Study on Dostarlimab Before Surgery for Stage II and III Colon Cancer with Deficient Mismatch Repair

Sponsor: University of Iowa

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05239546

Provider View

This clinical trial is testing the effects of the immunotherapy drug dostarlimab on certain types of colon cancer to see if surgery can be avoided. The study focuses on patients with Stage II and III colon cancer that have a specific genetic feature called deficient mismatch repair (dMMR).

Patient Parameters

Program Overview

The purpose of this study is to evaluate how well the immunotherapy drug dostarlimab works on colon cancer tumors with a specific genetic feature called deficient mismatch repair (dMMR). Researchers want to see if patients can avoid surgery if the tumors respond well to the treatment. If the tumors do not respond, surgery will still be an option.

Description

This study is designed to test the effects of dostarlimab, an immunotherapy drug, on colon cancer tumors that have a genetic feature known as deficient mismatch repair (dMMR). The goal is to see if patients with Stage II and III colon cancer can avoid surgery if the tumors respond well to the treatment. If the tumors do not respond, patients will still have the option to undergo surgery.

Participants will receive dostarlimab for up to 18 weeks, which is about 6 cycles of treatment. The study will monitor the rate of major clinical response, meaning how well the tumors shrink or disappear, and whether patients can manage their cancer without surgery.

The study is open to adults aged 18 and older who have been diagnosed with Stage II or III dMMR colon cancer. Participants must be able to understand and agree to the study requirements, and they must meet certain health criteria to ensure they can safely participate.

The study will involve regular health checks, including blood tests and imaging scans, to monitor the effects of the treatment and the health of the participants. Participants will also need to agree to use effective contraception during the study and for a period after the treatment ends.

Eligibility Criteria

Inclusion Criteria

  • Able to understand and agree to the study requirements, with informed consent signed.
  • Aged 18 years or older.
  • Diagnosed with Stage II or III colon cancer with deficient mismatch repair (dMMR), confirmed by biopsy.
  • Cancer must be potentially removable by surgery, but participants must be willing to avoid surgery if the study goals are met.
  • Good overall health with an ECOG performance status of 0 or 1.
  • No signs of cancer spread to other parts of the body.
  • Meet specific blood and organ function criteria, including:
    • Neutrophil count of at least 1,500/µL.
    • Platelet count of at least 100,000/µL.
    • Hemoglobin level of at least 9 g/dL.
    • Normal kidney and liver function as indicated by specific blood tests.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during and after the study.
  • Men must agree to use condoms or other effective contraception during and after the study.

Exclusion Criteria

  • More than one primary tumor.
  • Tumors causing blockage or requiring immediate surgery.
  • Tumors classified as T4b.
  • Allergic reactions to dostarlimab or its components.
  • Recent major surgery or investigational therapy.
  • Heavy bleeding from tumors requiring blood transfusions.
  • Other active cancers within two years.
  • Uncontrolled illnesses or infections.
  • Active autoimmune diseases requiring treatment in the past two years.
  • Immunodeficiency or recent use of immunosuppressive therapy.
  • Severe side effects from previous immunotherapy.
  • Recent opportunistic infections in HIV-positive patients.
  • Organ transplant recipients on immunosuppressive medications.
  • Active hepatitis B or untreated hepatitis C infections.
  • History of lung disease or recent live vaccines.
  • Insufficient tissue for testing.
  • Severe cognitive impairment.

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