Metastatic Uveal MelanomaPhase 2NCT06627244
Study of Tebentafusp and Radioembolization in the Treatment of Metastatic Uveal Melanoma
A Phase 2 study testing Tebentafusp and TheraSphere™ Yttrium-90 Trans-Arterial Radioembolization in people with Metastatic Uveal Melanoma and Metastatic Uveal Melanoma in the Liver, run by University of Miami at 1 site in United States.
Trial summary
The purpose of this study is to determine the effects (good and bad) that Tebentafusp in combination with Yttrium-90 (Y-90) radioembolization has on patients with metastatic uveal melanoma that has spread to the liver. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Uveal Melanoma, Metastatic Uveal Melanoma in the Liver
- What is being tested?
- Tebentafusp and TheraSphere™ Yttrium-90 Trans-Arterial Radioembolization
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2025to 17 Feb 2031
- 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
- Metastatic uveal melanoma, confined mainly to the liver, and documented by pathology review
- Serum bilirubin <2 mg/dl, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 5 x upper limit of normal (ULN)
- Mapping angiogram procedure shows radioembolization is feasible and safe to perform
- Human leukocyte antigen-A*02:01(HLA A⁕ 02:01) positive
- Patient age ≥ 18 years old
- Ability to provide and understand written informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Patients must have measurable disease or non-measurable disease according to RECIST 1.1 (Eisenhauer et al, 2009).
Who cannot join
- Patient with any tumor size > 8 cm
- Total bilirubin > 1.5 × ULN, except for patients with Gilbert's syndrome, who are excluded if total bilirubin > 3.0 × ULN or direct bilirubin > 1.5 × ULN
- Clinical laboratory measurements that meet any of the following criteria:
- Alanine aminotransferase (ALT) > 3 × ULN
- Aspartate aminotransferase (AST) > 3 × ULN
- Absolute neutrophil count (ANC) < 1.0 × 10^9 cells/L
Show all 53Show fewer
- Absolute lymphocyte count < 0.5 × 10^9 cells/L
- Platelet count < 75 × 109 platelets/L
- Hemoglobin < 8 g/dL
- Angiogram shows vascular shunting which prevents radioembolization
- History of severe hypersensitivity reactions (eg, anaphylaxis) to other biologic drugs or monoclonal antibodies
- Patients with clinically significant cardiac disease or impaired cardiac function, including any of the following:
- Congestive heart failure (New York Heart Association Class ≥ 3).
- Uncontrolled hypertension (consistent findings of systolic blood pressure [BP] > 160 mmHg or diastolic BP > 110 mmHg).
- History of ventricular arrhythmia currently requiring medical treatment.
- Uncontrolled atrial fibrillation.
- Electrocardiogram (ECG) QT interval corrected for heart rate by Fridericia's method (QTcF) > 470 msec during screening obtained on triplicate ECGs or known history of congenital prolonged QT syndrome.
- Acute myocardial infarction or unstable angina pectoris ≤ 6 months prior to screening.
- Presence of symptomatic or untreated central nervous system (CNS) metastases or CNS metastases that require doses of corticosteroids within 14 days prior to study treatment Day 1.
- Active infection requiring systemic antibiotic therapy. Patients requiring systemic antibiotics for infection must have completed therapy at least 1 week prior to the first dose of Tebentafusp.
- Known history of human immunodeficiency virus (HIV) infection. Testing for HIV status is not necessary unless clinically indicated.
- Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection per institutional protocol. Testing for HBV or HCV status is not necessary unless clinically indicated or the patient has a history of HBV or HCV infection.
- Malignant disease other than that being treated in this study. Exceptions to this exclusion include the following: malignancies that were treated curatively and have not recurred within 2 years prior to study treatment; completely resected basal cell and squamous cell skin cancers; any malignancy considered to be indolent and that has never required therapy; and completely resected carcinoma in situ of any type.
- Any medical condition that would, in the Investigator's or Sponsor's judgment, prevent the patient's participation in the clinical study due to safety concerns, compliance with clinical study procedures, or interpretation of study results
- Patients who received systemic treatment with steroids or any other immunosuppressive drug within 2 weeks of the planned first dose of study intervention. The following exceptions are permitted (Section 4.9.1):
- Treatment for well-controlled and asymptomatic adrenal insufficiency, but replacement dosing is limited to prednisone ≤ 12 mg daily or the equivalent.
