Study on Ifinatamab Deruxtecan for Treating Advanced Esophageal Cancer
Sponsor: Merck Sharp & Dohme LLC
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
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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
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| UPMC Hillman Cancer Center ( Site 3904) | 15232 | Pittsburgh | Pennsylvania |
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