Combination Chemotherapy With or Without Atezolizumab in Treating Patients With Stage III Colon Cancer and Deficient DNA Mismatch Repair
Phase 3
Active, not recruiting
NCT02912559
| Condition | Colon Adenocarcinoma, DNA Repair Disorder, Lynch Syndrome, Stage III Colon Cancer AJCC v8 |
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| Phase | Phase 3 |
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| Sponsor | National Cancer Institute (NCI) |
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| Status | Active, not recruiting |
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| Enrollment | 712 participants |
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| Interventions | Atezolizumab, Biospecimen Collection, Computed Tomography, Fluorouracil, Leucovorin Calcium |
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| Start date | Oct 16, 2017 |
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| Completion date | Feb 4, 2025 |
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| Results posted | Apr 14, 2026 |
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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.
Disease Free Survival (DFS)
3 years · percentage of participants
| Arm I (Combination Chemotherapy, Atezolizumab) | 86.3 percentage of participants |
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| Arm II (Combination Chemotherapy) | 76.2 percentage of participants |
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| p-value | 0.0002 |
| Hazard Ratio (HR) | 0.50 (95% CI 0.35–0.73) |
Open in BENITIONS
View on ClinicalTrials.gov
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