- Local steroid therapies (eg, optic, ophthalmic, intra-articular, or inhaled medications).
- Premedication for allergy to contrast reagent.
- Steroids for management of CNS metastases > 14 days prior to the planned first dose of study intervention.
- To treat asthma or chronic obstructive pulmonary disease exacerbations > 14 days prior to the planned first dose of study intervention (only short-term oral or IV use in doses > 12 mg/day prednisone equivalent).
- For inhalation in the management of asthma or chronic obstructive pulmonary disease.
- Any premedications required per protocol.
- Patient with morning cortisol < lower limit of normal (unless the participant has asymptomatic adrenal insufficiency and is receiving stable replacement doses). For additional information regarding patients with adrenal insufficiency.
- History of interstitial lung disease
- History of pneumonitis that required corticosteroid treatment or current pneumonitis
- Patients with active autoimmune disease requiring immunosuppressive treatment, including inflammatory bowel disease (ulcerative colitis or Crohn's disease), within 2 years of screening. Note: The following exceptions are permitted:
- Vitiligo
- Alopecia
- Managed hypothyroidism (on stable replacement doses)
- Asymptomatic adrenal insufficiency (on stable replacement doses) (For additional information regarding patients with adrenal insufficiency.
- Psoriasis
- Resolved childhood asthma/atopy
- Well-controlled asthma
- Type I diabetes mellitus
- Major surgery within 2 weeks of the first dose of study drug (minimally invasive procedures such as bronchoscopy, tumor biopsy, insertion of a central venous access device, and insertion of a feeding tube are not considered major surgery and are not exclusionary)
- Radiotherapy within 2 weeks of the first dose of study drug, with the exception of palliative radiotherapy to a limited field, such as for the treatment of bone pain or a focally painful tumor mass
- Use of hematopoietic colony-stimulating growth factors (eg, granulocyte colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF), macrophage colony-stimulating factor (M-CSF)) ≤ 3 weeks prior to start of Tebentafusp. An erythroid-stimulating agent is allowed as long as it was initiated at least 3 weeks prior to the first dose of study treatment and the patient is not red blood cell (RBC) transfusion dependent. For more information on the timing and use of hematopoietic colony-stimulating growth factors during study.
- Patient receiving a live or attenuated vaccine(s) ≤ 28 days prior to the first dose of study intervention. Note: Non-live vaccines (including adenoviral and messenger ribonucleic acid (mRNA)-based coronavirus disease-2019 (COVID-19) vaccines) are allowed but are not to be administered for at least 2 weeks before and 3 weeks after start of study treatment and within 24 hours before or after study treatment administration following the first 3 weeks of study treatment.
- Pregnant, likely to become pregnant, or lactating women (where pregnancy is defined as the state of a female after conception and until the termination of gestation)
- Women of childbearing potential (WoCBP) who are sexually active with a non-sterilized male partner, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective contraception during study treatment (defined in Section 4.12), and must agree to continue using such precautions for 6 months after the final dose of Tebentafusp; cessation of birth control after this point should be discussed with a responsible physician. Highly effective methods of contraception are described in Section 4.12.
- Male patients must be surgically sterile or use double barrier contraception methods as described in Section 4.12 from enrollment through treatment and for 6 months following administration of the last dose of Tebentafusp.
- Prior radioembolization or other regional, liver-directed therapy, including chemotherapy or embolization to same site in the liver
- Patients with impaired decision-making capacity.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Miami
Miami, Florida, 33136
Lynn Feun, MD, (305) 243-4981, lfeun@med.miami.edu
Benjamin Spieler, MD, (305) 243-4229, bspieler@med.miami.edu
About this study
Official title: Phase 2, Single Arm Study of Tebentafusp and Radioembolization in the Treatment of Metastatic Uveal Melanoma
The purpose of this study is to determine the effects (good and bad) that Tebentafusp in combination with Yttrium-90 (Y-90) radioembolization has on patients with metastatic uveal melanoma that has spread to the liver.
