At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed metastatic colorectal cancer that progressed on standard regimens (fluoropyrimidine, oxaliplatin, irinotecan, bevacizumab, and anti-EGFR antibody if RAS wild-type) or where treatment was not tolerated or contraindicated
- ✓Measurable disease (previously irradiated sites allowed if documented disease progression)
- ✓ECOG performance status 0-1
- ✓Capecitabine and bevacizumab considered appropriate treatment
- ✕Prior treatment with atezolizumab or another PD-L1/PD-1 therapy
- ✕Known untreated CNS metastases (radiated or resected lesions allowed if fully treated and inactive, asymptomatic, and no steroids ≤30 days prior)
- ✕Inadequately controlled hypertension (average systolic >150 mmHg and/or diastolic >100 mmHg)
- ✕History of myocardial infarction, unstable angina, cardiac stenting, angioplasty, or surgery ≤12 months prior
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Atezolizumab, Bevacizumab, and 3 other interventions for Metastatic Colorectal Carcinoma and 5 related conditions. Completed, enrolled 133 participants across 10 sites.
Detailed Summary
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.
Study Details
Timeline
Interventions
Given IV
Given IV
Given PO
Correlative studies
Given IV