Locally Advanced Unresectable Uveal MelanomaPhase 2NCT06414590
Neoadjuvant Tebentafusp for Uveal Melanoma
A Phase 2 study testing Tebentafusp-Tebn in people with Locally Advanced Unresectable Uveal Melanoma, run by Thomas Jefferson University at 2 sites in United States.
Trial summary
This is a prospective, single arm, phase II clinical trial of neoadjuvant Tebentafusp (KIMMTRAK®) in patients with locally advanced primary uveal melanoma. Patients must be HLA-A*02:01 with large, surgically unresectable (other than complete enucleation of the eye) primary uveal melanoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Unresectable Uveal Melanoma
- What is being tested?
- Tebentafusp-Tebn
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Sep 2025to Mar 2032
- 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
- Individuals must meet all of the following inclusion criteria in order to be eligible to participate in the study:
- 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.
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- 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.
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Symptomatic uveal melanoma that requires immediate ophthalmological intervention such as enucleation.
- Evidence of metastatic disease.
- Previous treatment with Tebentafusp.
- Patients with any out-of-range laboratory values defined as:
- Serum creatinine > 1.5 x upper limit of normal (ULN) and/or creatinine clearance (calculated using Cockcroft-Gault Formula, or measured) < 50 mL/minute
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- 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 treating physician and/or the principal investigator.
- 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.
- Clinically significant cardiac disease or impaired cardiac function, including any of the following:
- 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 treatment
- 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.
- Participants with a history of human immunodeficiency virus (HIV) infection. NOTE: Testing is not required unless mandated by the local health authority. Participants with HIV infection may be eligible if ALL of the following are applicable:
- Receiving an approved, stable, effective combination antiretroviral therapy regimen for > 3 months prior to the planned first study intervention. NOTE: please review Section 5.7 and consider whether any actions should be taken to minimize potential drug-drug interactions,
- 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 confirmed as undetectable during Screening may be eligible.
- 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 during screening.
- 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 judgement, prevent the patient's participation in the clinical study due to safety concerns, compliance with clinical study procedures or interpretation of study results.
- 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 considered major surgery and are not exclusionary).
- 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. An erythroid-stimulating agent is allowed as long as it was initiated at least 2 weeks prior to the first dose of study treatment and the patient is not red blood cell transfusion dependent.
- 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 study treatment (defined in Section 8.4.7), and must agree to continue using such precautions for 6 months after the final dose of study drug; cessation of birth control after this point should be discussed with a responsible physician.
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Rino Seedor, MD contact
United States2 sites, 1 recruiting
- Recruiting
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Rino Seedor, MD, 215-955-8874, rino.seedor@jefferson.edu
Rino Seedor, MD
- Active, not recruiting
Wills Eye Hospital
Philadelphia, Pennsylvania, 19107
About this study
Official title: Neoadjuvant Tebentafusp in Patients With Locally Advanced, Unresectable Primary Uveal Melanoma
This is a prospective, single arm, phase II clinical trial of neoadjuvant Tebentafusp (KIMMTRAK®) in patients with locally advanced primary uveal melanoma. Patients must be HLA-A*02:01 with large, surgically unresectable (other than complete enucleation of the eye) primary uveal melanoma. The efficacy of this treatment will be assessed with the Simon's two stage design. The choice of design is guided by a desire to stop the trial early if the actual regression rate of primary uveal melanoma is 1% or lower.
Read the detailed description
This is an investigator-initiated, Phase II trial evaluating neoadjuvant treatment for locally advanced, unresectable primary uveal melanoma with Tebentafusp. Given the success of Tebentafusp in the metastatic setting, we are interested in utilizing Tebentafusp in the neoadjuvant setting. Limited clinical research data suggest that Tebentafusp might accumulate in primary uveal melanoma and result in regression of primary uveal melanoma. This clinical trial will explore this possibility for patients with large and unresectable primary uveal melanoma. Changes in primary UM after Tebentafusp treatment and eye toxicity related to treatment will be monitored with ophthalmologic ultrasound, Optical coherence tomography (OCT) and clinical examination. Primary eye tumor biopsy pre-Tebentafusp and post-Tebentafusp treatment will also be performed by fine-needle aspiration. Blood and aqueous humor circulating tumor-derived DNA will also be measured as a potential biomarker for response.
We will consider regression of the primary uveal melanoma by a 20% reduction in tumor volume a meaningful endpoint for this early phase clinical study. Reduction in volume by 20% could result in a proportion of patients who had planned enucleation prior to therapy to become suitable for plaque brachytherapy (exploratory endpoint).
