Study on Combining Immunotherapy and Radiation for Treating Metastatic Colorectal Cancer

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06603818

Provider View

This clinical trial is testing a new treatment approach that combines two immunotherapy drugs, tiragolumab and atezolizumab, with radiation therapy to see if it can help control metastatic colorectal cancer that is microsatellite stable (MSS).

Patient Parameters

Program Overview

Metastatic colorectal cancer (mCRC) is a type of cancer that has spread beyond the colon and rectum. This study is exploring a new treatment combination of two immunotherapy drugs, tiragolumab and atezolizumab, with radiation therapy to see if it can help people with a specific type of mCRC called microsatellite stable (MSS). The goal is to find out if this combination can stop the cancer from progressing and improve outcomes for patients.

Description

This study is focused on treating metastatic colorectal cancer (mCRC) that is microsatellite stable (MSS), a type of cancer that doesn't respond well to current immune-based treatments. Researchers are testing a combination of two immunotherapy drugs, tiragolumab and atezolizumab, along with radiation therapy, to see if it can help control the disease.

Participants will receive the immunotherapy drugs through an IV every three weeks, and radiation therapy will be given on the first, third, and fifth days of the first treatment cycle. The treatment will continue for up to two years, with regular check-ups and imaging scans every nine weeks to monitor progress.

The study aims to determine the best dose of the combination therapy and to see how many participants remain free of cancer progression after nine weeks of treatment. Participants will also have follow-up visits after treatment ends to monitor their health and any long-term effects of the therapy.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of metastatic colorectal cancer (mCRC) that is microsatellite stable (MSS).
  • Have a good overall health status, with an ECOG performance score of 0 or 1.
  • Have at least two cancer lesions, one that can be treated with radiation and another that can be used to measure treatment response.
  • Have tried at least two standard treatments for mCRC without success.
  • Have adequate organ and blood function as shown by specific medical tests.
  • Be willing to provide a tumor sample for research purposes.
  • Women of childbearing potential must agree to use effective contraception during the study and for five months after the last dose of the study drugs.
  • Be willing to sign an informed consent form and participate in a related research study.

Exclusion Criteria

  • Cancer that can be removed with surgery.
  • Recent treatment with chemotherapy, radiation, or investigational drugs.
  • Previous treatment with certain types of immunotherapy or immunosuppressive medications.
  • Recent major surgery or severe infections.
  • History of severe allergic reactions to similar drugs.
  • Active or uncontrolled infections, including tuberculosis or significant heart disease.
  • Women who are pregnant or breastfeeding.
  • Any other medical condition that could interfere with the study or pose a risk to the participant.

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