- Being tested
- Tebentafusp, TheraSphere™ Yttrium-90 Trans-Arterial Radioembolization
- Medical subject headings
- Uveal Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TebentafuspDrug
Also called Tebentafusp-tebn
Tebentafusp will be administered intravenously to participants at or within 28 days of their first Y-90 TARE procedure. This 28-day period includes the 14- to 28-day Y-90 TARE Recovery Period. For administrative purposes, one cycle of tebentafusp treatment is 28 days in length. Tebentafusp will be administered on a dose escalation schedule for Cycle 1 starting at 20 mcg on Day 1, increasing to 30 mcg on Day 8, and a final dose of 68 mcg on Day 15, which will be administered once per week until unacceptable toxicity develops, disease progression, or withdrawal of consent, whichever occurs first.
TheraSphere™ Yttrium-90 Trans-Arterial RadioembolizationRadiation
Also called Y-90 TARE
Participants will undergo radiographic and 99mTC-labeled macroaggregated albumin (99mTc-MAA) assessment for suitability prior to Y-90 absorbed glass microsphere treatment per institutional procedures. Y-90 trans-arterial radioembolization (TARE) is a standard of care treatment for intrahepatic metastases of uveal melanoma as indicated in the National Comprehensive Cancer Network (NCCN) consensus guidelines (NCCN Guidelines®, 2023). Y-90 absorbed glass microspheres will be administered at least one time prior to initiating Tebentafusp treatment. After the Y90-TARE procedure, participants will have a 14- to 28-day Y-90 TARE Recovery Period.
| Study group | Role | What they receive |
|---|---|---|
| Tebentafusp in combination with Radioembolization Group | Experimental | Participants in this group will first be administered Yttrium 90 Trans-Arterial Radioembolization (Y90 TARE) therapy, followed by a 14 to 28 day recovery period. Participants will then be administered Tebentafusp once weekly during every 28-day cycle. Participants may receive up to 24 months or 24 cycles of Tebentafusp therapy.
Total participation is about 3 years. Receives: Drug: Tebentafusp; Radiation: TheraSphere™ Yttrium-90 Trans-Arterial Radioembolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
Progression-free survival (PFS) will be defined as the elapsed time in months from the first date of study treatment until documented disease progression, per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or death from any cause, whichever is earlier. For participants who remain alive without progression, follow-up time will be censored at the date of last disease assessment.
Measured: Up to 24 months
Number of Participants Experiencing Treatment-Related Adverse Events
The number of participants experiencing treatment-related adverse events (AEs) and serious adverse events (SAEs) in participants receiving protocol therapy will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5, per physician discretion.
Measured: Up to 24 months
Secondary outcomes (4)
Disease control rate (DCR) measured by proportion of patients
Disease control rate (DCR) is the proportion of patients whose best response per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria is complete response (CR), partial response (PR), or stable disease (SD) confirmed with new assessments by CT or MRI imaging prior to starting new anticancer therapies. Response recorded after non-protocol anticancer therapy will not be counted.
Measured: Up to 24 months
Overall response rate (ORR)
Overall response rate (ORR) is the proportion of patients whose best overall response per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria is complete response (CR) or partial response (PR). Response recorded after non-protocol anticancer therapy will not be counted.
Measured: Up to 2 years
Duration of response (DOR)
The duration of overall response (DOR) is measured from the time in months measurement criteria are met for complete response (CR) or partial response (PR) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). For participants without progression, follow-up time will be censored at the date of last disease assessment (as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1).
