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Metastatic Uveal MelanomaPhase 2NCT07276386

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

A Phase 2 study testing Melphalan/HDS (Percutaneous Hepatic Perfusion) and Tebentafusp in people with Metastatic Uveal Melanoma, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Uveal Melanoma
What is being tested?
Melphalan/HDS (Percutaneous Hepatic Perfusion) and Tebentafusp
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteUnited States
Study dates
31 Dec 2025to Dec 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.
  • 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.
  • 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.
  • 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.
  • Ability to provide and understand written informed consent prior to any study procedures.

Who cannot join

  • 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 precludes the use of general anesthesia.
  • 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.
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  • 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 to MRI TAP.
  • 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 and adrenal replacement doses >10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
  • 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 #14) or use of other investigational drugs.
  • 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 in the best interest of the patient to participate in the opinion of the treating investigator.
  • Previous treatment with PHP or tebentafusp.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Deanryan De Aquino contact

813-745-3998

Deanryan.Deaquino@moffitt.org

United States1 site, 1 recruiting

  • Moffitt Cancer Center

    Tampa, Florida, 33612

    Jonathan Zager, MD, FACS

    Joseph Markowitz, MD, PHD

    Recruiting

Other trials in United States

About this study

Official title: Phase 2 Sequential Treatment With Melphalan/HDS Via Percutaneous Hepatic Perfusion Followed by Tebentafusp in the Treatment of Metastatic Uveal Melanoma

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.

Being tested
Melphalan/HDS (Percutaneous Hepatic Perfusion), Tebentafusp
Medical subject headings
Uveal Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Melphalan/HDS (Percutaneous Hepatic Perfusion)Drug

    3 mg/kg ideal body weight (max 220 mg) infused via hepatic artery catheter.

  • TebentafuspDrug

    20 mcg IV day 1, 30 mcg day 8, 68 mcg day 15, then weekly thereafter.

Study groups in NCT07276386
Study groupRoleWhat they receive
Sequential PHP with Melphalan/HDS followed by TebentafuspExperimentalPatients will undergo two percutaneous hepatic perfusion (PHP) procedures with melphalan/HDS, spaced 6-8 weeks apart. Tebentafusp will be initiated within 6 weeks (+/- 2 weeks) after the second PHP and administered weekly for 1 year. Additional PHP procedures (up to 6 total) may be performed as standard of care if disease progression occurs while on tebentafusp.
Receives: Drug: Melphalan/HDS (Percutaneous Hepatic Perfusion); Drug: Tebentafusp

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival (PFS)

    PFS will be studied as time-to-event defined by the first documented disease progression or death due to any cause, whichever occurs first, from the start date of the study treatment. PFS will be determined based on tumor assessment (RECIST version 1.1 criteria).

    Measured: Up to 24 months

Secondary outcomes (7)

  1. Objective Response Rate (ORR)

    ORR defined as the percentage of patients achieving a confirmed complete or partial response, as defined by RECIST version 1.1 criteria.

    Measured: Up to 24 months

  2. Clinical Benefit Rate (CBR)

    CBR defined as the percentage of patients achieving confirmed SD at 26 weeks, OR any confirmed CR or PR. As defined by RECIST version 1.1 criteria.

    Measured: Up to 24 months

  3. Hepatic PFS (hPFS)

    hPFS is defined as the time-to-event defined by the first documented disease progression in the liver or death due to any cause, whichever occurs first, from the start date of the study treatment. hPFS will be determined based on tumor assessment (RECIST version 1.1 criteria).

    Measured: Up to 24 months

  4. Overall Survival (OS)

    OS is calculated as the time-to-event defined by death due to any cause from the start date of the study treatment.

    Measured: Up to 24 months

  5. Melanoma-Specific Survival (MSS)

    MSS is calculated as the time-to-event defined by death due to uveal melanoma from the start date of the study treatment.

    Measured: Up to 24 months

  6. Time to Response (TTR)

    TTR calculated as the time-to-event defined by the first documented CR or PR from the start date of the study treatment.

    Measured: Up to 24 months

  7. Duration of Response (DOR)

    DOR calculated as the time-to-event defined by the first documented progression or death due to underlying cancer from the first document CR or PR.

    Measured: Up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2025
  2. Study start31 Dec 2025
  3. Primary completionDec 2030 (estimated)
  4. Study completionDec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07276386
Sponsor's protocol ID
MCC-23724
Status last verified
Mar 2026
First submitted
1 Dec 2025
Last updated
31 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Melphalan/HDS (Percutaneous Hepatic Perfusion) and Tebentafusp in people with Metastatic Uveal Melanoma, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Deanryan De Aquino (813-745-3998, Deanryan.Deaquino@moffitt.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) (time frame: Up to 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07276386.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.

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