Study on Tebentafusp for Untreated Metastatic Uveal Melanoma in HLA-A*0201 Positive Patients

Sponsor: Diwakar Davar

Sponsor score: 0

ClinicalTrials ID:NCT06070012

Provider View

This clinical trial is testing a new treatment called tebentafusp for patients with metastatic uveal melanoma who have not received any prior treatment. The study focuses on patients with a specific genetic marker, HLA-A*0201, and includes monitoring of tumor DNA in the blood.

Patient Parameters

Program Overview

This study is exploring the use of tebentafusp, a new treatment for metastatic uveal melanoma, a rare eye cancer that often spreads to the liver. The trial is for patients who have not yet received any treatment for their cancer and have a specific genetic marker, HLA-A*0201. Researchers will also use a blood test to track tumor DNA during the study.

Description

Uveal melanoma is a rare type of eye cancer that can spread to other parts of the body, especially the liver. This study is testing a new treatment called tebentafusp in patients who have not yet received any treatment for their metastatic uveal melanoma. The study is open to patients who have a specific genetic marker, HLA-A*0201, which will be confirmed through a blood test.

Tebentafusp has been tested in several previous studies and has shown promise in treating this type of cancer. In this trial, patients will receive increasing doses of tebentafusp over time, starting with a lower dose and gradually increasing to the full dose. The study aims to determine if this treatment can help control the cancer and improve outcomes for patients.

Participants will need to provide a tumor sample and undergo regular blood tests to monitor their health and the treatment's effects. The study will also track the presence of tumor DNA in the blood to help assess the treatment's impact.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with untreated metastatic uveal melanoma.
  • Positive for the HLA-A*0201 genetic marker, confirmed by a blood test.
  • Willing to undergo a blood test to monitor tumor DNA.
  • Provide a new biopsy of a tumor that has not been treated with radiation.
  • Have not received any prior systemic therapy for metastatic cancer.
  • Life expectancy of more than 6 months.
  • Good overall health with a performance status of 0 or 1.
  • Have measurable disease according to standard criteria.
  • All other medical conditions must be stable and well-managed.

Exclusion Criteria

  • Severe allergic reactions to similar treatments.
  • Significant heart problems or uncontrolled heart disease.
  • Abnormal heart rhythm or recent heart attack.
  • Active or untreated brain metastases.
  • Active infection requiring antibiotics.
  • Uncontrolled HIV, hepatitis B, or hepatitis C infection.
  • Other active cancers, except for certain treated skin cancers or cancers that have not returned in 2 years.
  • Taking systemic steroids or immunosuppressive medications.
  • History of autoimmune diseases requiring treatment.
  • Recent major surgery or radiation therapy.
  • Use of certain growth factors or blood transfusions recently.
  • Pregnant or breastfeeding women.
  • Women of childbearing potential not using effective contraception.
  • Men not using effective contraception.
  • Recent receipt of live vaccines.

Locations

FACILITYZIPCITYSTATE
UPMC Hillman Cancer Center15232PittsburghPennsylvania

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