Metastatic Uveal Melanoma study: Tebentafusp
Official title Study of Tebentafusp and Radioembolization in the Treatment of Metastatic Uveal Melanoma
ClinicalTrials.gov ID: NCT06627244
What this study is testing
What is Tebentafusp?
Tebentafusp is an investigational medicine, given as an IV infusion (through a vein), being studied as a potential treatment for metastatic uveal melanoma.
Also referred to as Tebentafusp-tebn.
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 study is testing whether combining Tebentafusp with Y‑90 radioembolization helps treat metastatic uveal melanoma that has spread to the liver.
- Who it's for
- You may be able to join if you have eye cancer that has spread to your liver and meet the study’s health criteria.
- What's involved
- You will receive Tebentafusp injections and a Y‑90 radioembolization procedure. You will have regular visits for check‑ups and tests to see how you are doing.
- Time commitment
- The study lasts about 6 months, with several clinic visits and tests during that time.
- 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
- 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
You likely can't join if
- 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 \>...
- Alanine aminotransferase (ALT) \> 3 × ULN
- Aspartate aminotransferase (AST) \> 3 × ULN
- Absolute neutrophil count (ANC) \< 1.0 × 10\^9 cells/L
- Absolute lymphocyte count \< 0.5 × 10\^9 cells/L
See the full eligibility criteria
Who can 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).
What rules you out
- 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
- Alanine aminotransferase (ALT) \> 3 × ULN
- Aspartate aminotransferase (AST) \> 3 × ULN
- Absolute neutrophil count (ANC) \< 1.0 × 10\^9 cells/L
- 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
- 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...
- 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
- 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...
- 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).
- History of interstitial lung disease
- History of pneumonitis that required corticosteroid treatment or current pneumonitis
- 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...
- 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...
- Patient receiving a live or attenuated vaccine(s) ≤ 28 days prior to the first dose of study intervention.
- 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...
- 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...
- Prior radioembolization or other regional, liver-directed therapy, including chemotherapy or embolization to same site in the liver
- Patients with impaired decision-making capacity.
The study team makes the final eligibility decision.
Where it is enrolling
- Miami, 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, but 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?
This study is enrolling now at Miami, Florida, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.