologically or cytologically confirmed liver metastasis of uveal melanoma.
4. HLA-A\*02:01 positive status.
5. Measurable disease by computed tomography (CT) per RECIST 1.1 with at least one target lesion identified in the liver.
6. Patient deemed suitable for PHP and tebentafusp.
7. 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 serum pregnancy test will be required.
8. 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 if this is the usual lifestyle and preferred contraception for the subject.
9. 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 acceptable if this is the usual lifestyle and preferred contraception for the subject.
10. 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 trial - definition of "treatable" limited disease at the discretion of the PI.
11. Ability to provide and understand written informed consent prior to any study procedures.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

• Moffitt Cancer Center — Tampa, Florida

📞 Contact the Study Coordinator

Phone: (813) 745-3998

Email: Deanryan.Deaquino@moffitt.org

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Metastatic Uveal Melanoma

• Study of IDE196 in Patients With Solid Tumors Harboring GNAQ/11 Mutations or PRKC Fusions — Los Angeles, California
• Tebentafusp-tebn With LDT in Metastatic UM — Philadelphia, Pennsylvania
• Study of Cemiplimab Plus Ziv-Aflibercept for Subjects With Metastatic Uveal Melanoma — Los Angeles, California
• Binimetinib Plus Belinostat for Subjects With Metastatic Uveal Melanoma — Tampa, Florida
• A Randomized, Phase 2/3 Study to Investigate the Efficacy and Safety of RP2 in Combination With Nivolumab in Immune Checkpoint Inhibitor-Naïve Adult Patients With Metastatic Uveal Melanoma — Scottsdale, Arizona

Explore by condition: All Metastatic Uveal Melanoma clinical trials

💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Contact the study coordinator using the phone/email above.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.