Study on Atezolizumab, Bevacizumab, and Tiragolumab for Patients with Advanced Colorectal Cancer

Sponsor: University of Colorado, Denver

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06784947

Provider View

This clinical trial is testing a new combination of three drugs to see if they can effectively treat advanced colorectal cancer that is stable at the genetic level. The study will also check if the treatment is safe and how it affects the immune system.

Patient Parameters

Program Overview

The purpose of this study is to find out if a new combination of three drugs—atezolizumab, bevacizumab, and tiragolumab—can effectively treat advanced colorectal cancer that is stable at the genetic level. The study will also assess the safety of this treatment and its impact on the immune system. Participants will receive the treatment and undergo regular checkups, lab tests, and imaging tests to monitor their progress. Some participants will also have tumor biopsies to gather more information.

Description

This study is in Phase II and is looking at how well a combination of three drugs works for people with advanced colorectal cancer that hasn't responded to standard chemotherapy. All participants will receive the same treatment, which includes atezolizumab, bevacizumab, and tiragolumab, given through an IV every 21 days. The study will check how the cancer responds to the treatment every 9 weeks using imaging tests. Treatment will continue until the cancer progresses, side effects become too severe, the patient or doctor decides to stop, the patient becomes pregnant, or the study ends.

Participants will be divided into two groups: Group A will have additional tumor biopsies before and during treatment, while Group B will not have these biopsies. Both groups will receive the same drug treatment.

Eligibility Criteria

Inclusion Criteria

  • Able to understand and sign the consent form.
  • Willing and able to follow all study procedures and be available for the study duration.
  • 18 years or older.
  • Have advanced colorectal cancer that cannot be removed by surgery.
  • Have cancer that can be measured on scans.
  • If in Group A, willing to have tumor biopsies before and during treatment.
  • In good general health with a performance status score of 0-2.
  • Have cancer that is stable at the genetic level.
  • Have been tested for specific genetic mutations (KRAS, NRAS, BRAF).
  • Have tried standard treatments for advanced colorectal cancer without success.
  • Have good blood and organ function based on recent lab tests.
  • Not have active infections like HIV or hepatitis.
  • Women of childbearing age must agree to use birth control.
  • Men must agree to use condoms and not donate sperm.

Exclusion Criteria

  • Have a condition that makes it hard to follow study procedures.
  • Have a type of colorectal cancer that is not stable at the genetic level.
  • Have certain genetic mutations or unknown genetic status.
  • Have active liver metastases unless treated and stable for 6 months.
  • Have untreated or worsening brain metastases.
  • Have certain other medical conditions like uncontrolled pain or fluid buildup.
  • Have had another type of cancer in the last 3 years, except for certain low-risk cancers.
  • Have active autoimmune diseases or a history of such diseases requiring treatment.
  • Have had a stem cell or organ transplant.
  • Have certain lung diseases or active lung inflammation.
  • Have active bowel inflammation or certain abdominal conditions.
  • Have significant heart problems or uncontrolled high blood pressure.
  • Have certain blood or bleeding disorders.
  • Have had major surgery or a serious infection recently.
  • Have certain viral infections or are taking certain medications that interfere with the study.
  • Are pregnant or breastfeeding, or plan to become pregnant.
  • Have allergies to the study drugs or their components.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.