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Trial Summary


Protocol No.A021502
StatusOPEN TO ACCRUAL
Principal InvestigatorLoehrer, Patrick
ScopeNational
PhasePhase III
Age GroupAdult
TitleRANDOMIZED TRIAL OF STANDARD CHEMOTHERAPY ALONE OR COMBINED WITH ATEZOLIZUMAB AS ADJUVANT THERAPY FOR PATIENTS WITH STAGE III COLON CANCER AND DEFICIENT DNA MISMATCH REPAIR
DescriptionThis randomized 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. 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. Monoclonal antibodies, such as atezolizumab, 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 colon cancer.
Key EligibilityIn order to be eligible to take part in this trial, patients must meet the following criteria:

  • Histologically proven stage III colon adenocarcinoma (any T [Tx, T1, T2, T3, or T4], N1-2M0; includes N1C)
  • Presence of deficient (d) DNA mismatch repair (dMMR); MMR status must be assessed by immunohistochemistry (IHC) for MMR protein expression (MLH1, MSH2, MSH6, PMS2) where loss of one or more proteins indicates dMMR; dMMR may be determined either locally or by site-selected reference lab; Note: loss of MLH1 and PMS2 commonly occur together; formalin-fixed paraffin-embedded (FFPE) tumor tissue is required for subsequent retrospective central confirmation of dMMR status
For a full list of participation criteria, please visit clinicaltrials.gov.
Applicable Disease SitesColon
Participating InstitutionsIndiana University (IU)
    Treatment TypeTreatment
    ContactPhone: (317) 278-5632
    Email: iutrials@iu.edu