Tebentafusp for Untreated Metastatic Uveal Melanoma
This study is testing tebentafusp, an anti-cancer medication, in people with uveal melanoma that has spread (metastatic) and has not been treated before. Uveal melanoma is a rare type of eye cancer. To join, you must have a specific genetic marker called HLA-A*0201. Researchers want to see how tebentafusp affects circulating tumor DNA (ctDNA), which are small pieces of tumor DNA found in the blood. This will help them understand if the treatment is working. The study plans to enroll 44 participants.
- Study design
- This is a single-arm, multi-center study, meaning all 44 participants will receive the same treatment. It is an open-label study, so both you and your doctors will know you are receiving tebentafusp.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Researchers will measure changes in ctDNA at baseline, at week 10 of each 12-week cycle, and for up to 24 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06070012
Tebentafusp in HLA-A*0201 Positive Previously Untreated Metastatic Uveal Melanoma
Recruiting
PHASE2Ages 18+InterventionalTreatmentDiwakar DavarInvestigator-initiated
~44 participants
Updated 2026-09-09 on ClinicalTrials.gov
What's tested:Tebentafusp
At a glance
Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in ctDNA response
Measured over At Baseline, at Week 10 of each 12-week cycle, Up to 24 months]
Conditions
NCT06070012
Where you'd take part
This study runs at 4 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Georgetown University Medical Center
Washington D.C., District of Columbiastudy coordinator listed
Recruiting
The Ohio State University
Columbus, Ohiostudy coordinator listed
Recruiting
University of Colorado Cancer Center
Aurora, Coloradostudy coordinator listed
Recruiting
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvaniastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Diwakar Davar, MD, PhD · PRINCIPAL_INVESTIGATOR · UPMC Hillman Cancer Center
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Want this trial checked against your situation?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
If HLA-A status is not known, blood for HLA-A testing must be submitted during Screening, and HLA-A\*0201 positive status confirmed prior to enrollment using a CLIA- certified blood typing method.
If the patient is known to be HLA-A\*0201 positive, this information must be provided in the Screening packet and centrally reviewed by treating PI and Sponsor-Investigator prior to enrollment.
The following HLA testing methodologies are suitable to determine HLA-A\*0201 positivity:
Multiplex real-time PCR based testing performed by entities including but not limited to Labcorp, and American Red Cross.
HLA testing as part of peripheral blood molecular profiling technology including but not limited to Caris Life Sciences Molecular Profiling Technology.
Patients be willing to undergo ctDNA assessment using Signatera assay.
Have provided newly obtained core biopsy of a tumor lesion not previously irradiated.
Adequate organ function on screening labs obtained within 4 weeks of Week 1 day 1
Must meet the following criteria related to prior treatment:
No prior systemic therapy in the metastatic or advanced setting including chemotherapy, or targeted therapy.
NOTE: Patients must be tebentafusp naïve.
NOTE: Patients must not have received prior PD-1, CTLA-4, LAG-3 directed Immune Checkpoint Inhibitor therapy delivered in the adjuvant, and/or neoadjuvant settings unless such therapy was received \>6 months prior initial diagnosis of mUM.
No prior regional, liver-directed therapy including chemotherapy, radiotherapy, or embolization.
Prior surgical resection of oligometastatic disease is allowed.
Prior neoadjuvant or adjuvant therapy is allowed provided administered in the curative setting in patients with localized disease.
Life expectancy of \>6 months as estimated by the investigator.
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 at Screening.
Patients have measurable disease according to RECIST v.1.1.
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.
Exclusion
History of severe hypersensitivity reactions (eg, anaphylaxis) to other biologic drugs or monoclonal antibodies.
Clinically significant cardiac disease or impaired cardiac function, including any of the following:
Clinically significant and/or uncontrolled heart disease such as congestive heart failure (New York Heart Association grade ≥ 2), uncontrolled hypertension, or clinically significant arrhythmia currently requiring medical treatment.
QTcF \> 470 msec on screening electrocardiogram (ECG) or congenital long QT syndrome.
NOTE: If the initial automated QTcF interval is \> 470 msec at screening, for the purpose of determining eligibility, the mean QTcF, based on at least 3 ECGs obtained over a brief time interval (ie, within 30 minutes), should be manually determined by a medically qualified person.
NOTE: 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 the prior 3 weeks to study Day 1.
Presence of active brain metastases.
NOTE: Patients with brain metastases are eligible if all lesions have been treated surgically and/or radiosurgically and there is no evidence of progression for at least 2 weeks by MRI prior to the first dose of study drug.
NOTE: Patients with any evidence of leptomeningeal disease are excluded.
Active infection requiring systemic antibiotic therapy.
Known history of uncontrolled active human immunodeficiency virus (HIV), hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infection.
NOTE: Testing for HIV, HBV and/or HCV is not necessary unless clinically indicated or the patient has a history of HBV/HCV and/or HIV infection.
NOTE: Patients with curatively treated HBV and/or HCV infection may be enrolled. In these instances, HBV (quantitative HBV DNA) and/or HCV (quantitative HCV RNA) resolution must be documented using a quantitative viral load assay.
NOTE: Patients with HIV who are stably controlled on highly active antiretroviral therapy (HAART) therapy with a low HIV viral load may be enrolled. In these instances, stable control is defined as HAART compliant with a CD4 count of ≥200 cells/μL, and low viral load is defined as \<200 copies/mL on tests done during Screening.
Malignant disease, other than that being treated in this study. Exceptions to this exclusion include the following:
Completely resected carcinoma in situ of any type, resected basal cell and squamous cell carcinomas.
Malignancies that were treated curatively and have not recurred within 2 years prior to study treatment;
Any malignancy considered to be indolent that has never required therapy Sponsor-Investigator evaluation.
Any medical condition that would, in the judgment of the Sponsor-Investigator, 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, as these may interfere with the mechanism of action of study treatment.
History of symptomatic autoimmune disease including:
Interstitial lung disease.
Pneumonitis requiring corticosteroid treatment or current pneumonitis.
Colitis or inflammatory bowel disease. NOTE: However, patients with a history of autoimmune disease who are currently on physiologic hormone repletion (prednisone or equivalent of 10mg or less) and are otherwise asymptomatic may be enrolled.
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, 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, G-CSF, GM-CSF, 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 childbearing 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 and must agree to continue using such precautions for 6 months after the final dose of investigational product; 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 enrollment through treatment and for 6 months following administration of the last dose of study drug.
Receipt of live or attenuated vaccinations 2 weeks prior to starting study therapy. Patients may receive vaccinations on treatment.
What this trial measures
- Change in ctDNA responseAt Baseline, at Week 10 of each 12-week cycle, Up to 24 months]
ctDNA response (defined as ≥0.3 log reduction) in ctDNA-evaluable patients as measured by tumor-informed ctDNA assay.