Atezolizumab + Bevacizumab + Tiragolumab for Colorectal Cancer

Overseen By Puja Gupta Poddar

Age: 18+

Sex: Any

Trial Phase: Phase 2

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 All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 24

Duration: Up to 24 months

54 Participants Needed

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.

Research Team

Hannah Robinson, MD

Principal Investigator

University of Colorado, Denver

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.

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.

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

Treatment Details

Interventions

• Atezolizumab
• Bevacizumab
• Tiragolumab

Trial Overview 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.

Participant Groups

Group I: Treatment without Biopsy Experimental Treatment 3 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 Biopsy Experimental Treatment 5 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.

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Genentech, Inc.

Industry Sponsor

Trials

1,578

Recruited

569,000+

Ashley Magargee

Genentech, Inc.

Chief Executive Officer since 2024

MBA from Harvard University, BA from Princeton University

Levi Garraway

Genentech, Inc.

Chief Medical Officer since 2021

MD, PhD