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NCT02997228 · ClinicalTrials.gov registry record · Phase 3

Testing the Addition of Atezolizumab to Combination Chemotherapy or Atezolizumab Alone for Metastatic Colon or Rectal Cancer, the COMMIT Study

A Phase 3 study of Metastatic Colorectal Adenocarcinoma and Stage IV Colorectal Cancer AJCC v7, sponsored by National Cancer Institute (NCI).

Active
Registry status
Phase 3
Development phase
120
Enrollment target
20
Study locations

NCT02997228: Active Phase 3 study of Metastatic Colorectal Adenocarcinoma and Stage IV Colorectal Cancer AJCC v7, sponsored by National Cancer Institute (NCI).

NCT02997228 is a Phase 3 study of Metastatic Colorectal Adenocarcinoma and Stage IV Colorectal Cancer AJCC v7 that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 120 participants, above the 79-participant average among 14 other Metastatic Colorectal Adenocarcinoma trials with a reported enrollment target (52% higher). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02997228, a Phase 3 study of Metastatic Colorectal Adenocarcinoma and Stage IV Colorectal Cancer AJCC v7, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
120 participants
Enrollment target
20
Study locations

Study Summary

This phase III trial studies how well combination chemotherapy, bevacizumab, and/or atezolizumab work in treating patients with deficient deoxyribonucleic acid (DNA) mismatch repair colorectal cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Chemotherapy drugs, such as fluorouracil, oxaliplatin, and leucovorin calcium, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of the tumor. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving combination chemotherapy, bevacizumab, and atezolizumab may work better in treating patients with colorectal cancer.

Primary Outcome

The analysis set is intent-to-treat (ITT). The experimental arms will be compared to the control arm by the log-rank test stratified by BRAF status (V600E mutation or not), metastatic disease: (liver-only, extra-hepatic), and prior adjuvant therapy for colon cancer (yes, no). Hazard ratios and associated confidence intervals from a stratified Cox regression model will also be reported along with estimates of the distributions of time to PFS event by the method of Kaplan and Meier. Sensitivity an

Interventions

  • PROCEDURE Biospecimen Collection
  • PROCEDURE Computed Tomography
  • DRUG Atezolizumab
  • DRUG Fluorouracil
  • BIOLOGICAL Bevacizumab

Study Locations (20)

California

  • Kaiser Permanente-Anaheim - Anaheim
  • Kaiser Permanente-Baldwin Park - Baldwin Park
  • Kaiser Permanente-Bellflower - Bellflower
  • Alta Bates Summit Medical Center-Herrick Campus - Berkeley
  • John Muir Medical Center-Concord - Concord
  • Kaiser Permanente-Fontana - Fontana
  • Kaiser Permanente South Bay - Harbor City
  • Kaiser Permanente-Irvine - Irvine
  • Kaiser Permanente Los Angeles Medical Center - Los Angeles
  • Kaiser Permanente West Los Angeles - Los Angeles
  • Fremont - Rideout Cancer Center - Marysville
  • Memorial Medical Center - Modesto
  • Kaiser Permanente-Ontario - Ontario
  • Saint Joseph Hospital - Orange - Orange
  • UC Irvine Health/Chao Family Comprehensive Cancer Center - Orange
  • Kaiser Permanente - Panorama City - Panorama City
  • Kaiser Permanente-Riverside - Riverside
  • Sutter Medical Center Sacramento - Sacramento

Arizona

  • Kingman Regional Medical Center - Kingman

Arkansas

  • NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro - Jonesboro

Trial Details

FieldValue
Enrollment Target 120 participants
Start Date 2018-01-19
Est. Completion 2027-06-01
Phase Phase 3
National Cancer Institute (NCI)

3,257 total trials

What the registry record for NCT02997228 still lists

NCT02997228 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, above the 79-participant average among 14 other Metastatic Colorectal Adenocarcinoma trials with a reported enrollment target (52% higher).

The record links to 2 conditions, with Metastatic Colorectal Adenocarcinoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.

NCT02997228 names 20 study sites across 3 states, led by California, Arizona, Arkansas.

Frequently Asked Questions

What is clinical trial NCT02997228 about?

NCT02997228 is a clinical study titled "Testing the Addition of Atezolizumab to Combination Chemotherapy or Atezolizumab Alone for Metastatic Colon or Rectal Cancer, the COMMIT Study". This phase III trial studies how well combination chemotherapy, bevacizumab, and/or atezolizumab work in treating patients with deficient deoxyribonucleic acid (DNA) mismatch repair colorectal cancer that has spread from where it first started (primary site) to other places in the body (metastatic)....

What is the current status of trial NCT02997228?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 120 participants. The study started on 2018-01-19. Estimated completion is 2027-06-01.

What conditions does trial NCT02997228 study?

This clinical trial studies the following conditions: Metastatic Colorectal Adenocarcinoma, Stage IV Colorectal Cancer AJCC v7.

What interventions are being tested in trial NCT02997228?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Atezolizumab (DRUG), Fluorouracil (DRUG), Bevacizumab (BIOLOGICAL).

Who is sponsoring clinical trial NCT02997228?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02997228 being conducted?

This trial has 20 study locations across Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Metastatic Colorectal Adenocarcinoma

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT02997228's enrollment target sits among peer trials

120 3rd of 14 higher than 12 of 14 other Metastatic Colorectal Adenocarcinoma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Metastatic Colorectal Adenocarcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02997228, the US trial registry maintained by the National Library of Medicine. NCT02997228 (mid enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.