Genetic Testing in Screening Patients With Metastatic or Unresectable Colon or Rectal Cancer for a COLOMATE Trial

Inclusion Criteria:

Histological confirmation of adenocarcinoma of the colon or rectum that is metastatic and/ or unresectable
Progression, intolerance, or contraindication to a fluoropyrimidine (e.g., 5- fluorouracil or capecitabine), oxaliplatin, irinotecan, an anti-VEGF monoclonal antibody (bevacizumab, ziv-aflibercept, or ramucirumab), and an anti-PD-1 monoclonal antibody (nivolumab or pembrolizumab) if tumor has deficient mismatch repair proteins (dMMR) or is microsatellite instability-high (MSI-H)

For patients with KRAS and NRAS wild-type tumors, progression, intolerance, or contraindication to an anti-EGFR monoclonal antibody (cetuximab or panitumumab)

Note: If tissue is known to be positive for HER2 expression (IHC 3+) or the tumor has ERBB2 (HER2) amplification detected by a Clinical Laboratory Improvement Act (CLIA)-certified assay, prior treatment with anti-EGFR therapy is not required
At least one site of disease that is measurable by Response Evaluation Criteria in Solid Tumors (RECIST) criteria (version 1.1) that has not been previously irradiated; if the patient has had previous radiation to the target lesion(s), there must be evidence of progression since the radiation
Life expectancy >= 3 months per estimation of investigator
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2
Capable of understanding and complying with the protocol requirements and has signed the informed consent document

Satisfy at least one of the following two conditions:

Willing and able to provide blood sample for screening purposes
Guardant 360 testing completed =< 60 days prior to registration

Exclusion Criteria:

Evidence within the last 3 years of another malignancy which required systemic treatment. EXCEPTIONS: Non-melanotic skin cancer, carcinoma-in-situ of the cervix, or localized prostate cancer with a current PSA of < 1.0mg/dL on 2 successive evaluations, at least 90 days apart, with the most recent evaluation no more than 4 weeks prior to registration
Unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee
History of solid organ transplantation
Pregnant or planning to become pregnant within the next 12 months