Actively Recruiting
Neoadjuvant Tebentafusp for Uveal Melanoma
Led by Thomas Jefferson University · Updated on 2026-04-14
19
Participants Needed
2
Research Sites
338 weeks
Total Duration
On this page
Sponsors
T
Thomas Jefferson University
Lead Sponsor
I
Immunocore Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Neoadjuvant Tebentafusp for Uveal Melanoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients aged 18 years or older at consent
- Ability to understand and provide written informed consent
- Willing to undergo tumor biopsies before and after Tebentafusp treatment
- Treatment-naive primary uveal melanoma with T3 or T4 tumor size that cannot be surgically removed except by complete eye removal
- No surgical option to remove tumor without enucleation
- Clinically or cytologically confirmed primary uveal melanoma
- Positive for HLA-A*02:01
- Predicted life expectancy of at least 12 weeks
- ECOG performance status of 0 or 1 at screening
- Stable and well-managed medical conditions for at least 28 days before first dose
- No psychological, familial, sociological, or geographic factors that could interfere with study compliance
You will not qualify if you...
- Symptomatic uveal melanoma needing immediate eye removal
- Evidence of metastatic disease
- Previous Tebentafusp treatment
- Abnormal lab values outside specified limits (kidney, liver, blood counts, electrolytes, cortisol)
- History of severe allergic reactions to biologic drugs or monoclonal antibodies
- Significant heart disease or impaired heart function
- Active infection requiring systemic antibiotics or ongoing antibiotic treatment
- Known HIV infection unless stable on therapy with controlled viral load and immune counts
- Known active hepatitis B or C infection unless stable and controlled
- Other malignant diseases except certain treated or indolent cancers
- Any medical condition preventing safe study participation
- Use of systemic steroids or immunosuppressive drugs
- Major surgery or radiotherapy within 2 weeks before study drug
- Recent use of certain blood growth factors
- Pregnant or lactating women
- Women of childbearing potential not using effective contraception
- Male patients not surgically sterile or not using contraception
- Failure to obtain insurance approval for Tebentafusp treatment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
2
Wills Eye Hospital
Philadelphia, Pennsylvania, United States, 19107
Active, Not Recruiting
Research Team
R
Rino Seedor, MD
CONTACT
R
Rino Seedor, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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