Study on Ifinatamab Deruxtecan for Treating Advanced Esophageal Cancer

Sponsor: Merck Sharp & Dohme LLC

Sponsor score: 40

ClinicalTrials ID:NCT07405151

This clinical trial is testing a new treatment called ifinatamab deruxtecan (I-DXd) to see if it can help shrink or eliminate esophageal squamous cell carcinoma (ESCC) in patients whose cancer has advanced and cannot be surgically removed.

Patient Parameters

Program Overview

The aim of this study is to find out if a new drug, ifinatamab deruxtecan (I-DXd), can effectively treat esophageal squamous cell carcinoma (ESCC). I-DXd is a special type of treatment that targets cancer cells directly to destroy them. The trial will measure how many patients experience a reduction in their cancer size or complete disappearance of the cancer after receiving I-DXd.

Description

The trial is part of a larger research program called KEYMAKER-U06, which is focused on finding new treatments for esophageal cancer. Participants will be screened to ensure they meet the study requirements before receiving the treatment.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with advanced esophageal squamous cell carcinoma (ESCC) that cannot be surgically removed.
  • Cancer has worsened after 1 or 2 previous treatments.
  • Have at least one tumor that can be measured.
  • If living with HIV, the virus must be well-controlled with medication.
  • Must have good organ function as determined by medical tests.

Exclusion Criteria

  • Diagnosed with a different type of esophageal cancer, such as adenocarcinoma.
  • Have fluid buildup around the lungs, heart, or abdomen that requires frequent medical attention.
  • Have serious eye problems affecting the cornea.
  • Have had a stroke or similar event in the past 6 months.
  • If living with HIV, have a history of certain related diseases like Kaposi's sarcoma.
  • Have serious heart problems that are not controlled.
  • Have another active cancer that is growing or needed treatment in the last 3 years.
  • Have cancer that has spread to the brain or spinal cord.
  • Have a history of lung diseases like interstitial lung disease or pneumonitis, unless it was mild and did not need treatment.
  • Have an active infection needing treatment, except those allowed by the study.
  • Have severe lung problems from other illnesses or need extra oxygen.

Locations

FACILITYZIPCITYSTATE
UPMC Hillman Cancer Center ( Site 3904)15232PittsburghPennsylvania

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