Study on Tebentafusp Before Surgery or Radiation for Eye Melanoma

Sponsor: Thomas Jefferson University

Sponsor score: 0

ClinicalTrials ID:NCT06414590

Provider View

This clinical trial is exploring whether the drug tebentafusp can help shrink tumors in patients with uveal melanoma, a type of eye cancer, before they undergo surgery or radiation. The aim is to see if this approach can prevent the cancer from spreading and reduce the need for total eye removal.

Patient Parameters

Program Overview

This study is testing the effectiveness of tebentafusp, a drug that targets melanoma cells and activates the immune system to attack them, in shrinking tumors in patients with uveal melanoma. The trial focuses on cases where the cancer has spread to nearby tissues or lymph nodes, or cannot be removed by surgery. By administering tebentafusp before the main treatment, researchers hope to shrink the tumor, prevent the disease from spreading, and reduce the likelihood of needing to remove the entire eye.

Description

The main goal of this study is to see how well tebentafusp works in shrinking large uveal melanoma tumors that cannot be surgically removed without taking out the entire eye. Researchers will also look at the side effects of the drug and whether it affects the patient's vision.

Participants will receive tebentafusp through an IV once a week for four weeks, with the treatment cycle repeating once if needed. After the last dose, patients will undergo standard eye treatment, which could be radiation or eye removal, as decided by their doctor.

Throughout the study, patients will have various tests, including heart scans, eye exams, and imaging tests, to monitor their health and the tumor's response to the treatment. Blood samples and tissue biopsies will also be collected to help researchers understand how the drug works.

After completing the main eye treatment, patients will have follow-up visits every three months for up to five years to monitor their health and any long-term effects of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Able to understand and sign a consent form.
  • Willing to have tumor biopsies before and after treatment.
  • Have a large uveal melanoma tumor that cannot be removed without taking out the entire eye.
  • No surgical option to remove the tumor without removing the eye.
  • Confirmed diagnosis of uveal melanoma.
  • Must have a specific genetic marker (HLA-A*02:01 positive).
  • Expected to live at least 12 more weeks.
  • In good general health with a performance status of 0 or 1.
  • All other medical conditions must be stable for at least 28 days before starting the study.
  • No conditions that would interfere with the study or follow-up schedule.

Exclusion Criteria

  • Need immediate eye surgery due to symptoms.
  • Cancer has spread to other parts of the body.
  • Previously treated with tebentafusp.
  • Abnormal lab results, such as high creatinine or low blood counts.
  • Severe allergies to similar drugs.
  • Significant heart problems or recent heart attack.
  • Active infection requiring antibiotics.
  • History of HIV, unless well-controlled.
  • Chronic viral infections like hepatitis B or C, unless well-controlled.
  • Other active cancers, unless treated and not returned in the last two years.
  • Any condition that would make participation unsafe or affect study results.

Locations

FACILITYZIPCITYSTATE
Sidney Kimmel Cancer Center at Thomas Jefferson University19107PhiladelphiaPennsylvania

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.