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.Contact Information
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.
- Patients with asymptomatic untreated CNS metastases may be enrolled, provided all eligibility criteria are met, as well as the following conditions:
- 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.
Study Details
Clinical Trial Investigator
William T. Leslie, MD
Contact Information
RUSH MD Anderson Cancer Center Clinical Trials Office