Clinical Trial of All-trans-retinoic Acid, Bevacizumab, and Atezolizumab in Colorectal Cancer

Sponsor: University of Texas Southwestern Medical Center

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05999812

This study is exploring the effects of a combination of three drugs—All-trans-retinoic Acid (ATRA), Bevacizumab, and Atezolizumab—as a potential treatment for advanced colorectal cancer. Participants will receive these medications in a specific schedule to evaluate their benefits and side effects.

Patient Parameters

Program Overview

The main goal of this clinical trial is to understand the positive and negative effects of using a combination of three drugs—All-trans-retinoic Acid (ATRA), Bevacizumab, and Atezolizumab—for treating advanced colorectal cancer. Participants will take ATRA pills at home twice daily for 7 days, starting on the first day of each treatment cycle. Atezolizumab and Bevacizumab will be administered through a vein in the arm or a mediport at a healthcare center every two weeks.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with stage IV colon cancer that has spread, confirmed by lab tests.
  • Tumors must be from the colon, including those affecting the small bowel.
  • Must have specific genetic markers related to DNA repair or stability.
  • Have received at least two different chemotherapy treatments for metastatic cancer, including specific drugs unless not medically possible.
  • Be 18 years or older.
  • Be in good general health with a performance status score of 0 to 2.
  • Have adequate organ and bone marrow function, as shown by specific blood tests.
  • Negative HIV test, unless stable on treatment with a controlled viral load.
  • Negative hepatitis B and C tests.
  • Understand and agree to sign a consent form.
  • Agree to use effective birth control during the study and for 6 months after treatment.
  • Women must not be pregnant and must agree to a pregnancy test before starting treatment.

Exclusion Criteria

  • Have a type of colorectal cancer with specific genetic instability.
  • Have active autoimmune diseases or conditions requiring high doses of steroids.
  • Have used Atezolizumab or ATRA before.
  • Have had recent cancer treatments within 3 weeks before starting the study.
  • Have untreated brain metastases.
  • Have severe allergies to similar drugs used in the study.
  • Have uncontrolled high blood pressure or significant heart disease.
  • Have serious infections or other illnesses that could affect safety.
  • Be pregnant or breastfeeding.
  • Have had recent major surgery or plan to have surgery during the study.
  • Have active hepatitis B or C, tuberculosis, or uncontrolled HIV.

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