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Immunotherapy

Tebentafusp for Uveal Melanoma

Phase 2

Waitlist Available

Led By Diwakar Davar, MD, PhD

Research Sponsored by Diwakar Davar

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically or cytologically confirmed untreated metastatic uveal melanoma (mUM)

HLA-A*0201 genotype positive as assessed using a CLIA-certified blood typing method and confirmed by central review

Must not have

Known history of uncontrolled active human immunodeficiency virus (HIV), hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infection

Radiotherapy within 2 weeks of the first dose of study drug

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at two years (post start of treatment)

Awards & highlights

Summary

This trial tests a new medicine in people with metastatic uveal melanoma to see if it helps. It also looks at biomarkers in the blood.

Who is the study for?

This trial is for adults with untreated metastatic uveal melanoma who are HLA-A*0201 positive and have not had systemic therapy for advanced cancer. They must be willing to undergo a ctDNA test, have a life expectancy over 6 months, and an ECOG status of 0 or 1. Excluded are those with severe allergies to biologics, certain heart conditions, active brain metastases, uncontrolled HIV/HBV/HCV infections, recent major surgery or radiotherapy.

What is being tested?

The study tests Tebentafusp in patients with specific genetic makeup (HLA-A*0201) who haven't been treated before for their advanced eye melanoma. It's an open-label phase II trial where all participants receive the drug while also having their tumor DNA monitored.

What are the potential side effects?

While the exact side effects aren't listed here, similar treatments often cause immune reactions, fatigue, skin issues like rash or itching, feverish symptoms due to infusion reactions and potential liver function changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My eye melanoma has spread and hasn't been treated yet.

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My blood test shows I am HLA-A*0201 positive.

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I haven't had chemotherapy or targeted therapy for my advanced cancer.

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I have never been treated with tebentafusp.

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I am fully active or can carry out light work.

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I have provided a fresh biopsy of a tumor that hasn't been treated with radiation.

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I haven't had any liver-targeted treatments like chemo, radiation, or embolization.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have uncontrolled HIV, HBV, or HCV.

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I have not had radiotherapy in the last 2 weeks.

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I have no other cancer besides the one being treated in this study.

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I am currently taking steroids or other medications that weaken my immune system.

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I have heart problems that affect my daily life.

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I have active cancer spread to my brain.

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I am a male and will use double barrier contraception during and for 6 months after the study.

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I have not had major surgery within the last 2 weeks.

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I am currently on antibiotics for an infection.

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I have a history of autoimmune disease that causes symptoms.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at three years (post start of treatment)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at three years (post start of treatment)

This trial's timeline: 3 weeks for screening, Varies for treatment, and at three years (post start of treatment) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in ctDNA response

Secondary study objectives

1-year Overall Survival (OS)

1-year Progression-free Survival (PFS)

2-year Overall Survival (OS)

+6 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Tebentafusp (IMCgp100)Experimental Treatment1 Intervention

Dose: 20mcg W1D; 30mcg W2D1; 68mcg W3D1and subsequent doses Frequency: Weekly on D1 of 12-week cycles

0 / 17Eligibility criteria met

Find a Location

Who is running the clinical trial?

Diwakar DavarLead Sponsor

11 Previous Clinical Trials

370 Total Patients Enrolled

Immunocore LtdIndustry Sponsor

14 Previous Clinical Trials

3,902 Total Patients Enrolled

Diwakar Davar, MD, PhDPrincipal InvestigatorUPMC Hillman Cancer Center

1 Previous Clinical Trials

56 Total Patients Enrolled

~29 spots leftby Sep 2026

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