Locally Advanced Unresectable Uveal Melanoma study: Tebentafusp-Tebn
Official title Neoadjuvant Tebentafusp for Uveal Melanoma
ClinicalTrials.gov ID: NCT06414590
What this study is testing
What is Tebentafusp-Tebn?
An investigational once‑weekly injectable medicine being studied for locally advanced unresectable uveal melanoma. is designed to engage CD3 T cells and target gp100 peptides presented by HLA‑A*02:01.
Also referred to as KIMMTRAK®, IMCgp100, gp100 peptide‑HLA‑directed CD3 T cell engager.
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
- The study will see if Tebentafusp can reduce the size of advanced uveal melanoma before surgery. It uses a design that may stop early if the treatment shows very little effect.
- Who it's for
- Adults with large, surgically unresectable uveal melanoma who have the HLA‑A*02:01 genetic marker.
- What's involved
- Participants will receive Tebentafusp injections and have regular eye and imaging exams to monitor tumor size. No other experimental treatments are used.
- Time commitment
- The trial lasts about 6 months, with several clinic visits for injections and imaging during that time.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 5 years
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
- Male or female patient age ≥ 18 years of age at the time of informed consent.
- Ability to provide and understand written informed consent prior to any study procedures.
- Willingness to undergo tumor biopsies at baseline and post-Tebentafusp treatment.
- Treatment naïve primary uveal melanoma with T3 or T4 category tumor size that are surgically unresectable (other than complete enucleation of eye).
- No surgical indication to completely remove the tumor without enucleation.
You likely can't join if
- Symptomatic uveal melanoma that requires immediate ophthalmological intervention such as enucleation.
- Evidence of metastatic disease.
- Previous treatment with Tebentafusp.
- Serum creatinine \> 1.5 x upper limit of normal (ULN) and/or creatinine clearance (calculated using Cockcroft-Gault Formula, or measured) \< 50...
- Albumin \< 3.0 g/dl
- Total bilirubin \>1.5 mg/dL (or 1.3 x ULN). Patients with hyperbilirubinemia clinically consistent with an inherited disorder of bilirubin metabolism...
See the full eligibility criteria
Who can join
- Male or female patient age ≥ 18 years of age at the time of informed consent.
- Ability to provide and understand written informed consent prior to any study procedures.
- Willingness to undergo tumor biopsies at baseline and post-Tebentafusp treatment.
- Treatment naïve primary uveal melanoma with T3 or T4 category tumor size that are surgically unresectable (other than complete enucleation of eye).
- No surgical indication to completely remove the tumor without enucleation.
- Clinically or cytologically confirmed primary uveal melanoma.
- Participants must be HLA-A\ 02:01 positive.
- Predicted life expectancy of at least 12 weeks as estimated by investigator
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at screening.
- All other relevant medical conditions must be well-managed and stable, in the opinion of the investigator, for at least 28 days prior to first administration of study drug.
- Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
What rules you out
- Symptomatic uveal melanoma that requires immediate ophthalmological intervention such as enucleation.
- Evidence of metastatic disease.
- Previous treatment with Tebentafusp.
- Serum creatinine \> 1.5 x upper limit of normal (ULN) and/or creatinine clearance (calculated using Cockcroft-Gault Formula, or measured) \< 50 mL/minute
- Albumin \< 3.0 g/dl
- Total bilirubin \>1.5 mg/dL (or 1.3 x ULN). Patients with hyperbilirubinemia clinically consistent with an inherited disorder of bilirubin metabolism (e.g., Gilbert syndrome) will be eligible at the discretion of the...
- Alanine aminotransferase \> 1.5 x ULN
- Aspartate aminotransferase \> 1.5 x ULN
- Absolute neutrophil count \< 1.0 x 109 /L
- Absolute lymphocyte count \< 0.5 x 109 /L
- Platelet count \< 100 x 109 /L
- Hemoglobin \< 9.0 g/dL
- Uncorrectable abnormal potassium, magnesium, corrected calcium or phosphate abnormality of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v5.0) \> grade 1
- Morning cortisol \< lower limit of normal (unless the patient has asymptomatic adrenal insufficiency and is receiving stable replacement doses)
- History of severe hypersensitivity reactions (e.g., anaphylaxis) to other biologic drugs or monoclonal antibodies.
- Left Ventricular Ejection Fraction \<50%
- Clinically significant and/or uncontrolled heart disease such as congestive heart failure (New York Heart Association grade ≥ 2), uncontrolled hypertension, or clinically significant arrhythmia uncontrolled with medical...
- Acute myocardial infarction or unstable angina pectoris \< 6 months to Screening
- 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 study drug.
- Receiving an approved, stable, effective combination antiretroviral therapy regimen for \> 3 months prior to the planned first study intervention.
- CD4 T cell count \> 350 cells/µl,
- CD4 T cell nadir (lowest historical count) \> 200 cells/µl, and
- Viral load confirmed as \< 50 copies/mL during Screening.
- Participants with a known history of chronic viral infections as indicated below. NOTE: Testing for hepatitis B virus (HBV) or hepatitis C virus (HCV) is not required unless mandated by the local health authority.
- Known HBV infection defined as hepatitis B surface antigen reactive. NOTE: Participants with HBV infection on stable anti-viral therapy for \> 4 weeks prior to the planned first study intervention and viral load...
- Known active HCV infection defined as detectable HCV RNA (qualitative) infection. NOTE: History of HCV is not exclusionary if participants have received curative treatment and viral load is confirmed as undetectable...
- 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...
- Any medical condition that would, in the investigator's or Sponsor's judgement, prevent the patient's participation in the clinical study due to safety concerns, compliance with clinical study procedures or...
- Patients receiving systemic steroid therapy or any other immunosuppressive medication at any dose level. Local steroid therapies (e.g., otic, ophthalmic, intra-articular or inhaled medications) are acceptable.
- 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.
- Use of hematopoietic colony-stimulating growth factors (e.g., G-CSF, GMCSF, M-CSF) ≤ 2 weeks prior to start of study drug.
- 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 child-bearing potential 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...
- Male patients must be surgically sterile or use double barrier contraception methods from enrolment through treatment and for 6 months following administration of the last dose of study drug.
The study team makes the final eligibility decision.
Where it is enrolling
- Philadelphia, Pennsylvania, 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 study runs about 5 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you 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 Philadelphia, Pennsylvania, 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.