The efficacy of this combination treatment will be assessed using the Simon's two stage design [Optimal Design]. The trial is carried out in two stages. In stage I, a total number of 8 patients will be accrued. If there are 0 responses (at least a 20% reduction in tumor volume) among these 8 patients, further enrollment of patients may be stopped. Otherwise, an additional 11 patients will be accrued in stage II, resulting in a total sample size of 19. If there are 2 or more responses among these 19 patients, we reject the null hypothesis and claim that the treatment is promising.
PRIMARY OBJECTIVE:
To assess the efficacy of neoadjuvant Tebentafusp in patients with large surgically unresectable (other than complete enucleation of the eye) primary uveal melanoma.
SECONDARY OBJECTIVES:
- To assess the local (eye) and systemic toxicity with Tebentafusp treatment.
- To investigate the usefulness of ctDNA as a biomarker for response.
EXPLORATORY OBJECTIVES:
- To assess sight preservation.
- To assess the change in radiation dose to the fovea.
OUTLINE:
Participants may be screened at Wills Eye Hospital before being consented and treated at Thomas Jefferson University. Patients receive tebentafusp intravenously (IV) over 15-20 minutes on days 1, 8, 15, and 22 of each cycle. Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Within 28 days of their last dose of tebentafusp, patients undergo standard of care (SOC) primary eye treatment (plaque radiotherapy or eye enucleation), as decided by their treating physician. Patients also undergo ophthalmic ultrasound, optical coherence tomography (OCT), wide-angle fundus imaging, OCT angiography (OCTA), fluorescein angiography, orbit magnetic resonance imaging (MRI) or computerized tomography (CT) scan, and collection of blood samples throughout the trial, undergo biopsy and collection of aqueous humour samples at screening and on study, and undergo abdominal MRI and chest and pelvis CT at screening and during follow up.
After completion of primary eye treatment, patients are followed up at 3 months and then for survival for up to 5 years.
- Being tested
- Tebentafusp-Tebn
- Keywords
- Neoadjuvant Tebentafusp, Uveal Melanoma, Primary Uveal Melanoma, Neoadjuvant IMCgp100, gp100 peptide-HLA-directed CD3 T cell engager, HLA-A*02:01, KIMMTRAK®, Tebentafusp-tebn, IMCgp100, radioactive plaque therapy, enucleation, radioactive plaque, fine-needle aspiration, circulating tumor-derived DNA, Phase II, advanced primary uveal melanoma, Simon's two stage design
- Medical subject headings
- Uveal Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tebentafusp-TebnDrug
Also called KIMMTRAK®, IMCgp100, gp100 peptide-HLA-directed CD3 T cell engager
Tebentafusp will be administered as follows: 20mcg on Day 1, 30mcg on Day 8, 68 mcg on Day 15, and weekly doses of 68 mcg thereafter.
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant Tebentafusp in Patients Locally Advanced, Unresectable Primary Uveal Melanoma | Experimental | Tebentafusp administration: 20mcg on Day 1, 30mcg on Day 8, 68 mcg on Day 15, and weekly doses of 68 mcg thereafter. Eye evaluations including clinical examination, ophthalmic ultrasound, optical coherence tomography, and wide-angle fundus imaging will be performed at baseline, Cycle 1 day 1, Cycle 1 day 8, Cycle 2 day 1, prior to definitive treatment for primary uveal melanoma (post-Tebentafusp), and at post-eye treatment evaluation at 3 months. Additionally optical coherence tomography angiography, autofluorescence, fluorescein angiography and MRI scan or CT scan of orbit will be performed at baseline, post-tebentafusp, and at post-eye treatment evaluation. Blood circulating tumor-derived DNA will be performed at baseline, Cycle 2 day 1, post-Tebentafusp, and at post-eye treatment evaluation at 3 months. Primary eye tumor biopsy (collected by fine-needle aspiration) and aqueous circulating tumor-derived DNA will be performed at baseline and post-Tebentafusp. Receives: Drug: Tebentafusp-Tebn |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regression of primary uveal melanoma after Tebentafusp treatment in 20% of treated patients.
Regression is defined as ≥ 20% reduction in tumor volume. All estimates of rates will be presented with corresponding 95% exact confidence intervals. For regression rate, the method of Atkinson and Brown will be used to allow for the two-stage design.
Measured: 3 months post-eye treatment
Secondary outcomes (3)
Incidence of adverse events (AEs)
Will be graded by National Cancer Institute Common Terminology Criteria for Adverse Events (AE) version 5.0. All estimates of rates will be presented with corresponding 95% exact confidence intervals. AEs will be reported for each dose level and presented as tables of frequency of AEs by body system and by worse severity grade observed. AE term start and end date, severity, seriousness, outcome, action taken regarding study drugs and relationship to each study drug will also be reported. The summary tables will also discuss AEs leading to death and AEs leading to study drug(s) discontinuation. Tables should indicate related and unrelated events. Laboratory data will be presented by dose level at each observation time. Values outside normal limits will be identified and summarized by frequency distribution.