Measured: Up to 24 months
Overall survival (OS)
Overall survival (OS) is defined as the elapsed time in years from date of first study treatment until death from any cause. Participants without documented death will be censored at the last date known to be alive.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2024
- Study start14 Feb 2025
- Primary completion17 Feb 2028 (estimated)
- Study completion17 Feb 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Uveal MelanomaStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Immunocore Ltd
- Responsible party
- Principal investigator, Lynn Feun, MD, University of Miami
- Investigators
- Lynn Feun, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06627244
- Sponsor's protocol ID
- 20231324
- Status last verified
- Feb 2026
- First submitted
- 2 Oct 2024
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2, Single Arm Study of Tebentafusp and Radioembolization in the Treatment of Metastatic Uveal Melanoma
- ClinicalTrials.gov ID
- NCT06627244
- Acronym / sponsor ID
- 20231324
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Immunocore Ltd
- Study start
- 14 Feb 2025 (actual)
- Primary completion
- 17 Feb 2028 (estimated)
- Study completion
- 17 Feb 2031 (estimated)
- First posted
- 4 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effects (good and bad) that Tebentafusp in combination with Yttrium-90 (Y-90) radioembolization has on patients with metastatic uveal melanoma that has spread to the liver.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tebentafusp in combination with Radioembolization Group | Experimental | Drug: Tebentafusp, Radiation: TheraSphere™ Yttrium-90 Trans-Arterial RadioembolizationParticipants in this group will first be administered Yttrium 90 Trans-Arterial Radioembolization (Y90 TARE) therapy, followed by a 14 to 28 day recovery period. Participants will then be administered Tebentafusp once weekly during every 28-day cycle. Participants may receive up to 24 months or 24 cycles of Tebentafusp therapy. Total participation is about 3 years. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Metastatic uveal melanoma, confined mainly to the liver, and documented by pathology review
- Serum bilirubin <2 mg/dl, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 5 x upper limit of normal (ULN)
- Mapping angiogram procedure shows radioembolization is feasible and safe to perform
- Human leukocyte antigen-A*02:01(HLA A⁕ 02:01) positive
- Patient age ≥ 18 years old
Key exclusion criteria (53 listed)
- Patient with any tumor size > 8 cm
- Total bilirubin > 1.5 × ULN, except for patients with Gilbert's syndrome, who are excluded if total bilirubin > 3.0 × ULN or direct bilirubin > 1.5 × ULN
- Clinical laboratory measurements that meet any of the following criteria:
- Angiogram shows vascular shunting which prevents radioembolization
- History of severe hypersensitivity reactions (eg, anaphylaxis) to other biologic drugs or monoclonal antibodies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TebentafuspAlso: Tebentafusp-tebnTebentafusp will be administered intravenously to participants at or within 28 days of their first Y-90 TARE procedure. This 28-day period includes the 14- to 28-day Y-90 TARE Recovery Period. For administrative purposes, one cycle of tebentafusp treatment is 28 days in length. Tebentafusp will be administered on a dose escalation schedule for Cycle 1 starting at 20 mcg on Day 1, increasing to 30 mcg on Day 8, and a final dose of 68 mcg on Day 15, which will be administered once per week until unacceptable toxicity develops, disease progression, or withdrawal of consent, whichever occurs first. | Drug | Tebentafusp in combination with Radioembolization Group |
| TheraSphere™ Yttrium-90 Trans-Arterial RadioembolizationAlso: Y-90 TAREParticipants will undergo radiographic and 99mTC-labeled macroaggregated albumin (99mTc-MAA) assessment for suitability prior to Y-90 absorbed glass microsphere treatment per institutional procedures. Y-90 trans-arterial radioembolization (TARE) is a standard of care treatment for intrahepatic metastases of uveal melanoma as indicated in the National Comprehensive Cancer Network (NCCN) consensus guidelines (NCCN Guidelines®, 2023). Y-90 absorbed glass microspheres will be administered at least one time prior to initiating Tebentafusp treatment. After the Y90-TARE procedure, participants will have a 14- to 28-day Y-90 TARE Recovery Period. | Radiation | Tebentafusp in combination with Radioembolization Group |
Primary outcome
Progression Free Survival (PFS)
Time frame: Up to 24 months
Progression-free survival (PFS) will be defined as the elapsed time in months from the first date of study treatment until documented disease progression, per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or death from any cause, whichever is earlier. For participants who remain alive without progression, follow-up time will be censored at the date of last disease assessment.
Number of Participants Experiencing Treatment-Related Adverse Events
Time frame: Up to 24 months
The number of participants experiencing treatment-related adverse events (AEs) and serious adverse events (SAEs) in participants receiving protocol therapy will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5, per physician discretion.
4 secondary outcomes
Disease control rate (DCR) measured by proportion of patients
Time frame: Up to 24 months
Overall response rate (ORR)
Time frame: Up to 2 years
Duration of response (DOR)
Time frame: Up to 24 months
Overall survival (OS)
Time frame: Up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lynn Feun, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tebentafusp and TheraSphere™ Yttrium-90 Trans-Arterial Radioembolization in people with Metastatic Uveal Melanoma and Metastatic Uveal Melanoma in the Liver, run by University of Miami 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 8 inclusion and 53 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 23 Feb 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 Lynn Feun, MD ((305) 243-4981, lfeun@med.miami.edu), 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Feb 2026.