Study on Dostarlimab for Untreated Locally Advanced Rectal Cancer with Specific Genetic Features

Sponsor: GlaxoSmithKline

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05723562

Provider View

This clinical trial is exploring the use of dostarlimab as a standalone treatment for patients with locally advanced rectal cancer that has specific genetic characteristics. The aim is to see if this treatment can help patients avoid chemotherapy, radiation, and surgery.

Patient Parameters

Program Overview

The study is testing dostarlimab, a medication, to see if it can effectively treat patients with locally advanced rectal cancer that has certain genetic markers, known as dMMR or MSI-H. These patients have not received any previous treatment for their cancer. If the treatment is successful and the cancer responds well, patients may not need to undergo surgery or other traditional treatments. Instead, they will be closely monitored to ensure the cancer does not return.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of locally advanced rectal cancer, specifically Stage II to III.
  • The cancer must be visible and measurable through scans and endoscopy.
  • The tumor must have specific genetic features, known as dMMR or MSI-H, confirmed by tests.

Exclusion Criteria

  • Have cancer that has spread to other parts of the body.
  • Have received any previous treatment for rectal cancer, including radiation, chemotherapy, or surgery.
  • Have a history of lung diseases like interstitial lung disease or pneumonitis.
  • Have had severe side effects from previous immunotherapy treatments, such as serious skin reactions or heart inflammation.
  • Have another type of cancer that has progressed or needed treatment in the last 2 years, except for certain skin or bladder cancers.
  • Have an active autoimmune disease that required treatment in the last 2 years, except for replacement therapies like insulin or thyroid hormone.
  • Have severe allergies to similar medications or known allergies to dostarlimab.
  • Have received or plan to receive a donor stem cell transplant.

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