Measured: Up to 5 years
Detection of plasma circulating tumor-derived deoxyribonucleic acid (ctDNA) and correlation of antitumor response
Plasma of patients will be collected for all patients at baseline (within 28 days of first dose), cycle 2 day 1, post-tebentafusp (within 14 days of last dose), and at the 3 month post-treatment evaluation. ctDNA response will be measured (defined as ≥0.3 log reduction) in ctDNA-evaluable patients as measured using Signatera assay and correlated with eye tumor regression.
Measured: 22 months
Detection of aqueous humor ctDNA and correlation of antitumor response
Aqueous humor of patients will be collected at baseline and post-tebentafusp; if no ctDNA is detectable in the aqueous humor after 5 patients we will stop collecting aqueous ctDNA for the rest of the patients. ctDNA response will be measured (defined as ≥0.3 log reduction) in ctDNA-evaluable patients as measured using Signatera assay and correlated with eye tumor regression.
Measured: 22 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start5 Sep 2025
- Primary completionAug 2027 (estimated)
- Study completionMar 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Unresectable Uveal MelanomaStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe 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
- 19 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- Immunocore Ltd
- Responsible party
- Sponsor
- Investigators
- Rino Seedor, MD, Principal investigator, Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06414590
- Sponsor's protocol ID
- iRISID-2023-2369
- Other IDs
- JT 33504
- Status last verified
- Jun 2026
- First submitted
- 25 Mar 2024
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Tebentafusp in Patients With Locally Advanced, Unresectable Primary Uveal Melanoma
- ClinicalTrials.gov ID
- NCT06414590
- Acronym / sponsor ID
- iRISID-2023-2369
- Keywords
- Neoadjuvant Tebentafusp, Uveal Melanoma, Primary Uveal Melanoma, Neoadjuvant IMCgp100, gp100 peptide-HLA-directed CD3 T cell engager, HLA-A*02:01, KIMMTRAK®, Tebentafusp-tebn
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 19 participants (estimated)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- Immunocore Ltd
- Study start
- 5 Sep 2025 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Mar 2032 (estimated)
- First posted
- 16 May 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.
This is a prospective, single arm, phase II clinical trial of neoadjuvant Tebentafusp (KIMMTRAK®) in patients with locally advanced primary uveal melanoma. Patients must be HLA-A*02:01 with large, surgically unresectable (other than complete enucleation of the eye) primary uveal melanoma. The efficacy of this treatment will be assessed with the Simon's two stage design. The choice of design is guided by a desire to stop the trial early if the actual regression rate of primary uveal melanoma is 1% or lower.
Detailed description
This is an investigator-initiated, Phase II trial evaluating neoadjuvant treatment for locally advanced, unresectable primary uveal melanoma with Tebentafusp. Given the success of Tebentafusp in the metastatic setting, we are interested in utilizing Tebentafusp in the neoadjuvant setting. Limited clinical research data suggest that Tebentafusp might accumulate in primary uveal melanoma and result in regression of primary uveal melanoma. This clinical trial will explore this possibility for patients with large and unresectable primary uveal melanoma. Changes in primary UM after Tebentafusp treatment and eye toxicity related to treatment will be monitored with ophthalmologic ultrasound, Optical coherence tomography (OCT) and clinical examination. Primary eye tumor biopsy pre-Tebentafusp and post-Tebentafusp treatment will also be performed by fine-needle aspiration. Blood and aqueous humor circulating tumor-derived DNA will also be measured as a potential biomarker for response.
We will consider regression of the primary uveal melanoma by a 20% reduction in tumor volume a meaningful endpoint for this early phase clinical study. Reduction in volume by 20% could result in a proportion of patients who had planned enucleation prior to therapy to become suitable for plaque brachytherapy (exploratory endpoint).
The efficacy of this combination treatment will be assessed using the Simon's two stage design [Optimal Design]. The trial is carried out in two stages. In stage I, a total number of 8 patients will be accrued. If there are 0 responses (at least a 20% reduction in tumor volume) among these 8 patients, further enrollment of patients may be stopped. Otherwise, an additional 11 patients will be accrued in stage II, resulting in a total sample size of 19. If there are 2 or more responses among these 19 patients, we reject the null hypothesis and claim that the treatment is promising.
