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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.
Select...
My tumor is identified as mismatch-repair deficient or has high microsatellite instability.
Select...
I have metastatic colon or rectal cancer and haven't received chemotherapy for it.
Select...
I am 18 years old or older.
Select...
I can take care of myself and am up and about more than half of my waking hours.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression free survival (PFS)
Secondary outcome measures
Chromium
Duration of SD
Duration of overall response (CR or PR)
+4 more
Other outcome measures
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

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
~5280
Positron Emission Tomography
2008
Completed Phase 2
~2240
Atezolizumab
2017
Completed Phase 3
~5860
Biospecimen Collection
2004
Completed Phase 2
~1730
Computed Tomography
2017
Completed Phase 2
~2720
Fluorouracil
2014
Completed Phase 3
~11540
Leucovorin
2005
Completed Phase 4
~5730
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Oxaliplatin
2011
Completed Phase 4
~2560

Find a Location

Who is running the clinical trial?

NRG OncologyOTHER
231 Previous Clinical Trials
100,732 Total Patients Enrolled
National Cancer Institute (NCI)Lead Sponsor
13,660 Previous Clinical Trials
40,924,562 Total Patients Enrolled
Caio Max S Rocha LimaPrincipal InvestigatorNRG Oncology

Media Library

Atezolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT02997228 — Phase 3
Colorectal Cancer Research Study Groups: Arm III (atezolizumab, bevacizumab, mFOLFOX6), Arm I (bevacizumab, mFOLFOX6), Arm II (atezolizumab)
Colorectal Cancer Clinical Trial 2023: Atezolizumab Highlights & Side Effects. Trial Name: NCT02997228 — Phase 3
Atezolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02997228 — Phase 3
Colorectal Cancer Patient Testimony for trial: Trial Name: NCT02997228 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the FDA's current stance on Atezolizumab?

"Atezolizumab's safety is estimated to be a 3 on a scale of 1 to 3. This is due to the fact that this is a Phase 3 trial, which means that there is both some data supporting efficacy and multiple rounds of data supporting safety."

Answered by AI

Are there any more spots available for volunteers in this research project?

"The study, which was originally advertised on 11/7/2017, is still recruiting patients as of 11/16/2022 according to the listing on clinicaltrials.gov."

Answered by AI

What has Atezolizumab been traditionally used to treat?

"Atezolizumab is a common treatment for malignant neoplasms, but can also help patients with rectal carcinoma, locally advanced nonsquamous non-small cell lung cancer, and breast cancer (triple negative breast cancer (tnbc))."

Answered by AI

How many people are eligible for this clinical trial?

"In order to run this clinical trial, 231 patients who meet the pre-determined inclusion criteria are needed. These potential participants can go to Saint Joseph Hospital - Orange in Orange, California or Lehigh Valley Hospital-Cedar Crest in Allentown, Pennsylvania to take part in the study."

Answered by AI

Are there other precedents for Atezolizumab's testing in humans?

"Atezolizumab is currently being researched in 1128 studies, 319 of which are in Phase 3. The majority of these trials are taking place in Guangzhou, Guangdong; however, there are 53168 locations worldwide where Atezolizumab trials are running."

Answered by AI

At how many different hospitals is this clinical trial taking place?

"There are a total of 100 medical centres conducting this clinical trial, including Saint Joseph Hospital - Orange in Orange, Lehigh Valley Hospital-Cedar Crest in Allentown, Lafayette Family Cancer Center-EMMC in Brewer."

Answered by AI

Who else is applying?

What state do they live in?
Virginia
What site did they apply to?
Kaiser Permanente-Woodland Hills
Augusta Oncology Associates PC-Wheeler
CTCA at Southeastern Regional Medical Center
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Fortunately, so far, I have not needed treatement but am being moniored by my urologist. Obviously, I wish to take advantage of any process that may help avoid problems in the future.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Combination Chemotherapy, Bevacizumab, and/or Atezolizumab in Treating Patients With Deficient DNA Mismatch Repair Metastatic Colorectal Cancer, the COMMIT Study
2018. "Combination Chemotherapy, Bevacizumab, and/or Atezolizumab in Treating Patients With Deficient DNA Mismatch Repair Metastatic Colorectal Cancer, the COMMIT Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02997228.
All > Colorectal Cancer San Diego > Paid Studies Maine
~10 spots leftby Nov 2024
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