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Colorectal Cancer Metastatic dMMR Immuno-Therapy (COMMIT) Study

Clinical Trial Title: 
A randomized phase III study of mFOLFOX6/bevacizumab combination chemotherapy with or without atezolizumab or atezolizumab monotherapy in the first-line treatment of patients with deficient DNA mismatch repair (dMMR) metastatic colorectal cancer.
Clinical Trial Protocol ID: 
17112805
Clinical Trial Investigator Name: 
William T. Leslie, MD
Clinical Trial Protocol Description: 

Study for mFOLFOX6/bevacizumab combination chemotherapy with or without atezolizuma for subjects with metastatic colorectal cancer and to collect additional data on treatment safety.

Clinical Trial Eligibility Criteria: 

In order to participate you must meet the following criteria:

  • Are 18 years of age or older.
  • Have an ECOG Performance Status of 0, 1 or 2.
  • Have a diagnosis of metastatic adenocarcinoma of colon or rectum without previous chemotherapy or any other systemic therapy for metastatic colorectal cancer.
  • Have a tumor determined to be mismatch-repair deficient (dMMR) by CLIA-certified immunohistochemical (IHC) assay with a panel of all four IHC markers, including MLH1, MSH2, PMS2, and MSH6.
    Note: MSI-H diagnosed by MSI testing (either Bethesda markers or Pentaplex panel) or by next-generation sequencing (NGS) is not eligible unless dMMR is confirmed by CLIA-certified immunohistochemical (IHC).

You will be excluded from the study if any of the following criteria apply to you:

  • Have CNS metastases. Patients with the following exceptions, may be include:
    • Patients with asymptomatic untreated CNS metastases may be enrolled, provided all eligibility criteria are met, as well as the following conditions:
      • Have evaluable or measurable disease outside the CNS.
      • Have no metastases to brain stem, midbrain, pons, medulla, cerebellum, or within 10 mm of the optic apparatus (optic nerves and chiasm).
      • Have no history of intracranial hemorrhage or spinal cord hemorrhage.
      • Have no ongoing requirement for dexamethasone for CNS disease; patients on a stable dose of anticonvulsants are permitted.
      • Have no neurosurgical resection or brain biopsy within 28 days prior to randomization.
    • Patients with asymptomatic treated CNS metastases may be enrolled, provided all eligibility criteria are met, as well as the following conditions:
      • Have radiographic demonstration of improvement upon the completion of CNS-directed therapy and no evidence of interim progression between the completion of CNS-directed therapy and the screening radiographic study.
      • Have no stereotactic radiation or whole-brain radiation within 28 days prior to randomization.
      • Have screening CNS radiographic study 28 days from completion of radiotherapy and 14 days from discontinuation of corticosteroids.
  • Have known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies, fluoropyrimidines, folic acid derivatives or oxaliplatin.
  • Have uncontrolled high blood pressure defined as systolic BP > 150 mmHg or diastolic BP > 90 mmHg with or without anti-hypertensive medication. Patients with initial BP elevations are eligible if initiation or adjustment of BP medication lowers pressure to meet entry criteria.
  • Have any of the following cardiac conditions:
    • Documented NYHA Class III or IV congestive heart failure.
    • Myocardial infarction within 6 months prior to randomization.
    • Unstable angina within 6 months prior to randomization.
    • Symptomatic arrhythmia.

This is a partial list of inclusion and exclusion criteria.

Clinical Trial Area: 
Gastrointestinal Cancers
Contact Phone: 
(312) 563-3921
Contact Name: 
Emily Rubenstein, RN