54 Participants Needed

Atezolizumab + Bevacizumab + Tiragolumab for Colorectal Cancer

PG
Overseen ByPuja Gupta Poddar
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: University of Colorado, Denver
Must be taking: Fluoropyrimidine, Oxaliplatin, Irinotecan, EGFR inhibitors
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

HR

Hannah Robinson, MD

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

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.
See 14 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.
See 34 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Treatment without BiopsyExperimental Treatment3 Interventions
Group II: Treatment with BiopsyExperimental Treatment5 Interventions

Find a Clinic Near You

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 profile image

Ashley Magargee

Genentech, Inc.

Chief Executive Officer since 2024

MBA from Harvard University, BA from Princeton University

Levi Garraway profile image

Levi Garraway

Genentech, Inc.

Chief Medical Officer since 2021

MD, PhD

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