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Monoclonal Antibodies

Chemotherapy + Bevacizumab + Atezolizumab for Colorectal Cancer

Phase 3

Recruiting

Led By Caio Max S Rocha Lima

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Documentation by PET/CT scan, CT scan, or MRI that the patient has measurable metastatic disease per RECIST 1.1

Tumor must be determined to be mismatch-repair deficient (dMMR) or MSI-H

Must not have

Administration of a live, attenuated vaccine within 28 days prior to randomization

Documented New York Heart Association (NYHA) class III or IV congestive heart failure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial is testing a combination of chemotherapy drugs, bevacizumab, and atezolizumab to treat patients with metastatic colorectal cancer.

Who is the study for?

This trial is for adults with metastatic colorectal cancer that hasn't been treated systemically. They must have a certain type of tumor (dMMR or MSI-H), adequate organ function, and no recent heart issues or severe infections. Participants need to agree to use effective contraception and not be pregnant.

What is being tested?

The study tests how well a combination of chemotherapy drugs (fluorouracil, oxaliplatin, leucovorin) works with Bevacizumab and/or Atezolizumab in treating metastatic colorectal cancer. It looks at the effects on tumors that don't repair DNA mistakes well.

What are the potential side effects?

Possible side effects include fatigue, increased risk of infection, bleeding complications, allergic reactions to treatment components, high blood pressure, nerve damage symptoms like numbness or tingling in hands and feet.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My scans show measurable cancer spread.

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My tumor is identified as mismatch-repair deficient or has high microsatellite instability.

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I have metastatic colon or rectal cancer and haven't received chemotherapy for it.

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I am 18 years old or older.

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I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not received a live vaccine in the last 28 days.

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I have severe heart failure (NYHA class III or IV).

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I have a significant liver condition.

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I have not had a severe infection in the last 28 days.

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I have not had major surgery or a significant injury in the last 28 days.

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My high blood pressure is not under control.

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I have a history of lung conditions.

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I have a skin condition that meets certain criteria.

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I do not have active tuberculosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression free survival (PFS)

Secondary study objectives

Chromium

Duration of SD

Duration of overall response (CR or PR)

+3 more

Other study objectives

Change in T-cell diversity

Change in quantification of cell free deoxyribonucleic acid (cfDNA) mutations

Changes in T-cell repertoire diversity as a predictive biomarker of efficacy

+10 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Arm III (atezolizumab, bevacizumab, mFOLFOX6)Experimental Treatment11 Interventions

Patients receive atezolizumab IV over 30-60 minutes on day 1. Treatment repeats every 2 weeks for up to 48 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive bevacizumab IV over 30-90 minutes on day 1, oxaliplatin IV over 2 hours on day 1 cycles 1-10, leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV over 46-48 hours on day 1. Treatment with oxaliplatin repeats every 2 weeks for up to 10 cycles in the absence of disease progression or unacceptable toxicity. Treatment of bevacizumab, leucovorin calcium, and fluorouracil repeat every 2 weeks for up to 48 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT with or without PET or MRI throughout the trial. Patients may also undergo collection of optional blood samples throughout the trial.

Group II: Arm II (atezolizumab)Experimental Treatment7 Interventions

Patients receive atezolizumab IV over 30-60 minutes on day 1. Treatment repeats every 2 weeks for up to 48 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT with or without PET or MRI throughout the trial. Patients may also undergo collection of optional blood samples throughout the trial.

Group III: Arm I (bevacizumab, mFOLFOX6)Active Control10 Interventions

Patients receive bevacizumab intravenously (IV) over 30-90 minutes on day 1, oxaliplatin IV over 2 hours on day 1 of cycles 1-10, leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV over 46-48 hours on days 1 and 2. Treatment with oxaliplatin repeats every 2 weeks for up to 10 cycles in the absence of disease progression or unacceptable toxicity. Treatment of bevacizumab, leucovorin calcium, and fluorouracil repeat every 2 weeks for up to 48 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT with or without PET or MRI throughout the trial. Patients may also undergo collection of optional blood samples throughout the trial. (CLOSED TO ACCRUAL)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bevacizumab

2013

Completed Phase 4

~5540

Positron Emission Tomography

2011

Completed Phase 2

~2200