PRIMARY OBJECTIVE:
To assess the efficacy of neoadjuvant Tebentafusp in patients with large surgically unresectable (other than complete enucleation of the eye) primary uveal melanoma.
SECONDARY OBJECTIVES:
- To assess the local (eye) and systemic toxicity with Tebentafusp treatment.
- To investigate the usefulness of ctDNA as a biomarker for response.
EXPLORATORY OBJECTIVES:
- To assess sight preservation.
- To assess the change in radiation dose to the fovea.
OUTLINE:
Participants may be screened at Wills Eye Hospital before being consented and treated at Thomas Jefferson University. Patients receive tebentafusp intravenously (IV) over 15-20 minutes on days 1, 8, 15, and 22 of each cycle. Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Within 28 days of their last dose of tebentafusp, patients undergo standard of care (SOC) primary eye treatment (plaque radiotherapy or eye enucleation), as decided by their treating physician. Patients also undergo ophthalmic ultrasound, optical coherence tomography (OCT), wide-angle fundus imaging, OCT angiography (OCTA), fluorescein angiography, orbit magnetic resonance imaging (MRI) or computerized tomography (CT) scan, and collection of blood samples throughout the trial, undergo biopsy and collection of aqueous humour samples at screening and on study, and undergo abdominal MRI and chest and pelvis CT at screening and during follow up.
After completion of primary eye treatment, patients are followed up at 3 months and then for survival for up to 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant Tebentafusp in Patients Locally Advanced, Unresectable Primary Uveal Melanoma | Experimental | Drug: Tebentafusp-TebnTebentafusp administration: 20mcg on Day 1, 30mcg on Day 8, 68 mcg on Day 15, and weekly doses of 68 mcg thereafter. Eye evaluations including clinical examination, ophthalmic ultrasound, optical coherence tomography, and wide-angle fundus imaging will be performed at baseline, Cycle 1 day 1, Cycle 1 day 8, Cycle 2 day 1, prior to definitive treatment for primary uveal melanoma (post-Tebentafusp), and at post-eye treatment evaluation at 3 months. Additionally optical coherence tomography angiography, autofluorescence, fluorescein angiography and MRI scan or CT scan of orbit will be performed at baseline, post-tebentafusp, and at post-eye treatment evaluation. Blood circulating tumor-derived DNA will be performed at baseline, Cycle 2 day 1, post-Tebentafusp, and at post-eye treatment evaluation at 3 months. Primary eye tumor biopsy (collected by fine-needle aspiration) and aqueous circulating tumor-derived DNA will be performed at baseline and post-Tebentafusp. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Individuals must meet all of the following inclusion criteria in order to be eligible to participate in the study:
- 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).
Key exclusion criteria (40 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Symptomatic uveal melanoma that requires immediate ophthalmological intervention such as enucleation.
- Evidence of metastatic disease.
- Previous treatment with Tebentafusp.
- Patients with any out-of-range laboratory values defined as:
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 |
|---|---|---|
| Tebentafusp-TebnAlso: KIMMTRAK®, IMCgp100, gp100 peptide-HLA-directed CD3 T cell engagerTebentafusp will be administered as follows: 20mcg on Day 1, 30mcg on Day 8, 68 mcg on Day 15, and weekly doses of 68 mcg thereafter. | Drug | Neoadjuvant Tebentafusp in Patients Locally Advanced, Unresectable Primary Uveal Melanoma |
Primary outcome
Regression of primary uveal melanoma after Tebentafusp treatment in 20% of treated patients.
Time frame: 3 months post-eye treatment
Regression is defined as ≥ 20% reduction in tumor volume. All estimates of rates will be presented with corresponding 95% exact confidence intervals. For regression rate, the method of Atkinson and Brown will be used to allow for the two-stage design.
3 secondary outcomes
Incidence of adverse events (AEs)
Time frame: Up to 5 years
Detection of plasma circulating tumor-derived deoxyribonucleic acid (ctDNA) and correlation of antitumor response
Time frame: 22 months
Detection of aqueous humor ctDNA and correlation of antitumor response
Time frame: 22 months
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 12 Jun 2026.
- Individual participant dataSharing planned: No
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.
Rino Seedor, MD contact
Rino Seedor, MD principal investigator
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
2 sites 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-Tebn in people with Locally Advanced Unresectable Uveal Melanoma, run by Thomas Jefferson University at 2 sites 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 12 inclusion and 40 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 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Rino Seedor, MD (215-955-8874, Rino.Seedor@Jefferson.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Regression of primary uveal melanoma after Tebentafusp treatment in 20% of treated patients. (time frame: 3 months post-eye treatment). 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 12 Jun 2026; AzTrials last refreshed its copy on 1 Nov 2026.