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Combination Chemotherapy With or Without Atezolizumab in Treating Patients With Stage III Colon Cancer and Deficient DNA Mismatch Repair

NCT02912559 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 712

Last updated 2026-05-05

Study results available
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Summary

This phase III trial studies combination chemotherapy and atezolizumab to see how well it works compared with combination chemotherapy alone in treating patients with stage III colon cancer and deficient deoxyribonucleic acid (DNA) mismatch repair (dMMR). Drugs used in combination chemotherapy, such as oxaliplatin, leucovorin calcium, and fluorouracil, 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. 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 with atezolizumab may work better than combination chemotherapy alone in treating patients with dMMR colon cancer.

Conditions

  • Colon Adenocarcinoma
  • DNA Repair Disorder
  • Lynch Syndrome
  • Stage III Colon Cancer AJCC v8

Interventions

DRUG

Atezolizumab

Given IV

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Computed Tomography

Undergo CT

DRUG

Fluorouracil

Given IV

DRUG

Leucovorin Calcium

Given IV

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

DRUG

Oxaliplatin

Given IV

OTHER

Quality-of-Life Assessment

Ancillary studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Frank A Sinicrope · Alliance for Clinical Trials in Oncology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-16
Primary Completion
2025-02-04
Completion
2026-12-18
FDA Drug
Yes

Countries

  • United States
  • Germany
  • Puerto Rico

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02912559 on ClinicalTrials.gov