Atezolizumab + Bevacizumab + Tiragolumab for Colorectal Cancer

Recruiting in Palo Alto (17 mi)

Overseen byHannah Robinson, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: University of Colorado, Denver

Must be taking: Fluoropyrimidine, Oxaliplatin, Irinotecan, EGFR inhibitors

Must not be taking: Antidepressants, Immunosuppressants, Anticoagulants, others

Disqualifiers: Autoimmune disease, CNS metastases, Cardiovascular dysfunction, others

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?The goal of this study is to learn if a new combination treatment is effective for patients with microsatellite stable, advanced colorectal cancer. The study treatment combines 3 drugs: atezolizumab, bevacizumab, and tiragolumab. The main questions the study aims to answer are: 1. Does the study treatment effectively treat colorectal cancer? 2. Is the study treatment safe for patients with colorectal cancer? 3. How does the study treatment effect the immune system in patients with colorectal cancer? Participants in this study will receive the study treatment and undergo checkups, laboratory tests, and imaging tests for monitoring. Some participants will also undergo tumor biopsies.

Eligibility Criteria

This trial is for individuals with advanced colorectal cancer that has not responded to changes in their DNA repair system (microsatellite stable). Participants will receive a combination of three drugs and must be willing to undergo regular checkups, lab tests, imaging, and possibly tumor biopsies.

Inclusion Criteria

Able to sign the consent form

Negative hepatitis B surface antigen (HBsAg) test at screening

I am able to get out of my bed or chair and move around.

+15 more

Exclusion Criteria

I can understand and follow the study's requirements.

My cancer has been tested for MSI-H or dMMR, or the status is unknown.

I have brain metastases that are either untreated, worsening, or stable if previously treated.

+34 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a fixed-dose regimen of atezolizumab, bevacizumab, and tiragolumab every 21 days. Treatment continues until disease progression, unacceptable toxicity, or other specified criteria.

Up to 24 months

Every 21 days (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Correlative Studies

Participants in Cohort A undergo pre-treatment and on-treatment tumor biopsies for correlative analyses.

Approximately 42 days

Biopsies at pre-treatment and cycle 3, day 1

Participant Groups

The study is testing the effectiveness and safety of combining atezolizumab, bevacizumab, and tiragolumab as a treatment for advanced colorectal cancer. It also examines how this combination affects the immune system of patients.

2Treatment groups

Experimental Treatment

Group I: Treatment without BiopsyExperimental Treatment3 Interventions

In Cohort B, no study-related biopsies will be obtained. Outside of pre- and on-treatment biopsies, patients in Cohort A and Cohort B will receive identical treatments and assessments.

Group II: Treatment with BiopsyExperimental Treatment5 Interventions

Patients in Cohort A will undergo pre-treatment and on-treatment tumor biopsies for correlative analyses, with on-treatment biopsies obtained at cycle 3, day 1 (C3D1) +/- 3 days of treatment.