Study on Dostarlimab for Patients with Untreated Stage III or T4N0 Colon Cancer with Specific Genetic Markers

Sponsor: GlaxoSmithKline

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05855200

This clinical trial is testing the effectiveness of the drug dostarlimab compared to the usual treatment for patients with a specific type of colon cancer that has not been treated before. The cancer must be at a stage where it can be surgically removed and have certain genetic features.

Patient Parameters

Program Overview

The main goal of this study is to see if the drug dostarlimab is more effective than the standard treatment for patients with untreated colon cancer that is at a stage where it can be surgically removed. The cancer must have specific genetic characteristics known as dMMR or MSI-H, which can affect how the cancer grows and responds to treatment.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of colon cancer that has not been treated before.
  • The cancer must be at a stage where it can be surgically removed, specifically classified as T4N0 or Stage III.
  • The cancer must be visible on scans.
  • The tumor must have specific genetic markers known as dMMR or MSI-H.

Exclusion Criteria

  • Have cancer that has spread to distant parts of the body.
  • Have received any previous treatments like chemotherapy, immunotherapy, or surgery for colon cancer.
  • Have a tumor causing severe bowel blockage or needing urgent surgery.
  • Have had major surgery or a significant injury in the last 28 days.
  • Have a history of lung diseases like interstitial lung disease or pneumonitis.
  • Have liver disease or cirrhosis with symptoms like fluid buildup, confusion, or jaundice.
  • Have had a stem cell or organ transplant.
  • Are currently receiving any other cancer treatments or experimental therapies.
  • Are pregnant, breastfeeding, or planning to become pregnant during the study.
  • Have severe allergies to similar drugs or any components of the study medications.

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