Actively Recruiting
Tebentafusp in HLA-A*0201 Positive Previously Untreated Metastatic Uveal Melanoma
Led by Diwakar Davar · Updated on 2026-02-27
44
Participants Needed
3
Research Sites
267 weeks
Total Duration
On this page
Sponsors
D
Diwakar Davar
Lead Sponsor
I
Immunocore Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a phase II open-label, single-arm, multi-center study of tebentafusp in HLA- A\*0201 positive previously untreated (1L) untreated metastatic uveal melanoma (mUM) with an integrated circulating tumor DNA (ctDNA) biomarker.
CONDITIONS
Official Title
Tebentafusp in HLA-A*0201 Positive Previously Untreated Metastatic Uveal Melanoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed untreated metastatic uveal melanoma (mUM).
- Positive for HLA-A*0201 genotype confirmed by a CLIA-certified blood test.
- Willingness to undergo circulating tumor DNA (ctDNA) assessment using the Signatera assay.
- Newly obtained core biopsy of a tumor lesion not previously irradiated.
- Adequate organ function based on screening labs within 4 weeks prior to treatment.
- No prior systemic therapy for metastatic or advanced disease, including chemotherapy or targeted therapy.
- No prior regional liver-directed therapies such as chemotherapy, radiotherapy, or embolization.
- Prior surgical removal of limited metastatic disease is allowed.
- Prior neoadjuvant or adjuvant therapy allowed if given in the curative setting for localized disease.
- Life expectancy greater than 6 months.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Presence of measurable disease by RECIST v1.1.
- All other relevant medical conditions must be well-managed and stable for at least 28 days before starting treatment.
You will not qualify if you...
- History of severe allergic reactions to biologic drugs or monoclonal antibodies.
- Clinically significant or uncontrolled heart conditions including congestive heart failure (NYHA grade 2 or higher), uncontrolled hypertension, or arrhythmias requiring treatment.
- QTcF interval over 470 msec on ECG or congenital long QT syndrome.
- Acute myocardial infarction or unstable angina within 6 months before screening.
- Symptomatic or untreated central nervous system (CNS) metastases or CNS metastases requiring corticosteroids within 3 weeks before study start.
- Active brain metastases unless treated and stable for at least 2 weeks by MRI.
- Any evidence of leptomeningeal disease.
- Active infection requiring systemic antibiotics.
- Known uncontrolled active HIV, hepatitis B, or hepatitis C infections.
- Other malignant diseases except certain treated cancers that have not recurred within 2 years or indolent malignancies.
- Any medical condition that would prevent safe participation or compliance.
- Use of systemic steroids or immunosuppressive medications, except for local steroid treatments.
- History of symptomatic autoimmune diseases such as interstitial lung disease, pneumonitis needing corticosteroids, or inflammatory bowel disease, unless well-controlled.
- Major surgery within 2 weeks before first dose (minor procedures excluded).
- Radiotherapy within 2 weeks before first dose, except limited palliative radiotherapy.
- Use of hematopoietic growth factors within 2 weeks before treatment start.
- Pregnant, likely to become pregnant, or breastfeeding women.
- Women of childbearing potential not using highly effective contraception during and 6 months after treatment.
- Male patients not surgically sterile or not using double barrier contraception during and 6 months after treatment.
- Receipt of live or attenuated vaccines within 2 weeks before starting study therapy.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
Actively Recruiting
2
Georgetown University Medical Center
Washington D.C., District of Columbia, United States, 20007
Actively Recruiting
3
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
Research Team
A
Amy Rose, RN, BSN
CONTACT
D
Danielle L Bednarz, RN, BSN
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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