BACCI: A Phase II Randomized, Double-Blind, Placebo-Controlled Study of Capecitabine Bevacizumab Plus Atezolizumab Versus Capecitabine Bevacizumab Plus Placebo in Patients With Refractory Metastatic Colorectal Cancer
This randomized phase II trial studies how well capecitabine and bevacizumab with or without atezolizumab work in treating patients with colorectal cancer that is not responding to treatment and has spread to other places. Immunotherapy with monoclonal antibodies, such as atezolizumab and bevacizumab, may help the body?s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as capecitabine, 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. Giving atezolizumab with capecitabine and bevacizumab may be a better way in treating colorectal cancer.
• Histologically confirmed colorectal cancer that is either clinically or histologically proven to be metastatic and has progressed on regimens containing a fluoropyrimidine (e.g., 5-fluorouracil or capecitabine), oxaliplatin, irinotecan, bevacizumab and an anti-EGFR antibody (if tumor is RAS wild-type), or where the treatment was not tolerated or contraindicated
• Measurable disease; Note: previously irradiated sites can be included if there is documented disease progression in that site
• Capecitabine and bevacizumab considered appropriate treatment for the patient
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
• Absolute neutrophil count \>= 1,500/uL (obtained =\< 7 days prior to randomization)
• Platelets \>= 100,000/uL (obtained =\< 7 days prior to randomization)
• Total bilirubin =\< 1.5 X upper limit of normal (ULN) (obtained =\< 7 days prior to randomization); patients with known Gilbert?s syndrome who have serum bilirubin =\< 3 X ULN may enroll
• Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 1.5 X ULN; \< 3 X ULN if known hepatic metastases (obtained =\< 7 days prior to randomization)
• Hemoglobin \>= 9 g/dL continuation of erythropoietin products is permitted (obtained =\< 7 days prior to randomization); hemoglobin must be stable \>= 9 g/dL \>= 14 days without blood transfusion to maintain hemoglobin level
• Calculated creatinine clearance must be \>= 50 ml/min using the Cockcroft-Gault formula or a 24 hour urine (obtained =\< 7 days prior to randomization)
• The following laboratory values obtained =\< 14 days prior to randomization
⁃ Prothrombin time (PT)/partial thromboplastin time (PTT)/international normalized ratio (INR) =\< 1.5 X ULN if not anticoagulated; within local institutional guidelines per local physician if anticoagulated
• Negative pregnancy test done =\< 7 days prior to randomization, for women of childbearing potential only
• Provide informed written consent
• Willingness to return to enrolling institution for follow-up (during the active monitoring phase of the study)
• Willingness to provide tissue and blood samples for correlative research purposes
• Life expectancy of \>= 3 months