Study on Pembrolizumab for Treating Advanced or Returning Skin Cancer Around the Eye

Sponsor: University of Michigan Rogel Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06580054

Provider View

This clinical trial is exploring how well the drug pembrolizumab works in treating skin cancer around the eye that has spread to nearby areas or has come back after treatment. The study focuses on cancers that are difficult to treat with surgery or radiation.

Patient Parameters

Program Overview

This study is testing the effectiveness of pembrolizumab, an immunotherapy drug, in treating skin cancer located around the eye that has either spread to nearby tissues or returned after previous treatment. These types of skin cancers often have genetic changes that might make them more responsive to immunotherapy. Pembrolizumab works by helping the immune system attack cancer cells and is already approved for treating certain types of skin cancer that cannot be cured with surgery or radiation. The study aims to see if pembrolizumab can better treat these advanced or recurrent cancers around the eye.

Description

The main goal of this study is to see if pembrolizumab can help shrink tumors in patients with advanced or returning skin cancer around the eye. Researchers also want to find out if the treatment can help preserve the eye and prevent the cancer from getting worse.

Participants will receive pembrolizumab through an IV every 21 days, for up to 35 cycles, unless the cancer progresses or side effects become too severe. During the study, patients will have regular scans and photographs taken to monitor the cancer.

After finishing the treatment, patients will have follow-up visits 30 days later, then every 9 weeks for a year, and every 12 weeks for up to two years to check on their health and the cancer's status.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of advanced or returning skin cancer around the eye.
  • Women must not be pregnant or breastfeeding and must agree to use birth control during the study and for 120 days after the last treatment.
  • Must provide written consent to participate.
  • Have measurable cancer that can be tracked using standard criteria.
  • Be in good overall health with a performance status of 0 or 1, meaning fully active or restricted in strenuous activity but ambulatory.
  • Have adequate blood cell counts and organ function as determined by specific blood tests.
  • Have a life expectancy of at least 12 weeks.
  • HIV-positive patients must have their condition under control with treatment.
  • Patients with hepatitis B or C must have their condition under control with treatment.

Exclusion Criteria

  • Have a different type of skin cancer than the one being studied.
  • Women who are pregnant or have a positive pregnancy test before starting the study.
  • Have received certain prior cancer treatments or participated in other clinical trials recently.
  • Have active infections or other serious medical conditions.
  • Have a history of severe allergic reactions to pembrolizumab.
  • Have active autoimmune diseases requiring treatment in the past two years.
  • Have a history of lung inflammation or current lung issues.
  • Have active tuberculosis or other serious infections.
  • Have psychiatric or substance abuse issues that would interfere with the study.
  • Have had a recent heart attack, stroke, or serious heart condition.

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