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Colorectal Cancer Metastatic dMMR Immuno-Therapy (COMMIT) Study
Study for mFOLFOX6/bevacizumab combination chemotherapy with or without atezolizuma for subjects with metastatic colorectal cancer and to collect additional data on treatment safety.
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.